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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)

Primary Purpose

HIV Infections

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
CABENUVA
Sponsored by
ViiV Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV, CABENUVA, Intramuscular, Cabotegravir, Rilpivirine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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 on the last day of any other antiretroviral therapy
  • Agreement to receive CABENUVA IM injections at participating infusion center.

Exclusion Criteria:

  • Participants are excluded from the study as dictated in the Prescribing Information (CABENUVA United States Prescribing information [USPI], 2021) 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 staff
  • Have received more than 3 CABENUVA injections at the IC prior to enrolling in the study

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Participants receiving CABENUVA

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
July 26, 2021
Last Updated
May 31, 2023
Sponsor
ViiV Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT04982445
Brief Title
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.)
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 18, 2021 (Actual)
Primary Completion Date
July 18, 2023 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ViiV Healthcare

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, CABENUVA, Intramuscular, Cabotegravir, Rilpivirine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Click here to enter text.
Allocation
N/A
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Participants receiving CABENUVA
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CABENUVA
Intervention Description
CABENUVA will be administered IM at infusion centers/ASAs
Primary Outcome Measure Information:
Title
Proportion of participants who agree or completely agree (a score of 4 or higher) across all items on the Feasibility of Intervention Measure (FIM)
Description
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).
Time Frame
Month 8
Secondary Outcome Measure Information:
Title
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
Description
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).
Time Frame
Months 1 and 3
Title
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
Description
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).
Time Frame
Months 1, 4, and 8
Title
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
Description
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).
Time Frame
Prior to Month 1 and at Months 3 and 8
Title
Change in FIM score over time in participants at Month 3 and 8
Description
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).
Time Frame
Baseline (Month 1), at Months 3 and 8
Title
Change in FIM score over time in HIV care providers at Month 4 and 8
Description
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).
Time Frame
Baseline (Month 1), at Months 4 and 8
Title
Change in FIM score over time in IC/ ASA Staff at Month 3 and 8
Description
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).
Time Frame
Baseline (Month 1), at Months 3 and 8
Title
Feasibility of Cabenuva administration assessed by other quantitative questionnaires in participants at Month 1, 3 and 8
Time Frame
Month 1, 3 and 8
Title
Feasibility of Cabenuva administration assessed by other Quantitative questionnaires in HIV care providers at Month 1, 4 and 8
Time Frame
Month 1, 4 and 8
Title
Feasibility of Cabenuva administration assessed by other Quantitative questionnaires in IC/ ASA Staff prior to Month 1, Month 3 and 8
Time Frame
Prior to Month 1 and at Month 3 and 8
Title
Feasibility of Cabenuva administration assessed by Qualitative interviews in participants, HIV care providers and IC/ ASA staff at Month 8
Time Frame
Month 8
Title
Composite score of feasibility process indications
Description
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.
Time Frame
Up to and including Month 8
Title
Change in composite score of feasibility process indications
Description
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.
Time Frame
Baseline (Month 1) and up to Month 8
Title
Change in each individual item of composite score of feasibility process indications
Description
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.
Time Frame
Baseline (Month 1) and up to Month 8
Title
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)
Description
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).
Time Frame
Months 1, 4, and 8
Title
Change from Baseline in AIM score for HIV care providers over time
Description
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).
Time Frame
Baseline (Month 1), at Months 4 and 8
Title
Proportion of IC/ ASA participants who agree or completely agree (a score of 4 or higher) across all items on the AIM
Description
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)
Time Frame
Month 1, 3 and 8
Title
Proportion of IC/ ASA staff who agree or completely agree (a score of 4 or higher) across all items on the AIM
Description
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).
Time Frame
Prior to Month 1, and at Month 3 and 8
Title
Change from Baseline in AIM score for participants over time
Description
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).
Time Frame
Baseline (Month 1), at Months 3, and 8
Title
Change from Baseline in AIM score for IC/ ASA staff over time
Description
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).
Time Frame
Baseline (Month 1) and at Month 3 and 8
Title
Acceptability of CABENUVA administration at infusion center/ ASA assessed by other Quantitative questionnaire in Participants at Month 1, 3 and 8
Time Frame
Month 1, 3 and 8
Title
Acceptability of CABENUVA administration at infusion center/ ASA assessed by other Quantitative questionnaire in HIV care providers at Month 1, 4 and 8
Time Frame
Month 1, 4 and 8
Title
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
Time Frame
Prior to Month 1 and at Month 3 and 8
Title
Acceptability of CABENUVA administration at infusion center/ ASA assessed by Qualitative interviews in participants, HIV care providers and IC/ ASA staff at Month 8
Time Frame
Month 8
Title
Proportion of Expert Panel that agree or completely agree (a score of 4 or higher) across all items on the FIM Scale
Description
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).
Time Frame
Prior to Month 1, and at Month 3 and 6
Title
Change in FIM scale of Expert Panel over time through Month 6
Description
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).
Time Frame
Baseline (Prior to Month 1) and Up to Month 6
Title
Proportion of Expert Panel that agree or completely agree (a score of 4 or higher) across all items on the AIM Scale
Description
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).
Time Frame
Prior to Month 1, and at Month 3 and 6
Title
Change in AIM scale of Expert Panel over time through Month 6
Description
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).
Time Frame
Baseline (Prior to Month 1) and Up to Month 6
Title
Feasibility and acceptability of the process of CABENUVA administration assessed by Quantitative questionnaires in Expert Panel
Time Frame
Prior to Month 1 and at Month 3 and 6
Title
Feasibility and acceptability of the process of CABENUVA administration assessed by Qualitative interviews in Expert Panel
Time Frame
Prior to Month 1 and at Month 6
Title
Perceptions, facilitators, and barriers/concerns of CABENUVA administration assessed with other Quantitative questionnaires in Participants
Time Frame
Month 1, 3 and 8
Title
Perceptions, facilitators, and barriers/concerns of CABENUVA administration assessed with other Quantitative questionnaires in IC/ ASA Staff
Time Frame
Prior to Month 1 and at Month 3 and 8
Title
Perceptions, facilitators, and barriers/concerns of CABENUVA administration assessed with Quantitative questionnaires in HIV care provider
Time Frame
Month 1, 4 and 8
Title
Perceptions, facilitators, and barriers/concerns of CABENUVA administration assessed by Qualitative interviews in participants, HIV care providers and IC/ ASA staff
Time Frame
Month 8
Title
Preference on the location to receive CABENUVA assessed with other Quantitative questionnaires in participants
Time Frame
Month 1, 3 and 8
Title
Preference on the location to receive CABENUVA assessed by Qualitative interviews in participants
Time Frame
Month 8
Title
Advantages of receiving CABENUVA at IC/ ASA assessed by other Quantitative questionnaires in participants
Time Frame
Month 1, 3 and 8
Title
Advantages of referring participants to the IC/ ASA to receive CABENUVA assessed by other Quantitative questionnaires in HIV care providers
Time Frame
Month 1, 4 and 8
Title
Advantages of receiving CABENUVA at IC/ ASA assessed by Qualitative interviews with HIV care providers and Participants
Time Frame
Month 8
Title
Disadvantages of receiving CABENUVA at IC/ ASA assessed by other Quantitative questionnaires in participants
Time Frame
Month 1, 3 and 8
Title
Disadvantages of referring participants to the IC/ ASA to receive CABENUVA assessed by other Quantitative questionnaires in HIV care providers
Time Frame
Month 1, 4 and 8
Title
Disadvantages of receiving CABENUVA at IC/ ASA assessed by Qualitative interviews with HIV care providers and Participants
Time Frame
Month 8
Title
Acceptability of the process of receiving injections at ICs/ ASAs assessed by other Quantitative questionnaires in participants
Time Frame
Month 1, 3 and 8
Title
Acceptability of the process of referring participants to the IC/ ASA for CABENUVA assessed by other Quantitative questionnaires in HIV care providers
Time Frame
Month 1, 4 and 8
Title
Acceptability of the process of receiving injections at ICs/ ASAs assessed by Qualitative interviews in participants and HIV care providers
Time Frame
Month 8
Title
Usefulness of the blueprint intervention in IC/ ASA Staff assessed with other Quantitative questionnaires
Time Frame
Prior to Month 1 and Month 3 and 8
Title
Usefulness of Plan of Treatment (POT) assessed by other Quantitative questionnaires in HIV care providers
Time Frame
Month 4 and 8
Title
Usefulness of the blueprint intervention and POT assessed by Qualitative interviews in IC/ ASA Staff and HIV care providers
Time Frame
Month 8
Title
Overall opinion of administering the injection at an IC/ ASA assessed by other Quantitative questionnaires in IC/ ASA Staff
Time Frame
Prior to Month 1 and Month 3 and 8
Title
Overall opinion of receiving the injection at an IC/ ASA assessed by other Quantitative questionnaires in participants
Time Frame
Month 1, 3 and 8
Title
Overall opinion of referring the participant to an IC/ ASA assessed by other Quantitative questionnaires in HIV care provider
Time Frame
Month 1, 4 and 8
Title
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
Time Frame
Month 8
Title
Proportion of injections occurring within target window from target date
Description
To evaluate fidelity to treatment and dosing window.
Time Frame
Up to and including Month 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name or Official Title & Degree
EU GSK Clinical Trials Call Center
Phone
+44 (0) 20 89904466
Email
GSKClinicalSupportHD@gsk.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
ViiV Healthcare
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Evans
State/Province
Georgia
ZIP/Postal Code
30809
Country
United States
Individual Site Status
Completed
Facility Name
GSK Investigational Site
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Individual Site Status
Completed
Facility Name
GSK Investigational Site
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48823
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Center
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Khan Nedd
Facility Name
GSK Investigational Site
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49525
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Center
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Khan Nedd
Facility Name
GSK Investigational Site
City
Novi
State/Province
Michigan
ZIP/Postal Code
48377-2977
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Center
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Khan Nedd
Facility Name
GSK Investigational Site
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55446-3775
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Center
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Jason Raasch
Facility Name
GSK Investigational Site
City
Lee's Summit
State/Province
Missouri
ZIP/Postal Code
64063-1052
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Christine Smith
Facility Name
GSK Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28226
Country
United States
Individual Site Status
Completed
Facility Name
GSK Investigational Site
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27405
Country
United States
Individual Site Status
Completed
Facility Name
GSK Investigational Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Individual Site Status
Completed
Facility Name
GSK Investigational Site
City
Supply
State/Province
North Carolina
ZIP/Postal Code
29462
Country
United States
Individual Site Status
Completed
Facility Name
GSK Investigational Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Individual Site Status
Completed
Facility Name
GSK Investigational Site
City
Beaufort
State/Province
South Carolina
ZIP/Postal Code
29906
Country
United States
Individual Site Status
Completed
Facility Name
GSK Investigational Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Individual Site Status
Completed
Facility Name
GSK Investigational Site
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Individual Site Status
Completed
Facility Name
GSK Investigational Site
City
Florence
State/Province
South Carolina
ZIP/Postal Code
29501
Country
United States
Individual Site Status
Completed
Facility Name
GSK Investigational Site
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
28579
Country
United States
Individual Site Status
Completed
Facility Name
GSK Investigational Site
City
Okatie
State/Province
South Carolina
ZIP/Postal Code
29909
Country
United States
Individual Site Status
Completed
Facility Name
GSK Investigational Site
City
Pawleys Island
State/Province
South Carolina
ZIP/Postal Code
29585
Country
United States
Individual Site Status
Completed
Facility Name
GSK Investigational Site
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29483
Country
United States
Individual Site Status
Completed
Facility Name
GSK Investigational Site
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Individual Site Status
Completed
Facility Name
GSK Investigational Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76244-5307
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Indigo Dillard
Facility Name
GSK Investigational Site
City
Kingwood
State/Province
Texas
ZIP/Postal Code
77339
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Center
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Kevin Summers
Facility Name
GSK Investigational Site
City
North Richland Hills
State/Province
Texas
ZIP/Postal Code
76180-7379
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Roxana Ropos
Facility Name
GSK Investigational Site
City
Pasadena
State/Province
Texas
ZIP/Postal Code
77505-3959
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Kevin Summers
Facility Name
GSK Investigational Site
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Center
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Indigo Dillard

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
http://clinicalstudydatarequest.com

Learn more about this trial

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.)

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