Study Using CABENUVA™ for the Treatment of Human Immunodeficiency Virus (HIV)-1, Administered in Infusion Centers (IC) or Alternate Sites of Administration (ASA) in the United States (U.S.) (GLACIER)

A Phase 4, Open-label, Single Arm Study to Optimize Implementation of CABENUVA for the Treatment of HIV-1, for Administration in U.S. Community-based Infusion Centers or Other Alternate Sites of Administration

GLACIER (Giving Long Acting CABENUVA in an Infusion center/ASA) is an interventional study examining the administration of CABENUVA (Cabotegravir long acting [LA] plus Rilpivirine LA) intramuscular (IM) in infusion centers/ASAs in United States. In this study, the intervention is the process of using an infusion center/ASA as the location to receive the CABENUVA IM injections. The acceptability and feasibility of the IC/ASA to deliver CABENUVA IM injections will be assessed from the perspectives of the participants, HIV care providers and IC/ASA staff. In this study, Month 1 is the Baseline visit. CABENUVA is a registered trademark of ViiV Healthcare.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: CABENUVA

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Evans, Georgia, United States, 30809
      • GSK Investigational Site
  • Michigan
    • East Lansing, Michigan, United States, 48823
      • GSK Investigational Site
    • Novi, Michigan, United States, 48377-2977
      • GSK Investigational Site
  • Minnesota
    • Plymouth, Minnesota, United States, 55446
      • GSK Investigational Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28226
      • GSK Investigational Site
    • Greensboro, North Carolina, United States, 27405
      • GSK Investigational Site
    • Raleigh, North Carolina, United States, 27612
      • GSK Investigational Site
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • GSK Investigational Site
    • Florence, South Carolina, United States, 29501
      • GSK Investigational Site
    • Summerville, South Carolina, United States, 29483
      • GSK Investigational Site
    • West Columbia, South Carolina, United States, 29169
      • GSK Investigational Site
  • Texas
    • Fort Worth, Texas, United States, 76244-5307
      • GSK Investigational Site
    • Kingwood, Texas, United States, 77339
      • GSK Investigational Site
    • North Richland Hills, Texas, United States, 76180-7379
      • GSK Investigational Site
    • Plano, Texas, United States, 75093
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria

• Adults (greater than or equal to [>=]18 years old) at the time of signing the informed consent.
• HIV-1 infected and have been prescribed CABNEUVA per the United States Prescribing information (USPI).
• Participants can be enrolled
• If they have been taking oral VOCABRIA + EDURANT or other ART for approximately 1 month (at least 28 days) prior to Baseline/Month 1, or
• Already taking CABENUVA prior to Baseline/Month 1 and the last injections were within a 1 month +/- 7-day window or for every 2-month injections, the timing will vary if they are receiving the initiation injections (1 month +/- 7-day) or the continuation injections (2 months +/- 7 days) per the USPI, or
• Prescribed direct to inject and receive their 1st injection without an oral lead in at the Infusion Center/ASA on the last day of any other antiretroviral therapy
• Agreement to receive CABENUVA IM injections at participating infusion center/ASA.

Exclusion criteria

• Participants are excluded from the study as dictated in the Prescribing Information (CABENUVA [USPI]) in consultation with the HIV care provider.
• Contraindications, as per the current Prescribing Information [CABENUVA USPI]
• New health condition / prohibited medication reported - Other Reason at the discretion of the HIV care provider or IC/ ASA staff

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participants receiving CABENUVA; Eligible participants received CABENUVA injections intramuscularly at infusion centers/ASAs monthly or every-2-months.	Drug: CABENUVA; CABENUVA will be administered IM at infusion centers/ASAs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Agree or Completely Agree (a Score of 4 or Higher) Across All Items on the Feasibility of Intervention Measure (FIM)	Feasibility of Intervention Measure (FIM) were employed to evaluate the feasibility of CABENUVA administration at Infusion Centers (IC)/ alternate sites of administration (ASA). Higher scores on FIM indicate greater feasibility, where each item can be scored from 1 to 5: Completely disagree (score=1), disagree (score=2), neither agree or disagree (score=3), agree (score=4), completely agree (score=5). This scoring looked at the number responding '4' or '5' to each question divided by the number completing all 4-items where "items" refer to the individual questions or statements that participants respond to in order to assess their perceptions of an intervention. Each item is designed to measure a specific aspect of either acceptability or feasibility.	At Month 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Agree or Completely Agree (a Score of 4 or Higher) Across All Items on the FIM at Month 1 and 3		At Months 1 and 3
Number of HIV Care Providers Who Agree or Completely Agree (a Score of 4 or Higher) Across All Items on the FIM at Month 1, 4 and 8		At Months 1, 4, and 8
Number of IC/ ASA Staff Who Agree or Completely Agree (a Score of 4 or Higher) Across All Items on the FIM Prior to Month 1 and at Months 3 and 8		Prior to Month 1 (Baseline) and at Months 3 and 8
Change in FIM Score Over Time in Participants at Month 3 and 8	The mean score for feasibility of the intervention administration was calculated by averaging the responses from the 4 items. The responses were scored based on a scale of 1 to 5 where 1=completely disagree, 2=disagree, 3=neither agree nor disagree, 4=agree, and 5=completely agree.	From Month 1 (Baseline) to Months 3 and 8
Change in FIM Score Over Time in HIV Care Providers at Month 4 and 8		From Month 1 (Baseline) to Months 4 and 8
Change in FIM Score Over Time in IC/ ASA Staff at Month 3 and 8		From Month 1 (Baseline) to Months 3 and 8
Number of Participants Assessed for Feasibility of CABENUVA Administration by Other Quantitative Questionnaires at Month 1	The tailored questionnaire for participants receiving CABENUVA was developed specifically for this study and contains items regarding the reasons for switching to CABENUVA, adherence to their previous oral HIV medication, preferences and attitudes regarding their medication regimen, and perceived advantages and disadvantages of receiving injections at the IC/ASA. In this outcome measure, participants were asked about their views on the IC/ASA administration model (any/biggest concerns about receiving CABENUVA at an infusion center).	At Month 1
Number of Participants Assessed for Feasibility of CABENUVA Administration (Concern About Continuing to Receive CABENUVA) by Other Quantitative Questionnaires at Month 3 and 8	The tailored questionnaire for participants receiving CABENUVA was developed specifically for this study and contains items regarding the reasons for switching to CABENUVA, adherence to their previous oral HIV medication, preferences and attitudes regarding their medication regimen, and perceived advantages and disadvantages of receiving injections at the IC/ASA. In this outcome measure, participants were asked about their views on the IC/ASA administration model (any concerns about continuing to receive CABENUVA at an infusion center) at Months 3 and 8.	At Month 3 and 8
Number of Participants Assessed for Feasibility of CABENUVA Administration by Other Quantitative Questionnaires at Month 3 and 8	Participants were asked about their views on the IC/ASA administration model (biggest concerns about continuing to receive CABENUVA at an infusion center).	At Month 3 and 8
Number of HIV Care Providers Assessed for Feasibility of CABENUVA Administration in Participants by Other Quantitative Questionnaires at Month 1	The tailored HIV care provider/clinical staff questionnaire was developed specifically for this study and contains items regarding the provider's practice and experience, as well as their attitudes, expectations, and concerns regarding the use of CABENUVA/long-acting injectable administered by ICs/ASAs.	At Month 1
Number of HIV Care Providers Assessed for Feasibility of CABENUVA Administration in Participants by Other Quantitative Questionnaires at Month 4		At Month 4
Number of HIV Care Providers Assessed for Feasibility of CABENUVA Administration in Participants by Other Quantitative Questionnaires at Month 8		At Month 8
Number of IC/ASA Staff Assessed for Feasibility of CABENUVA Administration in Participants by Other Quantitative Questionnaires Prior to Month 1	The tailored IC staff questionnaire was developed specifically for this study and contains items regarding the staff member's role at the IC, as well as their attitudes, concerns, and anticipated/implemented procedures regarding the use of CABENUVA/long-acting injectable administered by ICs. The IC/ASA staff members were asked to indicate their level of concern across 16 areas of potential concern, on a five-point scale from "not at all concerned" to "extremely concerned."	Prior to Month 1 (Baseline)
Number of IC/ASA Staff Assessed for Feasibility of CABENUVA Administration in Participants Assessed by Other Quantitative Questionnaires at Month 3	The IC/ASA staff members were asked to indicate their level of concern across 16 areas of potential concern, on a five-point scale from "not at all concerned" to "extremely concerned."	At Month 3
Number of IC/ASA Staff Assessed for Feasibility of CABENUVA Administration in Participants by Other Quantitative Questionnaires at Month 8	The IC/ASA staff members were asked to indicate their level of concern across 16 areas of potential concern, on a five-point scale from "not at all concerned" to "extremely concerned."	At Month 8
Number of Participants Assessed for Feasibility of CABENUVA Administration by Qualitative Interviews at Month 8	Qualitative interviews were conducted at Month 8 to evaluate the opinions of participants on the feasibility of CABENUVA administration at IC/ASA.	At Month 8
Number of HIV Care Providers Assessed for Feasibility of CABENUVA Administration in Participants by Qualitative Interviews at Month 8	Qualitative interviews were conducted at Month 8 to evaluate the general opinion of HIV care providers on the feasibility of referring participants to receive CABENUVA at the IC/ASA.	At Month 8
Number of IC/ASA Staff Assessed for Feasibility of CABENUVA Administration in Participants by Qualitative Interviews at Month 8	Qualitative interviews were conducted at Month 8 to evaluate the general opinion of IC/ ASA staff on feasibility of CABENUVA administration at the IC/ASA.	At Month 8
Composite Score of Feasibility Process Indications	Composite score of feasibility process was calculated as the mean of the following four scores: FIM Score, Consent Rate, Show Rate, and Return Rate at Visit, on a 0 to 100 scale, where higher numbers correspond to better feasibility.	Up to and including Month 8
Change in Composite Score and Each Item of Composite Score Over Time	This outcome measure was planned to evaluate change in composite score from baseline to month 8 according to the protocol. The composite score was however not evaluated as a change over time but as a point in time at month 8 as the components of each of the feasibility composite score (FIM score, consent rate, show rate and return rate) were captured at different time intervals.	Baseline (Month 1) and at Month 8
Number of HIV Care Providers Who Agree or Completely Agree (a Score of 4 or Higher) Across All Items on the Acceptability of Intervention Measure (AIM)	AIM was employed to evaluate the acceptability of CABENUVA administration at Infusion Centers/ ASAs. Higher scores for AIM indicate greater acceptability, where each item was scored from 1 to 5: Completely disagree (score=1), disagree (score=2), neither agree or disagree (score=3), agree (score=4), completely agree (score=5).	Months 1 (Baseline), 4, and 8
Number of Participants Who Agree or Completely Agree (a Score of 4 or Higher) Across All Items on the AIM	AIM were employed to evaluate the acceptability of CABENUVA administration at Infusion Centers/ ASAs. Higher scores for AIM indicate greater acceptability, where each item was scored from 1 to 5: Completely disagree (score=1), disagree (score=2), neither agree or disagree (score=3), agree (score=4), completely agree (score=5).	Month 1 (Baseline), 3 and 8
Number of IC/ ASA Staff Who Agree or Completely Agree (a Score of 4 or Higher) Across All Items on the AIM	AIM were employed to evaluate the acceptability of CABENUVA administration at Infusion Centers/ ASAs. Higher scores for AIM indicate greater acceptability, where each item was scored from 1 to 5: Completely disagree (score=1), disagree (score=2), neither agree or disagree (score=3), agree (score=4), completely agree (score=5).	Prior to Month 1 (Baseline), and at Month 3 and 8
Change in AIM Score Over Time in HIV Care Providers at Month 4 and 8	The mean score for acceptability of the intervention is calculated by averaging the responses from 4 items. The responses were scored based on a scale of 1 to 5 where 1=completely disagree, 2=disagree, 3=neither agree nor disagree, 4=agree, and 5=completely agree.	Month 1 (Baseline), at Months 4 and 8
Change in AIM Score Over Time in Participants at Month 3 and 8	The mean score for acceptability of the intervention is calculated by averaging the responses from 4 items. The responses were scored based on a scale of 1 to 5 where 1=completely disagree, 2=disagree, 3=neither agree nor disagree, 4=agree, and 5=completely agree.	Month 1 (Baseline), at Months 3 and 8
Change in AIM Score Over Time in IC/ ASA Staff at Month 3 and 8	The mean score for acceptability of the intervention is calculated by averaging the responses from 4 items. The responses were scored based on a scale of 1 to 5 where 1=completely disagree, 2=disagree, 3=neither agree nor disagree, 4=agree, and 5=completely agree.	Month 1 (Baseline), at Months 3 and 8
Number of HIV Care Providers Assessed for Acceptability of CABENUVA Administration in Participants at IC/ ASA by Other Quantitative Questionnaire at Months 1, 4 and 8		At Months 1, 4 and 8
Number of Participants Assessed for Acceptability of CABENUVA Administration at IC/ ASA by Other Quantitative Questionnaire in at Months 1, 3 and 8	The participants were asked how acceptable it was to come to the IC/ASA for CABENUVA using a 7-point scale from "very acceptable" to "very unacceptable" where 1= very acceptable, 2= somewhat acceptable, 3= a little acceptable, 4= neutral, 5= a little unacceptable, 6= somewhat unacceptable and 7= very unacceptable.	At Months 1, 3 and 8
Number of IC/ ASA Staff Assessed for Acceptability of CABENUVA Administration in Participants at IC/ ASA by Other Quantitative Questionnaire Prior to Month 1		Prior to Month 1 (Baseline)
Number of IC/ ASA Staff Assessed for Acceptability of CABENUVA Administration in Participants at IC/ ASA by Other Quantitative Questionnaire at Months 3 and 8		At Months 3 and 8
Number of Participants Assessed for Acceptability of CABENUVA Administration at IC/ASA by Qualitative Interviews at Month 8	Participants were asked about their opinion on acceptability of CABENUVA administration at the IC/ASA.	At Month 8
Number of HIV Care Providers Assessed for Acceptability of CABENUVA Administration in Participants at IC/ASA by Qualitative Interviews at Month 8	HIV care providers were asked about their opinion on the acceptability of participants receiving CABENUVA at the IC/ASA.	At Month 8
Number of IC/ASA Staff Assessed for Acceptability of CABENUVA Administration in Participants at IC/ASA by Qualitative Interviews at Month 8	IC/ASA staff were asked about their opinion on the acceptability of administering CABENUVA at an IC/ASA.	At Month 8
Number of Expert Panel That Agree or Completely Agree (a Score of 4 or Higher) Across All Items on the FIM Scale		Prior to Month 1 (Baseline), and at Month 3 and 6
Number of Expert Panel That Agree or Completely Agree (a Score of 4 or Higher) Across All Items on the AIM Scale		Prior to Month 1 (Baseline), and at Month 3 and 6
Change in FIM Score of Expert Panel Over Time Through Month 6		Prior to Month 1 (Baseline) and Up to Month 6
Change in AIM Score of Expert Panel Over Time Through Month 6		Prior to Month 1 (Baseline) and Up to Month 6
Number of Expert Panel Members Assessed for Feasibility, Acceptability and Process of Insurance Coverage for CABENUVA Administration in Participants by Quantitative Questionnaires Prior to Month 1		Prior to Month 1 (Baseline)
Number of Expert Panel Members Assessed for Feasibility, Acceptability and Process of Communication for CABENUVA Administration in Participants by Quantitative Questionnaires Prior to Month 1		Prior to Month 1 (Baseline)
Number of Expert Panel Members Assessed for Feasibility, Acceptability and Process of CABENUVA Administration (Interval of Time) in Participants by Quantitative Questionnaires Prior to Month 1	In this outcome measure, Expert Panel members were asked about their views on the IC/ASA administration model (for patients receiving CABENUVA injections at the infusion center, what is the preferred interval of time for patients to be seen by their HIV provider).	Prior to Month 1 (Baseline)
Number of Expert Panel Members Assessed for Feasibility, Acceptability and Process of Referring Participants for CABENUVA Administration by Quantitative Questionnaires Prior to Month 1		Prior to Month 1 (Baseline)
Number of Expert Panel Members Assessed for Feasibility, Acceptability and Process of Insurance and Communication for CABENUVA Administration in Participants by Quantitative Questionnaires at Month 3		At Month 3
Number of Expert Panel Members Assessed for Feasibility, Acceptability and Process of Insurance and Communication for CABENUVA Administration in Participants by Quantitative Questionnaires at Month 6		At Month 6
Number of Expert Panel Members Assessed for Feasibility, Acceptability and Process of CABENUVA Administration in Participants by Qualitative Interviews Prior to Month 1	The Expert Panel were asked about the key steps focused on the process of CABENUVA administration at IC/ASAs in order to inform the development of the blueprint.	Prior to Month 1 (Baseline)
Number of Expert Panel Members Assessed for Feasibility, Acceptability and Process of CABENUVA Administration in Participants by Qualitative Interviews at Month 6	The Expert Panel were asked about the key steps focused on the process of CABENUVA administration at IC/ASAs in order to inform the development of the blueprint.	At Month 6
Number of Participants Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration With Other Quantitative Questionnaires at Month 1		At Month 1
Number of Participants Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration With Other Quantitative Questionnaires (Q 1) at Month 3 and 8		At Month 3 and 8
Number of Participants Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration With Other Quantitative Questionnaires (Q 2) at Months 3 and 8		At Months 3 and 8
Number of Participants Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration With Other Quantitative Questionnaires (Q 3) at Months 3 and 8		At Months 3 and 8
Number of Participants Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration With Other Quantitative Questionnaires (Q 4) at Months 3 and 8		At Months 3 and 8
Number of Participants Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration With Other Quantitative Questionnaires (Q 5) at Months 3 and 8		At Months 3 and 8
Number of Participants Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration With Other Quantitative Questionnaires (Q 6) at Months 3 and 8		At Months 3 and 8
Number of Participants Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration With Other Quantitative Questionnaires (Q 7) at Months 3 and 8		At Months 3 and 8
Number of Participants Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration With Other Quantitative Questionnaires (Q 8) at Months 3 and 8		At Months 3 and 8
Number of Participants Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration With Other Quantitative Questionnaires (Q 9) at Months 3 and 8		At Months 3 and 8
Number of Participants Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration With Other Quantitative Questionnaires (Q 10) at Months 3 and 8	Participants were asked their opinion on who did they reach out to obtain answers to their questions.	At Months 3 and 8
Number of Participants Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration With Other Quantitative Questionnaires (Q 11) at Months 3 and 8		At Months 3 and 8
Number of IC/ASA Staff Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration in Participants With Other Quantitative Questionnaires Prior to Month 1	Since CABENUVA must be administered within a two-week treatment window every month, IC/ASA staff were asked their opinion about the ease or difficulty in appointment re-scheduling and implementation of CABENUVA administration in their work-flow.	Prior to Month 1 (Baseline)
Number of IC/ASA Staff Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration in Participants With Other Quantitative Questionnaires at Month 3	Since CABENUVA must be administered within a two-week treatment window (+/-)7 days relative to the target treatment date), the IC/ASA staff was asked their opinion about the ease or difficulty in appointment scheduling and re-scheduling and implementation of CABENUVA administration in their workflow.	At Month 3
Number of IC/ASA Staff Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration in Participants With Other Quantitative Questionnaires at Month 8	Since CABENUVA must be administered within a two-week treatment window (+/-)7 days relative to the target treatment date), the IC/ASA staff was asked their opinion about the ease or difficulty in appointment scheduling and re-scheduling and implementation of CABENUVA administration in their workflow.	At Month 8
Number of HIV Care Providers Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration in Participants With Quantitative Questionnaires at Month 1		At Month 1
Number of HIV Care Providers Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration in Participants With Quantitative Questionnaires at Month 4		At Month 4
Number of HIV Care Providers Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration in Participants With Quantitative Questionnaires at Month 8		At Month 8
Number of Participants Assessed for Facilitators of CABENUVA Administration by Qualitative Interviews at Month 8	Participants were asked about facilitators that made the process of receiving CABENUVA at IC/ASAs easier.	At Month 8
Number of IC/ASA Staff Assessed for Barriers/Concerns of CABENUVA Administration in Participants by Qualitative Interviews at Month 8	IC/ASA staff were asked their opinion on the infrastructure impact of administering CABENUVA.	At Month 8
Number of HIV Care Providers Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration in Participants by Qualitative Interviews at Month 8	HIV care providers were asked about the facilitators and challenges related to referring participants to IC/ASAs.	At Month 8
Number of Participants Assessed for Preference on the Location to Receive CABENUVA With Other Quantitative Questionnaires at Months 1, 3 and 8		At Month 1, 3 and 8
Number of Participants Assessed for Preference on the Location to Receive CABENUVA by Qualitative Interviews at Month 8		At Month 8
Number of Participants Assessed for Advantages of Receiving CABENUVA at IC/ ASA by Other Quantitative Questionnaires at Month 1	In this outcome measure, participants were asked about their views on the IC/ASA administration model (advantages of going to the infusion center to receive CABENUVA).	At Month 1
Number of Participants Assessed for Advantages of Receiving CABENUVA at IC/ ASA by Other Quantitative Questionnaires at Months 3 and 8	In this outcome measure, participants were asked about their views on the IC/ASA administration model (advantages of going to the infusion center to receive CABENUVA).	At Months 3 and 8
Number of HIV Care Providers Assessed for Advantages of Referring Participants to the IC/ ASA to Receive CABENUVA by Other Quantitative Questionnaires at Month 1, 4 and 8	In this outcome measure, HIV care providers were asked about their views on the IC/ASA administration model (advantages of referring patients to an infusion center for CABENUVA).	At Months 1, 4 and 8
Number of Participants Assessed for Advantages of Receiving CABENUVA at IC/ ASA by Qualitative Interviews at Month 8		At Month 8
Number of HIV Care Providers Assessed for Advantages of Participants Receiving CABENUVA at IC/ ASA by Qualitative Interviews at Month 8		At Month 8
Number of Participants Assessed for Disadvantages of Receiving CABENUVA at IC/ ASA by Other Quantitative Questionnaires at Month 1	In this outcome measure, participants were asked about their views on the IC/ASA administration model (disadvantages of going to the infusion center to receive CABENUVA).	At Month 1
Number of Participants Assessed for Disadvantages of Receiving CABENUVA at IC/ ASA by Other Quantitative Questionnaires at Months 3 and 8	In this outcome measure, participants were asked about their views on the IC/ASA administration model (disadvantages of going to the infusion center to receive CABENUVA).	At Months 3 and 8
Number of HIV Care Providers Assessed for Disadvantages of Referring Participants to the IC/ ASA to Receive CABENUVA by Other Quantitative Questionnaires at Month 1	In this outcome measure, HIV care providers were asked about their views on the IC/ASA administration model (potential disadvantages of referring patients to an IC for CABENUVA).	At Month 1
Number of HIV Care Providers Assessed for Disadvantages of Referring Participants to the IC/ ASA to Receive CABENUVA by Other Quantitative Questionnaires at Months 4 and 8	In this outcome measure, HIV care providers were asked about their views on the IC/ASA administration model (disadvantages of referring patients to an IC for CABENUVA).	At Months 4 and 8
Number of Participants Assessed for Disadvantages of Receiving CABENUVA at IC/ ASA by Qualitative Interviews at Month 8		At Month 8
Number of HIV Care Providers Assessed for Disadvantages for Participants Receiving CABENUVA at IC/ ASA by Qualitative Interviews at Month 8	In this outcome measure, HIV care providers were asked about their views on the IC/ASA administration model (disadvantages for participants receiving CABENUVA at IC/ASAs).	At Month 8
Number of Participants Assessed for Acceptability of the Process of Receiving Injections at ICs/ ASAs by Other Quantitative Questionnaires at Month 1		At Month 1
Number of Participants Assessed for Acceptability of the Process of Receiving Injections at ICs/ ASAs by Other Quantitative Questionnaires at Month 3		At Month 3
Number of Participants Assessed for Acceptability of the Process of Receiving Injections at ICs/ ASAs by Other Quantitative Questionnaires at Month 8		At Month 8
Number of Participants Assessed for Acceptability of the Process of Receiving Injections at ICs/ ASAs (Time Spent at IC) by Other Quantitative Questionnaires at Months 3 and 8		At Months 3 and 8
Number of HIV Care Providers Assessed for Acceptability of the Process of Referring Participants to the IC/ ASA for CABENUVA by Other Quantitative Questionnaires at Months 1, 4 and 8	HIV care providers were asked about the type of patients they found acceptable to refer to an IC to receive CABENUVA.	At Months 1, 4 and 8
Number of Participants Assessed for Acceptability of the Process of Receiving Injections at ICs/ ASAs by Qualitative Interviews at Month 8	Participants were asked about their opinion on the acceptability of CABENUVA administration at the IC.	At Month 8
Number of HIV Care Providers Assessed for Acceptability of the Process of Participants Receiving Injections at ICs/ ASAs by Qualitative Interviews at Month 8		At Month 8
Number of IC/ASA Staff Assessed for Usefulness of the Blueprint Intervention With Other Quantitative Questionnaires Prior to Month 1	The blueprint guides IC/ASA staff on what to do with referrals to receive CABENUVA at the IC/ASA.	Prior to Month 1 (Baseline)
Number of IC/ASA Staff Assessed for Usefulness of the Blueprint Intervention With Other Quantitative Questionnaires at Month 3 and 8	The blueprint guides IC/ASA staff on what to do with referrals to receive CABENUVA at the IC/ASA.	At Months 3 and 8
Number of HIV Care Providers Assessed for Usefulness of Plan of Treatment (POT) by Other Quantitative Questionnaires at Months 4 and 8		At Months 4 and 8
Number of IC/ASA Staff Assessed for Usefulness of the Blueprint Intervention and POT Assessed by Qualitative Interviews at Month 8		Month 8
Number of HIV Care Providers Assessed for Usefulness of the Blueprint Intervention and POT by Qualitative Interviews at Month 8	The blueprint guides HIV care providers on what to do with referrals to receive CABENUVA at the IC/ASA.	Month 8
Number of IC/ASA Staff Assessed for Overall Opinion of Administering the Injection at an IC/ ASA by Other Quantitative Questionnaires Prior to Month 1 and at Months 3 and 8		Prior to Month 1 (Baseline) and Months 3 and 8
Number of Participants Assessed for Overall Opinion of Receiving the Injection at an IC/ ASA by Other Quantitative Questionnaires at Months 1, 3 and 8		At Months 1, 3 and 8
Number of HIV Care Providers Assessed for Overall Opinion of Referring the Participant to an IC/ ASA by Other Quantitative Questionnaires at Month 1		At Month 1
Number of HIV Care Providers Assessed for Overall Opinion of Referring the Participant to an IC/ ASA by Other Quantitative Questionnaires at Month 4		At Month 4
Number of HIV Care Providers Assessed for Overall Opinion of Referring the Participant to an IC/ ASA by Other Quantitative Questionnaires at Month 8		At Month 8
Number of HIV Care Providers Assessed for Overall Opinion of Continuing to Refer Participants to an IC/ ASA by Other Quantitative Questionnaires at Month 8		At Month 8
Number of Participants Assessed for Overall Opinion of Receiving the Injection at an IC/ ASA by Qualitative Interview at Month 8	Participants were asked about their overall favorable and non-favorable opinion of receiving CABENUVA at the IC/ASA.	At Month 8
Number of HIV Care Providers Assessed for Overall Opinion of Referring Patients to an IC/ ASA by Qualitative Interview at Month 8	HIV care providers were asked about their overall favoring and non-favoring opinions on referring participants to IC/ASA for CABENUVA administration.	At Month 8
Number of IC/ASA Staff Assessed for Overall Opinion of Administering the Injection at an IC/ ASA by Qualitative Interview at Month 8	IC/ASA staff was asked about their overall opinion on the participants referral process.	At Month 8
Number of Injections Occurring Within Target Window From Target Date	This outcome measure evaluates the fidelity to treatment and dosing window. Fidelity to treatment and dosing window was defined based on a ±7-day window from target treatment date based on the calendar date of baseline injection.	Up to and including Month 8

Collaborators and Investigators

• Sponsor: ViiV Healthcare
• Investigators: Study Director: GSK Clinical Trials, ViiV Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2021
• Primary Completion (Actual): January 31, 2024
• Study Completion (Actual): January 31, 2024

Study Registration Dates

• First Submitted: July 26, 2021
• First Submitted That Met QC Criteria: July 26, 2021
• First Posted (Actual): July 29, 2021

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 18, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: HIV; Rilpivirine; Cabotegravir; Intramuscular; CABENUVA
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; HIV Infections; Anti-Infective Agents; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; Cabotegravir, rilpivirine drug combination
• Other Study ID Numbers: 214747

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
• IPD Sharing Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
• IPD Sharing Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No