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.)

HIV Infections Clinical Trial

— GLACIER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04982445
• Other study ID #: 214747
• Status: Completed
• Phase: Phase 4
• Start date: November 18, 2021
• Est. completion date: January 31, 2024

Study information

• Verified date: May 2024
• Source: ViiV Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• CABENUVA
CABENUVA will be administered IM at infusion centers/ASAs

Locations

Country	Name	City	State
United States	GSK Investigational Site	Charleston	South Carolina
United States	GSK Investigational Site	Charlotte	North Carolina
United States	GSK Investigational Site	East Lansing	Michigan
United States	GSK Investigational Site	Evans	Georgia
United States	GSK Investigational Site	Florence	South Carolina
United States	GSK Investigational Site	Fort Worth	Texas
United States	GSK Investigational Site	Greensboro	North Carolina
United States	GSK Investigational Site	Kingwood	Texas
United States	GSK Investigational Site	North Richland Hills	Texas
United States	GSK Investigational Site	Novi	Michigan
United States	GSK Investigational Site	Plano	Texas
United States	GSK Investigational Site	Plymouth	Minnesota
United States	GSK Investigational Site	Raleigh	North Carolina
United States	GSK Investigational Site	Summerville	South Carolina
United States	GSK Investigational Site	West Columbia	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
ViiV Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Feasibility of Cabenuva administration assessed by other quantitative questionnaires in participants at Month 1, 3 and 8		Month 1, 3 and 8
Secondary	Feasibility of Cabenuva administration assessed by other Quantitative questionnaires in HIV care providers at Month 1, 4 and 8		Month 1, 4 and 8
Secondary	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
Secondary	Feasibility of Cabenuva administration assessed by Qualitative interviews in participants, HIV care providers and IC/ ASA staff at Month 8		Month 8
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Feasibility and acceptability of the process of CABENUVA administration assessed by Qualitative interviews in Expert Panel		Prior to Month 1 and at Month 6
Secondary	Perceptions, facilitators, and barriers/concerns of CABENUVA administration assessed with other Quantitative questionnaires in Participants		Month 1, 3 and 8
Secondary	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
Secondary	Perceptions, facilitators, and barriers/concerns of CABENUVA administration assessed with Quantitative questionnaires in HIV care provider		Month 1, 4 and 8
Secondary	Perceptions, facilitators, and barriers/concerns of CABENUVA administration assessed by Qualitative interviews in participants, HIV care providers and IC/ ASA staff		Month 8
Secondary	Preference on the location to receive CABENUVA assessed with other Quantitative questionnaires in participants		Month 1, 3 and 8
Secondary	Preference on the location to receive CABENUVA assessed by Qualitative interviews in participants		Month 8
Secondary	Advantages of receiving CABENUVA at IC/ ASA assessed by other Quantitative questionnaires in participants		Month 1, 3 and 8
Secondary	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
Secondary	Advantages of receiving CABENUVA at IC/ ASA assessed by Qualitative interviews with HIV care providers and Participants		Month 8
Secondary	Disadvantages of receiving CABENUVA at IC/ ASA assessed by other Quantitative questionnaires in participants		Month 1, 3 and 8
Secondary	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
Secondary	Disadvantages of receiving CABENUVA at IC/ ASA assessed by Qualitative interviews with HIV care providers and Participants		Month 8
Secondary	Acceptability of the process of receiving injections at ICs/ ASAs assessed by other Quantitative questionnaires in participants		Month 1, 3 and 8
Secondary	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
Secondary	Acceptability of the process of receiving injections at ICs/ ASAs assessed by Qualitative interviews in participants and HIV care providers		Month 8
Secondary	Usefulness of the blueprint intervention in IC/ ASA Staff assessed with other Quantitative questionnaires		Prior to Month 1 and Month 3 and 8
Secondary	Usefulness of Plan of Treatment (POT) assessed by other Quantitative questionnaires in HIV care providers		Month 4 and 8
Secondary	Usefulness of the blueprint intervention and POT assessed by Qualitative interviews in IC/ ASA Staff and HIV care providers		Month 8
Secondary	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
Secondary	Overall opinion of receiving the injection at an IC/ ASA assessed by other Quantitative questionnaires in participants		Month 1, 3 and 8
Secondary	Overall opinion of referring the participant to an IC/ ASA assessed by other Quantitative questionnaires in HIV care provider		Month 1, 4 and 8
Secondary	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
Secondary	Proportion of injections occurring within target window from target date	To evaluate fidelity to treatment and dosing window.	Up to and including Month 8