Trial Outcomes & Findings for Study to Identify and Determine Best Implementation Practices for Injectable Cabotegravir+Rilpivirine in the United States (US) (NCT NCT04001803)
NCT ID: NCT04001803
Last Updated: 2023-04-14
Results Overview
AIM is a four item survey that assessed the acceptability of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the AIM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The AIM total score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
115 participants
Primary outcome timeframe
Baseline and Month 4
Results posted on
2023-04-14
Participant Flow
Total 115 participants were enrolled in study and received study treatment. The 24 study staff population(HIV care providers,nurses/staff performing CAB+LA injections administrators/clinic managers)is not considered participants in the study and were not counted in the enrollment number nor reported in any modules that are considered for enrolled participants as study staff didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections.
Study staff participants only provided input through the completion of surveys, semi-structured interviews and facilitation calls. Participant flow, Baseline characteristics or adverse events for study staff participants were not collected because it was not required per study design.
Participant milestones
| Measure |
Participants With HIV Infection
In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART).
|
|---|---|
|
Intervention Phase (Up to Month 12)
STARTED
|
115
|
|
Intervention Phase (Up to Month 12)
COMPLETED
|
102
|
|
Intervention Phase (Up to Month 12)
NOT COMPLETED
|
13
|
|
Extension Phase (From Months 13 to 30)
STARTED
|
101
|
|
Extension Phase (From Months 13 to 30)
COMPLETED
|
95
|
|
Extension Phase (From Months 13 to 30)
NOT COMPLETED
|
6
|
|
Long-term Follow-up Phase(Up to Week 52)
STARTED
|
10
|
|
Long-term Follow-up Phase(Up to Week 52)
COMPLETED
|
7
|
|
Long-term Follow-up Phase(Up to Week 52)
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Participants With HIV Infection
In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART).
|
|---|---|
|
Intervention Phase (Up to Month 12)
Adverse Event
|
5
|
|
Intervention Phase (Up to Month 12)
Protocol Violation
|
3
|
|
Intervention Phase (Up to Month 12)
Physician Decision
|
1
|
|
Intervention Phase (Up to Month 12)
Withdrawal by Subject
|
4
|
|
Extension Phase (From Months 13 to 30)
Adverse Event
|
2
|
|
Extension Phase (From Months 13 to 30)
Protocol Violation
|
1
|
|
Extension Phase (From Months 13 to 30)
Lost to Follow-up
|
1
|
|
Extension Phase (From Months 13 to 30)
Withdrawal by Subject
|
2
|
|
Long-term Follow-up Phase(Up to Week 52)
Lost to Follow-up
|
1
|
|
Long-term Follow-up Phase(Up to Week 52)
Withdrawal by Subject
|
2
|
Baseline Characteristics
Study to Identify and Determine Best Implementation Practices for Injectable Cabotegravir+Rilpivirine in the United States (US)
Baseline characteristics by cohort
| Measure |
Participants With HIV Infection
n=115 Participants
In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART).
|
|---|---|
|
Age, Continuous
|
38.8 Years
STANDARD_DEVIATION 11.71 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
99 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan native
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
42 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White-White/Caucasian/European heritage
|
66 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American and White
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Month 4Population: All Staff study participants Population comprised of HIV care providers (HCPs), nurses/staff performing CAB+RPV LA injections and administrators/clinic managers at each investigational site.
AIM is a four item survey that assessed the acceptability of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the AIM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The AIM total score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Outcome measures
| Measure |
Staff Study Participants
n=24 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Change From Baseline in the Acceptability of Intervention Measure (AIM) Total Score in Staff Study Participants at Month 4
|
0.00 Scores on a scale
Standard Deviation 0.42
|
PRIMARY outcome
Timeframe: Baseline and Month 12Population: All staff study participants population. Only those staff study participants who completed the survey were included in the analysis.
AIM is a four item survey that assessed the acceptability of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the AIM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The AIM total score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Outcome measures
| Measure |
Staff Study Participants
n=23 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Change From Baseline in AIM Total Score in Staff Study Participants at Month 12
|
0.02 Scores on a scale
Standard Deviation 0.52
|
PRIMARY outcome
Timeframe: Baseline and Month 4Population: Safety population consisted of all participants who were enrolled and received atleast one dose of CAB LA + RPV LA. Only those participants who completed the survey were included in the analysis
AIM is a four item survey that assessed the acceptability of an implementation process. The participants were asked about their impressions of the CAB LA + RPV LA injection treatment for treating HIV on a five point rating scale (1=completely disagree to 5=completely agree). The AIM total score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Outcome measures
| Measure |
Staff Study Participants
n=105 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Change From Baseline in AIM Total Score in Participants With HIV Infection at Month 4
|
0.03 Scores on a scale
Standard Deviation 0.74
|
PRIMARY outcome
Timeframe: Baseline and Month 12Population: Safety population. Only those participants who completed the survey were included in the analysis
AIM is a four item survey that assessed the acceptability of an implementation process. The participants were asked about their impressions of the CAB LA + RPV LA injection treatment for treating HIV on a five point rating scale (1=completely disagree to 5=completely agree). The AIM total score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Outcome measures
| Measure |
Staff Study Participants
n=102 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Change From Baseline in AIM Total Score in Participants With HIV Infection at Month 12
|
0.19 Scores on a scale
Standard Deviation 0.52
|
PRIMARY outcome
Timeframe: Baseline and Month 4Population: All Staff study participants population
IAM is a four item survey that assessed the appropriateness of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the IAM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The IAM total score ranges from 1 to 5 with 1 indicating the least appropriateness and 5 the most appropriateness. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Outcome measures
| Measure |
Staff Study Participants
n=24 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Change From Baseline in Intervention Appropriateness Measure (IAM) Score in Staff Study Participants at Month 4
|
-0.03 Scores on a scale
Standard Deviation 0.50
|
PRIMARY outcome
Timeframe: Baseline and Month 12Population: All Staff study participant population. Only those staff study participants who completed the survey were included in the analysis.
IAM is a four item survey that assessed the appropriateness of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the IAM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The IAM total score ranges from 1 to 5 with 1 indicating the least appropriateness and 5 the most appropriateness. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Outcome measures
| Measure |
Staff Study Participants
n=23 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Change From Baseline in IAM Score in Staff Study Participants at Month 12
|
0.10 Scores on a scale
Standard Deviation 0.43
|
PRIMARY outcome
Timeframe: Baseline and Month 4Population: Safety population. Only those participants who completed the survey were included in the analysis.
IAM is a four item survey that assessed the appropriateness of an implementation process. The participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the IAM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The IAM total score ranges from 1 to 5 with 1 indicating the least appropriateness and 5 the most appropriateness. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Outcome measures
| Measure |
Staff Study Participants
n=105 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Change From Baseline in IAM Score in Participants With HIV Infection at Month 4
|
0.05 Scores on a scale
Standard Deviation 0.78
|
PRIMARY outcome
Timeframe: Baseline and Month 12Population: Safety population. Only those participants with data available at the specified data points were analyzed.
IAM is a four item survey that assessed the appropriateness of an implementation process. The participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the IAM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The IAM total score ranges from 1 to 5 with 1 indicating the least appropriateness and 5 the most appropriateness. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Outcome measures
| Measure |
Staff Study Participants
n=102 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Change From Baseline in IAM Score in Participants With HIV Infection at Month 12
|
0.19 Scores on a scale
Standard Deviation 0.58
|
PRIMARY outcome
Timeframe: Baseline and Month 4Population: All staff study participants Population
FIM is a four item survey that assessed the feasibility of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the FIM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The FIM total score ranges from 1 to 5 with 1 indicating the least feasibility and 5 the most feasibility. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Outcome measures
| Measure |
Staff Study Participants
n=24 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Change From Baseline in Feasibility of Intervention Measure (FIM) Total Score in Staff Study Participants at Month 4
|
-0.02 Scores on a scale
Standard Deviation 0.63
|
PRIMARY outcome
Timeframe: Baseline and Month 12Population: All staff study participants population. Only those staff study participants who completed the survey were included in the analysis.
FIM is a four item survey that assessed the feasibility of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the FIM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The FIM total score ranges from 1 to 5 with 1 indicating the least feasibility and 5 the most feasibility. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Outcome measures
| Measure |
Staff Study Participants
n=23 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Change From Baseline for FIM Total Score in Staff Study Participants at Month 12
|
0.07 Scores on a scale
Standard Deviation 0.69
|
SECONDARY outcome
Timeframe: At Month 4Population: All staff study participants population.
The helpfulness of the toolkit resources was identified using a 19-item survey and the helpfulness of the resources were rated on a five point scale where 1=Extremely helpful (EH), 2=Very helpful (VH), 3=Somewhat helpful (SH), 4=A little helpful (ALH) and 5=Not at all helpful (NAAH). Not Applicable (NA) in the categories mean response was not offered. The toolkit resources consisted of website for clinical staff, video on giving CAB + RPV LA, how to use new packaging card, study factsheet for healthcare providers, consultation aid, reminder e-application, reminder SMS/text, face-to-face training by healthcare staff, facilitation group calls, web-based (WB) treatment planner, WB health clinic capacity planning tool, injection flashcards, website for participants, what to expect factsheet, handbook, FAQ chatbot, trial guide app, video-what to expect and hot and cold packs. The number of participants with the rating on helpfulness for each toolkit resources at Month 4 is presented.
Outcome measures
| Measure |
Staff Study Participants
n=24 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Reminder e-app, SH
|
1 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Website for clinical staff, EH
|
2 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Website for clinical staff, VH
|
3 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Website for clinical staff, SH
|
3 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Website for clinical staff, ALH
|
5 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Video on giving CAB + RPV LA injection, EH
|
3 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Video on giving CAB + RPV LA injection, VH
|
6 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
How to use new packaging card, VH
|
6 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
How to use new packaging card, ALH
|
3 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Study factsheet for healthcare providers, ALH
|
1 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Study factsheet for healthcare providers, NAAH
|
1 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Study factsheet for healthcare providers, NA
|
9 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Consultation aid, EH
|
0 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Consultation aid, ALH
|
2 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Consultation aid, NAAH
|
1 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Reminder e-app, ALH
|
2 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Reminder e-app, NA
|
18 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Reminder SMS/text, NA
|
19 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Face to face (F2F) training by healthcare staff, EH
|
5 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
F2F training by healthcare staff, VH
|
6 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
F2F training by healthcare staff, ALH
|
1 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Facilitation group calls, ALH
|
8 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Facilitation group calls, NA
|
5 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
WB treatment planner, NAAH
|
1 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
WB health clinic capacity planning tool, SH
|
0 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
WB health clinic capacity planning tool, NA
|
22 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Injection flashcard for participants, VH
|
2 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Injection flashcard for participants, NAAH
|
0 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Website for participants, NAAH
|
0 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Website for participants, NA
|
15 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
What to expect factsheet for participants, SH
|
7 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
What to expect factsheet for participants, ALH
|
2 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Participant handbook, EH
|
3 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Participant handbook, VH
|
3 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Participant handbook, NA
|
12 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
FAQs chatbot, SH
|
3 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
FAQs chatbot, ALH
|
1 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
FAQs chatbot, NAAH
|
1 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Trial guide app, VH
|
1 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Trial guide app, ALH
|
1 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Video-what to expect, EH
|
7 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Video-what to expect, VH
|
4 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Video-what to expect, SH
|
1 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Video-what to expect, ALH
|
3 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Video-what to expect, NA
|
8 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Hot and cold packs for participants, SH
|
6 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Hot and cold packs for participants, ALH
|
2 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Website for clinical staff, NAAH
|
1 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Website for clinical staff, NA
|
10 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Video on giving CAB + RPV LA injection, SH
|
4 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Video on giving CAB + RPV LA injection, ALH
|
2 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Video on giving CAB + RPV LA injection, NAAH
|
0 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Video on giving CAB + RPV LA injection, NA
|
9 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
How to use new packaging card, EH
|
0 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
How to use new packaging card, SH
|
3 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
How to use new packaging card, NAAH
|
1 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
How to use new packaging card, NA
|
11 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Study factsheet for healthcare providers, EH
|
1 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Study factsheet for healthcare providers, VH
|
4 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Study factsheet for healthcare providers, SH
|
8 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Consultation aid, VH
|
4 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Consultation aid, SH
|
4 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Consultation aid, NA
|
13 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Reminder-electronic (e)-application (app), EH
|
1 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Reminder e-app, VH
|
2 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Reminder e-app, NAAH
|
0 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Reminder short message service (SMS)/text, EH
|
1 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Reminder SMS/text, VH
|
1 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Reminder SMS/text, SH
|
1 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Reminder SMS/text, ALH
|
2 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Reminder SMS/text, NAAH
|
0 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
F2F training by healthcare staff, SH
|
3 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
F2F training by healthcare staff, NAAH
|
0 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
F2F training by healthcare staff, NA
|
9 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Facilitation group calls, EH
|
0 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Facilitation group calls, VH
|
0 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Facilitation group calls, SH
|
7 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Facilitation group calls, NAAH
|
4 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Web-based (WB) treatment planner, EH
|
4 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
WB treatment planner, VH
|
5 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
WB treatment planner, SH
|
1 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
WB treatment planner, ALH
|
1 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
WB treatment planner, NA
|
12 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
WB health clinic capacity planning tool, EH
|
0 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
WB health clinic capacity planning tool, VH
|
1 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
WB health clinic capacity planning tool, ALH
|
0 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
WB health clinic capacity planning tool, NAAH
|
1 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Injection flashcard for participants, EH
|
2 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Injection flashcard for participants, SH
|
5 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Injection flashcard for participants, ALH
|
3 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Injection flashcard for participants, NA
|
12 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Website for participants, EH
|
0 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Website for participants, VH
|
3 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Website for participants, SH
|
4 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Website for participants, ALH
|
2 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
What to expect factsheet for participants, EH
|
1 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
What to expect factsheet for participants, VH
|
5 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
What to expect factsheet for participants, NAAH
|
0 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
What to expect factsheet for participants, NA
|
9 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Participant handbook, SH
|
5 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Participant handbook, ALH
|
0 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Participant handbook, NAAH
|
1 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Frequently asked questions (FAQs) chatbot, EH
|
0 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
FAQs chatbot, VH
|
1 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
FAQs chatbot, NA
|
18 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Trial guide app, EH
|
0 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Trial guide app, SH
|
2 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Trial guide app, NAAH
|
1 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Trial guide app, NA
|
19 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Video-what to expect, NAAH
|
1 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Hot and cold packs for participants, EH
|
5 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Hot and cold packs for participants, VH
|
5 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Hot and cold packs for participants, NAAH
|
0 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4
Hot and cold packs for participants, NA
|
6 Participants
|
SECONDARY outcome
Timeframe: At Month 12Population: All staff study participants population. Only those staff study participants who completed the survey were included in the analysis.
The helpfulness of the toolkit resources was identified using a 19-item survey and the helpfulness of the resources were rated on a five point scale where 1=Extremely helpful (EH), 2=Very helpful (VH), 3=Somewhat helpful (SH), 4=A little helpful (ALH) and 5=Not at all helpful (NAAH). Not Applicable (NA) in the categories mean response was not offered. The toolkit resources consisted of website for clinical staff, video on giving CAB + RPV LA, how to use new packaging card, study factsheet for healthcare providers, consultation aid, reminder e-application, reminder SMS/text, face-to-face training by healthcare staff, facilitation group calls, WB treatment planner, WB health clinic capacity planning tool, injection flashcards, website for participants, what to expect factsheet for participants, handbook, FAQ chatbot, trial guide app, video-what to expect and hot and cold packs. The number of participants with the rating on helpfulness for each toolkit resources at Month 12 is presented.
Outcome measures
| Measure |
Staff Study Participants
n=23 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Website for clinical staff, SH
|
6 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Website for clinical staff, ALH
|
0 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Website for clinical staff, NAAH
|
0 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Video on giving CAB + RPV LA injection, ALH
|
0 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Video on giving CAB + RPV LA injection, NAAH
|
0 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Study factsheet for healthcare providers, EH
|
1 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Study factsheet for healthcare providers, NAAH
|
0 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Consultation aid, NA
|
14 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Reminder e-app, EH
|
0 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Reminder SMS/text, VH
|
1 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
F2F training by healthcare staff, EH
|
6 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Facilitation group calls, ALH
|
5 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Facilitation group calls, NA
|
7 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
WB treatment planner, ALH
|
0 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
WB treatment planner, NAAH
|
1 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
WB health clinic capacity planning tool, SH
|
2 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
WB health clinic capacity planning tool, ALH
|
1 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Website for participants, EH
|
0 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Participant handbook, VH
|
5 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
FAQs chatbot, SH
|
0 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
FAQs chatbot, ALH
|
1 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Website for clinical staff, EH
|
2 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Website for clinical staff, VH
|
2 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Website for clinical staff, NA
|
13 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Video on giving CAB + RPV LA injection, EH
|
4 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Video on giving CAB + RPV LA injection, VH
|
6 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Video on giving CAB + RPV LA injection, SH
|
7 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Video on giving CAB + RPV LA injection, NA
|
6 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
How to use new packaging card, EH
|
1 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
How to use new packaging card, VH
|
3 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
How to use new packaging card, SH
|
5 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
How to use new packaging card, ALH
|
0 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
How to use new packaging card, NAAH
|
0 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
How to use new packaging card, NA
|
14 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Study factsheet for healthcare providers, VH
|
6 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Study factsheet for healthcare providers, SH
|
4 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Study factsheet for healthcare providers, ALH
|
1 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Study factsheet for healthcare providers, NA
|
11 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Consultation aid, EH
|
1 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Consultation aid, VH
|
1 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Consultation aid, SH
|
2 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Consultation aid, ALH
|
5 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Consultation aid, NAAH
|
0 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Reminder e-app, VH
|
1 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Reminder e-app, SH
|
0 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Reminder e-app, ALH
|
0 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Reminder e-app, NAAH
|
1 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Reminder e-app, NA
|
21 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Reminder SMS/text, EH
|
1 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Reminder SMS/text, SH
|
0 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Reminder SMS/text, ALH
|
1 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Reminder SMS/text, NAAH
|
2 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Reminder SMS/text, NA
|
18 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
F2F training by healthcare staff, VH
|
10 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
F2F training by healthcare staff, SH
|
3 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
F2F training by healthcare staff, ALH
|
0 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
F2F training by healthcare staff, NAAH
|
0 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
F2F training by healthcare staff, NA
|
4 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Facilitation group calls, EH
|
1 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Facilitation group calls, VH
|
1 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Facilitation group calls, SH
|
5 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Facilitation group calls, NAAH
|
4 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
WB treatment planner, EH
|
4 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
WB treatment planner, VH
|
1 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
WB treatment planner, SH
|
4 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
WB treatment planner, NA
|
13 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
WB health clinic capacity planning tool, EH
|
0 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
WB health clinic capacity planning tool, VH
|
0 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
WB health clinic capacity planning tool, NAAH
|
0 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
WB health clinic capacity planning tool, NA
|
20 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Injection flashcard for participants, EH
|
2 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Injection flashcard for participants, VH
|
7 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Injection flashcard for participants, SH
|
2 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Injection flashcard for participants, ALH
|
1 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Injection flashcard for participants, NAAH
|
0 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Injection flashcard for participants, NA
|
11 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Website for participants, VH
|
3 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Website for participants, SH
|
3 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Website for participants, ALH
|
0 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Website for participants, NAAH
|
0 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Website for participants, NA
|
17 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
What to expect factsheet for participants, EH
|
2 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
What to expect factsheet for participants, VH
|
7 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
What to expect factsheet for participants, SH
|
6 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
What to expect factsheet for participants, ALH
|
1 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
What to expect factsheet for participants, NAAH
|
0 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
What to expect factsheet for participants, NA
|
7 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Participant handbook, EH
|
1 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Participant handbook, SH
|
5 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Participant handbook, ALH
|
2 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Participant handbook, NAAH
|
0 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Participant handbook, NA
|
10 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
FAQs chatbot, EH
|
0 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
FAQs chatbot, VH
|
1 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
FAQs chatbot, NAAH
|
1 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
FAQs chatbot, NA
|
20 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Trial guide app, EH
|
0 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Trial guide app, VH
|
0 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Trial guide app, SH
|
0 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Trial guide app, ALH
|
0 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Trial guide app, NAAH
|
1 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Trial guide app, NA
|
22 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Video-what to expect, EH
|
4 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Video-what to expect, VH
|
7 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Video-what to expect, SH
|
3 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Video-what to expect, ALH
|
0 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Video-what to expect, NAAH
|
0 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Video-what to expect, NA
|
9 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Hot and cold packs for participants, EH
|
6 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Hot and cold packs for participants, VH
|
6 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Hot and cold packs for participants, SH
|
6 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Hot and cold packs for participants, ALH
|
3 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Hot and cold packs for participants, NAAH
|
0 Participants
|
|
Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12
Hot and cold packs for participants, NA
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline and Month 4Population: All staff study participants population.
BIM is a 23-item survey which assessed barriers (that is, difficulties and challenges) to successful implementation of the CAB LA + RPV LA injection treatment in the study clinic/practices. For each item, providers were asked to rate how much they agreed or disagreed that the issue is a barrier based on their experiences with implementing the CAB + RPV treatment on a five point rating scale (1=completely disagree to 5=completely agree). It is presented as fewer perceived barriers (FPB)=all negative change in scores from Baseline, some perceived barriers (SPB)=change in score of 0 from Baseline, and greater/more perceived barriers (MPB)=all positive change in scores from Baseline.
Outcome measures
| Measure |
Staff Study Participants
n=24 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Number of exam rooms for injection, MPB
|
6 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Staff preparation, FPB
|
9 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Scheduling of apt reminders, FPB
|
8 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Interest in the new treatment, FPB
|
15 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Interest in the new treatment, SPB
|
6 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Interest in the new treatment, MPB
|
3 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Incentives for clinical practice change, FPB
|
15 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Incentives for clinical practice change, SPB
|
3 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Incentives for clinical practice change, MPB
|
6 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Ability to keep monthly appointments (apts), FPB
|
14 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Ability to keep monthly appointments, SPB
|
5 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Ability to keep monthly appointments, MPB
|
5 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Failing due to missed doses/injection apts, FPB
|
13 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Failing due to missed doses/injection apts, SPB
|
9 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Failing due to missed doses/injection apts, MPB
|
2 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Lack of familiarity with tools/resources, FPB
|
13 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Lack of familiarity with tools/resources, SPB
|
8 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Lack of familiarity with tools/resources, MPB
|
3 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Transportation for monthly apts, FPB
|
12 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Transportation for monthly apts, SPB
|
10 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Transportation for monthly apts, MPB
|
2 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Injection (Inj)/pain soreness, FPB
|
12 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Injection/pain soreness, SPB
|
10 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Injection/pain soreness, MPB
|
2 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Rescheduling missed injections, FPB
|
12 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Rescheduling missed injections, SPB
|
9 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Rescheduling missed injections, MPB
|
3 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Time for new method implementation CAB+RPV LA, FPB
|
12 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Time for new method implementation CAB+RPV LA, SPB
|
11 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Time for new method implementation CAB+RPV LA, MPB
|
1 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Flagging/awareness of missed injection visits, FPB
|
11 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Flagging/awareness of missed injection visits, SPB
|
9 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Flagging/awareness of missed injection visits, MPB
|
4 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Competing clinic priorities, FPB
|
11 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Competing clinic priorities, SPB
|
10 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Competing clinic priorities, MPB
|
3 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Manage for inj visits with other care need, FPB
|
10 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Manage for inj visits with other care need,SPB
|
8 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Manage for inj visit with other care need, MPB
|
6 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Transition from oral to injection treatment, FPB
|
10 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Transition from oral to injection treatment, SPB
|
13 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Transition from oral to injection treatment, MPB
|
1 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Time to administer the injection, FPB
|
10 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Time to administer the injection, SPB
|
10 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Time to administer the injection, MPB
|
4 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Number of exam rooms for injection, FPB
|
9 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Number of exam rooms for injection, SPB
|
9 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Staff resourcing for clinic flow, FPB
|
9 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Staff resourcing for clinic flow, SPB
|
8 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Staff resourcing for clinic flow, MPB
|
7 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Staff buy-in, FPB
|
9 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Staff buy-in, SPB
|
13 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Staff buy-in, MPB
|
2 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Staff preparation, SPB
|
13 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Staff preparation, MPB
|
2 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Scheduling of apt reminders, SPB
|
12 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Scheduling of apt reminders, MPB
|
4 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Answering questions between visits, FPB
|
7 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Answering questions between visits, SPB
|
11 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Answering questions between visits, MPB
|
6 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Scheduling of monthly apts, FPB
|
7 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Scheduling of monthly apts, SPB
|
13 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Scheduling of monthly apts, MPB
|
4 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Leadership support, FPB
|
6 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Leadership support, SPB
|
14 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Leadership support, MPB
|
4 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Storage/refrigeration, FPB
|
5 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Storage/refrigeration, SPB
|
11 Participants
|
|
Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants
Storage/refrigeration, MPB
|
8 Participants
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: All staff study participants population. Only those participants with data available at the specified data points were analyzed.
BIM is a 23-item survey which assessed barriers (i.e., difficulties and challenges) to successful implementation of the CAB LA + RPV LA injection treatment in the study clinic/practices. For each item, providers were asked to rate how much they agreed or disagreed that the issue is a barrier based on their experiences with implementing the CAB + RPV treatment on a five point rating scale (1=completely disagree to 5=completely agree). It is presented as fewer perceived barriers (FPB)=all negative change in scores from Baseline, some perceived barriers (SPB)=change in score of 0 from Baseline, and greater/more perceived barriers (MPB)=all positive change in scores from Baseline.
Outcome measures
| Measure |
Staff Study Participants
n=23 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Time for new method implementation CAB+RPV LA, MPB
|
13.0 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Incentives for clinical practice change, FPB
|
60.7 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Competing clinic priorities, SPB
|
43.5 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Competing clinic priorities, MPB
|
4.3 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Manage for inj visits with other care need, FPB
|
52.1 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Manage for inj visits with other care need,SPB
|
43.5 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Manage for inj visit with other care need, MPB
|
4.3 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Number of exam rooms for injection, FPB
|
52.1 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Number of exam rooms for injection, SPB
|
21.7 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Number of exam rooms for injection, MPB
|
26.1 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Staff resourcing for clinic flow, FPB
|
52.1 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Staff resourcing for clinic flow, SPB
|
30.4 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Staff resourcing for clinic flow, MPB
|
17.4 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Scheduling of apt reminders, FPB
|
52.1 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Scheduling of apt reminders, SPB
|
34.8 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Scheduling of apt reminders, MPB
|
13.0 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Time to administer the injection, FPB
|
47.8 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Time to administer the injection, SPB
|
43.5 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Time to administer the injection, MPB
|
8.7 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Lack of familiarity with tools/resources, FPB
|
47.7 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Lack of familiarity with tools/resources, SPB
|
39.1 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Lack of familiarity with tools/resources, MPB
|
13.0 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Rescheduling missed injections, FPB
|
47.7 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Rescheduling missed injections, SPB
|
39.1 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Rescheduling missed injections, MPB
|
13.0 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Staff preparation, FPB
|
43.4 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Staff preparation, SPB
|
47.8 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Staff preparation, MPB
|
8.7 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Scheduling of monthly apts, FPB
|
43.4 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Scheduling of monthly apts, SPB
|
30.4 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Scheduling of monthly apts, MPB
|
8.7 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Answering questions between visits, FPB
|
39.1 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Answering questions between visits, SPB
|
43.5 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Answering questions between visits, MPB
|
17.4 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Leadership support, FPB
|
39.0 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Leadership support, SPB
|
43.5 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Leadership support, MPB
|
17.4 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Injection/pain soreness, FPB
|
34.8 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Injection/pain soreness, SPB
|
56.5 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Injection/pain soreness, MPB
|
8.7 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Staff buy-in, FPB
|
34.8 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Staff buy-in, SPB
|
56.5 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Staff buy-in, MPB
|
8.6 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Storage/refrigeration, FPB
|
34.8 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Storage/refrigeration, SPB
|
43.5 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Storage/refrigeration, MPB
|
21.7 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Failing due to missed doses/injection apts, FPB
|
78.1 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Failing due to missed doses/injection apts, SPB
|
13.0 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Failing due to missed doses/injection apts, MPB
|
8.7 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Flagging/awareness of missed injection visits, FPB
|
69.5 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Flagging/awareness of missed injection visits, SPB
|
26.1 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Flagging/awareness of missed injection visits, MPB
|
4.3 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Ability to keep monthly appointments, FPB
|
65.2 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Ability to keep monthly appointments, SPB
|
34.8 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Ability to keep monthly appointments, MPB
|
0.0 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Transportation for monthly apts, FPB
|
60.8 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Transportation for monthly apts, SPB
|
34.8 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Transportation for monthly apts, MPB
|
4.3 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Time for new method implementation CAB+RPV LA, FPB
|
60.8 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Time for new method implementation CAB+RPV LA, SPB
|
26.1 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Incentives for clinical practice change, SPB
|
21.7 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Incentives for clinical practice change, MPB
|
17.4 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Interest in the new treatment, FPB
|
56.5 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Interest in the new treatment, SPB
|
26.1 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Interest in the new treatment, MPB
|
17.4 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Transition from oral to injection treatment, FPB
|
56.5 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Transition from oral to injection treatment, SPB
|
39.1 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Transition from oral to injection treatment, MPB
|
4.3 Percentage of participants
|
|
Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants
Competing clinic priorities, FPB
|
52.1 Percentage of participants
|
SECONDARY outcome
Timeframe: At Month 12Population: Safety population. Only those participants with data available at the specified data points were analyzed.
The helpfulness of the toolkit resources was identified using a 19-item survey and the helpfulness of the resources were rated on a five point scale where 1=Extremely helpful (EH), 2=Very helpful (VH), 3=Somewhat helpful (SH), 4=A little helpful (ALH) and 5=Not at all helpful (NAAH). Categories for did not receive (DNR) and recevied but did not use (RBDNU) were presented as well. Not Applicable (NA) in the data means participants were not offered the response option. The toolkit resources consisted of information and resources, hot and cold pack, written materials, website for participants, video, verbal information, reminder calls, reminder text messages, reminder app, peer group information session and appointments outside work time. The number of participants with the rating on helpfulness for each toolkit resources is presented.
Outcome measures
| Measure |
Staff Study Participants
n=102 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Hot and cold pack, DNR
|
9 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Written materials, VH
|
37 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Written materials, SH
|
11 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Written materials, ALH
|
2 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Website for participants, EH
|
25 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Website for participants, Missing
|
0 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Video, EH
|
29 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Verbal information, RBDNU
|
0 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Reminder text messages, ALH
|
1 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Reminder text messages, DNR
|
15 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Reminder app, ALH
|
0 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Reminder app, DNR
|
28 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Reminder app, RBDNU
|
31 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Reminder app, Missing
|
0 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Peer group info session, VH
|
27 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Peer group info session, NAAH
|
20 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Apts outside work time, VH
|
22 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Apts outside work time, SH
|
13 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Apts outside work time, NAAH
|
3 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Apts outside work time, RBDNU
|
NA Participants
Participants were not offered the response option.
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Information and resources, EH
|
50 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Information and resources, VH
|
40 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Information and resources, SH
|
4 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Information and resources, ALH
|
2 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Information and resources, NAAH
|
0 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Information and resources, DNR
|
6 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Information and resources, RBDNU
|
0 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Information and resources, Missing
|
0 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Hot and cold pack, EH
|
18 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Hot and cold pack, VH
|
20 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Hot and cold pack, SH
|
14 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Hot and cold pack, ALH
|
6 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Hot and cold pack, NAAH
|
8 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Hot and cold pack, RBDNU
|
27 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Hot and cold pack, Missing
|
0 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Written materials, EH
|
37 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Written materials, NAAH
|
0 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Written materials, DNR
|
1 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Written materials, RBDNU
|
14 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Written materials, Missing
|
0 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Website for participants, VH
|
28 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Website for participants, SH
|
11 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Website for participants, ALH
|
2 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Website for participants, NAAH
|
1 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Website for participants, DNR
|
4 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Website for participants, RBDNU
|
31 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Video, VH
|
38 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Video, SH
|
13 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Video, ALH
|
5 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Video, NAAH
|
1 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Video, DNR
|
9 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Video, RBDNU
|
6 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Video, Missing
|
1 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Verbal information, EH
|
69 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Verbal information, VH
|
31 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Verbal information, SH
|
2 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Verbal information, ALH
|
0 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Verbal information, NAAH
|
0 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Verbal information, DNR
|
0 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Verbal information, Missing
|
0 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Reminder calls, EH
|
67 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Reminder calls, VH
|
24 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Reminder calls, SH
|
5 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Reminder calls, ALH
|
1 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Reminder calls, NAAH
|
1 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Reminder calls, DNR
|
4 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Reminder calls, RBDNU
|
0 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Reminder calls, Missing
|
0 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Reminder text messages, EH
|
63 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Reminder text messages, VH
|
19 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Reminder text messages, SH
|
4 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Reminder text messages, NAAH
|
0 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Reminder text messages, RBDNU
|
0 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Reminder text messages, Missing
|
0 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Reminder app, EH
|
26 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Reminder app, VH
|
14 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Reminder app, SH
|
3 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Reminder app, NAAH
|
0 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Peer group informational (info) session, EH
|
24 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Peer group info session, SH
|
25 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Peer group info session, ALH
|
6 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Peer group info session, DNR
|
NA Participants
Participants were not offered the response option.
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Peer group info session, RBDNU
|
NA Participants
Participants were not offered the response option.
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Peer group info session, Missing
|
0 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Apts outside work time, EH
|
63 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Apts outside work time, ALH
|
1 Participants
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Apts outside work time, DNR
|
NA Participants
Participants were not offered the response option.
|
|
Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12
Apts outside work time, Missing
|
0 Participants
|
SECONDARY outcome
Timeframe: At Month 12Population: Safety population. Only those participants with data available at the specified data points were analyzed.
Participants were asked to report any factors that were interfering with their ability to get the monthly CAB LA + RPV LA injection treatment. Number of participants along with the reasons for interference in ability to get CAB LA + RPV LA is presented.
Outcome measures
| Measure |
Staff Study Participants
n=102 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Number of Participants With HIV Reporting Barriers to CAB LA + RPV LA Injection Treatment at Month 12
Transportation to clinic/practice for inj visit
|
3 Participants
|
|
Number of Participants With HIV Reporting Barriers to CAB LA + RPV LA Injection Treatment at Month 12
Ease of parking at clinic/practice for inj visit
|
4 Participants
|
|
Number of Participants With HIV Reporting Barriers to CAB LA + RPV LA Injection Treatment at Month 12
Limited clinic/practice hours for inj visits
|
3 Participants
|
|
Number of Participants With HIV Reporting Barriers to CAB LA + RPV LA Injection Treatment at Month 12
Pain or soreness from the injection
|
15 Participants
|
|
Number of Participants With HIV Reporting Barriers to CAB LA + RPV LA Injection Treatment at Month 12
Scheduling upcoming injection visits
|
2 Participants
|
|
Number of Participants With HIV Reporting Barriers to CAB LA + RPV LA Injection Treatment at Month 12
Rescheduling missed injection visits
|
1 Participants
|
|
Number of Participants With HIV Reporting Barriers to CAB LA + RPV LA Injection Treatment at Month 12
Forgetting appointment for the injection visits
|
2 Participants
|
|
Number of Participants With HIV Reporting Barriers to CAB LA + RPV LA Injection Treatment at Month 12
Frequency of required visits to clinic for inj
|
6 Participants
|
|
Number of Participants With HIV Reporting Barriers to CAB LA + RPV LA Injection Treatment at Month 12
Missing work too frequently for the injection
|
7 Participants
|
|
Number of Participants With HIV Reporting Barriers to CAB LA + RPV LA Injection Treatment at Month 12
Less privacy for inj visits than daily HIV medicine
|
1 Participants
|
|
Number of Participants With HIV Reporting Barriers to CAB LA + RPV LA Injection Treatment at Month 12
Nothing is interfering with getting this treatment
|
75 Participants
|
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: Safety population
The barriers were analyzed using semi-structured interviews from the validated consolidated framework for implementation research (CFIR) across 7 calls. An implementation science approach was used to understand the barriers for participants with HIV for delivering CAB + RPV LA within an interventional clinical trial where the CAB + RPV LA regimen was delivered to HIV infected, virologically-suppressed participants.
Outcome measures
| Measure |
Staff Study Participants
n=115 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Number of Barriers Assessed Among Clinics Using Short-term Facilitation
Facilitation call 7
|
3 Barriers
|
|
Number of Barriers Assessed Among Clinics Using Short-term Facilitation
Facilitation call 1
|
5 Barriers
|
|
Number of Barriers Assessed Among Clinics Using Short-term Facilitation
Facilitation call 2
|
3 Barriers
|
|
Number of Barriers Assessed Among Clinics Using Short-term Facilitation
Facilitation call 3
|
7 Barriers
|
|
Number of Barriers Assessed Among Clinics Using Short-term Facilitation
Facilitation call 4
|
6 Barriers
|
|
Number of Barriers Assessed Among Clinics Using Short-term Facilitation
Facilitation call 5
|
4 Barriers
|
|
Number of Barriers Assessed Among Clinics Using Short-term Facilitation
Facilitation call 6
|
7 Barriers
|
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: Safety population
The facilitators were analyzed using semi-structured interviews from the validated CFIR across 7 calls. An implementation science approach was used to understand the facilitators for participants with HIV for delivering CAB + RPV LA within an interventional clinical trial where the CAB + RPV LA regimen was delivered to HIV infected, virologically-suppressed participants.
Outcome measures
| Measure |
Staff Study Participants
n=115 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Number of Facilitators Assessed Among Clinics Using Short-term Facilitation
Facilitation call 1
|
7 Facilitators
|
|
Number of Facilitators Assessed Among Clinics Using Short-term Facilitation
Facilitation call 2
|
3 Facilitators
|
|
Number of Facilitators Assessed Among Clinics Using Short-term Facilitation
Facilitation call 5
|
9 Facilitators
|
|
Number of Facilitators Assessed Among Clinics Using Short-term Facilitation
Facilitation call 6
|
9 Facilitators
|
|
Number of Facilitators Assessed Among Clinics Using Short-term Facilitation
Facilitation call 7
|
8 Facilitators
|
|
Number of Facilitators Assessed Among Clinics Using Short-term Facilitation
Facilitation call 3
|
3 Facilitators
|
|
Number of Facilitators Assessed Among Clinics Using Short-term Facilitation
Facilitation call 4
|
5 Facilitators
|
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: Safety population
The best practices were analyzed using short-term facilitation calls. An implementation science approach was used to understand the best practices for participants with HIV for delivering CAB + RPV LA within an interventional clinical trial where the CAB + RPV LA regimen was delivered to HIV infected, virologically-suppressed participants.
Outcome measures
| Measure |
Staff Study Participants
n=115 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Number of Best Practices Assessed Among Clinics Using Short-term Facilitation
Facilitation call 1
|
5 Best practices
|
|
Number of Best Practices Assessed Among Clinics Using Short-term Facilitation
Facilitation call 2
|
2 Best practices
|
|
Number of Best Practices Assessed Among Clinics Using Short-term Facilitation
Facilitation call 3
|
2 Best practices
|
|
Number of Best Practices Assessed Among Clinics Using Short-term Facilitation
Facilitation call 6
|
6 Best practices
|
|
Number of Best Practices Assessed Among Clinics Using Short-term Facilitation
Facilitation call 4
|
5 Best practices
|
|
Number of Best Practices Assessed Among Clinics Using Short-term Facilitation
Facilitation call 5
|
6 Best practices
|
|
Number of Best Practices Assessed Among Clinics Using Short-term Facilitation
Facilitation call 7
|
8 Best practices
|
SECONDARY outcome
Timeframe: At Month 4Population: All Staff study participants population
Number of staff study participants using support materials/toolkit at Month 4 was assessed by variables: Not used, Used similar resource, used the support materials/toolkit. The support materials/toolkit consisted of website for clinical staff, video on giving CAB + RPV LA, how to use new packaging card, study factsheet for healthcare providers, consultation aid, reminder e-application, reminder SMS/text, face-to-face training by healthcare staff, facilitation group calls, web-based (WB) treatment planner, WB health clinic capacity planning tool, injection flashcards, website for participants, what to expect factsheet for participants, handbook, FAQ chatbot, trial guide app, video-what to expect and hot and cold packs.
Outcome measures
| Measure |
Staff Study Participants
n=24 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
Website for clinical staff, used similar
|
1 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
Website for clinical staff, used
|
14 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
Video on giving CAB + RPV LA injection, used
|
15 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
Study factsheet for HCP, not used
|
8 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
Study factsheet for HCP, used similar
|
1 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
Study factsheet for HCP, used
|
15 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
Consultation aid, not used
|
12 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
WB treatment planner, not used
|
12 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
WB health clinic capacity planning tool, not used
|
20 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
WB health clinic capacity planning tool, used
|
2 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
Injection flashcard, used similar
|
2 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
Injection flashcard, used
|
12 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
Website for participants, not used
|
14 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
Website for participants, used similar
|
1 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
Website for participants, used
|
9 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
Participant handbook, not used
|
12 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
Trial guide app, not used
|
19 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
Trial guide app, used
|
5 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
Video-what to expect, not used
|
8 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
Hot and cold pack, not used
|
6 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
Website for clinical staff, not used
|
9 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
Video on giving CAB + RPV LA injection, not used
|
8 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
Video on giving CAB + RPV LA injection, used similar
|
1 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
How to use new packaging card, not used
|
11 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
How to use new packaging card, used similar
|
0 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
How to use new packaging card, used
|
13 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
Consultation aid, used similar
|
1 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
Consultation aid, used
|
11 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
Reminder, e-app, not used
|
16 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
Reminder e-app, used similar
|
2 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
Reminder e-app, used
|
6 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
Reminder SMS/text, not used
|
15 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
Reminder SMS/text, used similar
|
4 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
Reminder SMS/text, used
|
5 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
F2F training, not used
|
8 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
F2F training, used similar
|
1 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
F2F training, used
|
15 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
Facilitation group calls, not used
|
4 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
Facilitation group calls, used similar
|
1 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
Facilitation group calls, used
|
19 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
WB treatment planner, used similar
|
0 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
WB treatment planner, used
|
12 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
WB health clinic planning tool, used similar
|
2 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
Injection flashcard, not used
|
10 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
What to expect factsheet, not used
|
8 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
What to expect factsheet, used similar
|
1 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
What to expect factsheet, used
|
15 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
Participant handbook, used similar
|
0 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
Participant handbook, used
|
12 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
FAQ chatbot, not used
|
18 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
FAQ chatbot, used similar
|
0 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
FAQ chatbot, used
|
6 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
Trail guide app, used similar
|
0 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
Video-what to expect, used similar
|
0 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
Video-what to expect, used
|
16 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
Hot and cold pack, used similar
|
0 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 4
Hot and cold pack, used
|
18 Participants
|
SECONDARY outcome
Timeframe: At Month 12Population: All staff study participants population. Only those participants with data available at the specified data points were analyzed.
Number of staff study participants using support materials/toolkit at Month 12 was assessed by variables: Not used, Used similar resource, used the support materials/toolkit. The support materials/toolkit consisted of website for clinical staff, video on giving CAB + RPV LA, how to use new packaging card, study factsheet for healthcare providers, consultation aid, reminder e-application, reminder SMS/text, face-to-face training by healthcare staff, facilitation group calls, web-based (WB) treatment planner, WB health clinic capacity planning tool, injection flashcards, website for participants, what to expect factsheet for participants, handbook, FAQ chatbot, trial guide app, video-what to expect and hot and cold packs.
Outcome measures
| Measure |
Staff Study Participants
n=23 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
Website for clinical staff, used similar
|
0 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
Video on giving CAB + RPV LA injection, not used
|
6 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
Video on giving CAB + RPV LA injection, used similar
|
0 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
Video on giving CAB + RPV LA injection, used
|
17 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
How to use new packaging card, not used
|
14 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
How to use new packaging card, used
|
9 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
Study factsheet for HCP, not used
|
10 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
Study factsheet for HCP, used similar
|
1 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
Study factsheet for HCP, used
|
12 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
Consultation aid, not used
|
14 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
Consultation aid, used similar
|
0 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
Consultation aid, used
|
9 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
Reminder e-app, used similar
|
6 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
Reminder e-app, used
|
2 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
Reminder SMS/text, not used
|
8 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
Reminder SMS/text, used similar
|
10 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
F2F training, not used
|
3 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
F2F training, used similar
|
1 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
F2F training, used
|
19 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
WB health clinic planning tool, used similar
|
4 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
Injection flashcard, not used
|
9 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
Injection flashcard, used
|
12 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
Participant handbook, used similar
|
2 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
Trail guide app, used similar
|
2 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
Trial guide app, used
|
1 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
Video-what to expect, used
|
14 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
Hot and cold pack, used
|
21 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
Hot and cold pack, not used
|
2 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
Hot and cold pack, used similar
|
0 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
Website for clinical staff, not used
|
13 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
Website for clinical staff, used
|
10 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
How to use new packaging card, used similar
|
0 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
Reminder, e-app, not used
|
15 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
Reminder SMS/text, used
|
5 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
Facilitation group calls, not used
|
6 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
Facilitation group calls, used similar
|
1 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
Facilitation group calls, used
|
16 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
WB treatment planner, not used
|
11 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
WB treatment planner, used similar
|
2 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
WB treatment planner, used
|
10 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
WB health clinic capacity planning tool, not used
|
16 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
WB health clinic capacity planning tool, used
|
3 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
Injection flashcard, used similar
|
2 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
Website for participants, not used
|
15 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
Website for participants, used similar
|
2 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
Website for participants, used
|
6 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
What to expect factsheet, not used
|
5 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
What to expect factsheet, used similar
|
2 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
What to expect factsheet, used
|
16 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
Participant handbook, not used
|
8 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
Participant handbook, used
|
13 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
FAQ chatbot, not used
|
18 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
FAQ chatbot, used similar
|
2 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
FAQ chatbot, used
|
3 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
Trial guide app, not used
|
20 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
Video-what to expect, not used
|
8 Participants
|
|
Number of Staff Study Participants Using Support Materials/Toolkit at Month 12
Video-what to expect, used similar
|
1 Participants
|
SECONDARY outcome
Timeframe: At Month 4Population: Safety population. Only those participants with data available at the specified data points were analyzed.
Participants with HIV infection were asked about their utilization of each element of the support materials/toolkit and were asked to categorize it as Extremely helpful (EH) Very helpful (VH), Somewhat helpful (SH), A little helpful (ALH), Not at all helpful (NAAH), did not receive (DNR), Received but did not use (RBDNU) and missing. Not Applicable (NA) in the data means participants were not offered the response option. The support materials/toolkit consisted of information and resources, hot and cold pack, written materials, website for participants, video, verbal information, reminder calls, reminder text messages, reminder app, peer group information session and appointments outside work time. Percentage of participants with the rating on helpfulness for each toolkit resources is presented.
Outcome measures
| Measure |
Staff Study Participants
n=105 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Information and resources, NAAH
|
0.0 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Written materials, NAAH
|
1.0 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Apts outside work time, RBDNU
|
NA Percentage of participants
Participants were not offered the response option.
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Information and resources, EH
|
49.5 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Peer group info session, ALH
|
8.6 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Information and resources, VH
|
38.1 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Information and resources, SH
|
6.7 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Information and resources, ALH
|
1.9 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Information and resources, DNR
|
3.8 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Information and resources, RBDNU
|
0.0 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Information and resources, Missing
|
0.0 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Hot and cold pack, EH
|
19.0 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Hot and cold pack, VH
|
8.6 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Hot and cold pack, SH
|
21.9 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Hot and cold pack, ALH
|
8.6 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Hot and cold pack, NAAH
|
2.9 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Hot and cold pack, DNR
|
14.3 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Hot and cold pack, RBDNU
|
23.8 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Hot and cold pack, Missing
|
1.0 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Written materials, EH
|
38.1 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Written materials, VH
|
35.2 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Written materials, SH
|
12.4 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Written materials, ALH
|
1.9 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Written materials, DNR
|
1.9 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Written materials, RBDNU
|
9.5 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Written materials, Missing
|
0.0 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Website, EH
|
21.0 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Website, VH
|
28.6 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Website, SH
|
5.7 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Website, ALH
|
1.9 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Website, NAAH
|
1.9 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Website, DNR
|
6.7 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Website, RBDNU
|
34.3 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Website, Missing
|
0.0 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Video, EH
|
28.6 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Video, VH
|
41.0 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Video, SH
|
12.4 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Video, ALH
|
4.8 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Video, NAAH
|
1.9 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Video, DNR
|
8.6 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Video, RBDNU
|
2.9 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Video, Missing
|
0.0 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Verbal information, EH
|
62.9 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Verbal information, VH
|
32.4 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Verbal information, SH
|
3.8 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Verbal information, ALH
|
0.0 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Verbal information, NAAH
|
0.0 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Verbal information, DNR
|
0.0 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Verbal information, RBDNU
|
0.0 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Verbal information, Missing
|
1.0 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Reminder calls, EH
|
61.0 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Reminder calls, VH
|
23.8 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Reminder calls, SH
|
4.8 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Reminder calls, ALH
|
4.8 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Reminder calls, NAAH
|
0.0 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Reminder calls, DNR
|
4.8 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Reminder calls, RBDNU
|
0.0 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Reminder calls, Missing
|
1.0 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Reminder text messages, EH
|
56.2 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Reminder text messages, VH
|
19.0 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Reminder text messages, SH
|
4.8 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Reminder text messages, ALH
|
1.0 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Reminder text messages, NAAH
|
0.0 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Reminder text messages, DNR
|
18.1 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Reminder text messages, RBDNU
|
0.0 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Reminder text messages, Missing
|
1.0 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Reminder app, EH
|
23.8 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Reminder app, VH
|
16.2 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Reminder app, SH
|
2.9 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Reminder app, ALH
|
1.9 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Reminder app, NAAH
|
0.0 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Reminder app, DNR
|
26.7 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Reminder app, RBDNU
|
28.6 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Reminder app, Missing
|
0.0 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Peer group informational (info) session, EH
|
22.9 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Peer group info session, VH
|
20.0 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Peer group info session, SH
|
33.3 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Peer group info session, NAAH
|
14.3 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Peer group info session, DNR
|
NA Percentage of participants
Participants were not offered the response option.
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Peer group info session, RBDNU
|
NA Percentage of participants
Participants were not offered the response option.
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Peer group info session, Missing
|
1.0 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Apts outside work time, EH
|
57.1 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Apts outside work time, VH
|
26.7 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Apts outside work time, SH
|
6.7 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Apts outside work time, ALH
|
4.8 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Apts outside work time, NAAH
|
4.8 Percentage of participants
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Apts outside work time, DNR
|
NA Percentage of participants
Participants were not offered the response option.
|
|
Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4
Apts outside work time, Missing
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: At Month 4Population: Safety population. Only those participants with data available at the specified time points were analyzed.
Number of participants receiving injections within target window at Month 4 is presented. The target window is +/- 7 days from the target injection visit date.
Outcome measures
| Measure |
Staff Study Participants
n=105 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Number of Participants Receiving Injections Within Target Window at Month 4
|
100 Participants
|
SECONDARY outcome
Timeframe: At Month 12Population: Safety population. Only those participants with data available at the specified time points were analyzed.
Number of participants receiving injections within target window at Month 12 is presented. The target window is +/- 7 days from the target injection visit date.
Outcome measures
| Measure |
Staff Study Participants
n=102 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Number of Participants Receiving Injections Within Target Window at Month 12
|
96 Participants
|
SECONDARY outcome
Timeframe: At Month 12Population: All staff study participants population. Only those participants with data available at the specified data points were analyzed.
Implementation sustainability in staff study participants was assessed using PSAT tool that evaluated capability of clinics to maintain processes developed to administer CAB+RPV injection in routine clinical settings after study conclusion.It consisted of 6 domains(1.Environmental support,2.Organizational capacity,3.Program evaluation,4.Program adaptation,5.Communications and 6.Strategic planning).Each domain consisted of 5 items,each assessed using 7-point numerical rating scale:1=to not extent at all,7=to a very great extent and an eighth not applicable/not able to answer response(NA).Score ranges for total domain scores are 5 to 35 for each of 6 domains(5 items in each domain on 1 to 7 scale).Numeric response to each item within specific domain is summed to produce a total domain score then mean domain score is calculated(excluding any NA responses).Higher scores indicate better outcome(higher endorsement/more positive impressions by staff-study with sustainability survey concepts)
Outcome measures
| Measure |
Staff Study Participants
n=23 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Implementation Sustainability Assessed in Staff Study Participants Using Program Sustainability Assessment Tool (PSAT) Scores
Environmental support
|
5.82 Scores on a scale
Standard Deviation 0.20
|
|
Implementation Sustainability Assessed in Staff Study Participants Using Program Sustainability Assessment Tool (PSAT) Scores
Organizational capacity
|
5.74 Scores on a scale
Standard Deviation 0.28
|
|
Implementation Sustainability Assessed in Staff Study Participants Using Program Sustainability Assessment Tool (PSAT) Scores
Program evaluation
|
5.83 Scores on a scale
Standard Deviation 0.49
|
|
Implementation Sustainability Assessed in Staff Study Participants Using Program Sustainability Assessment Tool (PSAT) Scores
Program adaptation
|
5.98 Scores on a scale
Standard Deviation 0.15
|
|
Implementation Sustainability Assessed in Staff Study Participants Using Program Sustainability Assessment Tool (PSAT) Scores
Communications
|
6.09 Scores on a scale
Standard Deviation 0.06
|
|
Implementation Sustainability Assessed in Staff Study Participants Using Program Sustainability Assessment Tool (PSAT) Scores
Strategic planning
|
5.50 Scores on a scale
Standard Deviation 0.34
|
SECONDARY outcome
Timeframe: At Month 1Population: Safety population. Only those participants with data available at the specified data points were analyzed.
Participant satisfaction was measured using the validated HIV Treatment Satisfaction Questionnaire (HIV-TSQ), status version (HIV-TSQs), which measured satisfaction with the treatment used in the previous few weeks. HIVTSQs total treatment satisfaction score was computed with 1-11 items. Each item was scored from 0 (least satisfied) to 6 (most satisfied). Items 1-11 were summed to produce score with possible range of 0 to 66. Higher the score, greater improvement in satisfaction with treatment; lower score, greater the deterioration in satisfaction with treatment.
Outcome measures
| Measure |
Staff Study Participants
n=109 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
HIV Treatment Satisfaction Questionnaire Status Version (HIV-TSQs) Scores at Month 1
|
60.7 Scores on a scale
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: At Month 4Population: Safety population. Only those participants with data available at the specified data points were analyzed.
Participant satisfaction was measured using the validated HIV Treatment Satisfaction Questionnaire (HIV-TSQ), status version (HIV-TSQs), which measured satisfaction with the treatment used in the previous few weeks. HIVTSQs total treatment satisfaction score was computed with 1-11 items. Each item was scored from 0 (least satisfied) to 6 (most satisfied). Items 1-11 were summed to produce score with possible range of 0 to 66. Higher the score, greater improvement in satisfaction with treatment; lower score, greater the deterioration in satisfaction with treatment.
Outcome measures
| Measure |
Staff Study Participants
n=105 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
HIV-TSQs Scores at Month 4
|
62.12 Scores on a scale
Standard Deviation 5.79
|
SECONDARY outcome
Timeframe: At Month 12Population: Safety population. Only those participants with data available at the specified data points were analyzed.
Participant satisfaction was measured using the validated HIV Treatment Satisfaction Questionnaire (HIV-TSQ), status version (HIV-TSQs), which measured satisfaction with the treatment used in the previous few weeks. HIVTSQs total treatment satisfaction score was computed with 1-11 items. Each item was scored from 0 (least satisfied) to 6 (most satisfied). Items 1-11 were summed to produce score with possible range of 0 to 66. Higher the score, greater improvement in satisfaction with treatment; lower score, greater the deterioration in satisfaction with treatment.
Outcome measures
| Measure |
Staff Study Participants
n=102 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
HIV-TSQs Scores at Month 12
|
63.30 Scores on a scale
Standard Deviation 3.81
|
SECONDARY outcome
Timeframe: At Month 12Population: Safety population. Only those participants with data available at the specified data points were analyzed.
The results for participant reported acceptability of the amount of time spent in the clinic for each injection visit is presented. Participants were asked to rate the acceptability of the amount of time spent in the clinic for each injection visit as extremely acceptable, very acceptable, somewhat acceptable, a little acceptable and not at all acceptable.
Outcome measures
| Measure |
Staff Study Participants
n=102 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Number of Participants With Reported Acceptability of the Amount of Time Spent in the Clinic for Each Injection Visit
Extremely acceptable
|
62 Participants
|
|
Number of Participants With Reported Acceptability of the Amount of Time Spent in the Clinic for Each Injection Visit
Very acceptable
|
33 Participants
|
|
Number of Participants With Reported Acceptability of the Amount of Time Spent in the Clinic for Each Injection Visit
Somewhat acceptable
|
7 Participants
|
|
Number of Participants With Reported Acceptability of the Amount of Time Spent in the Clinic for Each Injection Visit
A little acceptable
|
0 Participants
|
|
Number of Participants With Reported Acceptability of the Amount of Time Spent in the Clinic for Each Injection Visit
Not at all acceptable
|
0 Participants
|
SECONDARY outcome
Timeframe: At Month 12Population: Safety population. Only those participants with data available at the specified data points were analyzed.
Number of participants with the reported time spent in clinic/practice for each injection visit is presented.
Outcome measures
| Measure |
Staff Study Participants
n=101 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Number of Participants With the Reported Time Spent in Clinic/Practice for Each Injection Visit
31-45 minutes
|
23 Participants
|
|
Number of Participants With the Reported Time Spent in Clinic/Practice for Each Injection Visit
1-15 minutes
|
14 Participants
|
|
Number of Participants With the Reported Time Spent in Clinic/Practice for Each Injection Visit
16-30 minutes
|
51 Participants
|
|
Number of Participants With the Reported Time Spent in Clinic/Practice for Each Injection Visit
46-60 minutes
|
12 Participants
|
|
Number of Participants With the Reported Time Spent in Clinic/Practice for Each Injection Visit
More than 60 minutes
|
1 Participants
|
SECONDARY outcome
Timeframe: At Month 12Population: Safety population. Only those participants with data available at the specified data points were analyzed.
Participants were asked to rate how knowledgeable they feel about the CAB LA + RPV LA treatment as extremely knowledgeable, very knowledgeable, somewhat knowledgeable, a little knowledgeable and not at all knowledgeable.
Outcome measures
| Measure |
Staff Study Participants
n=102 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Number of Participants With Extent of Knowledge About the CAB + RPV LA Treatment
A little knowledgeable
|
2 Participants
|
|
Number of Participants With Extent of Knowledge About the CAB + RPV LA Treatment
Extremely knowledgeable
|
34 Participants
|
|
Number of Participants With Extent of Knowledge About the CAB + RPV LA Treatment
Very knowledgeable
|
40 Participants
|
|
Number of Participants With Extent of Knowledge About the CAB + RPV LA Treatment
Somewhat knowledgeable
|
25 Participants
|
|
Number of Participants With Extent of Knowledge About the CAB + RPV LA Treatment
Not at all knowledgeable
|
1 Participants
|
SECONDARY outcome
Timeframe: At Months 1, 5 and 11Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Length of visit was calculated by subtracting the arrival time (Lead time \[actual start time of appointment - arrival time\] + process time \[actual end time of appointment - actual start time of appointment\]) from actual end time of appointment.
Outcome measures
| Measure |
Staff Study Participants
n=115 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Length of Participant Visit
At Month 1, n=109
|
63.4 Minutes
Standard Deviation 29.51
|
|
Length of Participant Visit
At Month 5, n=104
|
38.7 Minutes
Standard Deviation 19.91
|
|
Length of Participant Visit
At Month 11, n=100
|
36.3 Minutes
Standard Deviation 16.85
|
SECONDARY outcome
Timeframe: Month 1, Month 2, Month 4, Month 6, Month 8, Month 10 and Month 12Population: Safety population
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with plasma HIV-1 RNA \<50 c/mL (virologic success) was evaluated using the modified Food and Drug Administration (FDA) snapshot algorithm with Coronavirus Disease 2019 (COVID-19) related missing value imputed using the last observation carried forward (LOCF) approach.
Outcome measures
| Measure |
Staff Study Participants
n=115 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies/Milliliter (c/mL) by Modified Food and Drug Administration (FDA) Snapshot Algorithm
Month 10
|
87.8 Percentage of participants
|
|
Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies/Milliliter (c/mL) by Modified Food and Drug Administration (FDA) Snapshot Algorithm
Month 1
|
93.9 Percentage of participants
|
|
Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies/Milliliter (c/mL) by Modified Food and Drug Administration (FDA) Snapshot Algorithm
Month 2
|
94.8 Percentage of participants
|
|
Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies/Milliliter (c/mL) by Modified Food and Drug Administration (FDA) Snapshot Algorithm
Month 4
|
91.3 Percentage of participants
|
|
Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies/Milliliter (c/mL) by Modified Food and Drug Administration (FDA) Snapshot Algorithm
Month 6
|
90.4 Percentage of participants
|
|
Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies/Milliliter (c/mL) by Modified Food and Drug Administration (FDA) Snapshot Algorithm
Month 8
|
88.7 Percentage of participants
|
|
Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies/Milliliter (c/mL) by Modified Food and Drug Administration (FDA) Snapshot Algorithm
Month 12
|
88.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Months 1, Month 2, Month 4, Month 6, Month 8, Month 10, Month 12, Month 13, Month 15, Month 16, Month 18, Month 19, Month 21, Month 22, Month 24, Month 25, Month 27, Month 28 and Month 30Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Plasma samples were collected for quantitative analysis of HIV-1 RNA. The percentage value presented has been rounded off.
Outcome measures
| Measure |
Staff Study Participants
n=115 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL - Observed Case
Month 1; n=112
|
96 Percentage of participants
|
|
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL - Observed Case
Month 2; n=109
|
100 Percentage of participants
|
|
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL - Observed Case
Month 4; n=107
|
98 Percentage of participants
|
|
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL - Observed Case
Month 6; n=103
|
100 Percentage of participants
|
|
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL - Observed Case
Month 8; n=94
|
100 Percentage of participants
|
|
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL - Observed Case
Month 10; n=100
|
99 Percentage of participants
|
|
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL - Observed Case
Month 12, n=101
|
100 Percentage of participants
|
|
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL - Observed Case
Month 13; n=101
|
100 Percentage of participants
|
|
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL - Observed Case
Month 15; n=99
|
100 Percentage of participants
|
|
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL - Observed Case
Month 16; n=94
|
99 Percentage of participants
|
|
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL - Observed Case
Month 18; n=95
|
100 Percentage of participants
|
|
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL - Observed Case
Month 19; n=89
|
100 Percentage of participants
|
|
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL - Observed Case
Month 21; n=75
|
100 Percentage of participants
|
|
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL - Observed Case
Month 22; n=61
|
100 Percentage of participants
|
|
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL - Observed Case
Month 24; n=35
|
100 Percentage of participants
|
|
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL - Observed Case
Month 25; n=17
|
100 Percentage of participants
|
|
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL - Observed Case
Month 27; n=8
|
100 Percentage of participants
|
|
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL - Observed Case
Month 28; n=7
|
100 Percentage of participants
|
|
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL - Observed Case
Month 30; n=1
|
100 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 30 monthsPopulation: Safety population
Plasma samples were collected for quantitative analysis of HIV-1 RNA. The CVF is defined as rebound as indicated by two consecutive plasma HIV-1 RNA levels greater than or equal to (\>=)200 copies/mL after prior suppression to \<200 copies/mL.
Outcome measures
| Measure |
Staff Study Participants
n=115 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Percentage of Participants With Confirmed Virologic Failure (CVF)
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 30 monthsPopulation: Safety population. Only participants with CVF were included in the analysis
Plasma samples were collected for drug resistance testing. Number of participants who met CVF criteria (two consecutive plasma HIV-1 RNA levels \>=200 copies/mL after prior suppression to \<200 copies/mL) with emergent genotypic resistance is summarized.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 30 monthsPopulation: Safety population. Only participants with CVF were included in the analysis
Plasma samples were collected for drug resistance testing. Number of participants who met CVF criteria (two consecutive plasma HIV-1 RNA levels \>=200 copies/mL after prior suppression to \<200 copies/mL) with emergent phenotypic resistance is summarized.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 30 monthsPopulation: Safety population
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose may result in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity or is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. Number of participants with any SAE and common (\>=5%) non-SAEs are presented. Adverse events which were not serious have been considered as non-serious adverse events.
Outcome measures
| Measure |
Staff Study Participants
n=115 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Number of Participants With Serious Adverse Events (SAEs) and Common (>=5 Percent [%]) Non-serious Adverse Events (Non-SAEs)
Common (>=5%) non-SAEs
|
101 Participants
|
|
Number of Participants With Serious Adverse Events (SAEs) and Common (>=5 Percent [%]) Non-serious Adverse Events (Non-SAEs)
SAEs
|
9 Participants
|
SECONDARY outcome
Timeframe: Up to 30 monthsPopulation: Safety population
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Percentage of participants with adverse events leading to study treatment or study withdrawal has been presented. The percentage value presented has been rounded off.
Outcome measures
| Measure |
Staff Study Participants
n=115 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Percentage of Participants Who Discontinue Treatment or Withdraw From Study Due to AEs Over Time
|
7 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Safety Population
Blood samples were collected for the analysis of following hematology parameters: leukocytes, neutrophils and platelets. The parameters were graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scale from Grade 1 to 4, where Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). Higher the grade, more severe the symptoms.
Outcome measures
| Measure |
Staff Study Participants
n=115 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Leukocytes, increase from Grade 1 to 4
|
5 Participants
|
|
Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Leukocytes, increase from Grade 2 to 4
|
2 Participants
|
|
Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Leukocytes, increase from Grade 3 to 4
|
1 Participants
|
|
Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Neutrophils, increase from Grade 1 to 4
|
8 Participants
|
|
Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Neutrophils, increase from Grade 2 to 4
|
3 Participants
|
|
Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Neutrophils, increase from Grade 3 to 4
|
1 Participants
|
|
Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Platelets, increase from Grade 1 to 4
|
1 Participants
|
|
Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Platelets, increase from Grade 2 to 4
|
0 Participants
|
|
Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Platelets, increase from Grade 3 to 4
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 30 monthsPopulation: Safety Population
Blood samples were collected for the analysis of following hematology parameters: hemoglobin, leukocytes, neutrophils and platelets. The parameters were graded according to the DAIDS toxicity scale from Grade 1 to 4, where Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). Higher the grade, more severe the symptoms.
Outcome measures
| Measure |
Staff Study Participants
n=115 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
Hemoglobin, increase from Grades 1 to 4
|
1 Participants
|
|
Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
Hemoglobin, increase from Grades 2 to 4
|
0 Participants
|
|
Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
Hemoglobin, increase from Grades 3 to 4
|
0 Participants
|
|
Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
Leukocytes, increase from Grade 1 to 4
|
6 Participants
|
|
Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
Leukocytes, increase from Grade 2 to 4
|
2 Participants
|
|
Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
Leukocytes, increase from Grade 3 to 4
|
1 Participants
|
|
Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
Neutrophils, increase from Grade 1 to 4
|
9 Participants
|
|
Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
Neutrophils, increase from Grade 2 to 4
|
4 Participants
|
|
Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
Neutrophils, increase from Grade 3 to 4
|
2 Participants
|
|
Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
Platelets, increase from Grade 1 to 4
|
2 Participants
|
|
Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
Platelets, increase from Grade 2 to 4
|
0 Participants
|
|
Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
Platelets, increase from Grade 3 to 4
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Safety population
Blood samples were collected up to the Month 12 visit for the analysis of clinical chemistry parameters: alanine aminotransferase (ALT), alkaline phosphate (ALP), aspartate aminotransferase (AST), bilirubin, carbon dioxide (CO2), creatine kinase (CK), creatinine, direct bilirubin, glucose, lipase, phosphate, potassium and sodium. Any abnormality in clinical chemistry parameters were evaluated according to the DAIDS toxicity scale From Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). Higher the grade, more severe the symptoms.
Outcome measures
| Measure |
Staff Study Participants
n=115 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
ALT, increase from Grade 1 to 4
|
15 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
ALT, increase from Grade 2 to 4
|
3 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
ALT, increase from Grade 3 to 4
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
ALP, increase from Grade 1 to 4
|
3 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
ALP, increase from Grade 2 to 4
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
ALP, increase from Grade 3 to 4
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
AST, increase from Grade 1 to 4
|
8 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
AST, increase from Grade 2 to 4
|
4 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
AST, increase from Grade 3 to 4
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Bilirubin, increase from Grade 1 to 4
|
4 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Bilirubin, increase from Grade 2 to 4
|
1 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Bilirubin, increase from Grade 3 to 4
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
CO2, increase from Grade 1 to 4
|
16 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
CO2, increase from Grade 2 to 4
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
CO2, increase from Grade 3 to 4
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
CK, increase from Grade 1 to 4
|
11 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
CK, increase from Grade 2 to 4
|
4 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
CK, increase from Grade 3 to 4
|
1 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Creatinine, increase from Grade 1 to 4
|
2 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Creatinine, increase from Grade 2 to 4
|
1 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Creatinine, increase from Grade 3 to 4
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Direct bilirubin, increase from Grade 1 to 4
|
1 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Direct bilirubin, increase from Grade 2 to 4
|
1 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Direct bilirubin, increase from Grade 3 to 4
|
1 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Glucose, increase from Grade 1 to 4
|
18 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Glucose, increase from Grade 2 to 4
|
8 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Glucose, increase from Grade 3 to 4
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Lipase, increase from Grade 1 to 4
|
17 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Lipase, increase from Grade 2 to 4
|
11 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Lipase, increase from Grade 3 to 4
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Phosphate, increase from Grade 1 to 4
|
16 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Phosphate, increase from Grade 2 to 4
|
4 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Phosphate, increase from Grade 3 to 4
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Potassium, increase from Grade 1 to 4
|
4 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Potassium, increase from Grade 2 to 4
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Potassium, increase from Grade 3 to 4
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Sodium, increase from Grade 1 to 4
|
6 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Sodium, increase from Grade 2 to 4
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Sodium, increase from Grade 3 to 4
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 30 monthsPopulation: Safety population
Blood samples were collected for the analysis of clinical chemistry parameters: ALT, ALP, AST, bilirubin, CO2, CK, creatinine, direct bilirubin, Glomerular filtration rate (GFR) from Creatinine (Creat) Adjusted (Adj) using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), GFR From Creat Adj for body surface area (BSA), glucose, lipase, phosphate, potassium and sodium. Any abnormality in clinical chemistry parameters were evaluated according to the DAIDS toxicity scale From Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). Higher the grade, more severe the symptoms.
Outcome measures
| Measure |
Staff Study Participants
n=115 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
Sodium, increase from Grade 2 to 4
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
ALT, increase from Grade 1 to 4
|
24 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
ALT, increase from Grade 2 to 4
|
6 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
ALT, increase from Grade 3 to 4
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
ALP, increase from Grade 1 to 4
|
3 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
ALP, increase from Grade 2 to 4
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
ALP, increase from Grade 3 to 4
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
AST, increase from Grade 1 to 4
|
13 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
AST, increase from Grade 2 to 4
|
5 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
AST, increase from Grade 3 to 4
|
1 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
Bilirubin, increase from Grade 1 to 4
|
6 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
Bilirubin, increase from Grade 2 to 4
|
1 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
Bilirubin, increase from Grade 3 to 4
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
CO2, increase from Grade 1 to 4
|
18 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
CO2, increase from Grade 2 to 4
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
CO2, increase from Grade 3 to 4
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
CK, increase from Grade 1 to 4
|
18 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
CK, increase from Grade 2 to 4
|
9 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
CK, increase from Grade 3 to 4
|
4 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
Creatinine, increase from Grade 1 to 4
|
5 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
Creatinine, increase from Grade 2 to 4
|
1 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
Creatinine, increase from Grade 3 to 4
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
Direct bilirubin, increase from Grade 1 to 4
|
1 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
Direct bilirubin, increase from Grade 2 to 4
|
1 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
Direct bilirubin, increase from Grade 3 to 4
|
1 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
GFR From Creat Adj Using CKD-EPI increase from Grade 1 to 4
|
27 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
GFR From Creat Adj Using CKD-EPI increase from Grade 2 to 4
|
27 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
GFR From Creat Adj Using CKD-EPI increase from Grade 3 to 4
|
6 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
GFR From Creat Adj for BSA increase from Grade 1 to 4
|
27 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
GFR From Creat Adj for BSA increase from Grade 2 to 4
|
27 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
GFR From Creat Adj for BSA increase from Grade 3 to 4
|
6 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
Glucose, increase from Grade 1 to 4
|
26 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
Glucose, increase from Grade 2 to 4
|
16 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
Glucose, increase from Grade 3 to 4
|
2 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
Lipase, increase from Grade 1 to 4
|
23 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
Lipase, increase from Grade 2 to 4
|
16 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
Lipase, increase from Grade 3 to 4
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
Phosphate, increase from Grade 1 to 4
|
22 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
Phosphate, increase from Grade 2 to 4
|
6 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
Phosphate, increase from Grade 3 to 4
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
Potassium, increase from Grade 1 to 4
|
4 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
Potassium, increase from Grade 2 to 4
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
Potassium, increase from Grade 3 to 4
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
Sodium, increase from Grade 1 to 4
|
7 Participants
|
|
Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study
Sodium, increase from Grade 3 to 4
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Safety population
Urine samples were collected to analyze the urine parameters: Protein, occult blood or glucose. Potential clinical importance is defined as an increase in protein (dipstick) or occult blood (dipstick) post-Baseline relative to Baseline. Number of participants with results of potential clinical importance in any of the urine parameters is presented.
Outcome measures
| Measure |
Staff Study Participants
n=115 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Number of Participants With Urinalysis Result of Potential Clinical Importance
|
8 Participants
|
SECONDARY outcome
Timeframe: Up to 30 monthsPopulation: Safety population
Urine samples were collected to analyze the urine parameters: Protein, occult blood or glucose. Potential clinical importance is defined as an increase in protein (dipstick) or occult blood (dipstick) post-Baseline relative to Baseline. Number of participants with results of potential clinical importance in any of the urine parameters is presented.
Outcome measures
| Measure |
Staff Study Participants
n=115 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Number of Participants With Urinalysis Result of Potential Clinical Importance Through End of Study
|
1 Participants
|
SECONDARY outcome
Timeframe: Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12Population: Safety population.
Local tolerability was measured by injection site reaction (ISR), for example; bruise at the site of injection and/or itching, pain, blistering or skin damage. ISRs were assigned to the most recent planned injection visit prior to/on the onset date of the ISR. Number of participants with ISRs by each assigned injection visit is presented.
Outcome measures
| Measure |
Staff Study Participants
n=115 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Number of Participants With Injection Site Reactions (ISRs) Over Time
Month 1
|
109 Participants
|
|
Number of Participants With Injection Site Reactions (ISRs) Over Time
Month 5
|
104 Participants
|
|
Number of Participants With Injection Site Reactions (ISRs) Over Time
Month 2
|
108 Participants
|
|
Number of Participants With Injection Site Reactions (ISRs) Over Time
Month 3
|
106 Participants
|
|
Number of Participants With Injection Site Reactions (ISRs) Over Time
Month 4
|
105 Participants
|
|
Number of Participants With Injection Site Reactions (ISRs) Over Time
Month 6
|
103 Participants
|
|
Number of Participants With Injection Site Reactions (ISRs) Over Time
Month 7
|
103 Participants
|
|
Number of Participants With Injection Site Reactions (ISRs) Over Time
Month 8
|
102 Participants
|
|
Number of Participants With Injection Site Reactions (ISRs) Over Time
Month 9
|
100 Participants
|
|
Number of Participants With Injection Site Reactions (ISRs) Over Time
Month 10
|
100 Participants
|
|
Number of Participants With Injection Site Reactions (ISRs) Over Time
Month 11
|
100 Participants
|
|
Number of Participants With Injection Site Reactions (ISRs) Over Time
Month 12
|
101 Participants
|
SECONDARY outcome
Timeframe: Months 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29 and 30Population: Safety population.
Local tolerability was measured by injection site reaction (ISR), for example; bruise at the site of injection and/or itching, pain, blistering or skin damage. ISRs were assigned to the most recent planned injection visit prior to/on the onset date of the ISR. Number of participants with ISRs by each assigned injection visit is presented.
Outcome measures
| Measure |
Staff Study Participants
n=115 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Number of Participants With Injection Site Reactions (ISRs) Over Time From Month 13 to Month 30
Month 30
|
1 Participants
|
|
Number of Participants With Injection Site Reactions (ISRs) Over Time From Month 13 to Month 30
Month 13
|
99 Participants
|
|
Number of Participants With Injection Site Reactions (ISRs) Over Time From Month 13 to Month 30
Month 14
|
99 Participants
|
|
Number of Participants With Injection Site Reactions (ISRs) Over Time From Month 13 to Month 30
Month 15
|
98 Participants
|
|
Number of Participants With Injection Site Reactions (ISRs) Over Time From Month 13 to Month 30
Month 16
|
96 Participants
|
|
Number of Participants With Injection Site Reactions (ISRs) Over Time From Month 13 to Month 30
Month 17
|
95 Participants
|
|
Number of Participants With Injection Site Reactions (ISRs) Over Time From Month 13 to Month 30
Month 18
|
97 Participants
|
|
Number of Participants With Injection Site Reactions (ISRs) Over Time From Month 13 to Month 30
Month 19
|
95 Participants
|
|
Number of Participants With Injection Site Reactions (ISRs) Over Time From Month 13 to Month 30
Month 20
|
86 Participants
|
|
Number of Participants With Injection Site Reactions (ISRs) Over Time From Month 13 to Month 30
Month 21
|
75 Participants
|
|
Number of Participants With Injection Site Reactions (ISRs) Over Time From Month 13 to Month 30
Month 22
|
65 Participants
|
|
Number of Participants With Injection Site Reactions (ISRs) Over Time From Month 13 to Month 30
Month 23
|
49 Participants
|
|
Number of Participants With Injection Site Reactions (ISRs) Over Time From Month 13 to Month 30
Month 24
|
35 Participants
|
|
Number of Participants With Injection Site Reactions (ISRs) Over Time From Month 13 to Month 30
Month 25
|
19 Participants
|
|
Number of Participants With Injection Site Reactions (ISRs) Over Time From Month 13 to Month 30
Month 26
|
11 Participants
|
|
Number of Participants With Injection Site Reactions (ISRs) Over Time From Month 13 to Month 30
Month 27
|
8 Participants
|
|
Number of Participants With Injection Site Reactions (ISRs) Over Time From Month 13 to Month 30
Month 28
|
7 Participants
|
|
Number of Participants With Injection Site Reactions (ISRs) Over Time From Month 13 to Month 30
Month 29
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline and up to Month 12Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the hematology parameters: Platelet count, WBC count, Basophil count, Eosinophil count, Lymphocyte count, Monocyte count and Neutrophil count. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Outcome measures
| Measure |
Staff Study Participants
n=115 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count
Platelet count, n=100
|
-0.66 10^9 cells per Liter
Standard Deviation 33.512
|
|
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count
WBC count, n=101
|
0.27 10^9 cells per Liter
Standard Deviation 1.412
|
|
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count
Basophil count, n=101
|
0.006 10^9 cells per Liter
Standard Deviation 0.0232
|
|
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count
Eosinophil count, n=101
|
0.018 10^9 cells per Liter
Standard Deviation 0.1632
|
|
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count
Lymphocyte count, n=101
|
-0.0005 10^9 cells per Liter
Standard Deviation 0.49237
|
|
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count
Monocyte count, n=101
|
0.029 10^9 cells per Liter
Standard Deviation 0.1434
|
|
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count
Neutrophil count, n=101
|
0.214 10^9 cells per Liter
Standard Deviation 1.1746
|
SECONDARY outcome
Timeframe: Baseline and up to Month 12Population: Safety population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected to analyze the hematology parameter: RBC count. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Outcome measures
| Measure |
Staff Study Participants
n=101 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Change From Baseline in Hematology Parameter: Red Blood Cell (RBC) Count
|
0.18 10^12 cells per liter
Standard Deviation 0.260
|
SECONDARY outcome
Timeframe: Baseline and up to Month 12Population: Safety population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected to analyze the hematology parameter: Hemoglobin. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Outcome measures
| Measure |
Staff Study Participants
n=101 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Change From Baseline in Hematology Parameter: Hemoglobin
|
-1.11 Grams per liter
Standard Deviation 7.221
|
SECONDARY outcome
Timeframe: Baseline and up to Month 12Population: Safety population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected to analyze the hematology parameter: Hematocrit (fraction of 1). Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Outcome measures
| Measure |
Staff Study Participants
n=101 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Change From Baseline in Hematology Parameter: Hematocrit
|
-0.0022 Percentage of red blood cells in blood
Standard Deviation 0.02554
|
SECONDARY outcome
Timeframe: Baseline and up to Month 12Population: Safety population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected to analyze the hematology parameter: Erythrocytes MCV. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Outcome measures
| Measure |
Staff Study Participants
n=101 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume (MCV)
|
-3.90 Femtoliter
Standard Deviation 2.961
|
SECONDARY outcome
Timeframe: Baseline and Months 15, 18, 21, 24, 27, 30Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the hematology parameters: Platelet count, WBC count, Basophil count, Eosinophil count, Lymphocyte count, Monocyte count and Neutrophil count. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Outcome measures
| Measure |
Staff Study Participants
n=115 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30
Lymphocyte count, Month 27, n=8
|
0.0237 10^9 cells per Liter
Standard Deviation 0.47192
|
|
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30
Eosinophil count, Month 24, n=35
|
-0.033 10^9 cells per Liter
Standard Deviation 0.2489
|
|
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30
Eosinophil count, Month 27, n=8
|
-0.060 10^9 cells per Liter
Standard Deviation 0.0650
|
|
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30
Eosinophil count, Month 30, n=1
|
0.010 10^9 cells per Liter
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
|
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30
Platelet count, Month 15, n=98
|
5.47 10^9 cells per Liter
Standard Deviation 41.191
|
|
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30
Platelet count, Month 18, n=96
|
9.59 10^9 cells per Liter
Standard Deviation 57.934
|
|
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30
Platelet count, Month 21, n=75
|
8.07 10^9 cells per Liter
Standard Deviation 34.613
|
|
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30
Platelet count, Month 24, n=35
|
14.51 10^9 cells per Liter
Standard Deviation 24.923
|
|
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30
Platelet count, Month 27, n=8
|
31.13 10^9 cells per Liter
Standard Deviation 48.265
|
|
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30
Platelet count, Month 30, n=1
|
73.00 10^9 cells per Liter
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
|
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30
WBC count, Month 15, n=99
|
0.66 10^9 cells per Liter
Standard Deviation 1.648
|
|
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30
WBC count, Month 18, n=97
|
0.23 10^9 cells per Liter
Standard Deviation 1.718
|
|
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30
WBC count, Month 21, n=75
|
0.30 10^9 cells per Liter
Standard Deviation 1.452
|
|
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30
WBC count, Month 24, n=35
|
-0.04 10^9 cells per Liter
Standard Deviation 1.463
|
|
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30
WBC count, Month 27, n=8
|
-0.05 10^9 cells per Liter
Standard Deviation 1.543
|
|
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30
WBC count, Month 30, n=1
|
0.40 10^9 cells per Liter
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
|
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30
Basophil count, Month 15, n=99
|
0.009 10^9 cells per Liter
Standard Deviation 0.0292
|
|
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30
Basophil count, Month 18, n=97
|
0.008 10^9 cells per Liter
Standard Deviation 0.0374
|
|
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30
Basophil count, Month 21, n=75
|
0.001 10^9 cells per Liter
Standard Deviation 0.0243
|
|
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30
Basophil count, Month 24, n=35
|
-0.002 10^9 cells per Liter
Standard Deviation 0.0268
|
|
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30
Basophil count, Month 27, n=8
|
0.010 10^9 cells per Liter
Standard Deviation 0.0351
|
|
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30
Basophil count, Month 30, n=1
|
0.060 10^9 cells per Liter
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
|
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30
Eosinophil count, Month 15, n=99
|
0.019 10^9 cells per Liter
Standard Deviation 0.1623
|
|
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30
Eosinophil count, Month 18, n=97
|
0.008 10^9 cells per Liter
Standard Deviation 0.1609
|
|
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30
Eosinophil count, Month 21, n=75
|
-0.001 10^9 cells per Liter
Standard Deviation 0.1683
|
|
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30
Lymphocyte count, Month 15, n=99
|
0.1654 10^9 cells per Liter
Standard Deviation 0.53448
|
|
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30
Lymphocyte count, Month 18, n=97
|
0.1315 10^9 cells per Liter
Standard Deviation 0.71555
|
|
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30
Lymphocyte count, Month 21, n=75
|
0.0360 10^9 cells per Liter
Standard Deviation 0.51313
|
|
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30
Lymphocyte count, Month 24, n=35
|
-0.1046 10^9 cells per Liter
Standard Deviation 0.50251
|
|
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30
Lymphocyte count, Month 30, n=1
|
-0.2100 10^9 cells per Liter
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
|
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30
Monocyte count, Month 15, n=99
|
0.091 10^9 cells per Liter
Standard Deviation 0.1707
|
|
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30
Monocyte count, Month 18, n=97
|
0.085 10^9 cells per Liter
Standard Deviation 0.2257
|
|
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30
Monocyte count, Month 21, n=75
|
0.048 10^9 cells per Liter
Standard Deviation 0.1280
|
|
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30
Monocyte count, Month 24, n=35
|
-0.009 10^9 cells per Liter
Standard Deviation 0.1228
|
|
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30
Monocyte count, Month 27, n=8
|
-0.030 10^9 cells per Liter
Standard Deviation 0.1743
|
|
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30
Monocyte count, Month 30, n=1
|
0.110 10^9 cells per Liter
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
|
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30
Neutrophil count, Month 15, n=99
|
0.365 10^9 cells per Liter
Standard Deviation 1.3448
|
|
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30
Neutrophil count, Month 18, n=97
|
-0.007 10^9 cells per Liter
Standard Deviation 1.2956
|
|
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30
Neutrophil count, Month 21, n=75
|
0.211 10^9 cells per Liter
Standard Deviation 1.2534
|
|
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30
Neutrophil count, Month 24, n=35
|
0.109 10^9 cells per Liter
Standard Deviation 1.2653
|
|
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30
Neutrophil count, Month 27, n=8
|
-0.003 10^9 cells per Liter
Standard Deviation 1.0602
|
|
Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30
Neutrophil count, Month 30, n=1
|
0.350 10^9 cells per Liter
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
SECONDARY outcome
Timeframe: Baseline and Months 15, 18, 21, 24, 27, 30Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the hematology parameter: RBC count. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Outcome measures
| Measure |
Staff Study Participants
n=115 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Change From Baseline in Hematology Parameter-Red Blood Cell (RBC) Count From Month 15 to Month 30
Month 15, n=99
|
0.17 10^12 cells per liter
Standard Deviation 0.245
|
|
Change From Baseline in Hematology Parameter-Red Blood Cell (RBC) Count From Month 15 to Month 30
Month 18, n=97
|
0.19 10^12 cells per liter
Standard Deviation 0.313
|
|
Change From Baseline in Hematology Parameter-Red Blood Cell (RBC) Count From Month 15 to Month 30
Month 21, n=75
|
0.19 10^12 cells per liter
Standard Deviation 0.248
|
|
Change From Baseline in Hematology Parameter-Red Blood Cell (RBC) Count From Month 15 to Month 30
Month 24, n=35
|
0.16 10^12 cells per liter
Standard Deviation 0.274
|
|
Change From Baseline in Hematology Parameter-Red Blood Cell (RBC) Count From Month 15 to Month 30
Month 27, n=8
|
0.14 10^12 cells per liter
Standard Deviation 0.267
|
|
Change From Baseline in Hematology Parameter-Red Blood Cell (RBC) Count From Month 15 to Month 30
Month 30, n=1
|
0.10 10^12 cells per liter
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
SECONDARY outcome
Timeframe: Baseline and Months 15, 18, 21, 24, 27, 30Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the hematology parameter: Hemoglobin. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Outcome measures
| Measure |
Staff Study Participants
n=115 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Change From Baseline in Hematology Parameter-Hemoglobin From Month 15 to Month 30
Month 15, n=99
|
-0.71 Grams per liter
Standard Deviation 7.172
|
|
Change From Baseline in Hematology Parameter-Hemoglobin From Month 15 to Month 30
Month 18, n=97
|
-0.29 Grams per liter
Standard Deviation 9.920
|
|
Change From Baseline in Hematology Parameter-Hemoglobin From Month 15 to Month 30
Month 21, n=75
|
-1.09 Grams per liter
Standard Deviation 6.717
|
|
Change From Baseline in Hematology Parameter-Hemoglobin From Month 15 to Month 30
Month 24, n=35
|
-2.26 Grams per liter
Standard Deviation 7.636
|
|
Change From Baseline in Hematology Parameter-Hemoglobin From Month 15 to Month 30
Month 27, n=8
|
-3.25 Grams per liter
Standard Deviation 5.203
|
|
Change From Baseline in Hematology Parameter-Hemoglobin From Month 15 to Month 30
Month 30, n=1
|
-4.00 Grams per liter
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
SECONDARY outcome
Timeframe: Baseline and Months 15, 18, 21, 24, 27, 30Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the hematology parameter: Hematocrit (fraction of 1). Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Outcome measures
| Measure |
Staff Study Participants
n=115 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Change From Baseline in Hematology Parameter-Hematocrit From Month 15 to Month 30
Month 18, n=97
|
-0.0134 Percentage of red blood cells in blood
Standard Deviation 0.02963
|
|
Change From Baseline in Hematology Parameter-Hematocrit From Month 15 to Month 30
Month 15, n=99
|
-0.0133 Percentage of red blood cells in blood
Standard Deviation 0.02272
|
|
Change From Baseline in Hematology Parameter-Hematocrit From Month 15 to Month 30
Month 21, n=75
|
-0.0091 Percentage of red blood cells in blood
Standard Deviation 0.02346
|
|
Change From Baseline in Hematology Parameter-Hematocrit From Month 15 to Month 30
Month 24, n=35
|
-0.0102 Percentage of red blood cells in blood
Standard Deviation 0.02364
|
|
Change From Baseline in Hematology Parameter-Hematocrit From Month 15 to Month 30
Month 27, n=8
|
-0.0166 Percentage of red blood cells in blood
Standard Deviation 0.01935
|
|
Change From Baseline in Hematology Parameter-Hematocrit From Month 15 to Month 30
Month 30, n=1
|
-0.0340 Percentage of red blood cells in blood
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
SECONDARY outcome
Timeframe: Baseline and Months 15, 18, 21, 24, 27, 30Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the hematology parameter: Erythrocytes MCV. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Outcome measures
| Measure |
Staff Study Participants
n=115 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Volume (MCV) From Month 15 to Month 30
Month 15, n=99
|
-6.13 Femtoliter
Standard Deviation 2.724
|
|
Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Volume (MCV) From Month 15 to Month 30
Month 18, n=97
|
-6.64 Femtoliter
Standard Deviation 3.004
|
|
Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Volume (MCV) From Month 15 to Month 30
Month 21, n=75
|
-5.61 Femtoliter
Standard Deviation 3.413
|
|
Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Volume (MCV) From Month 15 to Month 30
Month 24, n=35
|
-5.37 Femtoliter
Standard Deviation 2.691
|
|
Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Volume (MCV) From Month 15 to Month 30
Month 27, n=8
|
-6.25 Femtoliter
Standard Deviation 3.770
|
|
Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Volume (MCV) From Month 15 to Month 30
Month 30, n=1
|
-7.00 Femtoliter
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected for the analysis of hematology parameters including platelet count, WBC count, basophil count, eosinophil count, lymphocyte count, monocyte count and neutrophil count.
Outcome measures
| Measure |
Staff Study Participants
n=115 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Absolute Values of the Hematology Parameters: Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count
Platelet count, n=100
|
238.78 10^9 cells per liter
Standard Deviation 56.321
|
|
Absolute Values of the Hematology Parameters: Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count
WBC count, n=101
|
5.81 10^9 cells per liter
Standard Deviation 1.606
|
|
Absolute Values of the Hematology Parameters: Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count
Basophil count, n=101
|
0.042 10^9 cells per liter
Standard Deviation 0.0239
|
|
Absolute Values of the Hematology Parameters: Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count
Eosinophil count, n=101
|
0.160 10^9 cells per liter
Standard Deviation 0.1305
|
|
Absolute Values of the Hematology Parameters: Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count
Lymphocyte count, n=101
|
1.9528 10^9 cells per liter
Standard Deviation 0.58037
|
|
Absolute Values of the Hematology Parameters: Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count
Monocyte count, n=101
|
0.388 10^9 cells per liter
Standard Deviation 0.1352
|
|
Absolute Values of the Hematology Parameters: Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count
Neutrophil count, n=101
|
3.269 10^9 cells per liter
Standard Deviation 1.3055
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Safety population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected to analyze the hematology parameter: RBC count.
Outcome measures
| Measure |
Staff Study Participants
n=101 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Absolute Values of Hematology Parameter: RBC Count
|
4.84 10^12 cells per liter
Standard Deviation 0.504
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Safety population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected to analyze the hematology parameter: Hemoglobin
Outcome measures
| Measure |
Staff Study Participants
n=101 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Absolute Values of Hematology Parameter: Hemoglobin
|
145.19 Grams per liter
Standard Deviation 11.121
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Safety population. Only those participants with data available at the specified data points were analyzed
Blood samples were collected to analyze the hematology parameter: Hematocrit (fraction of 1)
Outcome measures
| Measure |
Staff Study Participants
n=101 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Absolute Values of Hematology Parameter: Hematocrit
|
0.4445 Percentage of red blood cells in blood
Standard Deviation 0.03412
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Safety population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected to analyze the hematology parameter: Erythrocytes MCV.
Outcome measures
| Measure |
Staff Study Participants
n=101 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Absolute Values of Hematology Parameter: Erythrocytes MCV
|
92.37 Femtoliter
Standard Deviation 5.546
|
SECONDARY outcome
Timeframe: Months 15, 18, 21, 24, 27, 30Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected for the analysis of hematology parameters including platelet count, WBC count, basophil count, eosinophil count, lymphocyte count, monocyte count and neutrophil count.
Outcome measures
| Measure |
Staff Study Participants
n=115 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30
Lymphocyte count, Month 15, n=99
|
2.1271 10^9 cells per Liter
Standard Deviation 0.61543
|
|
Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30
Lymphocyte count, Month 18, n=97
|
2.0999 10^9 cells per Liter
Standard Deviation 0.74371
|
|
Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30
Neutrophil count, Month 15, n=99
|
3.423 10^9 cells per Liter
Standard Deviation 1.6355
|
|
Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30
Neutrophil count, Month 18, n=97
|
3.056 10^9 cells per Liter
Standard Deviation 1.3502
|
|
Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30
Neutrophil count, Month 27, n=8
|
3.906 10^9 cells per Liter
Standard Deviation 1.6430
|
|
Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30
Neutrophil count, Month 30, n=1
|
9.640 10^9 cells per Liter
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
|
Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30
Platelet count, Month 15, n=99
|
245.56 10^9 cells per Liter
Standard Deviation 62.285
|
|
Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30
Platelet count, Month 18, n=97
|
250.99 10^9 cells per Liter
Standard Deviation 68.610
|
|
Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30
Platelet count, Month 21, n=75
|
247.04 10^9 cells per Liter
Standard Deviation 50.792
|
|
Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30
Platelet count, Month 24, n=35
|
245.43 10^9 cells per Liter
Standard Deviation 54.199
|
|
Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30
Platelet count, Month 27, n=8
|
271.63 10^9 cells per Liter
Standard Deviation 81.512
|
|
Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30
Platelet count, Month 30, n=1
|
417.00 10^9 cells per Liter
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
|
Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30
WBC count, Month 15, n=99
|
6.21 10^9 cells per Liter
Standard Deviation 1.983
|
|
Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30
WBC count, Month 18, n=97
|
5.79 10^9 cells per Liter
Standard Deviation 1.748
|
|
Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30
WBC count, Month 21, n=75
|
5.92 10^9 cells per Liter
Standard Deviation 1.626
|
|
Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30
WBC count, Month 24, n=35
|
5.75 10^9 cells per Liter
Standard Deviation 1.377
|
|
Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30
WBC count, Month 27, n=8
|
6.55 10^9 cells per Liter
Standard Deviation 1.787
|
|
Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30
WBC count, Month 30, n=1
|
12.30 10^9 cells per Liter
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
|
Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30
Basophil count, Month 15, n=99
|
0.045 10^9 cells per Liter
Standard Deviation 0.0255
|
|
Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30
Basophil count, Month 18, n=97
|
0.044 10^9 cells per Liter
Standard Deviation 0.0344
|
|
Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30
Basophil count, Month 21, n=75
|
0.037 10^9 cells per Liter
Standard Deviation 0.0222
|
|
Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30
Basophil count, Month 24, n=35
|
0.033 10^9 cells per Liter
Standard Deviation 0.0214
|
|
Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30
Basophil count, Month 27, n=8
|
0.039 10^9 cells per Liter
Standard Deviation 0.0210
|
|
Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30
Basophil count, Month 30, n=1
|
0.090 10^9 cells per Liter
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
|
Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30
Eosinophil count, Month 15, n=99
|
0.163 10^9 cells per Liter
Standard Deviation 0.1238
|
|
Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30
Eosinophil count, Month 18, n=97
|
0.151 10^9 cells per Liter
Standard Deviation 0.1052
|
|
Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30
Eosinophil count, Month 21, n=75
|
0.141 10^9 cells per Liter
Standard Deviation 0.1085
|
|
Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30
Eosinophil count, Month 24, n=35
|
0.143 10^9 cells per Liter
Standard Deviation 0.1366
|
|
Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30
Eosinophil count, Month 27, n=8
|
0.090 10^9 cells per Liter
Standard Deviation 0.0366
|
|
Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30
Eosinophil count, Month 30, n=1
|
0.090 10^9 cells per Liter
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
|
Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30
Lymphocyte count, Month 21, n=75
|
2.0521 10^9 cells per Liter
Standard Deviation 0.58855
|
|
Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30
Lymphocyte count, Month 24, n=35
|
1.9229 10^9 cells per Liter
Standard Deviation 0.53307
|
|
Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30
Lymphocyte count, Month 27, n=8
|
2.1350 10^9 cells per Liter
Standard Deviation 0.63370
|
|
Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30
Lymphocyte count, Month 30, n=1
|
1.9100 10^9 cells per Liter
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
|
Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30
Monocyte count, Month 15, n=99
|
0.451 10^9 cells per Liter
Standard Deviation 0.1617
|
|
Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30
Monocyte count, Month 18, n=97
|
0.444 10^9 cells per Liter
Standard Deviation 0.2301
|
|
Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30
Monocyte count, Month 21, n=75
|
0.423 10^9 cells per Liter
Standard Deviation 0.1379
|
|
Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30
Monocyte count, Month 24, n=35
|
0.388 10^9 cells per Liter
Standard Deviation 0.0859
|
|
Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30
Monocyte count, Month 27, n=8
|
0.396 10^9 cells per Liter
Standard Deviation 0.1640
|
|
Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30
Monocyte count, Month 30, n=1
|
0.540 10^9 cells per Liter
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
|
Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30
Neutrophil count, Month 21, n=75
|
3.275 10^9 cells per Liter
Standard Deviation 1.2803
|
|
Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30
Neutrophil count, Month 24, n=35
|
3.273 10^9 cells per Liter
Standard Deviation 1.1311
|
SECONDARY outcome
Timeframe: Months 15, 18, 21, 24, 27, 30Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the hematology parameter: RBC count.
Outcome measures
| Measure |
Staff Study Participants
n=115 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Absolute Values of Hematology Parameter-RBC Count From Month 15 to Month 30
Month 15, n=99
|
4.85 10^12 cells per liter
Standard Deviation 0.482
|
|
Absolute Values of Hematology Parameter-RBC Count From Month 15 to Month 30
Month 18, n=97
|
4.85 10^12 cells per liter
Standard Deviation 0.534
|
|
Absolute Values of Hematology Parameter-RBC Count From Month 15 to Month 30
Month 21, n=75
|
4.84 10^12 cells per liter
Standard Deviation 0.474
|
|
Absolute Values of Hematology Parameter-RBC Count From Month 15 to Month 30
Month 24, n=35
|
4.90 10^12 cells per liter
Standard Deviation 0.513
|
|
Absolute Values of Hematology Parameter-RBC Count From Month 15 to Month 30
Month 27, n=8
|
4.88 10^12 cells per liter
Standard Deviation 0.557
|
|
Absolute Values of Hematology Parameter-RBC Count From Month 15 to Month 30
Month 30, n=1
|
5.10 10^12 cells per liter
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
SECONDARY outcome
Timeframe: Months 15, 18, 21, 24, 27, 30Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the hematology parameter: Hemoglobin.
Outcome measures
| Measure |
Staff Study Participants
n=115 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Absolute Values of Hematology Parameter-Hemoglobin From Month 15 to Month 30
Month 15, n=99
|
145.84 Grams per liter
Standard Deviation 10.827
|
|
Absolute Values of Hematology Parameter-Hemoglobin From Month 15 to Month 30
Month 18, n=97
|
146.08 Grams per liter
Standard Deviation 14.021
|
|
Absolute Values of Hematology Parameter-Hemoglobin From Month 15 to Month 30
Month 21, n=75
|
144.52 Grams per liter
Standard Deviation 11.781
|
|
Absolute Values of Hematology Parameter-Hemoglobin From Month 15 to Month 30
Month 24, n=35
|
144.46 Grams per liter
Standard Deviation 11.559
|
|
Absolute Values of Hematology Parameter-Hemoglobin From Month 15 to Month 30
Month 27, n=8
|
138.25 Grams per liter
Standard Deviation 18.344
|
|
Absolute Values of Hematology Parameter-Hemoglobin From Month 15 to Month 30
Month 30, n=1
|
130.00 Grams per liter
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
SECONDARY outcome
Timeframe: Months 15, 18, 21, 24, 27, 30Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the hematology parameter: Hematocrit (fraction of 1).
Outcome measures
| Measure |
Staff Study Participants
n=115 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Absolute Values of Hematology Parameter-Hematocrit From Month 15 to Month 30
Month 21, n=75
|
0.4349 Percentage of red blood cells in blood
Standard Deviation 0.03472
|
|
Absolute Values of Hematology Parameter-Hematocrit From Month 15 to Month 30
Month 15, n=99
|
0.4341 Percentage of red blood cells in blood
Standard Deviation 0.03251
|
|
Absolute Values of Hematology Parameter-Hematocrit From Month 15 to Month 30
Month 18, n=97
|
0.4335 Percentage of red blood cells in blood
Standard Deviation 0.04229
|
|
Absolute Values of Hematology Parameter-Hematocrit From Month 15 to Month 30
Month 24, n=35
|
0.4377 Percentage of red blood cells in blood
Standard Deviation 0.03484
|
|
Absolute Values of Hematology Parameter-Hematocrit From Month 15 to Month 30
Month 27, n=8
|
0.4183 Percentage of red blood cells in blood
Standard Deviation 0.05263
|
|
Absolute Values of Hematology Parameter-Hematocrit From Month 15 to Month 30
Month 30, n=1
|
0.3960 Percentage of red blood cells in blood
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
SECONDARY outcome
Timeframe: Months 15, 18, 21, 24, 27, 30Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the hematology parameter: Erythrocytes MCV.
Outcome measures
| Measure |
Staff Study Participants
n=115 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Absolute Values of Hematology Parameter-Erythrocytes MCV From Month 15 to Month 30
Month 30, n=1
|
78.00 Femtoliter
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
|
Absolute Values of Hematology Parameter-Erythrocytes MCV From Month 15 to Month 30
Month 15, n=99
|
90.16 Femtoliter
Standard Deviation 5.138
|
|
Absolute Values of Hematology Parameter-Erythrocytes MCV From Month 15 to Month 30
Month 18, n=97
|
89.64 Femtoliter
Standard Deviation 5.048
|
|
Absolute Values of Hematology Parameter-Erythrocytes MCV From Month 15 to Month 30
Month 21, n=75
|
90.39 Femtoliter
Standard Deviation 5.533
|
|
Absolute Values of Hematology Parameter-Erythrocytes MCV From Month 15 to Month 30
Month 24, n=35
|
89.74 Femtoliter
Standard Deviation 5.468
|
|
Absolute Values of Hematology Parameter-Erythrocytes MCV From Month 15 to Month 30
Month 27, n=8
|
85.75 Femtoliter
Standard Deviation 4.652
|
SECONDARY outcome
Timeframe: Baseline and up to Month 12Population: Safety population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected to analyze the chemistry parameters: Sodium, potassium, carbon dioxide, chloride, glucose, urea and phosphate. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Outcome measures
| Measure |
Staff Study Participants
n=101 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate
Sodium
|
0.2 Millimoles per liter
Standard Deviation 2.00
|
|
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate
Potassium
|
0.02 Millimoles per liter
Standard Deviation 0.295
|
|
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate
Carbon dioxide
|
-0.0 Millimoles per liter
Standard Deviation 2.20
|
|
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate
Chloride
|
-0.8 Millimoles per liter
Standard Deviation 2.34
|
|
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate
Glucose
|
-0.37 Millimoles per liter
Standard Deviation 1.636
|
|
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate
Urea
|
0.13 Millimoles per liter
Standard Deviation 1.324
|
|
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate
Phosphate
|
-0.005 Millimoles per liter
Standard Deviation 0.1853
|
SECONDARY outcome
Timeframe: Baseline and up to Month 12Population: Safety Population. Only those participants with data available at the indicated time points were analyzed.
Blood samples were collected to analyze the chemistry parameters: Creatinine and Bilirubin. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Outcome measures
| Measure |
Staff Study Participants
n=101 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Change From Baseline in Clinical Laboratory Parameters: Creatinine and Bilirubin
Creatinine
|
-1.59 Micromoles per liter
Standard Deviation 14.736
|
|
Change From Baseline in Clinical Laboratory Parameters: Creatinine and Bilirubin
Bilirubin
|
0.9 Micromoles per liter
Standard Deviation 4.24
|
SECONDARY outcome
Timeframe: Baseline and up to Month 12Population: Safety Population. Only those participants with data available at the indicated time points were analyzed.
Blood samples were collected to analyze the chemistry parameters: ALT, AST, ALP and creatine kinase. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Outcome measures
| Measure |
Staff Study Participants
n=101 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase
ALT
|
1.1 International units per liter
Standard Deviation 14.17
|
|
Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase
AST
|
0.5 International units per liter
Standard Deviation 11.59
|
|
Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase
ALP
|
0.3 International units per liter
Standard Deviation 12.27
|
|
Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase
Creatine kinase
|
-29.1 International units per liter
Standard Deviation 278.65
|
SECONDARY outcome
Timeframe: Baseline and up to Month 12Population: Safety Population. Only those participants with data available at the indicated time points were analyzed.
Blood samples were collected from participants at indicated time points to analyze the clinical chemistry parameter: GFR from creatinine adjusted for BSA. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Outcome measures
| Measure |
Staff Study Participants
n=101 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Change From Baseline in Clinical Laboratory Parameter: Glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA)
|
0.00520 Milliliters/seconds/1.73 meter square
Standard Deviation 0.221404
|
SECONDARY outcome
Timeframe: Baseline and up to Month 12Population: Safety Population. Only those participants with data available at the indicated time points were analyzed.
Blood samples were collected for the analysis of clinical chemistry parameter: Lipase. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Outcome measures
| Measure |
Staff Study Participants
n=101 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Change From Baseline in Clinical Laboratory Parameter: Lipase
|
-2.3 Units per liter
Standard Deviation 21.54
|
SECONDARY outcome
Timeframe: Baseline and up to Month 12Population: Safety Population. Only those participants with data available at the indicated time points were analyzed.
Blood samples were collected for the analysis of clinical chemistry parameter: Albumin. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Outcome measures
| Measure |
Staff Study Participants
n=101 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Change From Baseline in Clinical Laboratory Parameter: Albumin
|
0.2 Grams per liter
Standard Deviation 2.54
|
SECONDARY outcome
Timeframe: Baseline and Months 15, 18, 21, 24, 27, 30Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the chemistry parameters: Sodium, potassium, carbon dioxide, chloride, glucose, urea and phosphate. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Outcome measures
| Measure |
Staff Study Participants
n=115 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Potassium, Month 21, n=75
|
-0.05 Millimoles per liter
Standard Deviation 0.321
|
|
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Potassium, Month 24, n=35
|
-0.10 Millimoles per liter
Standard Deviation 0.335
|
|
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Sodium, Month 15, n=99
|
-0.2 Millimoles per liter
Standard Deviation 1.93
|
|
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Sodium, Month 18, n=97
|
-0.2 Millimoles per liter
Standard Deviation 1.78
|
|
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Sodium, Month 21, n=75
|
-0.6 Millimoles per liter
Standard Deviation 1.97
|
|
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Sodium, Month 24, n=35
|
-0.9 Millimoles per liter
Standard Deviation 2.39
|
|
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Sodium, Month 27, n=8
|
-1.1 Millimoles per liter
Standard Deviation 2.03
|
|
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Sodium, Month 30, n=1
|
-2.0 Millimoles per liter
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
|
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Potassium, Month 15, n=99
|
0.02 Millimoles per liter
Standard Deviation 0.325
|
|
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Potassium, Month 18, n=97
|
0.03 Millimoles per liter
Standard Deviation 0.315
|
|
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Potassium, Month 27, n=8
|
-0.13 Millimoles per liter
Standard Deviation 0.271
|
|
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Potassium, Month 30,n=1
|
0.40 Millimoles per liter
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
|
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Carbon dioxide, Month 15, n=99
|
0.7 Millimoles per liter
Standard Deviation 2.10
|
|
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Carbon dioxide, Month 18, n=97
|
1.0 Millimoles per liter
Standard Deviation 2.26
|
|
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Carbon dioxide, Month 21, n=75
|
0.6 Millimoles per liter
Standard Deviation 1.86
|
|
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Carbon dioxide, Month 24, n=35
|
0.3 Millimoles per liter
Standard Deviation 2.09
|
|
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Carbon dioxide, Month 27, n=8
|
0.4 Millimoles per liter
Standard Deviation 2.72
|
|
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Carbon dioxide, Month 30, n=1
|
2.0 Millimoles per liter
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
|
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Chloride, Month 15, n=99
|
-1.5 Millimoles per liter
Standard Deviation 2.29
|
|
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Chloride, Month 18, n=97
|
-1.6 Millimoles per liter
Standard Deviation 2.31
|
|
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Chloride, Month 21, n=75
|
-2.2 Millimoles per liter
Standard Deviation 2.30
|
|
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Chloride, Month 24, n=35
|
-1.8 Millimoles per liter
Standard Deviation 2.21
|
|
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Chloride, Month 27, n=8
|
-1.3 Millimoles per liter
Standard Deviation 1.58
|
|
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Chloride, Month 30, n=1
|
-3.0 Millimoles per liter
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
|
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Glucose, Month 15, n=99
|
0.05 Millimoles per liter
Standard Deviation 1.907
|
|
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Glucose, Month 18, n=97
|
0.22 Millimoles per liter
Standard Deviation 2.804
|
|
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Glucose, Month 21, n=75
|
0.24 Millimoles per liter
Standard Deviation 2.033
|
|
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Glucose, Month 24, n=35
|
0.42 Millimoles per liter
Standard Deviation 2.546
|
|
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Glucose, Month 27, n=8
|
-0.30 Millimoles per liter
Standard Deviation 1.278
|
|
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Glucose, Month 30, n=1
|
-0.30 Millimoles per liter
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
|
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Urea; Month 15, n=99
|
-0.15 Millimoles per liter
Standard Deviation 1.157
|
|
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Urea; Month 18, n=97
|
0.04 Millimoles per liter
Standard Deviation 1.364
|
|
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Urea; Month 21, n=75
|
-0.06 Millimoles per liter
Standard Deviation 1.271
|
|
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Urea; Month 24, n=35
|
0.04 Millimoles per liter
Standard Deviation 1.114
|
|
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Urea; Month 27 , n=8
|
0.63 Millimoles per liter
Standard Deviation 1.458
|
|
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Urea; Month 30, n=1
|
1.00 Millimoles per liter
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
|
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Phosphate; Month 15, n=99
|
0.006 Millimoles per liter
Standard Deviation 0.2069
|
|
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Phosphate; Month 18, n=97
|
-0.007 Millimoles per liter
Standard Deviation 0.2015
|
|
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Phosphate; Month 21, n=75
|
0.001 Millimoles per liter
Standard Deviation 0.1940
|
|
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Phosphate; Month 24, n=35
|
-0.009 Millimoles per liter
Standard Deviation 0.2248
|
|
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Phosphate; Month 27, n=8
|
0.031 Millimoles per liter
Standard Deviation 0.2120
|
|
Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Phosphate; Month 30, n=1
|
0.350 Millimoles per liter
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
SECONDARY outcome
Timeframe: Baseline and Months 15, 18, 21, 24, 27, 30Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the chemistry parameters: Creatinine and Bilirubin. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Outcome measures
| Measure |
Staff Study Participants
n=115 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Change From Baseline in Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30
Creatinine, Month 15, n=99
|
-2.73 Micromoles per liter
Standard Deviation 13.479
|
|
Change From Baseline in Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30
Creatinine, Month 18, n=97
|
3.19 Micromoles per liter
Standard Deviation 12.588
|
|
Change From Baseline in Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30
Creatinine, Month 21, n=75
|
-2.92 Micromoles per liter
Standard Deviation 14.496
|
|
Change From Baseline in Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30
Creatinine, Month 24, n=35
|
-6.80 Micromoles per liter
Standard Deviation 16.452
|
|
Change From Baseline in Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30
Creatinine, Month 27, n=8
|
-6.95 Micromoles per liter
Standard Deviation 9.095
|
|
Change From Baseline in Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30
Creatinine, Month 30, n=1
|
-10.60 Micromoles per liter
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
|
Change From Baseline in Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30
Bilirubin, Month 15, n=99
|
0.7 Micromoles per liter
Standard Deviation 4.99
|
|
Change From Baseline in Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30
Bilirubin, Month 18, n=97
|
0.4 Micromoles per liter
Standard Deviation 4.42
|
|
Change From Baseline in Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30
Bilirubin, Month 21 n=75
|
1.7 Micromoles per liter
Standard Deviation 4.34
|
|
Change From Baseline in Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30
Bilirubin, Month 24, n=35
|
1.9 Micromoles per liter
Standard Deviation 5.75
|
|
Change From Baseline in Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30
Bilirubin, Month 27 n=8
|
0.8 Micromoles per liter
Standard Deviation 1.04
|
|
Change From Baseline in Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30
Bilirubin, Month 30, n=1
|
-4.0 Micromoles per liter
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
SECONDARY outcome
Timeframe: Baseline and Months 15, 18, 21, 24, 27, 30Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the chemistry parameters: ALT, AST, ALP and creatine kinase. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Outcome measures
| Measure |
Staff Study Participants
n=115 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30
Creatine Kinase, Month 21, n=75
|
28.0 International units per liter
Standard Deviation 454.78
|
|
Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30
ALT, Month 15, n=99
|
4.0 International units per liter
Standard Deviation 20.92
|
|
Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30
ALT, Month 18, n=97
|
2.9 International units per liter
Standard Deviation 14.96
|
|
Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30
ALT, Month 21, n=75
|
3.1 International units per liter
Standard Deviation 23.81
|
|
Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30
ALT, Month 24, n=35
|
-0.2 International units per liter
Standard Deviation 12.35
|
|
Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30
ALT, Month 27, n=8
|
1.6 International units per liter
Standard Deviation 16.16
|
|
Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30
ALT, Month 30 n=1
|
-2.0 International units per liter
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
|
Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30
ALP, Month 15, n=99
|
-2.1 International units per liter
Standard Deviation 13.62
|
|
Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30
ALP, Month 18, n=97
|
-0.8 International units per liter
Standard Deviation 14.45
|
|
Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30
ALP, Month 21, n=75
|
-0.2 International units per liter
Standard Deviation 13.61
|
|
Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30
ALP, Month 24, n=35
|
0.1 International units per liter
Standard Deviation 10.35
|
|
Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30
ALP, Month 27, n=8
|
5.5 International units per liter
Standard Deviation 12.32
|
|
Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30
ALP, Month 30, n=1
|
-9.0 International units per liter
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
|
Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30
AST, Month 15, n=99
|
1.2 International units per liter
Standard Deviation 9.63
|
|
Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30
AST, Month 18, n=97
|
4.1 International units per liter
Standard Deviation 26.52
|
|
Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30
AST, Month 21, n=75
|
1.4 International units per liter
Standard Deviation 8.80
|
|
Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30
AST, Month 24, n=35
|
-0.5 International units per liter
Standard Deviation 5.54
|
|
Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30
AST, Month 27, n=8
|
1.6 International units per liter
Standard Deviation 9.65
|
|
Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30
AST, Month 30, n=1
|
-1.0 International units per liter
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
|
Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30
Creatine Kinase, Month 15, n=99
|
-25.0 International units per liter
Standard Deviation 306.57
|
|
Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30
Creatine Kinase, Month 18, n=97
|
132.5 International units per liter
Standard Deviation 1053.02
|
|
Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30
Creatine Kinase, Month 24, n=35
|
-61.7 International units per liter
Standard Deviation 376.27
|
|
Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30
Creatine Kinase, Month 27, n=8
|
70.8 International units per liter
Standard Deviation 107.32
|
|
Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30
Creatine Kinase, Month 30, n=1
|
-8.0 International units per liter
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
SECONDARY outcome
Timeframe: Baseline and Months 15, 18, 21, 24, 27, 30Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected from participants at indicated time points to analyze the clinical chemistry parameter: GFR from creatinine adjusted for BSA. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Outcome measures
| Measure |
Staff Study Participants
n=115 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Change From Baseline in Clinical Laboratory Parameter-glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA) From Month 15 to Month 30
Month 15, n=99
|
0.03216 Milliliters/seconds/1.73 meter square
Standard Deviation 0.210193
|
|
Change From Baseline in Clinical Laboratory Parameter-glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA) From Month 15 to Month 30
Month 18, n=93
|
-0.09140 Milliliters/seconds/1.73 meter square
Standard Deviation 0.190551
|
|
Change From Baseline in Clinical Laboratory Parameter-glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA) From Month 15 to Month 30
Month 21, n=75
|
0.02044 Milliliters/seconds/1.73 meter square
Standard Deviation 0.203936
|
|
Change From Baseline in Clinical Laboratory Parameter-glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA) From Month 15 to Month 30
Month 24, n=35
|
0.07667 Milliliters/seconds/1.73 meter square
Standard Deviation 0.252677
|
|
Change From Baseline in Clinical Laboratory Parameter-glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA) From Month 15 to Month 30
Month 27, n=7
|
0.06905 Milliliters/seconds/1.73 meter square
Standard Deviation 0.173056
|
|
Change From Baseline in Clinical Laboratory Parameter-glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA) From Month 15 to Month 30
Month 30, n=1
|
0.20000 Milliliters/seconds/1.73 meter square
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
SECONDARY outcome
Timeframe: Baseline and Months 15, 18, 21, 24, 27, 30Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected for the analysis of clinical chemistry parameter: Lipase. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Outcome measures
| Measure |
Staff Study Participants
n=115 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Change From Baseline in Clinical Laboratory Parameter- Lipase From Month 15 to Month 30
Month 21, n=75
|
-1.3 Units per liter
Standard Deviation 29.74
|
|
Change From Baseline in Clinical Laboratory Parameter- Lipase From Month 15 to Month 30
Month 24, n=35
|
-9.9 Units per liter
Standard Deviation 53.42
|
|
Change From Baseline in Clinical Laboratory Parameter- Lipase From Month 15 to Month 30
Month 15, n=99
|
2.2 Units per liter
Standard Deviation 32.47
|
|
Change From Baseline in Clinical Laboratory Parameter- Lipase From Month 15 to Month 30
Month 18, n=93
|
0.9 Units per liter
Standard Deviation 31.03
|
|
Change From Baseline in Clinical Laboratory Parameter- Lipase From Month 15 to Month 30
Month 27, n=8
|
5.9 Units per liter
Standard Deviation 23.43
|
|
Change From Baseline in Clinical Laboratory Parameter- Lipase From Month 15 to Month 30
Month 30, n=1
|
2.0 Units per liter
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
SECONDARY outcome
Timeframe: Baseline and Months 15, 18, 21, 24, 27, 30Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected for the analysis of clinical chemistry parameter-Albumin. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Outcome measures
| Measure |
Staff Study Participants
n=115 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Change From Baseline in Clinical Laboratory Parameter-Albumin From Month 15 to Month 30
Month 15, n=99
|
-0.0 Grams per liter
Standard Deviation 2.63
|
|
Change From Baseline in Clinical Laboratory Parameter-Albumin From Month 15 to Month 30
Month 18, n=97
|
-0.2 Grams per liter
Standard Deviation 2.75
|
|
Change From Baseline in Clinical Laboratory Parameter-Albumin From Month 15 to Month 30
Month 21, n=75
|
-0.3 Grams per liter
Standard Deviation 2.16
|
|
Change From Baseline in Clinical Laboratory Parameter-Albumin From Month 15 to Month 30
Month 24, n=35
|
-0.5 Grams per liter
Standard Deviation 2.09
|
|
Change From Baseline in Clinical Laboratory Parameter-Albumin From Month 15 to Month 30
Month 27, n=8
|
0.0 Grams per liter
Standard Deviation 1.85
|
|
Change From Baseline in Clinical Laboratory Parameter-Albumin From Month 15 to Month 30
Month 30, n=1
|
0.0 Grams per liter
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Safety population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected to analyze the chemistry parameters: Sodium, potassium, carbon dioxide, chloride, glucose, urea and phosphate.
Outcome measures
| Measure |
Staff Study Participants
n=101 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Absolute Values of Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate
Sodium
|
139.7 Millimoles per liter
Standard Deviation 1.67
|
|
Absolute Values of Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate
Potassium
|
4.15 Millimoles per liter
Standard Deviation 0.309
|
|
Absolute Values of Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate
Carbon dioxide
|
23.1 Millimoles per liter
Standard Deviation 2.02
|
|
Absolute Values of Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate
Chloride
|
103.8 Millimoles per liter
Standard Deviation 2.18
|
|
Absolute Values of Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate
Glucose
|
5.26 Millimoles per liter
Standard Deviation 1.425
|
|
Absolute Values of Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate
Urea
|
5.08 Millimoles per liter
Standard Deviation 1.588
|
|
Absolute Values of Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate
Phosphate
|
1.087 Millimoles per liter
Standard Deviation 0.1687
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Safety Population. Only those participants with data available at the indicated time points were analyzed.
Blood samples were collected to analyze the chemistry parameters: Creatinine and Bilirubin.
Outcome measures
| Measure |
Staff Study Participants
n=101 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Absolute Values of Clinical Laboratory Parameters: Creatinine and Bilirubin
Creatinine
|
89.10 Micromoles per liter
Standard Deviation 15.229
|
|
Absolute Values of Clinical Laboratory Parameters: Creatinine and Bilirubin
Bilirubin
|
10.0 Micromoles per liter
Standard Deviation 5.10
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Safety Population. Only those participants with data available at the indicated time points were analyzed.
Blood samples were collected to analyze the chemistry parameters: ALT, AST, ALP and creatine kinase.
Outcome measures
| Measure |
Staff Study Participants
n=101 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase
ALT
|
24.6 International units per liter
Standard Deviation 17.52
|
|
Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase
AST
|
21.7 International units per liter
Standard Deviation 14.31
|
|
Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase
ALP
|
69.0 International units per liter
Standard Deviation 19.42
|
|
Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase
Creatine kinase
|
181.4 International units per liter
Standard Deviation 153.58
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Safety Population. Only those participants with data available at the indicated time points were analyzed.
Blood samples were collected from participants to analyze the clinical chemistry parameter: GFR from Creatinine adjusted for BSA
Outcome measures
| Measure |
Staff Study Participants
n=101 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Absolute Values of Clinical Laboratory Parameter: Glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA)
|
1.60853 Milliliters/seconds/1.73 meter square
Standard Deviation 0.305979
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Safety Population. Only those participants with data available at the indicated time points were analyzed.
Blood samples were collected for the analysis of clinical chemistry parameter: Lipase.
Outcome measures
| Measure |
Staff Study Participants
n=101 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Absolute Values of Clinical Laboratory Parameter: Lipase
|
31.6 Units per liter
Standard Deviation 25.92
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Safety Population. Only those participants with data available at the indicated time points were analyzed.
Blood samples were collected for the analysis of clinical chemistry parameter: Albumin.
Outcome measures
| Measure |
Staff Study Participants
n=101 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Absolute Values of Clinical Laboratory Parameter: Albumin
|
44.7 Grams per liter
Standard Deviation 2.74
|
SECONDARY outcome
Timeframe: Months 15, 18, 21, 24, 27, 30Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the chemistry parameters: Sodium, potassium, carbon dioxide, chloride, glucose, urea and phosphate.
Outcome measures
| Measure |
Staff Study Participants
n=115 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Carbon dioxide, Month 30, n=1
|
24.0 Millimoles per liter
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
|
Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Chloride, Month 15, n=99
|
103.1 Millimoles per liter
Standard Deviation 2.29
|
|
Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Sodium, Month 15, n=99
|
139.3 Millimoles per liter
Standard Deviation 1.81
|
|
Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Sodium, Month 18, n=97
|
139.3 Millimoles per liter
Standard Deviation 1.92
|
|
Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Sodium, Month 21, n=75
|
139.0 Millimoles per liter
Standard Deviation 1.89
|
|
Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Sodium, Month 24, n=35
|
138.7 Millimoles per liter
Standard Deviation 1.87
|
|
Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Sodium, Month 27, n=8
|
138.1 Millimoles per liter
Standard Deviation 1.36
|
|
Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Sodium, Month 30, n=1
|
137.0 Millimoles per liter
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
|
Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Potassium, Month 15, n=99
|
4.15 Millimoles per liter
Standard Deviation 0.366
|
|
Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Potassium, Month 18, n=97
|
4.16 Millimoles per liter
Standard Deviation 0.340
|
|
Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Potassium, Month 21, n=75
|
4.08 Millimoles per liter
Standard Deviation 0.313
|
|
Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Potassium, Month 24, n=35
|
4.02 Millimoles per liter
Standard Deviation 0.308
|
|
Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Potassium, Month 27, n=8
|
3.94 Millimoles per liter
Standard Deviation 0.119
|
|
Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Potassium, Month 30,n=1
|
4.10 Millimoles per liter
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
|
Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Carbon dioxide, Month 15, n=99
|
23.8 Millimoles per liter
Standard Deviation 2.18
|
|
Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Carbon dioxide, Month 18, n=97
|
24.1 Millimoles per liter
Standard Deviation 2.11
|
|
Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Carbon dioxide, Month 21, n=75
|
23.8 Millimoles per liter
Standard Deviation 2.24
|
|
Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Carbon dioxide, Month 24, n=35
|
23.8 Millimoles per liter
Standard Deviation 2.09
|
|
Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Carbon dioxide, Month 27, n=8
|
23.5 Millimoles per liter
Standard Deviation 2.27
|
|
Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Chloride, Month 18, n=97
|
103.0 Millimoles per liter
Standard Deviation 2.37
|
|
Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Chloride, Month 21, n=75
|
102.6 Millimoles per liter
Standard Deviation 2.24
|
|
Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Chloride, Month 24, n=35
|
102.9 Millimoles per liter
Standard Deviation 2.18
|
|
Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Chloride, Month 27, n=8
|
103.0 Millimoles per liter
Standard Deviation 1.85
|
|
Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Chloride, Month 30, n=1
|
101.0 Millimoles per liter
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
|
Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Glucose, Month 15, n=99
|
5.72 Millimoles per liter
Standard Deviation 2.344
|
|
Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Glucose, Month 18, n=97
|
5.89 Millimoles per liter
Standard Deviation 3.089
|
|
Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Glucose, Month 21, n=75
|
5.86 Millimoles per liter
Standard Deviation 2.382
|
|
Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Glucose, Month 24, n=35
|
6.14 Millimoles per liter
Standard Deviation 3.294
|
|
Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Glucose, Month 27, n=8
|
5.33 Millimoles per liter
Standard Deviation 0.654
|
|
Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Glucose, Month 30, n=1
|
4.40 Millimoles per liter
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
|
Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Urea; Month 15, n=99
|
4.81 Millimoles per liter
Standard Deviation 1.362
|
|
Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Urea; Month 18, n=97
|
4.96 Millimoles per liter
Standard Deviation 1.413
|
|
Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Urea; Month 21, n=75
|
4.94 Millimoles per liter
Standard Deviation 1.529
|
|
Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Urea; Month 24, n=35
|
4.79 Millimoles per liter
Standard Deviation 1.313
|
|
Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Urea; Month 27 , n=8
|
5.69 Millimoles per liter
Standard Deviation 1.668
|
|
Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Urea; Month 30, n=1
|
5.00 Millimoles per liter
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
|
Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Phosphate; Month 15, n=99
|
1.091 Millimoles per liter
Standard Deviation 0.1919
|
|
Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Phosphate; Month 18, n=97
|
1.079 Millimoles per liter
Standard Deviation 0.1844
|
|
Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Phosphate; Month 21, n=75
|
1.083 Millimoles per liter
Standard Deviation 0.1848
|
|
Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Phosphate; Month 24, n=35
|
1.091 Millimoles per liter
Standard Deviation 0.1574
|
|
Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Phosphate; Month 27, n=8
|
1.119 Millimoles per liter
Standard Deviation 0.1252
|
|
Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30
Phosphate; Month 30, n=1
|
1.300 Millimoles per liter
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
SECONDARY outcome
Timeframe: Months 15, 18, 21, 24, 27, 30Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the chemistry parameters: Creatinine and Bilirubin.
Outcome measures
| Measure |
Staff Study Participants
n=115 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Absolute Values of Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30
Creatinine, Month 15, n=99
|
88.50 Micromoles per liter
Standard Deviation 13.908
|
|
Absolute Values of Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30
Creatinine, Month 18, n=97
|
94.26 Micromoles per liter
Standard Deviation 12.797
|
|
Absolute Values of Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30
Creatinine, Month 21, n=75
|
88.09 Micromoles per liter
Standard Deviation 14.410
|
|
Absolute Values of Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30
Creatinine, Month 24, n=35
|
87.77 Micromoles per liter
Standard Deviation 14.390
|
|
Absolute Values of Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30
Creatinine, Month 27, n=8
|
88.85 Micromoles per liter
Standard Deviation 12.854
|
|
Absolute Values of Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30
Creatinine, Month 30, n=1
|
91.90 Micromoles per liter
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
|
Absolute Values of Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30
Bilirubin, Month 15, n=99
|
9.9 Micromoles per liter
Standard Deviation 4.67
|
|
Absolute Values of Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30
Bilirubin, Month 18, n=97
|
9.5 Micromoles per liter
Standard Deviation 4.69
|
|
Absolute Values of Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30
Bilirubin, Month 21 n=75
|
10.7 Micromoles per liter
Standard Deviation 5.49
|
|
Absolute Values of Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30
Bilirubin, Month 24, n=35
|
10.9 Micromoles per liter
Standard Deviation 6.69
|
|
Absolute Values of Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30
Bilirubin, Month 27 n=8
|
8.5 Micromoles per liter
Standard Deviation 4.38
|
|
Absolute Values of Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30
Bilirubin, Month 30, n=1
|
4.0 Micromoles per liter
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
SECONDARY outcome
Timeframe: Months 15, 18, 21, 24, 27, 30Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the chemistry parameters: ALT, AST, ALP and creatine kinase.
Outcome measures
| Measure |
Staff Study Participants
n=115 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30
AST, Month 24, n=35
|
19.8 International units per liter
Standard Deviation 5.57
|
|
Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30
ALT, Month 15, n=99
|
27.9 International units per liter
Standard Deviation 23.06
|
|
Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30
ALT, Month 18, n=97
|
26.4 International units per liter
Standard Deviation 16.91
|
|
Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30
ALT, Month 21, n=75
|
26.2 International units per liter
Standard Deviation 23.02
|
|
Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30
ALT, Month 24, n=35
|
24.1 International units per liter
Standard Deviation 12.23
|
|
Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30
ALT, Month 27, n=8
|
24.1 International units per liter
Standard Deviation 8.03
|
|
Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30
ALT, Month 30 n=1
|
17.0 International units per liter
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
|
Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30
ALP, Month 15, n=99
|
66.3 International units per liter
Standard Deviation 19.77
|
|
Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30
ALP, Month 18, n=97
|
67.5 International units per liter
Standard Deviation 22.26
|
|
Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30
ALP, Month 21, n=75
|
68.3 International units per liter
Standard Deviation 21.10
|
|
Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30
ALP, Month 24, n=35
|
65.9 International units per liter
Standard Deviation 18.86
|
|
Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30
ALP, Month 27, n=8
|
76.9 International units per liter
Standard Deviation 15.25
|
|
Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30
ALP, Month 30, n=1
|
70.0 International units per liter
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
|
Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30
AST, Month 15, n=99
|
22.4 International units per liter
Standard Deviation 10.72
|
|
Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30
AST, Month 18, n=97
|
25.2 International units per liter
Standard Deviation 27.55
|
|
Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30
AST, Month 21, n=75
|
21.7 International units per liter
Standard Deviation 8.73
|
|
Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30
AST, Month 27, n=8
|
20.5 International units per liter
Standard Deviation 5.32
|
|
Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30
AST, Month 30, n=1
|
14.0 International units per liter
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
|
Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30
Creatine Kinase, Month 15, n=99
|
178.6 International units per liter
Standard Deviation 198.96
|
|
Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30
Creatine Kinase, Month 18, n=97
|
338.4 International units per liter
Standard Deviation 1050.63
|
|
Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30
Creatine Kinase, Month 21, n=75
|
226.9 International units per liter
Standard Deviation 374.26
|
|
Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30
Creatine Kinase, Month 24, n=35
|
151.9 International units per liter
Standard Deviation 70.67
|
|
Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30
Creatine Kinase, Month 27, n=8
|
251.9 International units per liter
Standard Deviation 139.79
|
|
Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30
Creatine Kinase, Month 30, n=1
|
165.0 International units per liter
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
SECONDARY outcome
Timeframe: Months 15, 18, 21, 24, 27, 30Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected from participants to analyze the clinical chemistry parameter: GFR from Creatinine adjusted for BSA.
Outcome measures
| Measure |
Staff Study Participants
n=115 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Absolute Values of Clinical Laboratory Parameter-glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA) From Month 15 to Month 30
Month 15, n=99
|
1.62074 Milliliters/seconds/1.73 meter square
Standard Deviation 0.285224
|
|
Absolute Values of Clinical Laboratory Parameter-glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA) From Month 15 to Month 30
Month 18, n=93
|
1.51293 Milliliters/seconds/1.73 meter square
Standard Deviation 0.275550
|
|
Absolute Values of Clinical Laboratory Parameter-glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA) From Month 15 to Month 30
Month 21, n=75
|
1.58759 Milliliters/seconds/1.73 meter square
Standard Deviation 0.293326
|
|
Absolute Values of Clinical Laboratory Parameter-glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA) From Month 15 to Month 30
Month 24, n=35
|
1.61813 Milliliters/seconds/1.73 meter square
Standard Deviation 0.292292
|
|
Absolute Values of Clinical Laboratory Parameter-glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA) From Month 15 to Month 30
Month 27, n=7
|
1.68813 Milliliters/seconds/1.73 meter square
Standard Deviation 0.187510
|
|
Absolute Values of Clinical Laboratory Parameter-glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA) From Month 15 to Month 30
Month 30, n=1
|
1.81670 Milliliters/seconds/1.73 meter square
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
SECONDARY outcome
Timeframe: Months 15, 18, 21, 24, 27, 30Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected for the analysis of clinical chemistry parameter-Lipase.
Outcome measures
| Measure |
Staff Study Participants
n=115 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Absolute Values of Clinical Laboratory Parameter-Lipase From Month 15 to Month 30
Month 21, n=75
|
34.5 Units per liter
Standard Deviation 33.39
|
|
Absolute Values of Clinical Laboratory Parameter-Lipase From Month 15 to Month 30
Month 24, n=35
|
34.6 Units per liter
Standard Deviation 26.30
|
|
Absolute Values of Clinical Laboratory Parameter-Lipase From Month 15 to Month 30
Month 27, n=8
|
38.6 Units per liter
Standard Deviation 30.26
|
|
Absolute Values of Clinical Laboratory Parameter-Lipase From Month 15 to Month 30
Month 15, n=99
|
36.0 Units per liter
Standard Deviation 33.52
|
|
Absolute Values of Clinical Laboratory Parameter-Lipase From Month 15 to Month 30
Month 18, n=93
|
35.0 Units per liter
Standard Deviation 30.44
|
|
Absolute Values of Clinical Laboratory Parameter-Lipase From Month 15 to Month 30
Month 30, n=1
|
35.0 Units per liter
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
SECONDARY outcome
Timeframe: Months 15, 18, 21, 24, 27, 30Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected for the analysis of clinical chemistry parameter-Albumin.
Outcome measures
| Measure |
Staff Study Participants
n=115 Participants
Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls
|
|---|---|
|
Absolute Values of Clinical Laboratory Parameter-Albumin From Month 15 to Month 30
Month 15, n=99
|
44.5 Grams per liter
Standard Deviation 3.02
|
|
Absolute Values of Clinical Laboratory Parameter-Albumin From Month 15 to Month 30
Month 18, n=97
|
44.3 Grams per liter
Standard Deviation 2.71
|
|
Absolute Values of Clinical Laboratory Parameter-Albumin From Month 15 to Month 30
Month 21, n=75
|
44.1 Grams per liter
Standard Deviation 2.49
|
|
Absolute Values of Clinical Laboratory Parameter-Albumin From Month 15 to Month 30
Month 24, n=35
|
43.7 Grams per liter
Standard Deviation 3.05
|
|
Absolute Values of Clinical Laboratory Parameter-Albumin From Month 15 to Month 30
Month 27, n=8
|
43.8 Grams per liter
Standard Deviation 2.82
|
|
Absolute Values of Clinical Laboratory Parameter-Albumin From Month 15 to Month 30
Month 30, n=1
|
39.0 Grams per liter
Standard Deviation NA
NA indicates that data was not available as standard deviation could not be calculated for a single participant.
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and up to Month 12Population: Safety population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
Urine samples were not planned to be collected for the analysis of urine albumin to creatinine ratio. The results for this outcome measure will never be posted.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and up to Month 12Population: Safety population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
Urine samples were not planned to be collected for the analysis of urine protein to creatinine ratio. The results for this outcome measure will never be posted.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and up to Month 12Population: Safety population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
Urine samples were not planned to be collected for the analysis of urine phosphate. The results for this outcome measure will never be posted.
Outcome measures
Outcome data not reported
Adverse Events
Participants With HIV Infection
Serious events: 9 serious events
Other events: 101 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Participants With HIV Infection
n=115 participants at risk
In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART).
|
|---|---|
|
Psychiatric disorders
Mental status changes
|
1.7%
2/115 • Number of events 2 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to 30 months
Adverse events were reported for Safety Population which comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA.Study staff participants only provided input through completion of surveys,semi-structured interviews and facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for study staff participants were not collected because it was not required per study design
|
|
Infections and infestations
Abscess limb
|
0.87%
1/115 • Number of events 1 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to 30 months
Adverse events were reported for Safety Population which comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA.Study staff participants only provided input through completion of surveys,semi-structured interviews and facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for study staff participants were not collected because it was not required per study design
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.87%
1/115 • Number of events 1 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to 30 months
Adverse events were reported for Safety Population which comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA.Study staff participants only provided input through completion of surveys,semi-structured interviews and facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for study staff participants were not collected because it was not required per study design
|
|
General disorders
Chest pain
|
1.7%
2/115 • Number of events 2 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to 30 months
Adverse events were reported for Safety Population which comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA.Study staff participants only provided input through completion of surveys,semi-structured interviews and facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for study staff participants were not collected because it was not required per study design
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.87%
1/115 • Number of events 1 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to 30 months
Adverse events were reported for Safety Population which comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA.Study staff participants only provided input through completion of surveys,semi-structured interviews and facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for study staff participants were not collected because it was not required per study design
|
|
Psychiatric disorders
Drug abuse
|
0.87%
1/115 • Number of events 1 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to 30 months
Adverse events were reported for Safety Population which comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA.Study staff participants only provided input through completion of surveys,semi-structured interviews and facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for study staff participants were not collected because it was not required per study design
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.87%
1/115 • Number of events 1 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to 30 months
Adverse events were reported for Safety Population which comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA.Study staff participants only provided input through completion of surveys,semi-structured interviews and facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for study staff participants were not collected because it was not required per study design
|
|
Injury, poisoning and procedural complications
Overdose
|
0.87%
1/115 • Number of events 1 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to 30 months
Adverse events were reported for Safety Population which comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA.Study staff participants only provided input through completion of surveys,semi-structured interviews and facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for study staff participants were not collected because it was not required per study design
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.87%
1/115 • Number of events 1 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to 30 months
Adverse events were reported for Safety Population which comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA.Study staff participants only provided input through completion of surveys,semi-structured interviews and facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for study staff participants were not collected because it was not required per study design
|
|
Infections and infestations
Staphylococcal infection
|
0.87%
1/115 • Number of events 1 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to 30 months
Adverse events were reported for Safety Population which comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA.Study staff participants only provided input through completion of surveys,semi-structured interviews and facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for study staff participants were not collected because it was not required per study design
|
|
Infections and infestations
Appendicitis
|
0.87%
1/115 • Number of events 1 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to 30 months
Adverse events were reported for Safety Population which comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA.Study staff participants only provided input through completion of surveys,semi-structured interviews and facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for study staff participants were not collected because it was not required per study design
|
|
Cardiac disorders
Cardiac failure congestive
|
0.87%
1/115 • Number of events 1 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to 30 months
Adverse events were reported for Safety Population which comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA.Study staff participants only provided input through completion of surveys,semi-structured interviews and facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for study staff participants were not collected because it was not required per study design
|
|
Gastrointestinal disorders
Pancreatitis
|
0.87%
1/115 • Number of events 1 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to 30 months
Adverse events were reported for Safety Population which comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA.Study staff participants only provided input through completion of surveys,semi-structured interviews and facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for study staff participants were not collected because it was not required per study design
|
|
Hepatobiliary disorders
Cholecystitis
|
0.87%
1/115 • Number of events 1 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to 30 months
Adverse events were reported for Safety Population which comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA.Study staff participants only provided input through completion of surveys,semi-structured interviews and facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for study staff participants were not collected because it was not required per study design
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.87%
1/115 • Number of events 1 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to 30 months
Adverse events were reported for Safety Population which comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA.Study staff participants only provided input through completion of surveys,semi-structured interviews and facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for study staff participants were not collected because it was not required per study design
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.87%
1/115 • Number of events 1 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to 30 months
Adverse events were reported for Safety Population which comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA.Study staff participants only provided input through completion of surveys,semi-structured interviews and facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for study staff participants were not collected because it was not required per study design
|
Other adverse events
| Measure |
Participants With HIV Infection
n=115 participants at risk
In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART).
|
|---|---|
|
General disorders
Injection site pain
|
55.7%
64/115 • Number of events 720 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to 30 months
Adverse events were reported for Safety Population which comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA.Study staff participants only provided input through completion of surveys,semi-structured interviews and facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for study staff participants were not collected because it was not required per study design
|
|
General disorders
Injection site discomfort
|
26.1%
30/115 • Number of events 259 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to 30 months
Adverse events were reported for Safety Population which comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA.Study staff participants only provided input through completion of surveys,semi-structured interviews and facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for study staff participants were not collected because it was not required per study design
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.4%
20/115 • Number of events 25 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to 30 months
Adverse events were reported for Safety Population which comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA.Study staff participants only provided input through completion of surveys,semi-structured interviews and facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for study staff participants were not collected because it was not required per study design
|
|
Gastrointestinal disorders
Diarrhoea
|
17.4%
20/115 • Number of events 23 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to 30 months
Adverse events were reported for Safety Population which comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA.Study staff participants only provided input through completion of surveys,semi-structured interviews and facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for study staff participants were not collected because it was not required per study design
|
|
General disorders
Fatigue
|
20.0%
23/115 • Number of events 53 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to 30 months
Adverse events were reported for Safety Population which comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA.Study staff participants only provided input through completion of surveys,semi-structured interviews and facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for study staff participants were not collected because it was not required per study design
|
|
General disorders
Injection site induration
|
13.0%
15/115 • Number of events 27 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to 30 months
Adverse events were reported for Safety Population which comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA.Study staff participants only provided input through completion of surveys,semi-structured interviews and facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for study staff participants were not collected because it was not required per study design
|
|
Nervous system disorders
Headache
|
13.9%
16/115 • Number of events 26 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to 30 months
Adverse events were reported for Safety Population which comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA.Study staff participants only provided input through completion of surveys,semi-structured interviews and facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for study staff participants were not collected because it was not required per study design
|
|
General disorders
Injection site nodule
|
12.2%
14/115 • Number of events 25 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to 30 months
Adverse events were reported for Safety Population which comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA.Study staff participants only provided input through completion of surveys,semi-structured interviews and facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for study staff participants were not collected because it was not required per study design
|
|
General disorders
Injection site swelling
|
12.2%
14/115 • Number of events 27 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to 30 months
Adverse events were reported for Safety Population which comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA.Study staff participants only provided input through completion of surveys,semi-structured interviews and facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for study staff participants were not collected because it was not required per study design
|
|
Psychiatric disorders
Insomnia
|
11.3%
13/115 • Number of events 13 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to 30 months
Adverse events were reported for Safety Population which comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA.Study staff participants only provided input through completion of surveys,semi-structured interviews and facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for study staff participants were not collected because it was not required per study design
|
|
Gastrointestinal disorders
Nausea
|
11.3%
13/115 • Number of events 15 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to 30 months
Adverse events were reported for Safety Population which comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA.Study staff participants only provided input through completion of surveys,semi-structured interviews and facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for study staff participants were not collected because it was not required per study design
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.3%
13/115 • Number of events 14 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to 30 months
Adverse events were reported for Safety Population which comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA.Study staff participants only provided input through completion of surveys,semi-structured interviews and facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for study staff participants were not collected because it was not required per study design
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.0%
15/115 • Number of events 18 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to 30 months
Adverse events were reported for Safety Population which comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA.Study staff participants only provided input through completion of surveys,semi-structured interviews and facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for study staff participants were not collected because it was not required per study design
|
|
General disorders
Injection site bruising
|
8.7%
10/115 • Number of events 13 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to 30 months
Adverse events were reported for Safety Population which comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA.Study staff participants only provided input through completion of surveys,semi-structured interviews and facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for study staff participants were not collected because it was not required per study design
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.7%
10/115 • Number of events 12 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to 30 months
Adverse events were reported for Safety Population which comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA.Study staff participants only provided input through completion of surveys,semi-structured interviews and facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for study staff participants were not collected because it was not required per study design
|
|
Infections and infestations
COVID-19
|
15.7%
18/115 • Number of events 18 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to 30 months
Adverse events were reported for Safety Population which comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA.Study staff participants only provided input through completion of surveys,semi-structured interviews and facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for study staff participants were not collected because it was not required per study design
|
|
Infections and infestations
Influenza
|
6.1%
7/115 • Number of events 7 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to 30 months
Adverse events were reported for Safety Population which comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA.Study staff participants only provided input through completion of surveys,semi-structured interviews and facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for study staff participants were not collected because it was not required per study design
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.4%
12/115 • Number of events 16 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to 30 months
Adverse events were reported for Safety Population which comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA.Study staff participants only provided input through completion of surveys,semi-structured interviews and facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for study staff participants were not collected because it was not required per study design
|
|
Infections and infestations
Proctitis gonococcal
|
6.1%
7/115 • Number of events 8 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to 30 months
Adverse events were reported for Safety Population which comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA.Study staff participants only provided input through completion of surveys,semi-structured interviews and facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for study staff participants were not collected because it was not required per study design
|
|
General disorders
Pyrexia
|
7.8%
9/115 • Number of events 28 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to 30 months
Adverse events were reported for Safety Population which comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA.Study staff participants only provided input through completion of surveys,semi-structured interviews and facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for study staff participants were not collected because it was not required per study design
|
|
Infections and infestations
Sinusitis
|
7.0%
8/115 • Number of events 8 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to 30 months
Adverse events were reported for Safety Population which comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA.Study staff participants only provided input through completion of surveys,semi-structured interviews and facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for study staff participants were not collected because it was not required per study design
|
|
General disorders
Chills
|
6.1%
7/115 • Number of events 8 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to 30 months
Adverse events were reported for Safety Population which comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA.Study staff participants only provided input through completion of surveys,semi-structured interviews and facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for study staff participants were not collected because it was not required per study design
|
|
Infections and infestations
Nasopharyngitis
|
9.6%
11/115 • Number of events 11 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to 30 months
Adverse events were reported for Safety Population which comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA.Study staff participants only provided input through completion of surveys,semi-structured interviews and facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for study staff participants were not collected because it was not required per study design
|
|
Infections and infestations
Syphilis
|
8.7%
10/115 • Number of events 10 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to 30 months
Adverse events were reported for Safety Population which comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA.Study staff participants only provided input through completion of surveys,semi-structured interviews and facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for study staff participants were not collected because it was not required per study design
|
|
Infections and infestations
Upper respiratory tract infection
|
7.8%
9/115 • Number of events 12 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to 30 months
Adverse events were reported for Safety Population which comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA.Study staff participants only provided input through completion of surveys,semi-structured interviews and facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for study staff participants were not collected because it was not required per study design
|
|
Infections and infestations
Oropharyngeal gonococcal infection
|
7.0%
8/115 • Number of events 10 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to 30 months
Adverse events were reported for Safety Population which comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA.Study staff participants only provided input through completion of surveys,semi-structured interviews and facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for study staff participants were not collected because it was not required per study design
|
|
Infections and infestations
Pharyngitis
|
7.0%
8/115 • Number of events 11 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to 30 months
Adverse events were reported for Safety Population which comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA.Study staff participants only provided input through completion of surveys,semi-structured interviews and facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for study staff participants were not collected because it was not required per study design
|
|
Infections and infestations
Gastroenteritis
|
6.1%
7/115 • Number of events 9 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to 30 months
Adverse events were reported for Safety Population which comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA.Study staff participants only provided input through completion of surveys,semi-structured interviews and facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for study staff participants were not collected because it was not required per study design
|
|
Infections and infestations
Pharyngitis streptococcal
|
5.2%
6/115 • Number of events 8 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to 30 months
Adverse events were reported for Safety Population which comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA.Study staff participants only provided input through completion of surveys,semi-structured interviews and facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for study staff participants were not collected because it was not required per study design
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.8%
9/115 • Number of events 10 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to 30 months
Adverse events were reported for Safety Population which comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA.Study staff participants only provided input through completion of surveys,semi-structured interviews and facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for study staff participants were not collected because it was not required per study design
|
|
Gastrointestinal disorders
Abdominal pain
|
5.2%
6/115 • Number of events 7 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to 30 months
Adverse events were reported for Safety Population which comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA.Study staff participants only provided input through completion of surveys,semi-structured interviews and facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for study staff participants were not collected because it was not required per study design
|
|
Psychiatric disorders
Depression
|
6.1%
7/115 • Number of events 7 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to 30 months
Adverse events were reported for Safety Population which comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA.Study staff participants only provided input through completion of surveys,semi-structured interviews and facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for study staff participants were not collected because it was not required per study design
|
|
Psychiatric disorders
Anxiety
|
5.2%
6/115 • Number of events 6 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to 30 months
Adverse events were reported for Safety Population which comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA.Study staff participants only provided input through completion of surveys,semi-structured interviews and facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for study staff participants were not collected because it was not required per study design
|
|
Renal and urinary disorders
Dysuria
|
6.1%
7/115 • Number of events 7 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to 30 months
Adverse events were reported for Safety Population which comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA.Study staff participants only provided input through completion of surveys,semi-structured interviews and facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for study staff participants were not collected because it was not required per study design
|
|
Investigations
Blood creatine phosphokinase increased
|
5.2%
6/115 • Number of events 7 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to 30 months
Adverse events were reported for Safety Population which comprised of all participants enrolled,who received atleast 1 dose of CAB LA+RPV LA.Study staff participants only provided input through completion of surveys,semi-structured interviews and facilitation calls and didn't have to complete the informed consent process and did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for study staff participants were not collected because it was not required per study design
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER