Trial Outcomes & Findings for A Study Evaluating Implementation Strategies for Cabotegravir (CAB)+ Rilpivirine (RPV) Long-acting (LA) Injectables for Human Immunodeficiency Virus (HIV)-1 Treatment in European Countries (NCT NCT04399551)

Results Overview

The AIM-Imp was designed to assess the acceptability of an implementation process (i.e., perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory). The measure consists of four items/statements (1. The implementation support thus far meets my approval 2. The implementation support thus far is appealing to me 3. I like the implementation support I have received 4. I welcome implementation support for the CAB + RPV injection treatment), each with a five-point rating scale (1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = completely agree). The mean score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

437 participants

Primary outcome timeframe

Baseline (Month 1) and Month 12

Results posted on

2024-04-05

Participant Flow

A total of 437 patient study participants (PSPs) \[people living with HIV\] were enrolled. 430 PSP received study treatment and were included in the safety population. Staff Study Participants (SSP) (HIV care providers, nurses/staff performing injections administrators/clinic managers) were not counted as enrolled. SSP were randomized based on implementation strategy - Enhanced (Arm-E) and Standard (Arm -S).

SSP provided input through surveys, semi-structured interviews and a selected group from the enhanced arm (Arm-E) participated in facilitation calls. Participant flow, Baseline characteristics or adverse events for SSP were not collected as it was not required per study design.

Participant milestones

Participant milestones
Measure	Patient Study Participants PSPs received one tablet of cabotegravir (CAB) 30 milligrams (mg) + rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month during the oral lead-in phase (OLI). Participants received last dose of oral regimen followed by CAB long-acting injectable (LA) 600 mg + RPV LA 900 mg injections in Month 1, one month later (Month 2), and every 2 months (Q2M) thereafter via intramuscular (IM) route.
Overall Study STARTED	430
Overall Study COMPLETED	402
Overall Study NOT COMPLETED	28

Reasons for withdrawal

Reasons for withdrawal
Measure	Patient Study Participants PSPs received one tablet of cabotegravir (CAB) 30 milligrams (mg) + rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month during the oral lead-in phase (OLI). Participants received last dose of oral regimen followed by CAB long-acting injectable (LA) 600 mg + RPV LA 900 mg injections in Month 1, one month later (Month 2), and every 2 months (Q2M) thereafter via intramuscular (IM) route.
Overall Study Adverse Event	15
Overall Study Withdrawal by Subject	6
Overall Study Physician Decision	3
Overall Study Lost to Follow-up	2
Overall Study Protocol Deviation	2

Baseline Characteristics

A Study Evaluating Implementation Strategies for Cabotegravir (CAB)+ Rilpivirine (RPV) Long-acting (LA) Injectables for Human Immunodeficiency Virus (HIV)-1 Treatment in European Countries

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patient Study Participants n=430 Participants PSPs received one tablet of cabotegravir (CAB) 30 milligrams (mg) + rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month during the oral lead-in phase (OLI). Participants received last dose of oral regimen followed by CAB long-acting injectable (LA) 600 mg + RPV LA 900 mg injections in Month 1, one month later (Month 2), and every 2 months (Q2M) thereafter via intramuscular (IM) route.
Age, Continuous	44.2 Years STANDARD_DEVIATION 10.13 • n=5 Participants
Sex: Female, Male Female	115 Participants n=5 Participants
Sex: Female, Male Male	315 Participants n=5 Participants
Race/Ethnicity, Customized American Indian Or Alaska Native	7 Participants n=5 Participants
Race/Ethnicity, Customized Asian	9 Participants n=5 Participants
Race/Ethnicity, Customized Black Or African American	76 Participants n=5 Participants
Race/Ethnicity, Customized White	336 Participants n=5 Participants
Race/Ethnicity, Customized Multiple	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Month 1) and Month 12

Population: Full analysis set included all staff study participants (SSPs) who completed at least one survey at any timepoint. Only those participants with data available at the specified time points were analyzed.

The AIM-Imp was designed to assess the acceptability of an implementation process (i.e., perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory). The measure consists of four items/statements (1. The implementation support thus far meets my approval 2. The implementation support thus far is appealing to me 3. I like the implementation support I have received 4. I welcome implementation support for the CAB + RPV injection treatment), each with a five-point rating scale (1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = completely agree). The mean score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability.

Outcome measures

Outcome measures
Measure	Staff Study Participants - Enhanced Implementation Arm n=34 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, SWAT meeting with sponsor team and principal clinic stakeholders, on-demand SWAT meeting, monthly continuous quality improvement (CQI) calls, face-to-face injection training, monthly FRAME assessment, access to patient and HCP level toolkit and CAB + RPV medical lead site visit.	Staff Study Participants - Standard Implementation Arm n=36 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI). SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.
Change From Baseline in Acceptability of Implementation Measure (AIM-Imp) Score in SSP at Month 12 Baseline (Month 1)	3.8 Scores on a scale Standard Deviation 0.76	3.9 Scores on a scale Standard Deviation 0.75
Change From Baseline in Acceptability of Implementation Measure (AIM-Imp) Score in SSP at Month 12 Month 12	0.28 Scores on a scale Standard Deviation 0.828	0.33 Scores on a scale Standard Deviation 0.666

PRIMARY outcome

Timeframe: Baseline (Month 1) and Month 12

Population: Full analysis set included all staff study participants (SSPs) who completed at least one survey at any timepoint. Only those participants with data available at the specified time points were analyzed.

The IAM-Imp is designed to assess the appropriateness of an implementation process (i.e., the perceived fit, relevance, or compatibility of the innovation for a given practice setting, provider, or consumer, and the perceived fit of the innovation to address a particular issue or problem). The IAM-Imp is a four-item/statement measure (1. The implementation support thus far seems fitting 2. The implementation support seems suitable for using the CAB + RPV injection treatment 3. The implementation support seems applicable for the CAB + RPV injection treatment 4. The implementation support seems like a good match) with a five-point rating scale (1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = completely agree). The mean score ranges from 1 to 5 with 1 indicating the least appropriateness and 5 the most appropriateness.

Outcome measures

Outcome measures
Measure	Staff Study Participants - Enhanced Implementation Arm n=34 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, SWAT meeting with sponsor team and principal clinic stakeholders, on-demand SWAT meeting, monthly continuous quality improvement (CQI) calls, face-to-face injection training, monthly FRAME assessment, access to patient and HCP level toolkit and CAB + RPV medical lead site visit.	Staff Study Participants - Standard Implementation Arm n=36 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI). SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.
Change From Baseline in Implementation Appropriateness Measure (IAM-Imp) Score in SSPs at Month 12 Baseline (Month 1)	3.8 Scores on a scale Standard Deviation 0.78	3.9 Scores on a scale Standard Deviation 0.78
Change From Baseline in Implementation Appropriateness Measure (IAM-Imp) Score in SSPs at Month 12 Month 12	0.22 Scores on a scale Standard Deviation 0.740	0.31 Scores on a scale Standard Deviation 0.729

PRIMARY outcome

Timeframe: Baseline (Month 1) and Month 12

Population: Full analysis set included all staff study participants (SSPs) who completed at least one survey at any timepoint. Only those participants with data available at the specified time points were analyzed.

The FIM-Imp was a four-item/statement measure (1. The implementation support seems implementable in our clinic/practice 2. The implementation support seems possible in our clinic/practice 3. The implementation support seems doable in our clinic/practice 4. The implementation support seems easy to use in our clinic/practice) and was measured on a five-point rating scale (1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = completely agree). The mean score ranges from 1 to 5 with 1 indicating the least feasibility and 5 the most feasibility.

Outcome measures

Outcome measures
Measure	Staff Study Participants - Enhanced Implementation Arm n=34 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, SWAT meeting with sponsor team and principal clinic stakeholders, on-demand SWAT meeting, monthly continuous quality improvement (CQI) calls, face-to-face injection training, monthly FRAME assessment, access to patient and HCP level toolkit and CAB + RPV medical lead site visit.	Staff Study Participants - Standard Implementation Arm n=36 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI). SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.
Change From Baseline in Feasibility of Implementation Measure (FIM-Imp) Score at Month 12 Month 12	0.06 Scores on a scale Standard Deviation 1.047	0.34 Scores on a scale Standard Deviation 0.773
Change From Baseline in Feasibility of Implementation Measure (FIM-Imp) Score at Month 12 Baseline (Month 1)	4.0 Scores on a scale Standard Deviation 0.66	4.0 Scores on a scale Standard Deviation 0.64

PRIMARY outcome

Timeframe: Up to 12 Months

Population: Full analysis set included all staff study participants (SSPs) who completed at least one survey at any timepoint. Only those participants with data available at the specified time points were analyzed.

A semi-structured interview guide was designed to support the discussion surrounding experience with the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the acceptability from the SSPs' perspective. The results of themes that are integral to successful implementation are presented based on implementation strategies.

Outcome measures

Outcome measures
Measure	Staff Study Participants - Enhanced Implementation Arm n=32 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, SWAT meeting with sponsor team and principal clinic stakeholders, on-demand SWAT meeting, monthly continuous quality improvement (CQI) calls, face-to-face injection training, monthly FRAME assessment, access to patient and HCP level toolkit and CAB + RPV medical lead site visit.	Staff Study Participants - Standard Implementation Arm n=30 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI). SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Acceptability ADMINISTRATION OUTSIDE CLINIC: Other clinical settings	15 Participants	15 Participants
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Acceptability Positive opinion about CAB+RPV LA	28 Participants	28 Participants
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Acceptability Negative opinion about CAB+RPV LA	0 Participants	0 Participants
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Acceptability Ambivalent opinion about CAB+RPV LA	3 Participants	1 Participants
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Acceptability Opinion about CAB+RPV LA did not change	15 Participants	14 Participants
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Acceptability Opinion about CAB+RPV LA changed	9 Participants	11 Participants
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Acceptability Treatment and/or its implementation is better than expected	7 Participants	11 Participants
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Acceptability Treatment and/or its implementation is worse than expected	2 Participants	0 Participants
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Acceptability Implementation facilitators reported	16 Participants	19 Participants
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Acceptability Did NOT encounter resistance to using CAB+RPV LA	8 Participants	19 Participants
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Acceptability ADMINISTRATION OUTSIDE CLINIC: Self-administered	20 Participants	23 Participants
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Acceptability What would do differently	2 Participants	4 Participants

PRIMARY outcome

Timeframe: Up to Month 12

Population: Full analysis set included all staff study participants (SSPs) who completed at least one survey at any timepoint. Only those participants with data available at the specified time points were analyzed.

A semi-structured interview guide was designed to support the discussion surrounding experience with the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the appropriateness from the SSPs' perspective. The results of themes that are integral to successful implementation are presented based on implementation strategies.

Outcome measures

Outcome measures
Measure	Staff Study Participants - Enhanced Implementation Arm n=32 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, SWAT meeting with sponsor team and principal clinic stakeholders, on-demand SWAT meeting, monthly continuous quality improvement (CQI) calls, face-to-face injection training, monthly FRAME assessment, access to patient and HCP level toolkit and CAB + RPV medical lead site visit.	Staff Study Participants - Standard Implementation Arm n=30 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI). SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Appropriateness Implementation facilitators reported	16 Participants	19 Participants
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Appropriateness ADMINISTRATION OUTSIDE CLINIC: Home administration by HCP	24 Participants	19 Participants
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Appropriateness What would do differently	2 Participants	4 Participants
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Appropriateness Recommended strategies to support patient adherence	20 Participants	22 Participants

PRIMARY outcome

Timeframe: Up to Month 12

Population: Full analysis set included all staff study participants (SSPs) who completed at least one survey at any timepoint. Only those participants with data available at the specified time points were analyzed.

A semi-structured interview guide was designed to support the discussion surrounding experience with the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the feasibility from the SSPs' perspective. The results of themes that are integral to successful implementation are presented based on implementation strategies.

Outcome measures

Outcome measures
Measure	Staff Study Participants - Enhanced Implementation Arm n=32 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, SWAT meeting with sponsor team and principal clinic stakeholders, on-demand SWAT meeting, monthly continuous quality improvement (CQI) calls, face-to-face injection training, monthly FRAME assessment, access to patient and HCP level toolkit and CAB + RPV medical lead site visit.	Staff Study Participants - Standard Implementation Arm n=30 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI). SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility Staffing and workload issues: Still a challenge	7 Participants	4 Participants
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility Availability of rooms and designated space: How overcame this challenge	9 Participants	7 Participants
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility Availability of rooms and designated space: Still a challenge	8 Participants	4 Participants
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility Coordination between the clinic and pharmacy: Not a challenge at present	0 Participants	4 Participants
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility Medication supply and storage: Was a challenge	9 Participants	3 Participants
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility Medication supply and storage: How tried to/overcame this challenge	7 Participants	2 Participants
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility Being able to administer injections: Was not a challenge	24 Participants	17 Participants
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility Being able to administer injections: ViiV supportive of CAB+RPV LA implementation	31 Participants	23 Participants
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility No changes made to accommodate clinic needs	10 Participants	7 Participants
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility Changes made to accommodate clinic needs	22 Participants	22 Participants
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility Implementation facilitators reported	16 Participants	19 Participants
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility Developed supplemental materials for implementation	3 Participants	5 Participants
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility Staffing and workload issues was not a challenge	12 Participants	7 Participants
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility Staffing and workload issues was a challenge	18 Participants	14 Participants
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility Staffing and workload issues: How tried to/overcame this challenge	7 Participants	10 Participants
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility Staffing and workload issues: Not a challenge at present	8 Participants	5 Participants
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility Availability of rooms and designated space: Was not a challenge	19 Participants	15 Participants
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility Availability of rooms and designated space: Was a challenge	13 Participants	7 Participants
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility Availability of rooms and designated space: Not a challenge at present	4 Participants	3 Participants
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility Coordination between the clinic and pharmacy: Was not a challenge	23 Participants	17 Participants
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility Coordination between the clinic and pharmacy: Was a challenge	4 Participants	9 Participants
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility Coordination between the clinic and pharmacy: How overcame this challenge	3 Participants	6 Participants
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility Coordination between the clinic and pharmacy: Still a challenge	3 Participants	3 Participants
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility Medication supply and storage: Was not a challenge	16 Participants	15 Participants
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility Medication supply and storage: Still a challenge	2 Participants	1 Participants
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility Medication supply and storage: Not a challenge at present	5 Participants	2 Participants
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility Being able to administer injections: Was a challenge	3 Participants	3 Participants
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility Being able to administer injections: How overcame this challenge	1 Participants	3 Participants
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility Being able to administer injections: Still a challenge	1 Participants	2 Participants
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility Being able to administer injections: Not a challenge at present	2 Participants	1 Participants
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility Being able to administer injections: ViiV not supportive of CAB+RPV LA implementation	0 Participants	5 Participants
Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility Being able to administer injections: What would do differently	2 Participants	4 Participants

SECONDARY outcome

Timeframe: Up to 12 Months

Population: Full analysis set included all staff study participants (SSPs) who completed at least one survey at any timepoint. Only those participants with data available at the specified time points were analyzed.

A semi-structured interview guide was designed to support the discussion surrounding experience with the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the acceptability from the SSPs' perspective. The results for facilitators that are integral to successful implementation are presented.

Outcome measures

Outcome measures
Measure	Staff Study Participants - Enhanced Implementation Arm n=32 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, SWAT meeting with sponsor team and principal clinic stakeholders, on-demand SWAT meeting, monthly continuous quality improvement (CQI) calls, face-to-face injection training, monthly FRAME assessment, access to patient and HCP level toolkit and CAB + RPV medical lead site visit.	Staff Study Participants - Standard Implementation Arm n=30 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI). SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.
Number of Staff Study Participants That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) Improved Patient's Quality of Life	0 Participants	1 Participants
Number of Staff Study Participants That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) Injection pain management	2 Participants	0 Participants
Number of Staff Study Participants That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) No commute to clinic	1 Participants	3 Participants

SECONDARY outcome

Timeframe: Up to 12 Months

Population: Full analysis set included all staff study participants (SSPs) who completed at least one survey at any timepoint. Only those participants with data available at the specified time points were analyzed.

A semi-structured interview guide was designed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the acceptability from the SSPs' perspective. The results for barriers that are integral to successful implementation are presented.

Outcome measures

Outcome measures
Measure	Staff Study Participants - Enhanced Implementation Arm n=32 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, SWAT meeting with sponsor team and principal clinic stakeholders, on-demand SWAT meeting, monthly continuous quality improvement (CQI) calls, face-to-face injection training, monthly FRAME assessment, access to patient and HCP level toolkit and CAB + RPV medical lead site visit.	Staff Study Participants - Standard Implementation Arm n=30 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI). SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.
Number of Staff Study Participants That Discussed Barriers for Acceptability Assessed Via SSIs	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 12 Months

Population: Full analysis set included all staff study participants (SSPs) who completed at least one survey at any timepoint. Only those participants with data available at the specified time points were analyzed.

A semi-structured interview guide was designed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the appropriateness from the SSPs' perspective. The results for facilitators that are integral to successful implementation are presented.

Outcome measures

Outcome measures
Measure	Staff Study Participants - Enhanced Implementation Arm n=32 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, SWAT meeting with sponsor team and principal clinic stakeholders, on-demand SWAT meeting, monthly continuous quality improvement (CQI) calls, face-to-face injection training, monthly FRAME assessment, access to patient and HCP level toolkit and CAB + RPV medical lead site visit.	Staff Study Participants - Standard Implementation Arm n=30 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI). SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.
Number of Staff Study Participants That Discussed Facilitators for Appropriateness Assessed Via SSIs Patient selection	0 Participants	2 Participants
Number of Staff Study Participants That Discussed Facilitators for Appropriateness Assessed Via SSIs Hours of home visit	1 Participants	1 Participants
Number of Staff Study Participants That Discussed Facilitators for Appropriateness Assessed Via SSIs Patient characteristics	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to 12 Months

Population: Full analysis set included all staff study participants (SSPs) who completed at least one survey at any timepoint. Only those participants with data available at the specified time points were analyzed.

A semi-structured interview guide was designed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the appropriateness from the SSPs' perspective. The results for barriers that are integral to successful implementation are presented.

Outcome measures

Outcome measures
Measure	Staff Study Participants - Enhanced Implementation Arm n=32 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, SWAT meeting with sponsor team and principal clinic stakeholders, on-demand SWAT meeting, monthly continuous quality improvement (CQI) calls, face-to-face injection training, monthly FRAME assessment, access to patient and HCP level toolkit and CAB + RPV medical lead site visit.	Staff Study Participants - Standard Implementation Arm n=30 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI). SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.
Number of Staff Study Participants That Discussed Barriers for Appropriateness Assessed Via SSIs	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 12 Months

Population: Full analysis set included all staff study participants (SSPs) who completed at least one survey at any timepoint. Only those participants with data available at the specified time points were analyzed.

A semi-structured interview guide was designed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the feasibility from the SSPs' perspective. The results for facilitators that are integral to successful implementation are presented.

Outcome measures

Outcome measures
Measure	Staff Study Participants - Enhanced Implementation Arm n=32 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, SWAT meeting with sponsor team and principal clinic stakeholders, on-demand SWAT meeting, monthly continuous quality improvement (CQI) calls, face-to-face injection training, monthly FRAME assessment, access to patient and HCP level toolkit and CAB + RPV medical lead site visit.	Staff Study Participants - Standard Implementation Arm n=30 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI). SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.
Number of Staff Study Participants That Discussed Facilitators for Feasibility Assessed Via SSIs Staff availability	0 Participants	2 Participants
Number of Staff Study Participants That Discussed Facilitators for Feasibility Assessed Via SSIs Clinic or unit characteristics (e.g., autonomy, size, flexibility)	2 Participants	3 Participants
Number of Staff Study Participants That Discussed Facilitators for Feasibility Assessed Via SSIs Experience with the medication	0 Participants	1 Participants
Number of Staff Study Participants That Discussed Facilitators for Feasibility Assessed Via SSIs Implementation processes	2 Participants	2 Participants
Number of Staff Study Participants That Discussed Facilitators for Feasibility Assessed Via SSIs Medication storage	2 Participants	1 Participants
Number of Staff Study Participants That Discussed Facilitators for Feasibility Assessed Via SSIs Number of patients	1 Participants	2 Participants
Number of Staff Study Participants That Discussed Facilitators for Feasibility Assessed Via SSIs Nursing staff in consultation department	0 Participants	1 Participants
Number of Staff Study Participants That Discussed Facilitators for Feasibility Assessed Via SSIs Pharmacy flexibility	0 Participants	1 Participants
Number of Staff Study Participants That Discussed Facilitators for Feasibility Assessed Via SSIs Room/space characteristics	1 Participants	1 Participants
Number of Staff Study Participants That Discussed Facilitators for Feasibility Assessed Via SSIs Staff characteristics (e.g., experience, qualification, motivation)	6 Participants	8 Participants
Number of Staff Study Participants That Discussed Facilitators for Feasibility Assessed Via SSIs Training	1 Participants	0 Participants
Number of Staff Study Participants That Discussed Facilitators for Feasibility Assessed Via SSIs ViiV support and materials	3 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 12 Months

Population: Full analysis set included all staff study participants (SSPs) who completed at least one survey at any timepoint. Only those participants with data available at the specified time points were analyzed.

A semi-structured interview guide was designed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the feasibility from the SSPs' perspective. The results for barriers that are integral to successful implementation are presented.

Outcome measures

Outcome measures
Measure	Staff Study Participants - Enhanced Implementation Arm n=32 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, SWAT meeting with sponsor team and principal clinic stakeholders, on-demand SWAT meeting, monthly continuous quality improvement (CQI) calls, face-to-face injection training, monthly FRAME assessment, access to patient and HCP level toolkit and CAB + RPV medical lead site visit.	Staff Study Participants - Standard Implementation Arm n=30 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI). SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.
Number of Staff Study Participants That Discussed Barriers for Feasibility Assessed Via SSIs	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Month 1) and Month 12

Population: Full analysis set included all staff study participants (SSPs) who completed at least one survey at any timepoint. Only those participants with data available at the specified time points were analyzed.

The ILS is a 12-item (facilitate implementation, obstacles, clear department standards, knowledge, ability to answer questions, awareness of concept, recognition, support employee efforts to learn, support employee efforts to use intervention, persevere(s) through the ups and downs, carries on through the challenges and reaction to criticial issues) measure that assesses SSP understanding of the degree to which leadership in their clinic/practice setting is proactive, knowledgeable, supportive, and perseverant with regards to implementing the CAB LA + RPV LA injection treatment in their settings. The items are measured on a five-point rating scale (1 = very great extent, 2 = great extent, 3 = moderate extent, 4 = slight extent, and 5 = not at all). The mean score ranges from 1 to 5. Higher the score means less understanding in leadership.

Outcome measures

Outcome measures
Measure	Staff Study Participants - Enhanced Implementation Arm n=34 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, SWAT meeting with sponsor team and principal clinic stakeholders, on-demand SWAT meeting, monthly continuous quality improvement (CQI) calls, face-to-face injection training, monthly FRAME assessment, access to patient and HCP level toolkit and CAB + RPV medical lead site visit.	Staff Study Participants - Standard Implementation Arm n=35 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI). SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.
Change From Baseline in Implementation Leadership Scale (ILS) Score at Month 12 Baseline (Month 1)	2.3 Scores on a scale Standard Deviation 0.86	2.0 Scores on a scale Standard Deviation 0.81
Change From Baseline in Implementation Leadership Scale (ILS) Score at Month 12 Month 12	-0.1 Scores on a scale Standard Deviation 1.19	0.2 Scores on a scale Standard Deviation 0.51

SECONDARY outcome

Timeframe: Month 1 and Month 12

Population: Full Analysis Set. Only those participants with data available at the specified time points were analyzed.

The ICS is a 9 item (team's main goals, importance of implementation, top priority, workshops, treatment training, training material, staff adaptability, flexibility, openness to new intervention) measure that assesses SSPs' perceptions of their team (i.e., the people that they work with) while using the CAB LA + RPV LA injection treatment in their clinic/practice setting. The items were measured on a five-point rating scale (1 = very great extent, 2 = great extent, 3 = moderate extent, 4 = slight extent, and 5 = not at all). The mean score ranges from 1 to 5. Higher the score means less seriousness for implementation in staff.

Outcome measures

Outcome measures
Measure	Staff Study Participants - Enhanced Implementation Arm n=34 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, SWAT meeting with sponsor team and principal clinic stakeholders, on-demand SWAT meeting, monthly continuous quality improvement (CQI) calls, face-to-face injection training, monthly FRAME assessment, access to patient and HCP level toolkit and CAB + RPV medical lead site visit.	Staff Study Participants - Standard Implementation Arm n=35 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI). SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.
Absolute Values of Implementation Climate Scale (ICS) Scores at Month 1 and Month 12 Month 1	2.5 Scores on a scale Standard Deviation 0.65	2.8 Scores on a scale Standard Deviation 0.80
Absolute Values of Implementation Climate Scale (ICS) Scores at Month 1 and Month 12 Month 12	2.7 Scores on a scale Standard Deviation 0.72	2.6 Scores on a scale Standard Deviation 0.80

SECONDARY outcome

Timeframe: Month 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12

Population: Full analysis set included all staff study participants (SSPs) who completed at least one survey at any timepoint. Only those participants with data available at the specified time points were analyzed.

The Framework for Reporting Adaptations and Modifications to Evidence-based interventions - Implementation Strategies (FRAME-IS) was a seven-question measure (contained both open and closed categorical questions) used to record details the modifications made to the implementation of the CAB LA + RPV LA injection treatment procedures.

Outcome measures

Outcome measures
Measure	Staff Study Participants - Enhanced Implementation Arm n=34 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, SWAT meeting with sponsor team and principal clinic stakeholders, on-demand SWAT meeting, monthly continuous quality improvement (CQI) calls, face-to-face injection training, monthly FRAME assessment, access to patient and HCP level toolkit and CAB + RPV medical lead site visit.	Staff Study Participants - Standard Implementation Arm n=35 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI). SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.
Number of Modifications Reported by SSPs Assessed Via FRAME-IS Month 3	10 Number of Modifications	2 Number of Modifications
Number of Modifications Reported by SSPs Assessed Via FRAME-IS Month 4	5 Number of Modifications	2 Number of Modifications
Number of Modifications Reported by SSPs Assessed Via FRAME-IS Month 8	0 Number of Modifications	0 Number of Modifications
Number of Modifications Reported by SSPs Assessed Via FRAME-IS Month 9	3 Number of Modifications	0 Number of Modifications
Number of Modifications Reported by SSPs Assessed Via FRAME-IS Month 11	3 Number of Modifications	1 Number of Modifications
Number of Modifications Reported by SSPs Assessed Via FRAME-IS Month 12	0 Number of Modifications	1 Number of Modifications
Number of Modifications Reported by SSPs Assessed Via FRAME-IS Month 2	15 Number of Modifications	7 Number of Modifications
Number of Modifications Reported by SSPs Assessed Via FRAME-IS Month 5	1 Number of Modifications	1 Number of Modifications
Number of Modifications Reported by SSPs Assessed Via FRAME-IS Month 6	3 Number of Modifications	0 Number of Modifications
Number of Modifications Reported by SSPs Assessed Via FRAME-IS Month 7	4 Number of Modifications	0 Number of Modifications
Number of Modifications Reported by SSPs Assessed Via FRAME-IS Month 10	0 Number of Modifications	0 Number of Modifications

SECONDARY outcome

Timeframe: Month 2 to Month 7

Population: Full Analysis Set. Only those participants with data available at the specified time points were analyzed.

CQI were a 60 minutes calls involved working through a plan to address the identified barriers, optimize processes, and evaluate these efforts. This process of addressing barriers was guided by a series of Plan, Do, Study, Act (PDSA) cycles. Number of PDSA cycles developed are presented.

Outcome measures

Outcome measures
Measure	Staff Study Participants - Enhanced Implementation Arm n=18 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, SWAT meeting with sponsor team and principal clinic stakeholders, on-demand SWAT meeting, monthly continuous quality improvement (CQI) calls, face-to-face injection training, monthly FRAME assessment, access to patient and HCP level toolkit and CAB + RPV medical lead site visit.	Staff Study Participants - Standard Implementation Arm SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI). SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.
Number of Plan, Do, Study, Act (PDSA) Cycles Developed During the Continuous Quality Improvement (CQI) Calls Course	23 Cycles	—

SECONDARY outcome

Timeframe: Up to Month 12

Population: Patient study participants (PSPs) included all participants who successfully completed the survey at Month 12. Only those participants with data available at the specified time points were analyzed.

Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The average time was categorized as: Up to 20 Minutes, Up to 40 Minutes, Up to 60 Minutes, Up to 90 Minutes, More than 90 Minutes and missing. Missing include participants who did not provide a response for the question.

Outcome measures

Outcome measures
Measure	Staff Study Participants - Enhanced Implementation Arm n=379 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, SWAT meeting with sponsor team and principal clinic stakeholders, on-demand SWAT meeting, monthly continuous quality improvement (CQI) calls, face-to-face injection training, monthly FRAME assessment, access to patient and HCP level toolkit and CAB + RPV medical lead site visit.	Staff Study Participants - Standard Implementation Arm SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI). SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.
Number of Participants Spending Average Time in the Clinic/Practice for Each Injection Visit Assessed Via Questionnaire More than 90 Minutes	19 Participants	—
Number of Participants Spending Average Time in the Clinic/Practice for Each Injection Visit Assessed Via Questionnaire Missing	8 Participants	—
Number of Participants Spending Average Time in the Clinic/Practice for Each Injection Visit Assessed Via Questionnaire Up to 20 Minutes	71 Participants	—
Number of Participants Spending Average Time in the Clinic/Practice for Each Injection Visit Assessed Via Questionnaire Up to 40 Minutes	134 Participants	—
Number of Participants Spending Average Time in the Clinic/Practice for Each Injection Visit Assessed Via Questionnaire Up to 60 Minutes	99 Participants	—
Number of Participants Spending Average Time in the Clinic/Practice for Each Injection Visit Assessed Via Questionnaire Up to 90 Minutes	48 Participants	—

SECONDARY outcome

Timeframe: Month 12

Population: Patient study participants (PSPs) included all participants who successfully completed the survey at Month 12. Only those participants with data available at the specified time points were analyzed.

Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The average time was categorized as: Up to 10 Minutes, 11-20 Minutes, 21-30 Minutes, 31-45 Minutes, More than 45 Minutes and Missing. Missing include participants who did not provide a response for the question.

Outcome measures

Outcome measures
Measure	Staff Study Participants - Enhanced Implementation Arm n=379 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, SWAT meeting with sponsor team and principal clinic stakeholders, on-demand SWAT meeting, monthly continuous quality improvement (CQI) calls, face-to-face injection training, monthly FRAME assessment, access to patient and HCP level toolkit and CAB + RPV medical lead site visit.	Staff Study Participants - Standard Implementation Arm SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI). SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.
Number of Participants Spending Average Time in an Exam Room Waiting for a Nurse (or Other Healthcare Provider) to Get the Injection Administered Assessed Via Questionnaire 11-20 Minutes	100 Participants	—
Number of Participants Spending Average Time in an Exam Room Waiting for a Nurse (or Other Healthcare Provider) to Get the Injection Administered Assessed Via Questionnaire Up to 10 Minutes	190 Participants	—
Number of Participants Spending Average Time in an Exam Room Waiting for a Nurse (or Other Healthcare Provider) to Get the Injection Administered Assessed Via Questionnaire 21-30 Minutes	54 Participants	—
Number of Participants Spending Average Time in an Exam Room Waiting for a Nurse (or Other Healthcare Provider) to Get the Injection Administered Assessed Via Questionnaire 31-45 Minutes	25 Participants	—
Number of Participants Spending Average Time in an Exam Room Waiting for a Nurse (or Other Healthcare Provider) to Get the Injection Administered Assessed Via Questionnaire More than 45 Minutes	5 Participants	—
Number of Participants Spending Average Time in an Exam Room Waiting for a Nurse (or Other Healthcare Provider) to Get the Injection Administered Assessed Via Questionnaire Missing	5 Participants	—

SECONDARY outcome

Timeframe: Month 12

Population: Patient study participants (PSPs) included all participants who successfully completed the survey at Month 12. Only those participants with data available at the specified time points were analyzed.

Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The rating of acceptability was categorized as extremely acceptable, very acceptable, somewhat acceptable, a little acceptable, not at all acceptable and missing. Missing include participants who did not provide a response for the question.

Outcome measures

Outcome measures
Measure	Staff Study Participants - Enhanced Implementation Arm n=379 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, SWAT meeting with sponsor team and principal clinic stakeholders, on-demand SWAT meeting, monthly continuous quality improvement (CQI) calls, face-to-face injection training, monthly FRAME assessment, access to patient and HCP level toolkit and CAB + RPV medical lead site visit.	Staff Study Participants - Standard Implementation Arm SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI). SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.
Number of Participants Rating Acceptability With the Amount of Time Spent in The Clinic/Practice for Each Injection Visit Assessed Via Questionnaire Not at all acceptable	0 Participants	—
Number of Participants Rating Acceptability With the Amount of Time Spent in The Clinic/Practice for Each Injection Visit Assessed Via Questionnaire Extremely acceptable	140 Participants	—
Number of Participants Rating Acceptability With the Amount of Time Spent in The Clinic/Practice for Each Injection Visit Assessed Via Questionnaire Very acceptable	151 Participants	—
Number of Participants Rating Acceptability With the Amount of Time Spent in The Clinic/Practice for Each Injection Visit Assessed Via Questionnaire Somewhat acceptable	72 Participants	—
Number of Participants Rating Acceptability With the Amount of Time Spent in The Clinic/Practice for Each Injection Visit Assessed Via Questionnaire A little acceptable	11 Participants	—
Number of Participants Rating Acceptability With the Amount of Time Spent in The Clinic/Practice for Each Injection Visit Assessed Via Questionnaire Missing	5 Participants	—

SECONDARY outcome

Timeframe: Month 12

Population: Patient study participants (PSPs) included all participants who successfully completed the survey at Month 12. Only those participants with data available at the specified time points were analyzed.

Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The rating of acceptability was categorized as extremely acceptable, very acceptable, somewhat acceptable, a little acceptable, not at all acceptable and missing. Missing include participants who did not provide a response for the question.

Outcome measures

Outcome measures
Measure	Staff Study Participants - Enhanced Implementation Arm n=379 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, SWAT meeting with sponsor team and principal clinic stakeholders, on-demand SWAT meeting, monthly continuous quality improvement (CQI) calls, face-to-face injection training, monthly FRAME assessment, access to patient and HCP level toolkit and CAB + RPV medical lead site visit.	Staff Study Participants - Standard Implementation Arm SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI). SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.
Number of Participants Rating Acceptability to Come to the Clinic/Practice Every 2 Months for the Injection Visit Assessed Via Questionnaire Extremely acceptable	163 Participants	—
Number of Participants Rating Acceptability to Come to the Clinic/Practice Every 2 Months for the Injection Visit Assessed Via Questionnaire Very acceptable	154 Participants	—
Number of Participants Rating Acceptability to Come to the Clinic/Practice Every 2 Months for the Injection Visit Assessed Via Questionnaire Somewhat acceptable	51 Participants	—
Number of Participants Rating Acceptability to Come to the Clinic/Practice Every 2 Months for the Injection Visit Assessed Via Questionnaire A little acceptable	6 Participants	—
Number of Participants Rating Acceptability to Come to the Clinic/Practice Every 2 Months for the Injection Visit Assessed Via Questionnaire Not at all acceptable	0 Participants	—
Number of Participants Rating Acceptability to Come to the Clinic/Practice Every 2 Months for the Injection Visit Assessed Via Questionnaire Missing	5 Participants	—

SECONDARY outcome

Timeframe: Month 12

Population: Patient study participants (PSPs) included all participants who successfully completed the survey at Month 12. Only those participants with data available at the specified time points were analyzed.

Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The time off responses were categorized as Whole day annual leave, Half day annual leave, Whole day sick leave, Half day sick leave, Whole day unpaid, Half day unpaid, Other, Not taken time off and missing. Missing include participants who did not provide a response for the question.

Outcome measures

Outcome measures
Measure	Staff Study Participants - Enhanced Implementation Arm n=379 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, SWAT meeting with sponsor team and principal clinic stakeholders, on-demand SWAT meeting, monthly continuous quality improvement (CQI) calls, face-to-face injection training, monthly FRAME assessment, access to patient and HCP level toolkit and CAB + RPV medical lead site visit.	Staff Study Participants - Standard Implementation Arm SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI). SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.
Number of Participants Taking Time Off From Work to Attend Appointment Assessed Via Questionnaire Missing	9 Participants	—
Number of Participants Taking Time Off From Work to Attend Appointment Assessed Via Questionnaire Half day annual leave	20 Participants	—
Number of Participants Taking Time Off From Work to Attend Appointment Assessed Via Questionnaire Whole day sick leave	5 Participants	—
Number of Participants Taking Time Off From Work to Attend Appointment Assessed Via Questionnaire Half day sick leave	3 Participants	—
Number of Participants Taking Time Off From Work to Attend Appointment Assessed Via Questionnaire Whole day unpaid	9 Participants	—
Number of Participants Taking Time Off From Work to Attend Appointment Assessed Via Questionnaire Half day unpaid	20 Participants	—
Number of Participants Taking Time Off From Work to Attend Appointment Assessed Via Questionnaire Other	64 Participants	—
Number of Participants Taking Time Off From Work to Attend Appointment Assessed Via Questionnaire Not taken Time Off	222 Participants	—
Number of Participants Taking Time Off From Work to Attend Appointment Assessed Via Questionnaire Whole day annual leave	27 Participants	—

SECONDARY outcome

Timeframe: Month 12

Population: Patient study participants (PSPs) included all participants who successfully completed the survey at Month 12. Only those participants with data available at the specified time points were analyzed.

Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The responses were categorized as Up to 15 minutes, 16-30 minutes, 31-45 minutes, 46-60 minutes, More than 60 minutes, and missing. Missing include participants who did not provide a response for the question.

Outcome measures

Outcome measures
Measure	Staff Study Participants - Enhanced Implementation Arm n=379 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, SWAT meeting with sponsor team and principal clinic stakeholders, on-demand SWAT meeting, monthly continuous quality improvement (CQI) calls, face-to-face injection training, monthly FRAME assessment, access to patient and HCP level toolkit and CAB + RPV medical lead site visit.	Staff Study Participants - Standard Implementation Arm SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI). SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.
Number of Participants With Time it Took Them to Get to the Clinic Where They Receive HIV Treatment/Check-ups Assessed Via Questionnaire Up to 15 minutes	66 Participants	—
Number of Participants With Time it Took Them to Get to the Clinic Where They Receive HIV Treatment/Check-ups Assessed Via Questionnaire 31-45 minutes	87 Participants	—
Number of Participants With Time it Took Them to Get to the Clinic Where They Receive HIV Treatment/Check-ups Assessed Via Questionnaire 16-30 minutes	138 Participants	—
Number of Participants With Time it Took Them to Get to the Clinic Where They Receive HIV Treatment/Check-ups Assessed Via Questionnaire 46-60 minutes	44 Participants	—
Number of Participants With Time it Took Them to Get to the Clinic Where They Receive HIV Treatment/Check-ups Assessed Via Questionnaire More than 60 minutes	39 Participants	—
Number of Participants With Time it Took Them to Get to the Clinic Where They Receive HIV Treatment/Check-ups Assessed Via Questionnaire Missing	5 Participants	—

SECONDARY outcome

Timeframe: Month 12

Population: Patient study participants (PSPs) included all participants who successfully completed the survey at Month 12. Only those participants with data available at the specified time points were analyzed.

Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The responses were categorized as Yes, No, Not Applicable and Missing. Missing include participants who did not provide a response for the question.

Outcome measures

Outcome measures
Measure	Staff Study Participants - Enhanced Implementation Arm n=379 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, SWAT meeting with sponsor team and principal clinic stakeholders, on-demand SWAT meeting, monthly continuous quality improvement (CQI) calls, face-to-face injection training, monthly FRAME assessment, access to patient and HCP level toolkit and CAB + RPV medical lead site visit.	Staff Study Participants - Standard Implementation Arm SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI). SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.
Number of Participants Who Seek Additional Care From a Dependent to Attend Appointment Assessed Via Questionnaire Yes	16 Participants	—
Number of Participants Who Seek Additional Care From a Dependent to Attend Appointment Assessed Via Questionnaire No	318 Participants	—
Number of Participants Who Seek Additional Care From a Dependent to Attend Appointment Assessed Via Questionnaire Not Applicable	39 Participants	—
Number of Participants Who Seek Additional Care From a Dependent to Attend Appointment Assessed Via Questionnaire Missing	6 Participants	—

SECONDARY outcome

Timeframe: Month 12

Population: Patient study participants (PSPs) included all participants who successfully completed the survey at Month 12. Only those participants with data available at the specified time points were analyzed.

Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The responses were categorized as Taxi- Transportation service, Dropped-off, Private vehicle, Bicycle/scooter/ skateboard/ walked, Public transport and Missing. Missing include participants who did not provide a response for the question.

Outcome measures

Outcome measures
Measure	Staff Study Participants - Enhanced Implementation Arm n=379 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, SWAT meeting with sponsor team and principal clinic stakeholders, on-demand SWAT meeting, monthly continuous quality improvement (CQI) calls, face-to-face injection training, monthly FRAME assessment, access to patient and HCP level toolkit and CAB + RPV medical lead site visit.	Staff Study Participants - Standard Implementation Arm SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI). SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.
Number of Participants That Endorsed Type of Transportation Used to Attend Appointments Public transport	138 Participants	—
Number of Participants That Endorsed Type of Transportation Used to Attend Appointments Missing	3 Participants	—
Number of Participants That Endorsed Type of Transportation Used to Attend Appointments Taxi-Transportation service	13 Participants	—
Number of Participants That Endorsed Type of Transportation Used to Attend Appointments Dropped-off	12 Participants	—
Number of Participants That Endorsed Type of Transportation Used to Attend Appointments Private vehicle	164 Participants	—
Number of Participants That Endorsed Type of Transportation Used to Attend Appointments Bicycle/ scooter/ skateboard/ walked	49 Participants	—

SECONDARY outcome

Timeframe: Month 12

Population: Patient study participants (PSPs) included all participants who successfully completed the survey at Month 12. Only those participants with data available at the specified time points were analyzed.

Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The time off responses were categorized as No, Yes - On the day of receiving the treatment, Yes - One day after receiving the treatment, Yes-Two days after receiving the treatment, Yes-More than two days after receiving the treatment, Not Applicable, Missing and Missing Response for 'Yes'. Missing include participants who did not provide a response for the question. Missing Response for 'Yes' include participants who responded 'Yes' but did not provide duration of time off.

Outcome measures

Outcome measures
Measure	Staff Study Participants - Enhanced Implementation Arm n=379 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, SWAT meeting with sponsor team and principal clinic stakeholders, on-demand SWAT meeting, monthly continuous quality improvement (CQI) calls, face-to-face injection training, monthly FRAME assessment, access to patient and HCP level toolkit and CAB + RPV medical lead site visit.	Staff Study Participants - Standard Implementation Arm SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI). SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.
Number of Participants Taking Time Off From Work to Recover From Any Injection Site Reaction Issue Assessed Via Questionnaire No	294 Participants	—
Number of Participants Taking Time Off From Work to Recover From Any Injection Site Reaction Issue Assessed Via Questionnaire Yes, on the day of receiving the treatment	45 Participants	—
Number of Participants Taking Time Off From Work to Recover From Any Injection Site Reaction Issue Assessed Via Questionnaire Yes, one day after receiving the treatment	9 Participants	—
Number of Participants Taking Time Off From Work to Recover From Any Injection Site Reaction Issue Assessed Via Questionnaire Yes, two days after receiving the treatment	7 Participants	—
Number of Participants Taking Time Off From Work to Recover From Any Injection Site Reaction Issue Assessed Via Questionnaire Yes, more than two days after receiving the treatment	5 Participants	—
Number of Participants Taking Time Off From Work to Recover From Any Injection Site Reaction Issue Assessed Via Questionnaire Not Applicable	16 Participants	—
Number of Participants Taking Time Off From Work to Recover From Any Injection Site Reaction Issue Assessed Via Questionnaire Missing	5 Participants	—
Number of Participants Taking Time Off From Work to Recover From Any Injection Site Reaction Issue Assessed Via Questionnaire Missing response for 'Yes'	2 Participants	—

SECONDARY outcome

Timeframe: Month 12

Population: Patient study participants (PSPs) included all participants who successfully completed the survey at Month 12. Only those participants with data available at the specified time points were analyzed.

Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The convenience responses were categorized as Extremely convenient, Very convenient, Somewhat convenient, A little convenient, Not at all convenient, and Missing. Missing include participants who did not provide a response for the question.

Outcome measures

Outcome measures
Measure	Staff Study Participants - Enhanced Implementation Arm n=379 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, SWAT meeting with sponsor team and principal clinic stakeholders, on-demand SWAT meeting, monthly continuous quality improvement (CQI) calls, face-to-face injection training, monthly FRAME assessment, access to patient and HCP level toolkit and CAB + RPV medical lead site visit.	Staff Study Participants - Standard Implementation Arm SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI). SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.
Number of Participants Rating Convenience of Clinic/Practice's Procedures for Scheduling Injections Assessed Via Questionnaire Extremely convenient	175 Participants	—
Number of Participants Rating Convenience of Clinic/Practice's Procedures for Scheduling Injections Assessed Via Questionnaire Very convenient	154 Participants	—
Number of Participants Rating Convenience of Clinic/Practice's Procedures for Scheduling Injections Assessed Via Questionnaire Somewhat convenient	43 Participants	—
Number of Participants Rating Convenience of Clinic/Practice's Procedures for Scheduling Injections Assessed Via Questionnaire A little convenient	4 Participants	—
Number of Participants Rating Convenience of Clinic/Practice's Procedures for Scheduling Injections Assessed Via Questionnaire Not at all convenient	0 Participants	—
Number of Participants Rating Convenience of Clinic/Practice's Procedures for Scheduling Injections Assessed Via Questionnaire Missing	3 Participants	—

SECONDARY outcome

Timeframe: Month 12

Population: Patient study participants (PSPs) included all participants who successfully completed the survey at Month 12. Only those participants with data available at the specified time points were analyzed.

Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The responses were categorized as Extremely convenient, Very convenient, Somewhat convenient, A little convenient, Not at all convenient, Not applicable; I did not have to reschedule and Missing. Missing include participants who did not provide a response for the question.

Outcome measures

Outcome measures
Measure	Staff Study Participants - Enhanced Implementation Arm n=379 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, SWAT meeting with sponsor team and principal clinic stakeholders, on-demand SWAT meeting, monthly continuous quality improvement (CQI) calls, face-to-face injection training, monthly FRAME assessment, access to patient and HCP level toolkit and CAB + RPV medical lead site visit.	Staff Study Participants - Standard Implementation Arm SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI). SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.
Number of Participants Rating Convenience of Clinic/Practice's Procedures for Rescheduling Injections Assessed Via Questionnaire Extremely convenient	158 Participants	—
Number of Participants Rating Convenience of Clinic/Practice's Procedures for Rescheduling Injections Assessed Via Questionnaire Very convenient	153 Participants	—
Number of Participants Rating Convenience of Clinic/Practice's Procedures for Rescheduling Injections Assessed Via Questionnaire Somewhat convenient	25 Participants	—
Number of Participants Rating Convenience of Clinic/Practice's Procedures for Rescheduling Injections Assessed Via Questionnaire A little convenient	2 Participants	—
Number of Participants Rating Convenience of Clinic/Practice's Procedures for Rescheduling Injections Assessed Via Questionnaire Not at all convenient	0 Participants	—
Number of Participants Rating Convenience of Clinic/Practice's Procedures for Rescheduling Injections Assessed Via Questionnaire Not applicable; I did not have to schedule	39 Participants	—
Number of Participants Rating Convenience of Clinic/Practice's Procedures for Rescheduling Injections Assessed Via Questionnaire Missing	2 Participants	—

SECONDARY outcome

Timeframe: Month 12

Population: Patient study participants (PSPs) included all participants who successfully completed the survey at Month 12. Only those participants with data available at the specified time points were analyzed.

Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The responses were categorized as Extremely positive, Very positive, Somewhat positive, A little positive, Not at all positive and Missing. Missing include participants who did not provide a response for the question.

Outcome measures

Outcome measures
Measure	Staff Study Participants - Enhanced Implementation Arm n=379 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, SWAT meeting with sponsor team and principal clinic stakeholders, on-demand SWAT meeting, monthly continuous quality improvement (CQI) calls, face-to-face injection training, monthly FRAME assessment, access to patient and HCP level toolkit and CAB + RPV medical lead site visit.	Staff Study Participants - Standard Implementation Arm SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI). SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.
Number of Participants Rating Feelings About Getting CAB+RPV Injection Treatment Assessed Via Questionnaire Extremely positive	234 Participants	—
Number of Participants Rating Feelings About Getting CAB+RPV Injection Treatment Assessed Via Questionnaire Very positive	112 Participants	—
Number of Participants Rating Feelings About Getting CAB+RPV Injection Treatment Assessed Via Questionnaire Somewhat positive	23 Participants	—
Number of Participants Rating Feelings About Getting CAB+RPV Injection Treatment Assessed Via Questionnaire A little positive	4 Participants	—
Number of Participants Rating Feelings About Getting CAB+RPV Injection Treatment Assessed Via Questionnaire Not at all positive	0 Participants	—
Number of Participants Rating Feelings About Getting CAB+RPV Injection Treatment Assessed Via Questionnaire Missing	6 Participants	—

SECONDARY outcome

Timeframe: Month 12

Population: Patient study participants (PSPs) included all participants who successfully completed the survey at Month 12. Only those participants with data available at the specified time points were analyzed.

Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The responses were categorized as Extremely knowledgeable, Very knowledgeable, Somewhat knowledgeable, A little knowledgeable, Not at all knowledgeable and Missing. Missing include participants who did not provide a response for the question.

Outcome measures

Outcome measures
Measure	Staff Study Participants - Enhanced Implementation Arm n=379 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, SWAT meeting with sponsor team and principal clinic stakeholders, on-demand SWAT meeting, monthly continuous quality improvement (CQI) calls, face-to-face injection training, monthly FRAME assessment, access to patient and HCP level toolkit and CAB + RPV medical lead site visit.	Staff Study Participants - Standard Implementation Arm SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI). SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.
Number of Participants That Rated Perceived Knowledge About CAB+RPV Injection Treatment Assessed Via Questionnaire Extremely knowledgeable	124 Participants	—
Number of Participants That Rated Perceived Knowledge About CAB+RPV Injection Treatment Assessed Via Questionnaire Very knowledgeable	188 Participants	—
Number of Participants That Rated Perceived Knowledge About CAB+RPV Injection Treatment Assessed Via Questionnaire Somewhat knowledgeable	57 Participants	—
Number of Participants That Rated Perceived Knowledge About CAB+RPV Injection Treatment Assessed Via Questionnaire A little knowledgeable	6 Participants	—
Number of Participants That Rated Perceived Knowledge About CAB+RPV Injection Treatment Assessed Via Questionnaire Not at all knowledgeable	0 Participants	—
Number of Participants That Rated Perceived Knowledge About CAB+RPV Injection Treatment Assessed Via Questionnaire Missing	4 Participants	—

SECONDARY outcome

Timeframe: Month 12

Population: Patient study participants (PSPs) included all participants who successfully completed the survey at Month 12. Only those participants with data available at the specified time points were analyzed.

Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question.The responses were categorized as Phone calls, Text/SMS messages, Existing clinic app, E-mail, Reminder in the mail, Another reminder and I did not receive reminders. The responses are not mutually exclusive.

Outcome measures

Outcome measures
Measure	Staff Study Participants - Enhanced Implementation Arm n=379 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, SWAT meeting with sponsor team and principal clinic stakeholders, on-demand SWAT meeting, monthly continuous quality improvement (CQI) calls, face-to-face injection training, monthly FRAME assessment, access to patient and HCP level toolkit and CAB + RPV medical lead site visit.	Staff Study Participants - Standard Implementation Arm SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI). SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.
Number of Participants With Appointment Reminders Received Assessed Via Questionnaire Phone calls	80 Participants	—
Number of Participants With Appointment Reminders Received Assessed Via Questionnaire Text/SMS messages	275 Participants	—
Number of Participants With Appointment Reminders Received Assessed Via Questionnaire Existing clinic app	48 Participants	—
Number of Participants With Appointment Reminders Received Assessed Via Questionnaire E-mail	161 Participants	—
Number of Participants With Appointment Reminders Received Assessed Via Questionnaire Reminder in the mail	21 Participants	—
Number of Participants With Appointment Reminders Received Assessed Via Questionnaire Another reminder	3 Participants	—
Number of Participants With Appointment Reminders Received Assessed Via Questionnaire I did not receive reminders	14 Participants	—

SECONDARY outcome

Timeframe: Month 12

Population: Patient study participants (PSPs) included all participants who successfully completed the survey at Month 12. Only those participants with data available at the specified time points were analyzed.

Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The responses were categorized as Extremely helpful, Very helpful, Somewhat helpful, A Little helpful, Not at all helpful and Missing. Missing include participants who did not provide a response for the question.

Outcome measures

Outcome measures
Measure	Staff Study Participants - Enhanced Implementation Arm n=379 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, SWAT meeting with sponsor team and principal clinic stakeholders, on-demand SWAT meeting, monthly continuous quality improvement (CQI) calls, face-to-face injection training, monthly FRAME assessment, access to patient and HCP level toolkit and CAB + RPV medical lead site visit.	Staff Study Participants - Standard Implementation Arm SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI). SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.
Number of Participants Who Rated Helpfulness of Appointment Outside of Typical Work Times Assessed Via Questionnaire Missing	5 Participants	—
Number of Participants Who Rated Helpfulness of Appointment Outside of Typical Work Times Assessed Via Questionnaire Extremely helpful	135 Participants	—
Number of Participants Who Rated Helpfulness of Appointment Outside of Typical Work Times Assessed Via Questionnaire Very helpful	123 Participants	—
Number of Participants Who Rated Helpfulness of Appointment Outside of Typical Work Times Assessed Via Questionnaire Somewhat helpful	50 Participants	—
Number of Participants Who Rated Helpfulness of Appointment Outside of Typical Work Times Assessed Via Questionnaire A Little helpful	38 Participants	—
Number of Participants Who Rated Helpfulness of Appointment Outside of Typical Work Times Assessed Via Questionnaire Not at all helpful	28 Participants	—

SECONDARY outcome

Timeframe: Month 12

Population: Patient study participants (PSPs) included all participants who successfully completed the survey at Month 12. Only those participants with data available at the specified time points were analyzed.

Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The responses were categorized as Completely agree, Agree, Neutral, Disagree, Completely disagree and Missing. Missing include participants who did not provide a response for the question.

Outcome measures

Outcome measures
Measure	Staff Study Participants - Enhanced Implementation Arm n=379 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, SWAT meeting with sponsor team and principal clinic stakeholders, on-demand SWAT meeting, monthly continuous quality improvement (CQI) calls, face-to-face injection training, monthly FRAME assessment, access to patient and HCP level toolkit and CAB + RPV medical lead site visit.	Staff Study Participants - Standard Implementation Arm SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI). SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.
Number of Participants That Rated Agreement in Recommending the CAB+RPV Injections to Others Assessed Via Questionnaire Completely agree	283 Participants	—
Number of Participants That Rated Agreement in Recommending the CAB+RPV Injections to Others Assessed Via Questionnaire Agree	75 Participants	—
Number of Participants That Rated Agreement in Recommending the CAB+RPV Injections to Others Assessed Via Questionnaire Neutral	15 Participants	—
Number of Participants That Rated Agreement in Recommending the CAB+RPV Injections to Others Assessed Via Questionnaire Disagree	1 Participants	—
Number of Participants That Rated Agreement in Recommending the CAB+RPV Injections to Others Assessed Via Questionnaire Completely disagree	1 Participants	—
Number of Participants That Rated Agreement in Recommending the CAB+RPV Injections to Others Assessed Via Questionnaire Missing	4 Participants	—

SECONDARY outcome

Timeframe: Month 12

Population: Patient study participants (PSPs) included all participants who successfully completed the survey at Month 12.

Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The responses were categorized as Take over-the-counter pain relievers, Use a hot compress, Use a cold compress, Avoid sitting for long periods of time, Light stretching and exercise, None of the above, Other and I don't get sore after my injections.

Outcome measures

Outcome measures
Measure	Staff Study Participants - Enhanced Implementation Arm n=379 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, SWAT meeting with sponsor team and principal clinic stakeholders, on-demand SWAT meeting, monthly continuous quality improvement (CQI) calls, face-to-face injection training, monthly FRAME assessment, access to patient and HCP level toolkit and CAB + RPV medical lead site visit.	Staff Study Participants - Standard Implementation Arm SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI). SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.
Number of Participants With Things Tried to Reduce Soreness Following Injections Assessed Via Questionnaire Take over-the-counter pain relievers	139 Participants	—
Number of Participants With Things Tried to Reduce Soreness Following Injections Assessed Via Questionnaire Use a hot compress	20 Participants	—
Number of Participants With Things Tried to Reduce Soreness Following Injections Assessed Via Questionnaire Use a cold compress	19 Participants	—
Number of Participants With Things Tried to Reduce Soreness Following Injections Assessed Via Questionnaire Avoid sitting for long periods of time	87 Participants	—
Number of Participants With Things Tried to Reduce Soreness Following Injections Assessed Via Questionnaire Light stretching and exercise	71 Participants	—
Number of Participants With Things Tried to Reduce Soreness Following Injections Assessed Via Questionnaire None of the above	61 Participants	—
Number of Participants With Things Tried to Reduce Soreness Following Injections Assessed Via Questionnaire Other	31 Participants	—
Number of Participants With Things Tried to Reduce Soreness Following Injections Assessed Via Questionnaire I don't get sore after my injections	72 Participants	—

SECONDARY outcome

Timeframe: Up to Month 12

Population: Patient study participants (PSPs) who participated in interviews were analysed. Only those participants with data available at the specified time points were analysed.

A semi-structured interview guide was developed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the Acceptability, Appropriateness, Feasibility, and Sustainability from the PSPs' perspective. Results of number of PSPs that discussed facilitators for acceptability are presented.

Outcome measures

Outcome measures
Measure	Staff Study Participants - Enhanced Implementation Arm n=110 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, SWAT meeting with sponsor team and principal clinic stakeholders, on-demand SWAT meeting, monthly continuous quality improvement (CQI) calls, face-to-face injection training, monthly FRAME assessment, access to patient and HCP level toolkit and CAB + RPV medical lead site visit.	Staff Study Participants - Standard Implementation Arm SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI). SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.
Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) Feeling informed about CAB+RPV LA injection	105 Participants	—
Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) Overall positive experience with CAB+RPV LA	100 Participants	—
Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) Acceptable overall experience at clinic	82 Participants	—
Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) In-person communication with HCP	76 Participants	—
Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) Not thinking and/or worrying about taking medication	66 Participants	—
Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) Experienced injector	64 Participants	—
Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) Acceptable clinic hours to receive CAB+RPV LA injections	51 Participants	—
Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) CAB+RPV LA injection experience met expectations	43 Participants	—
Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) Patient travel facilitation	33 Participants	—
Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) CAB+RPV LA injection experience better than expected	32 Participants	—
Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) Staff responsiveness	34 Participants	—
Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) Number of visits	30 Participants	—
Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) Satisfaction with rescheduling process	29 Participants	—
Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) Distance to clinic	27 Participants	—
Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) Not being reminded about HIV	26 Participants	—
Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) Acceptable time spent in clinic	25 Participants	—
Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) Treatment adherence	24 Participants	—
Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) Gaining a sense of freedom	24 Participants	—
Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) Discreet treatment	23 Participants	—
Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) Communication with staff	22 Participants	—
Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) Reduced stigma due to CAB+RPV LA injection	22 Participants	—
Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) Reduction in injection pain	20 Participants	—
Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) [Patient-perspective] Medication for injection pain management	19 Participants	—
Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) Reduced stress or worry due to CAB+RPV LA injection	19 Participants	—
Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) HCP advice on pain management	18 Participants	—
Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) [Patient-perspective] Activities to avoid for injection pain management	16 Participants	—
Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) Website and/or internet	15 Participants	—
Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) Characteristics of HCP communication	14 Participants	—
Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) Written materials and brochures	14 Participants	—
Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) Study materials	14 Participants	—
Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) Time of informing	13 Participants	—
Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) Medication collection, storage and/or preparation	12 Participants	—
Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) Fewer side effects	12 Participants	—
Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) Time-saving approach	12 Participants	—
Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) [Patient-perspective] Activities to do for injection pain management	11 Participants	—
Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) Administration in other clinical setting	11 Participants	—

SECONDARY outcome

Timeframe: Up to Month 12

Population: Patient study participants (PSPs) who participated in interviews were analysed. Only those participants with data available at the specified time points were analysed.

A semi-structured interview guide was developed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the Acceptability, Appropriateness, Feasibility, and Sustainability from the PSPs' perspective. Results of number of PSPs that discussed barriers for acceptability are presented.

Outcome measures

Outcome measures
Measure	Staff Study Participants - Enhanced Implementation Arm n=110 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, SWAT meeting with sponsor team and principal clinic stakeholders, on-demand SWAT meeting, monthly continuous quality improvement (CQI) calls, face-to-face injection training, monthly FRAME assessment, access to patient and HCP level toolkit and CAB + RPV medical lead site visit.	Staff Study Participants - Standard Implementation Arm SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI). SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.
Number of PSPs That Discussed Barriers for Acceptability Assessed Via SSIs Injection side effects including pain (Topic - Treatment Components Difficult for PSP)	67 Participants	—
Number of PSPs That Discussed Barriers for Acceptability Assessed Via SSIs Injection side effects including pain (Topic-Experienced Challenges to Receive CAB+PRV LA Injection)	33 Participants	—
Number of PSPs That Discussed Barriers for Acceptability Assessed Via SSIs CAB+RPV LA injection experience worse than expected	11 Participants	—
Number of PSPs That Discussed Barriers for Acceptability Assessed Via SSIs Waiting time	11 Participants	—

SECONDARY outcome

Timeframe: Up to Month 12

Population: Patient study participants (PSPs) who participated in interviews were analysed. Only those participants with data available at the specified time points were analysed.

A semi-structured interview guide was developed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the Acceptability, Appropriateness, Feasibility, and Sustainability from the PSPs' perspective. Results of number of PSPs that discussed facilitators for appropriateness are presented.

Outcome measures

Outcome measures
Measure	Staff Study Participants - Enhanced Implementation Arm n=110 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, SWAT meeting with sponsor team and principal clinic stakeholders, on-demand SWAT meeting, monthly continuous quality improvement (CQI) calls, face-to-face injection training, monthly FRAME assessment, access to patient and HCP level toolkit and CAB + RPV medical lead site visit.	Staff Study Participants - Standard Implementation Arm SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI). SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.
Number of PSPs That Discussed Facilitators for Appropriateness Assessed Via SSIs	0 Participants	—

SECONDARY outcome

Timeframe: Up to Month 12

Population: Patient study participants (PSPs) who participated in interviews were analysed. Only those participants with data available at the specified time points were analysed.

A semi-structured interview guide was developed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the Acceptability, Appropriateness, Feasibility, and Sustainability from the PSPs' perspective. Results of number of PSPs with barriers for appropriateness are presented.

Outcome measures

Outcome measures
Measure	Staff Study Participants - Enhanced Implementation Arm n=110 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, SWAT meeting with sponsor team and principal clinic stakeholders, on-demand SWAT meeting, monthly continuous quality improvement (CQI) calls, face-to-face injection training, monthly FRAME assessment, access to patient and HCP level toolkit and CAB + RPV medical lead site visit.	Staff Study Participants - Standard Implementation Arm SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI). SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.
Number of PSPs That Discussed Barriers for Appropriateness Assessed Via SSIs Patient fearing or squeamish about injections	22 Participants	—
Number of PSPs That Discussed Barriers for Appropriateness Assessed Via SSIs Patients not tolerating intramuscular injection	12 Participants	—

SECONDARY outcome

Timeframe: Up to Month 12

Population: Patient study participants (PSPs) who participated in interviews were analysed. Only those participants with data available at the specified time points were analysed.

A semi-structured interview guide was developed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the Acceptability, Appropriateness, Feasibility, and Sustainability from the PSPs' perspective. Results of number of PSPs that discussed facilitators for feasibility are presented.

Outcome measures

Outcome measures
Measure	Staff Study Participants - Enhanced Implementation Arm n=110 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, SWAT meeting with sponsor team and principal clinic stakeholders, on-demand SWAT meeting, monthly continuous quality improvement (CQI) calls, face-to-face injection training, monthly FRAME assessment, access to patient and HCP level toolkit and CAB + RPV medical lead site visit.	Staff Study Participants - Standard Implementation Arm SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI). SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.
Number of PSPs That Discussed Facilitators for Feasibility Assessed Via SSIs Person to contact during CARISEL study	102 Participants	—
Number of PSPs That Discussed Facilitators for Feasibility Assessed Via SSIs [Patient-perspective] Calendar, Diary, Notes and/or Reminders	69 Participants	—
Number of PSPs That Discussed Facilitators for Feasibility Assessed Via SSIs No missed appointment and/or rescheduling	65 Participants	—
Number of PSPs That Discussed Facilitators for Feasibility Assessed Via SSIs Target date explained	57 Participants	—
Number of PSPs That Discussed Facilitators for Feasibility Assessed Via SSIs Easy to contact	57 Participants	—
Number of PSPs That Discussed Facilitators for Feasibility Assessed Via SSIs Contacting clinic staff during CARISEL study	52 Participants	—
Number of PSPs That Discussed Facilitators for Feasibility Assessed Via SSIs Home administration by HCP	41 Participants	—
Number of PSPs That Discussed Facilitators for Feasibility Assessed Via SSIs No issues due to transportation and/or parking	37 Participants	—
Number of PSPs That Discussed Facilitators for Feasibility Assessed Via SSIs No challenges to receive CAB+RPV LA injection	33 Participants	—
Number of PSPs That Discussed Facilitators for Feasibility Assessed Via SSIs Not contacting clinic staff during CARISEL study	31 Participants	—
Number of PSPs That Discussed Facilitators for Feasibility Assessed Via SSIs No issues due to work	28 Participants	—
Number of PSPs That Discussed Facilitators for Feasibility Assessed Via SSIs Clinic Reminder [all types]	27 Participants	—
Number of PSPs That Discussed Facilitators for Feasibility Assessed Via SSIs Term of target date helpful	25 Participants	—
Number of PSPs That Discussed Facilitators for Feasibility Assessed Via SSIs [Patient-perspective] Setting reminders	23 Participants	—
Number of PSPs That Discussed Facilitators for Feasibility Assessed Via SSIs CAB+RPV LA administration at GP office	22 Participants	—
Number of PSPs That Discussed Facilitators for Feasibility Assessed Via SSIs CAB+RPV LA administration at nurse office and/or healthcare centers	19 Participants	—
Number of PSPs That Discussed Facilitators for Feasibility Assessed Via SSIs No issues to attend visits due to childcare or family commitments	16 Participants	—
Number of PSPs That Discussed Facilitators for Feasibility Assessed Via SSIs [Patient-perspective] Arrangements at work	16 Participants	—
Number of PSPs That Discussed Facilitators for Feasibility Assessed Via SSIs Clinic reminder: Text and/or SMS	14 Participants	—
Number of PSPs That Discussed Facilitators for Feasibility Assessed Via SSIs [Patient-perspective] Appointment scheduling strategies	14 Participants	—
Number of PSPs That Discussed Facilitators for Feasibility Assessed Via SSIs No issues due to clinic hours	13 Participants	—

SECONDARY outcome

Timeframe: Up to Month 12

Population: Patient study participants (PSPs) who participated in interviews were analysed. Only those participants with data available at the specified time points were analysed.

A semi-structured interview guide was developed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the Acceptability, Appropriateness, Feasibility, and Sustainability from the PSPs' perspective. Results of number of PSPs that discussed barriers for feasibility are presented.

Outcome measures

Outcome measures
Measure	Staff Study Participants - Enhanced Implementation Arm n=110 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, SWAT meeting with sponsor team and principal clinic stakeholders, on-demand SWAT meeting, monthly continuous quality improvement (CQI) calls, face-to-face injection training, monthly FRAME assessment, access to patient and HCP level toolkit and CAB + RPV medical lead site visit.	Staff Study Participants - Standard Implementation Arm SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI). SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.
Number of PSPs That Discussed Barriers for Feasibility Assessed Via SSIs Target date not explained	38 Participants	—
Number of PSPs That Discussed Barriers for Feasibility Assessed Via SSIs Missed appointment and/or rescheduling	23 Participants	—
Number of PSPs That Discussed Barriers for Feasibility Assessed Via SSIs Issues due to work	21 Participants	—
Number of PSPs That Discussed Barriers for Feasibility Assessed Via SSIs Issues due to transportation and/or parking	14 Participants	—

SECONDARY outcome

Timeframe: Baseline (Month 1) and Month 12

Population: PSPs who completed the surveys at the relevant timepoints were included in the analysis. Only those participants with data available at the specified time points were analysed.

AIM assesses the acceptability of an intervention (i.e., perception among stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory). It is a four-item (1. The CAB+RPV injection treatment meets my approval for treating my HIV, 2. The CAB+RPV injection treatment is appealing to me, 3. I like the CAB+RPV injection treatment for my HIV, 4. I welcome the CAB+RPV injection treatment for my HIV) measure with a five-point rating scale, where 1=completely disagree, 2=disagree, 3=neither agree nor disagree, 4=agree, and 5=completely agree. The mean score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability.

Outcome measures

Outcome measures
Measure	Staff Study Participants - Enhanced Implementation Arm n=424 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, SWAT meeting with sponsor team and principal clinic stakeholders, on-demand SWAT meeting, monthly continuous quality improvement (CQI) calls, face-to-face injection training, monthly FRAME assessment, access to patient and HCP level toolkit and CAB + RPV medical lead site visit.	Staff Study Participants - Standard Implementation Arm SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI). SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.
Change From Baseline in Acceptability of Intervention Measure (AIM) Score in PSPs at Month 12 Baseline (Month 1)	4.55 Scores on a scale Standard Deviation 0.666	—
Change From Baseline in Acceptability of Intervention Measure (AIM) Score in PSPs at Month 12 Month 12	0.10 Scores on a scale Standard Deviation 0.834	—

SECONDARY outcome

Timeframe: Baseline (Month 1) and Month 12

Population: PSPs who completed the surveys at the relevant timepoints were included in the analysis. Only those participants with data available at the specified time points were analysed.

IAM assesses the appropriateness of an intervention (i.e., the perceived fit, relevance, or compatibility of the innovation for a given practice setting, provider, or consumer; and the perceived fit of the innovation to address a particular issue or problem). It is a four-item (1. The CAB+RPV injection treatment is fitting for my life, 2. The CAB+RPV injection treatment is suitable for my life, 3. The CAB+RPV injection treatment is applicable to my life, 4. The CAB+RPV injection treatment is a good match for my life) measure with a five-point rating scale, where 1=completely disagree, 2=disagree, 3=neither agree nor disagree, 4=agree, and 5=completely agree. The mean score ranges from 1 to 5 with 1 indicating the least appropriateness and 5 the most appropriateness.

Outcome measures

Outcome measures
Measure	Staff Study Participants - Enhanced Implementation Arm n=423 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, SWAT meeting with sponsor team and principal clinic stakeholders, on-demand SWAT meeting, monthly continuous quality improvement (CQI) calls, face-to-face injection training, monthly FRAME assessment, access to patient and HCP level toolkit and CAB + RPV medical lead site visit.	Staff Study Participants - Standard Implementation Arm SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI). SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.
Change From Baseline in Intervention Appropriateness Measure (IAM) Score in PSPs at Month 12 Baseline (Month 1)	4.47 Scores on a scale Standard Deviation 0.762	—
Change From Baseline in Intervention Appropriateness Measure (IAM) Score in PSPs at Month 12 Month 12	0.13 Scores on a scale Standard Deviation 0.928	—

SECONDARY outcome

Timeframe: Baseline (Month 1) and Month 12

Population: PSPs who completed the surveys at the relevant timepoints were included in the analysis. Only those participants with data available at the specified time points were analysed.

The four-item (1. The CAB+RPV injection treatment seems implementable in my life 2. The CAB+RPV injection treatment every 2 months is possible for me to use 3. The CAB+RPV injection treatment every 2 months seems doable in my life 4. The CAB+RPV injection treatment every 2 months seems easy to use in my life). FIM assesses perceived intervention feasibility. The items are measured on a five-point rating scale, where 1=completely disagree, 2=disagree, 3=neither agree nor disagree, 4=agree, and 5=completely agree. The mean score ranges from 1 to 5 with 1 indicating the least feasibility and 5 the most feasibility.

Outcome measures

Outcome measures
Measure	Staff Study Participants - Enhanced Implementation Arm n=424 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, SWAT meeting with sponsor team and principal clinic stakeholders, on-demand SWAT meeting, monthly continuous quality improvement (CQI) calls, face-to-face injection training, monthly FRAME assessment, access to patient and HCP level toolkit and CAB + RPV medical lead site visit.	Staff Study Participants - Standard Implementation Arm SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI). SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.
Change From Baseline in Feasibility of Intervention Measure (FIM) Score in PSPs at Month 12 Baseline (Month 1)	4.51 Scores on a scale Standard Deviation 0.672	—
Change From Baseline in Feasibility of Intervention Measure (FIM) Score in PSPs at Month 12 Month 12	0.07 Scores on a scale Standard Deviation 0.857	—

SECONDARY outcome

Timeframe: Month 12

Population: Full Analysis Set. Only those participants with data available at the specified time points were analyzed.

The APCSAT is a 35-item measure that assesses SSP impressions of the data in their clinic. Sustainability refers to the ability to maintain and expand the CAB LA + RPV LA injection treatment and its benefits over time. SSPs were asked to rate their clinic/practice along a range of specific domains that affect sustainability, including: 'Engages Staff \& Leadership,' 'Engaging Stakeholders,' 'Monitoring and Evaluation,' 'Implementation \& Training,' 'Outcomes \& Effectiveness,' 'Workflow Integration,' and 'Organizational Readiness.' Five items were presented to SSPs in each section. The items were measured on a seven-point rating scale (1 = little to no extent to 7 = to a very great extent. Domain total was divided by the total number of items with a score to get average score.

Outcome measures

Outcome measures
Measure	Staff Study Participants - Enhanced Implementation Arm n=32 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, SWAT meeting with sponsor team and principal clinic stakeholders, on-demand SWAT meeting, monthly continuous quality improvement (CQI) calls, face-to-face injection training, monthly FRAME assessment, access to patient and HCP level toolkit and CAB + RPV medical lead site visit.	Staff Study Participants - Standard Implementation Arm n=30 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI). SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.
Associated Person Clinical Sustainability Assessment Tool (APCSAT) Average Domain Score at Month 12 Engages Staff & Leadership	5.57 Scores on a scale Standard Deviation 0.72	5.58 Scores on a scale Standard Deviation 0.49
Associated Person Clinical Sustainability Assessment Tool (APCSAT) Average Domain Score at Month 12 Outcomes & Effectiveness	5.39 Scores on a scale Standard Deviation 0.70	5.41 Scores on a scale Standard Deviation 0.69
Associated Person Clinical Sustainability Assessment Tool (APCSAT) Average Domain Score at Month 12 Workflow Integration	5.46 Scores on a scale Standard Deviation 0.35	5.23 Scores on a scale Standard Deviation 0.34
Associated Person Clinical Sustainability Assessment Tool (APCSAT) Average Domain Score at Month 12 Organizational Readiness	5.30 Scores on a scale Standard Deviation 0.32	5.05 Scores on a scale Standard Deviation 0.36
Associated Person Clinical Sustainability Assessment Tool (APCSAT) Average Domain Score at Month 12 Engaging Stakeholders	5.00 Scores on a scale Standard Deviation 1.06	5.05 Scores on a scale Standard Deviation 0.79
Associated Person Clinical Sustainability Assessment Tool (APCSAT) Average Domain Score at Month 12 Monitoring and Evaluation	5.37 Scores on a scale Standard Deviation 0.16	5.49 Scores on a scale Standard Deviation 0.11
Associated Person Clinical Sustainability Assessment Tool (APCSAT) Average Domain Score at Month 12 Implementation & Training	5.62 Scores on a scale Standard Deviation 0.56	5.56 Scores on a scale Standard Deviation 0.43

SECONDARY outcome

Timeframe: Day -7 to Day 7 of Month 2, 4, 6, 8, 10 and 12

Population: Safety population included all enrolled participants who received at least one dose of CAB + RPV Oral or CAB LA + RPV LA.

The target window for participants to receive injection was from Day -7 to Day 7.

Outcome measures

Outcome measures
Measure	Staff Study Participants - Enhanced Implementation Arm n=430 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, SWAT meeting with sponsor team and principal clinic stakeholders, on-demand SWAT meeting, monthly continuous quality improvement (CQI) calls, face-to-face injection training, monthly FRAME assessment, access to patient and HCP level toolkit and CAB + RPV medical lead site visit.	Staff Study Participants - Standard Implementation Arm SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI). SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.
Percentage of PSP Receiving Injections Within Target Window Month 2	99 Percentage of Participants	—
Percentage of PSP Receiving Injections Within Target Window Month 4	93 Percentage of Participants	—
Percentage of PSP Receiving Injections Within Target Window Month 6	91 Percentage of Participants	—
Percentage of PSP Receiving Injections Within Target Window Month 8	91 Percentage of Participants	—
Percentage of PSP Receiving Injections Within Target Window Month 10	94 Percentage of Participants	—
Percentage of PSP Receiving Injections Within Target Window Month 12	91 Percentage of Participants	—

SECONDARY outcome

Timeframe: Month 1, 2, 4, 8 and 12

Population: Safety population

Plasma samples were collected from the participant at specific time points.

Outcome measures

Outcome measures
Measure	Staff Study Participants - Enhanced Implementation Arm n=430 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, SWAT meeting with sponsor team and principal clinic stakeholders, on-demand SWAT meeting, monthly continuous quality improvement (CQI) calls, face-to-face injection training, monthly FRAME assessment, access to patient and HCP level toolkit and CAB + RPV medical lead site visit.	Staff Study Participants - Standard Implementation Arm SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI). SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.
Percentage of PSPs With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies Per Milliliter (c/ml) Month 1	99 Percentage of Participants Interval 97.0 to 99.5	—
Percentage of PSPs With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies Per Milliliter (c/ml) Month 2	96 Percentage of Participants Interval 93.7 to 97.7	—
Percentage of PSPs With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies Per Milliliter (c/ml) Month 4	93 Percentage of Participants Interval 90.5 to 95.4	—
Percentage of PSPs With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies Per Milliliter (c/ml) Month 8	86 Percentage of Participants Interval 82.7 to 89.4	—
Percentage of PSPs With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies Per Milliliter (c/ml) Month 12	87 Percentage of Participants Interval 83.2 to 89.8	—

SECONDARY outcome

Timeframe: Month 1, 2, 4, 8, 10 and 12

Population: Safety population

CVF was defined as rebound as indicated by two consecutive plasma HIV-1 RNA levels \>=200 c/ml.

Outcome measures

Outcome measures
Measure	Staff Study Participants - Enhanced Implementation Arm n=430 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, SWAT meeting with sponsor team and principal clinic stakeholders, on-demand SWAT meeting, monthly continuous quality improvement (CQI) calls, face-to-face injection training, monthly FRAME assessment, access to patient and HCP level toolkit and CAB + RPV medical lead site visit.	Staff Study Participants - Standard Implementation Arm SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI). SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.
Number of Participants With Confirmed Virologic Failure (CVF) Over Time Month 10	1 Participants	—
Number of Participants With Confirmed Virologic Failure (CVF) Over Time Month 1	0 Participants	—
Number of Participants With Confirmed Virologic Failure (CVF) Over Time Month 2	0 Participants	—
Number of Participants With Confirmed Virologic Failure (CVF) Over Time Month 4	0 Participants	—
Number of Participants With Confirmed Virologic Failure (CVF) Over Time Month 6	0 Participants	—
Number of Participants With Confirmed Virologic Failure (CVF) Over Time Month 8	0 Participants	—
Number of Participants With Confirmed Virologic Failure (CVF) Over Time Month 12	0 Participants	—

SECONDARY outcome

Timeframe: Up to 12 Months

Population: 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.

Outcome measures

Outcome measures
Measure	Staff Study Participants - Enhanced Implementation Arm n=430 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, SWAT meeting with sponsor team and principal clinic stakeholders, on-demand SWAT meeting, monthly continuous quality improvement (CQI) calls, face-to-face injection training, monthly FRAME assessment, access to patient and HCP level toolkit and CAB + RPV medical lead site visit.	Staff Study Participants - Standard Implementation Arm SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI). SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.
Number of PSPs With Adverse Events (AEs) And Serious AEs (SAEs) Any AEs	420 Participants	—
Number of PSPs With Adverse Events (AEs) And Serious AEs (SAEs) Any SAEs	15 Participants	—

SECONDARY outcome

Timeframe: Up to 12 Months

Population: 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.

Outcome measures

Outcome measures
Measure	Staff Study Participants - Enhanced Implementation Arm n=430 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, SWAT meeting with sponsor team and principal clinic stakeholders, on-demand SWAT meeting, monthly continuous quality improvement (CQI) calls, face-to-face injection training, monthly FRAME assessment, access to patient and HCP level toolkit and CAB + RPV medical lead site visit.	Staff Study Participants - Standard Implementation Arm SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI). SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.
Number of PSPs Discontinuing Treatment Due to AEs	2 Participants	—

SECONDARY outcome

Timeframe: Up to 12 Months

Population: Patient study participants (PSPs) included all participants who successfully completed the survey at Month 12. Only those participants with data available at the specified time points were analyzed.

PSPs were asked to think about their experience of using the long-acting injectable medication versus the daily oral HIV medication, and to select their preferred treatment and all the reasons that support their preference. Results are categorized as: 'long-acting injectable HIV medication', 'daily oral HIV medication', 'no preference', Missing and Erroneous. Missing include participants who did not provide a response for the question. PSPs who completed this question incorrectly (i.e., checked reasons without a ticking a leading preference or checked more than one leading preference box) were included in Erroneous.

Outcome measures

Outcome measures
Measure	Staff Study Participants - Enhanced Implementation Arm n=379 Participants SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, SWAT meeting with sponsor team and principal clinic stakeholders, on-demand SWAT meeting, monthly continuous quality improvement (CQI) calls, face-to-face injection training, monthly FRAME assessment, access to patient and HCP level toolkit and CAB + RPV medical lead site visit.	Staff Study Participants - Standard Implementation Arm SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI). SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.
Number of PSP With Preference for Therapy Assessed Via Preference Questionnaire Daily oral HIV medication	2 Participants	—
Number of PSP With Preference for Therapy Assessed Via Preference Questionnaire Long-acting injectable HIV medication	275 Participants	—
Number of PSP With Preference for Therapy Assessed Via Preference Questionnaire No preference	0 Participants	—
Number of PSP With Preference for Therapy Assessed Via Preference Questionnaire Missing	2 Participants	—
Number of PSP With Preference for Therapy Assessed Via Preference Questionnaire Erroneous	100 Participants	—

Adverse Events

Patient Study Participants

Serious events: 17 serious events

Other events: 384 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Patient Study Participants n=430 participants at risk PSPs received one tablet of cabotegravir (CAB) 30 milligrams (mg) + rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month during the oral lead-in phase (OLI). Participants received last dose of oral regimen followed by CAB long-acting injectable (LA) 600 mg + RPV LA 900 mg injections in Month 1, one month later (Month 2), and every 2 months (Q2M) thereafter via intramuscular (IM) route.
Infections and infestations Appendicitis	0.23% 1/430 • Number of events 1 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to Month 26. Adverse events were reported for safety population which comprised of all participants enrolled and who received at least 1 dose of CAB LA+RPV LA. Staff Study Participants (SSP) did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for SSP were not collected because it was not required per study design.
Infections and infestations COVID-19	0.23% 1/430 • Number of events 1 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to Month 26. Adverse events were reported for safety population which comprised of all participants enrolled and who received at least 1 dose of CAB LA+RPV LA. Staff Study Participants (SSP) did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for SSP were not collected because it was not required per study design.
Infections and infestations Peritonitis	0.23% 1/430 • Number of events 1 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to Month 26. Adverse events were reported for safety population which comprised of all participants enrolled and who received at least 1 dose of CAB LA+RPV LA. Staff Study Participants (SSP) did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for SSP were not collected because it was not required per study design.
Infections and infestations Yersinia infection	0.23% 1/430 • Number of events 1 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to Month 26. Adverse events were reported for safety population which comprised of all participants enrolled and who received at least 1 dose of CAB LA+RPV LA. Staff Study Participants (SSP) did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for SSP were not collected because it was not required per study design.
Gastrointestinal disorders Abdominal pain	0.23% 1/430 • Number of events 1 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to Month 26. Adverse events were reported for safety population which comprised of all participants enrolled and who received at least 1 dose of CAB LA+RPV LA. Staff Study Participants (SSP) did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for SSP were not collected because it was not required per study design.
Gastrointestinal disorders Appendicitis noninfective	0.23% 1/430 • Number of events 1 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to Month 26. Adverse events were reported for safety population which comprised of all participants enrolled and who received at least 1 dose of CAB LA+RPV LA. Staff Study Participants (SSP) did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for SSP were not collected because it was not required per study design.
Injury, poisoning and procedural complications Clavicle fracture	0.23% 1/430 • Number of events 1 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to Month 26. Adverse events were reported for safety population which comprised of all participants enrolled and who received at least 1 dose of CAB LA+RPV LA. Staff Study Participants (SSP) did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for SSP were not collected because it was not required per study design.
Injury, poisoning and procedural complications Subdural haematoma	0.23% 1/430 • Number of events 1 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to Month 26. Adverse events were reported for safety population which comprised of all participants enrolled and who received at least 1 dose of CAB LA+RPV LA. Staff Study Participants (SSP) did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for SSP were not collected because it was not required per study design.
Injury, poisoning and procedural complications Subdural haemorrhage	0.23% 1/430 • Number of events 1 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to Month 26. Adverse events were reported for safety population which comprised of all participants enrolled and who received at least 1 dose of CAB LA+RPV LA. Staff Study Participants (SSP) did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for SSP were not collected because it was not required per study design.
Psychiatric disorders Major depression	0.23% 1/430 • Number of events 1 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to Month 26. Adverse events were reported for safety population which comprised of all participants enrolled and who received at least 1 dose of CAB LA+RPV LA. Staff Study Participants (SSP) did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for SSP were not collected because it was not required per study design.
Psychiatric disorders Suicidal ideation	0.23% 1/430 • Number of events 1 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to Month 26. Adverse events were reported for safety population which comprised of all participants enrolled and who received at least 1 dose of CAB LA+RPV LA. Staff Study Participants (SSP) did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for SSP were not collected because it was not required per study design.
Reproductive system and breast disorders Haematospermia	0.23% 1/430 • Number of events 1 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to Month 26. Adverse events were reported for safety population which comprised of all participants enrolled and who received at least 1 dose of CAB LA+RPV LA. Staff Study Participants (SSP) did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for SSP were not collected because it was not required per study design.
Reproductive system and breast disorders Ovarian cyst	0.23% 1/430 • Number of events 1 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to Month 26. Adverse events were reported for safety population which comprised of all participants enrolled and who received at least 1 dose of CAB LA+RPV LA. Staff Study Participants (SSP) did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for SSP were not collected because it was not required per study design.
General disorders Pyrexia	0.23% 1/430 • Number of events 1 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to Month 26. Adverse events were reported for safety population which comprised of all participants enrolled and who received at least 1 dose of CAB LA+RPV LA. Staff Study Participants (SSP) did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for SSP were not collected because it was not required per study design.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.23% 1/430 • Number of events 1 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to Month 26. Adverse events were reported for safety population which comprised of all participants enrolled and who received at least 1 dose of CAB LA+RPV LA. Staff Study Participants (SSP) did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for SSP were not collected because it was not required per study design.
Nervous system disorders Orthostatic intolerance	0.23% 1/430 • Number of events 1 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to Month 26. Adverse events were reported for safety population which comprised of all participants enrolled and who received at least 1 dose of CAB LA+RPV LA. Staff Study Participants (SSP) did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for SSP were not collected because it was not required per study design.
Renal and urinary disorders Haematuria	0.23% 1/430 • Number of events 1 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to Month 26. Adverse events were reported for safety population which comprised of all participants enrolled and who received at least 1 dose of CAB LA+RPV LA. Staff Study Participants (SSP) did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for SSP were not collected because it was not required per study design.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.23% 1/430 • Number of events 1 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to Month 26. Adverse events were reported for safety population which comprised of all participants enrolled and who received at least 1 dose of CAB LA+RPV LA. Staff Study Participants (SSP) did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for SSP were not collected because it was not required per study design.
Vascular disorders Aortic dissection	0.23% 1/430 • Number of events 1 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to Month 26. Adverse events were reported for safety population which comprised of all participants enrolled and who received at least 1 dose of CAB LA+RPV LA. Staff Study Participants (SSP) did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for SSP were not collected because it was not required per study design.
Gastrointestinal disorders Inguinal hernia	0.23% 1/430 • Number of events 1 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to Month 26. Adverse events were reported for safety population which comprised of all participants enrolled and who received at least 1 dose of CAB LA+RPV LA. Staff Study Participants (SSP) did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for SSP were not collected because it was not required per study design.
Reproductive system and breast disorders Varicocele	0.23% 1/430 • Number of events 1 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to Month 26. Adverse events were reported for safety population which comprised of all participants enrolled and who received at least 1 dose of CAB LA+RPV LA. Staff Study Participants (SSP) did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for SSP were not collected because it was not required per study design.

Other adverse events

Other adverse events
Measure	Patient Study Participants n=430 participants at risk PSPs received one tablet of cabotegravir (CAB) 30 milligrams (mg) + rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month during the oral lead-in phase (OLI). Participants received last dose of oral regimen followed by CAB long-acting injectable (LA) 600 mg + RPV LA 900 mg injections in Month 1, one month later (Month 2), and every 2 months (Q2M) thereafter via intramuscular (IM) route.
General disorders Injection site pain	80.2% 345/430 • Number of events 1632 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to Month 26. Adverse events were reported for safety population which comprised of all participants enrolled and who received at least 1 dose of CAB LA+RPV LA. Staff Study Participants (SSP) did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for SSP were not collected because it was not required per study design.
General disorders Injection site induration	11.2% 48/430 • Number of events 79 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to Month 26. Adverse events were reported for safety population which comprised of all participants enrolled and who received at least 1 dose of CAB LA+RPV LA. Staff Study Participants (SSP) did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for SSP were not collected because it was not required per study design.
General disorders Injection site discomfort	8.8% 38/430 • Number of events 94 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to Month 26. Adverse events were reported for safety population which comprised of all participants enrolled and who received at least 1 dose of CAB LA+RPV LA. Staff Study Participants (SSP) did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for SSP were not collected because it was not required per study design.
General disorders Pyrexia	9.5% 41/430 • Number of events 54 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to Month 26. Adverse events were reported for safety population which comprised of all participants enrolled and who received at least 1 dose of CAB LA+RPV LA. Staff Study Participants (SSP) did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for SSP were not collected because it was not required per study design.
General disorders Injection site nodule	7.4% 32/430 • Number of events 57 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to Month 26. Adverse events were reported for safety population which comprised of all participants enrolled and who received at least 1 dose of CAB LA+RPV LA. Staff Study Participants (SSP) did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for SSP were not collected because it was not required per study design.
General disorders Injection site swelling	6.3% 27/430 • Number of events 38 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to Month 26. Adverse events were reported for safety population which comprised of all participants enrolled and who received at least 1 dose of CAB LA+RPV LA. Staff Study Participants (SSP) did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for SSP were not collected because it was not required per study design.
General disorders Asthenia	6.3% 27/430 • Number of events 32 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to Month 26. Adverse events were reported for safety population which comprised of all participants enrolled and who received at least 1 dose of CAB LA+RPV LA. Staff Study Participants (SSP) did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for SSP were not collected because it was not required per study design.
Infections and infestations COVID-19	18.4% 79/430 • Number of events 85 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to Month 26. Adverse events were reported for safety population which comprised of all participants enrolled and who received at least 1 dose of CAB LA+RPV LA. Staff Study Participants (SSP) did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for SSP were not collected because it was not required per study design.
Infections and infestations Nasopharyngitis	7.0% 30/430 • Number of events 33 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to Month 26. Adverse events were reported for safety population which comprised of all participants enrolled and who received at least 1 dose of CAB LA+RPV LA. Staff Study Participants (SSP) did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for SSP were not collected because it was not required per study design.
Musculoskeletal and connective tissue disorders Back pain	8.1% 35/430 • Number of events 36 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to Month 26. Adverse events were reported for safety population which comprised of all participants enrolled and who received at least 1 dose of CAB LA+RPV LA. Staff Study Participants (SSP) did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for SSP were not collected because it was not required per study design.
Nervous system disorders Headache	9.5% 41/430 • Number of events 50 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to Month 26. Adverse events were reported for safety population which comprised of all participants enrolled and who received at least 1 dose of CAB LA+RPV LA. Staff Study Participants (SSP) did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for SSP were not collected because it was not required per study design.
Gastrointestinal disorders Diarrhoea	7.0% 30/430 • Number of events 35 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to Month 26. Adverse events were reported for safety population which comprised of all participants enrolled and who received at least 1 dose of CAB LA+RPV LA. Staff Study Participants (SSP) did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for SSP were not collected because it was not required per study design.
Musculoskeletal and connective tissue disorders Arthralgia	5.3% 23/430 • Number of events 26 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to Month 26. Adverse events were reported for safety population which comprised of all participants enrolled and who received at least 1 dose of CAB LA+RPV LA. Staff Study Participants (SSP) did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for SSP were not collected because it was not required per study design.
Musculoskeletal and connective tissue disorders Pain in extremity	5.1% 22/430 • Number of events 23 • Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to Month 26. Adverse events were reported for safety population which comprised of all participants enrolled and who received at least 1 dose of CAB LA+RPV LA. Staff Study Participants (SSP) did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for SSP were not collected because it was not required per study design.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

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