Trial Outcomes & Findings for Improving Treatment and Retention Adherence in Nontraditional Settings (NCT NCT04973254)
NCT ID: NCT04973254
Last Updated: 2025-01-15
Results Overview
The number of participants who received CAB-RPV LA injections within the treatment window.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
3 months, 6 months
Results posted on
2025-01-15
Participant Flow
Participant milestones
| Measure |
Cohort 1- HIV Injection at a Community-based Site
CAB-RPV LA administered to patients in an alternative community-based site
CAB-RPV LA: Monthly administration of injectable HIV medication
|
Cohort 2- HIV Injection at a HIV Clinic
CAB-RPV LA administered to patients in the HIV clinic
CAB-RPV LA: Monthly administration of injectable HIV medication
|
Cohort 3- Standard of Care for HIV
Individuals who share characteristics of cohort 1 and are engaged in standard of care
Standard treatment within an HIV clinic: Standard of care for HIV positive patients will be provided in the HIV clinic that may include HIV medication or may include oral medications.
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
18
|
2
|
|
Overall Study
COMPLETED
|
5
|
17
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1- HIV Injection at a Community-based Site
CAB-RPV LA administered to patients in an alternative community-based site
CAB-RPV LA: Monthly administration of injectable HIV medication
|
Cohort 2- HIV Injection at a HIV Clinic
CAB-RPV LA administered to patients in the HIV clinic
CAB-RPV LA: Monthly administration of injectable HIV medication
|
Cohort 3- Standard of Care for HIV
Individuals who share characteristics of cohort 1 and are engaged in standard of care
Standard treatment within an HIV clinic: Standard of care for HIV positive patients will be provided in the HIV clinic that may include HIV medication or may include oral medications.
|
|---|---|---|---|
|
Overall Study
Not adherent
|
0
|
1
|
0
|
Baseline Characteristics
Improving Treatment and Retention Adherence in Nontraditional Settings
Baseline characteristics by cohort
| Measure |
Cohort 1- HIV Injection at a Community-based Site
n=5 Participants
CAB-RPV LA administered to patients in an alternative community-based site
CAB-RPV LA: Monthly administration of injectable HIV medication
|
Cohort 2- HIV Injection at a HIV Clinic
n=18 Participants
CAB-RPV LA administered to patients in the HIV clinic
CAB-RPV LA: Monthly administration of injectable HIV medication
|
Cohort 3- Standard of Care for HIV
n=2 Participants
Individuals who share characteristics of cohort 1 and are engaged in standard of care
Standard treatment within an HIV clinic: Standard of care for HIV positive patients will be provided in the HIV clinic that may include HIV medication or may include oral medications.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
36 years
n=5 Participants
|
45 years
n=7 Participants
|
53.5 years
n=5 Participants
|
46 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
18 participants
n=7 Participants
|
2 participants
n=5 Participants
|
25 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 3 months, 6 monthsPopulation: Data were only analyzed for Cohorts 1 and 2 for this outcome measure since the 2 participants in Cohort 3 never came in for a study visit so no data were collected.
The number of participants who received CAB-RPV LA injections within the treatment window.
Outcome measures
| Measure |
Cohort 1- HIV Injection at a Community-based Site
n=5 Participants
CAB-RPV LA administered to patients in an alternative community-based site
CAB-RPV LA: Monthly administration of injectable HIV medication
|
Cohort 2- HIV Injection at a HIV Clinic
n=18 Participants
CAB-RPV LA administered to patients in the HIV clinic
CAB-RPV LA: Monthly administration of injectable HIV medication
|
Cohort 3- Standard of Care for HIV
Individuals who share characteristics of cohort 1 and are engaged in standard of care.
Standard of care for HIV positive patients will be provided in the HIV clinic that may include HIV medication or may include oral medications.
|
|---|---|---|---|
|
Adherence to Cabenuva Injections
3 months
|
1 Participants
|
17 Participants
|
0 Participants
|
|
Adherence to Cabenuva Injections
6 months
|
1 Participants
|
17 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 3 months, 6 monthsPopulation: Data were only analyzed for Cohorts 1 and 2 for this outcome measure since the 2 participants in Cohort 3 never came in for a study visit so no data were collected.
The number participants who had a primary care appointment in the previous 3 months.
Outcome measures
| Measure |
Cohort 1- HIV Injection at a Community-based Site
n=5 Participants
CAB-RPV LA administered to patients in an alternative community-based site
CAB-RPV LA: Monthly administration of injectable HIV medication
|
Cohort 2- HIV Injection at a HIV Clinic
n=17 Participants
CAB-RPV LA administered to patients in the HIV clinic
CAB-RPV LA: Monthly administration of injectable HIV medication
|
Cohort 3- Standard of Care for HIV
Individuals who share characteristics of cohort 1 and are engaged in standard of care.
Standard of care for HIV positive patients will be provided in the HIV clinic that may include HIV medication or may include oral medications.
|
|---|---|---|---|
|
Adherence to Primary Care Appointments
3 months
|
5 Participants
|
17 Participants
|
0 Participants
|
|
Adherence to Primary Care Appointments
6 months
|
2 Participants
|
16 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 3 months, 6 monthsPopulation: Data were only analyzed for Cohorts 1 and 2 for this outcome measure since the 2 participants in Cohort 3 never came in for a study visit so no data were collected.
The number participants who had a mental health/behavioral appointment in the previous 3 months.
Outcome measures
| Measure |
Cohort 1- HIV Injection at a Community-based Site
n=5 Participants
CAB-RPV LA administered to patients in an alternative community-based site
CAB-RPV LA: Monthly administration of injectable HIV medication
|
Cohort 2- HIV Injection at a HIV Clinic
n=17 Participants
CAB-RPV LA administered to patients in the HIV clinic
CAB-RPV LA: Monthly administration of injectable HIV medication
|
Cohort 3- Standard of Care for HIV
Individuals who share characteristics of cohort 1 and are engaged in standard of care.
Standard of care for HIV positive patients will be provided in the HIV clinic that may include HIV medication or may include oral medications.
|
|---|---|---|---|
|
Adherence to Mental Health/Behavioral Appointments
3 months
|
2 Participants
|
4 Participants
|
0 Participants
|
|
Adherence to Mental Health/Behavioral Appointments
6 months
|
1 Participants
|
3 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 3 months, 6 monthsPopulation: Data were only analyzed for Cohorts 1 and 2 for this outcome measure since the 2 participants in Cohort 3 never came in for a study visit so no data were collected.
The number participants who had a substance abuse appointment in the previous 3 months.
Outcome measures
| Measure |
Cohort 1- HIV Injection at a Community-based Site
n=5 Participants
CAB-RPV LA administered to patients in an alternative community-based site
CAB-RPV LA: Monthly administration of injectable HIV medication
|
Cohort 2- HIV Injection at a HIV Clinic
n=17 Participants
CAB-RPV LA administered to patients in the HIV clinic
CAB-RPV LA: Monthly administration of injectable HIV medication
|
Cohort 3- Standard of Care for HIV
Individuals who share characteristics of cohort 1 and are engaged in standard of care.
Standard of care for HIV positive patients will be provided in the HIV clinic that may include HIV medication or may include oral medications.
|
|---|---|---|---|
|
Adherence to Substance Abuse Appointments in Cohorts 1 and 2
6 months
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Adherence to Substance Abuse Appointments in Cohorts 1 and 2
3 months
|
5 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Cohort 1- HIV Injection at a Community-based Site
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 2- HIV Injection at a HIV Clinic
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 3- Standard of Care for HIV
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place