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.)

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: CABENUVA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants receiving CABENUVA<br> | Drug: CABENUVA<br>* CABENUVA will be administered IM at infusion centers/ASAs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants who agree or completely agree (a score of 4 or higher) across all items on the Feasibility of Intervention Measure (FIM) | FIM will be employed to evaluate the feasibility of CABENUVA administration at Infusion Centers/ ASAs. 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). | Month 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants who agree or completely agree (a score of 4 or higher) across all items on the FIM at Month 1 and 3 | FIM will be employed to evaluate the feasibility of CABENUVA administration at infusion centers/ ASAs. 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). | Months 1 and 3 | 
| Proportion 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 | FIM will be employed to evaluate the feasibility of CABENUVA administration at Infusion Centers/ ASAs. 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). | Months 1, 4, and 8 | 
| Proportion 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 | FIM will be employed to evaluate the feasibility of CABENUVA administration at Infusion Centers/ ASAs. 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). | Prior to Month 1 and at Months 3 and 8 | 
| Change in FIM score over time in participants at Month 3 and 8 | FIM will be employed to evaluate the feasibility of CABENUVA administration at Infusion Centers/ ASAs. 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). | Baseline (Month 1), at Months 3 and 8 | 
| Change in FIM score over time in HIV care providers at Month 4 and 8 | FIM will be employed to evaluate the feasibility of CABENUVA administration at Infusion Centers/ASAs. 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). | Baseline (Month 1), at Months 4 and 8 | 
| Change in FIM score over time in IC/ ASA Staff at Month 3 and 8 | FIM will be employed to evaluate the feasibility of CABENUVA administration at Infusion Centers/ ASAs. 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). | Baseline (Month 1), at Months 3 and 8 | 
| Feasibility of Cabenuva administration assessed by other quantitative questionnaires in participants at Month 1, 3 and 8 |  | Month 1, 3 and 8 | 
| Feasibility of Cabenuva administration assessed by other Quantitative questionnaires in HIV care providers at Month 1, 4 and 8 |  | Month 1, 4 and 8 | 
| Feasibility of Cabenuva administration assessed by other Quantitative questionnaires in IC/ ASA Staff prior to Month 1, Month 3 and 8 |  | Prior to Month 1 and at Month 3 and 8 | 
| Feasibility of Cabenuva administration assessed by Qualitative interviews in participants, HIV care providers and IC/ ASA staff at Month 8 |  | Month 8 | 
| Composite score of feasibility process indications | Composite score of feasibility process will include of sub score from following measures: FIM Score, Consent Rate, Show Rate, Participant Notification, HIV Care Provider Notification and Return Rate at Visit. | Up to and including Month 8 | 
| Change in composite score of feasibility process indications | Composite score of feasibility process will include of sub score from following measures: FIM Score, Consent Rate, Show Rate, Participant Notification, HIV Care Provider Notification and Return Rate at Visit. | Baseline (Month 1) and up to Month 8 | 
| Change in each individual item of composite score of feasibility process indications | Composite score of feasibility process will include of sub score from following measures: FIM Score, Consent Rate, Show Rate, Participant Notification, HIV Care Provider Notification and Return Rate at Visit. | Baseline (Month 1) and up to Month 8 | 
| Proportion 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 will be employed to evaluate the acceptability of CABENUVA administration at Infusion Centers/ ASAs. Higher scores for AIM indicate greater acceptability, 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). | Months 1, 4, and 8 | 
| Change from Baseline in AIM score for HIV care providers over time | AIM will be employed to evaluate the acceptability of CABENUVA administration at Infusion Centers/ ASAs. Higher scores for AIM indicate greater acceptability, 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). | Baseline (Month 1), at Months 4 and 8 | 
| Proportion of IC/ ASA participants who agree or completely agree (a score of 4 or higher) across all items on the AIM | AIM will be employed to evaluate the acceptability of CABENUVA administration at Infusion Centers/ ASAs. Higher scores for AIM indicate greater acceptability, 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) | Month 1, 3 and 8 | 
| Proportion of IC/ ASA staff who agree or completely agree (a score of 4 or higher) across all items on the AIM | AIM will be employed to evaluate the acceptability of CABENUVA administration at Infusion Centers/ ASAs. Higher scores for AIM indicate greater acceptability, 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). | Prior to Month 1, and at Month 3 and 8 | 
| Change from Baseline in AIM score for participants over time | AIM will be employed to evaluate the acceptability of CABENUVA administration at Infusion Centers/ ASAs. Higher scores for AIM indicate greater acceptability, 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). | Baseline (Month 1), at Months 3, and 8 | 
| Change from Baseline in AIM score for IC/ ASA staff over time | AIM will be employed to evaluate the acceptability of CABENUVA administration at Infusion Centers/ ASAs. Higher scores for AIM indicate greater acceptability, 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). | Baseline (Month 1) and at Month 3 and 8 | 
| Acceptability of CABENUVA administration at infusion center/ ASA assessed by other Quantitative questionnaire in Participants at Month 1, 3 and 8 |  | Month 1, 3 and 8 | 
| Acceptability of CABENUVA administration at infusion center/ ASA assessed by other Quantitative questionnaire in HIV care providers at Month 1, 4 and 8 |  | Month 1, 4 and 8 | 
| Acceptability of CABENUVA administration at infusion center/ ASA assessed by other Quantitative questionnaire in IC/ ASA Staff prior to Month 1 and Months 3 and 8 |  | Prior to Month 1 and at Month 3 and 8 | 
| Acceptability of CABENUVA administration at infusion center/ ASA assessed by Qualitative interviews in participants, HIV care providers and IC/ ASA staff at Month 8 |  | Month 8 | 
| Proportion of Expert Panel that agree or completely agree (a score of 4 or higher) across all items on the FIM Scale | FIM will be employed to evaluate the feasibility of CABENUVA administration at Infusion Centers/ ASAs. 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). | Prior to Month 1, and at Month 3 and 6 | 
| Change in FIM scale of Expert Panel over time through Month 6 | FIM will be employed to evaluate the feasibility of CABENUVA administration at Infusion Centers/ ASAs. 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). | Baseline (Prior to Month 1) and Up to Month 6 | 
| Proportion of Expert Panel that agree or completely agree (a score of 4 or higher) across all items on the AIM Scale | AIM will be employed to evaluate the acceptability of CABENUVA administration at Infusion Centers/ ASAs. Higher scores for AIM indicate greater acceptability, 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). | Prior to Month 1, and at Month 3 and 6 | 
| Change in AIM scale of Expert Panel over time through Month 6 | AIM will be employed to evaluate the acceptability of CABENUVA administration at Infusion Centers/ ASAs. Higher scores for AIM indicate greater acceptability, 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). | Baseline (Prior to Month 1) and Up to Month 6 | 
| Feasibility and acceptability of the process of CABENUVA administration assessed by Quantitative questionnaires in Expert Panel |  | Prior to Month 1 and at Month 3 and 6 | 
| Feasibility and acceptability of the process of CABENUVA administration assessed by Qualitative interviews in Expert Panel |  | Prior to Month 1 and at Month 6 | 
| Perceptions, facilitators, and barriers/concerns of CABENUVA administration assessed with other Quantitative questionnaires in Participants |  | Month 1, 3 and 8 | 
| Perceptions, facilitators, and barriers/concerns of CABENUVA administration assessed with other Quantitative questionnaires in IC/ ASA Staff |  | Prior to Month 1 and at Month 3 and 8 | 
| Perceptions, facilitators, and barriers/concerns of CABENUVA administration assessed with Quantitative questionnaires in HIV care provider |  | Month 1, 4 and 8 | 
| Perceptions, facilitators, and barriers/concerns of CABENUVA administration assessed by Qualitative interviews in participants, HIV care providers and IC/ ASA staff |  | Month 8 | 
| Preference on the location to receive CABENUVA assessed with other Quantitative questionnaires in participants |  | Month 1, 3 and 8 | 
| Preference on the location to receive CABENUVA assessed by Qualitative interviews in participants |  | Month 8 | 
| Advantages of receiving CABENUVA at IC/ ASA assessed by other Quantitative questionnaires in participants |  | Month 1, 3 and 8 | 
| Advantages of referring participants to the IC/ ASA to receive CABENUVA assessed by other Quantitative questionnaires in HIV care providers |  | Month 1, 4 and 8 | 
| Advantages of receiving CABENUVA at IC/ ASA assessed by Qualitative interviews with HIV care providers and Participants |  | Month 8 | 
| Disadvantages of receiving CABENUVA at IC/ ASA assessed by other Quantitative questionnaires in participants |  | Month 1, 3 and 8 | 
| Disadvantages of referring participants to the IC/ ASA to receive CABENUVA assessed by other Quantitative questionnaires in HIV care providers |  | Month 1, 4 and 8 | 
| Disadvantages of receiving CABENUVA at IC/ ASA assessed by Qualitative interviews with HIV care providers and Participants |  | Month 8 | 
| Acceptability of the process of receiving injections at ICs/ ASAs assessed by other Quantitative questionnaires in participants |  | Month 1, 3 and 8 | 
| Acceptability of the process of referring participants to the IC/ ASA for CABENUVA assessed by other Quantitative questionnaires in HIV care providers |  | Month 1, 4 and 8 | 
| Acceptability of the process of receiving injections at ICs/ ASAs assessed by Qualitative interviews in participants and HIV care providers |  | Month 8 | 
| Usefulness of the blueprint intervention in IC/ ASA Staff assessed with other Quantitative questionnaires |  | Prior to Month 1 and Month 3 and 8 | 
| Usefulness of Plan of Treatment (POT) assessed by other Quantitative questionnaires in HIV care providers |  | Month 4 and 8 | 
| Usefulness of the blueprint intervention and POT assessed by Qualitative interviews in IC/ ASA Staff and HIV care providers |  | Month 8 | 
| Overall opinion of administering the injection at an IC/ ASA assessed by other Quantitative questionnaires in IC/ ASA Staff |  | Prior to Month 1 and Month 3 and 8 | 
| Overall opinion of receiving the injection at an IC/ ASA assessed by other Quantitative questionnaires in participants |  | Month 1, 3 and 8 | 
| Overall opinion of referring the participant to an IC/ ASA assessed by other Quantitative questionnaires in HIV care provider |  | Month 1, 4 and 8 | 
| Overall opinion of receiving and administering the injection at an IC/ ASA assessed by Qualitative interview in participants, HIV care providers and IC/ ASA staff |  | Month 8 | 
| Proportion of injections occurring within target window from target date | To evaluate fidelity to treatment and dosing window. | Up to and including Month 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, CABENUVA, Intramuscular, Cabotegravir, Rilpivirine