Clinical trial NCT04982445: 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.)
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Keywords: HIV
CABENUVA
Intramuscular
Cabotegravir
Rilpivirine
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
First posted: 2021-07-29
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Participants Who Agree or Completely Agree (a Score of 4 or Higher) Across All Items on the Feasibility of Intervention Measure (FIM)
timeFrame: At Month 8
Secondary outcomes:
measure: 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
timeFrame: At Months 1 and 3
measure: 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
timeFrame: At Months 1, 4, and 8
measure: 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
timeFrame: Prior to Month 1 (Baseline) and at Months 3 and 8
measure: Change in FIM Score Over Time in Participants at Month 3 and 8
timeFrame: From Month 1 (Baseline) to Months 3 and 8
measure: Change in FIM Score Over Time in HIV Care Providers at Month 4 and 8
timeFrame: From Month 1 (Baseline) to Months 4 and 8
measure: Change in FIM Score Over Time in IC/ ASA Staff at Month 3 and 8
timeFrame: From Month 1 (Baseline) to Months 3 and 8
measure: Number of Participants Assessed for Feasibility of CABENUVA Administration by Other Quantitative Questionnaires at Month 1
timeFrame: At Month 1
measure: Number of Participants Assessed for Feasibility of CABENUVA Administration (Concern About Continuing to Receive CABENUVA) by Other Quantitative Questionnaires at Month 3 and 8
timeFrame: At Month 3 and 8
measure: Number of Participants Assessed for Feasibility of CABENUVA Administration by Other Quantitative Questionnaires at Month 3 and 8
timeFrame: At Month 3 and 8
measure: Number of HIV Care Providers Assessed for Feasibility of CABENUVA Administration in Participants by Other Quantitative Questionnaires at Month 1
timeFrame: At Month 1
measure: Number of HIV Care Providers Assessed for Feasibility of CABENUVA Administration in Participants by Other Quantitative Questionnaires at Month 4
timeFrame: At Month 4
measure: Number of HIV Care Providers Assessed for Feasibility of CABENUVA Administration in Participants by Other Quantitative Questionnaires at Month 8
timeFrame: At Month 8
measure: Number of IC/ASA Staff Assessed for Feasibility of CABENUVA Administration in Participants by Other Quantitative Questionnaires Prior to Month 1
timeFrame: Prior to Month 1 (Baseline)
measure: Number of IC/ASA Staff Assessed for Feasibility of CABENUVA Administration in Participants Assessed by Other Quantitative Questionnaires at Month 3
timeFrame: At Month 3
measure: Number of IC/ASA Staff Assessed for Feasibility of CABENUVA Administration in Participants by Other Quantitative Questionnaires at Month 8
timeFrame: At Month 8
measure: Number of Participants Assessed for Feasibility of CABENUVA Administration by Qualitative Interviews at Month 8
timeFrame: At Month 8
measure: Number of HIV Care Providers Assessed for Feasibility of CABENUVA Administration in Participants by Qualitative Interviews at Month 8
timeFrame: At Month 8
measure: Number of IC/ASA Staff Assessed for Feasibility of CABENUVA Administration in Participants by Qualitative Interviews at Month 8
timeFrame: At Month 8
measure: Composite Score of Feasibility Process Indications
timeFrame: Up to and including Month 8
measure: Change in Composite Score and Each Item of Composite Score Over Time
timeFrame: Baseline (Month 1) and at Month 8
measure: 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)
timeFrame: Months 1 (Baseline), 4, and 8
measure: Number of Participants Who Agree or Completely Agree (a Score of 4 or Higher) Across All Items on the AIM
timeFrame: Month 1 (Baseline), 3 and 8
measure: Number of IC/ ASA Staff Who Agree or Completely Agree (a Score of 4 or Higher) Across All Items on the AIM
timeFrame: Prior to Month 1 (Baseline), and at Month 3 and 8
measure: Change in AIM Score Over Time in HIV Care Providers at Month 4 and 8
timeFrame: Month 1 (Baseline), at Months 4 and 8
measure: Change in AIM Score Over Time in Participants at Month 3 and 8
timeFrame: Month 1 (Baseline), at Months 3 and 8
measure: Change in AIM Score Over Time in IC/ ASA Staff at Month 3 and 8
timeFrame: Month 1 (Baseline), at Months 3 and 8
measure: 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
timeFrame: At Months 1, 4 and 8
measure: Number of Participants Assessed for Acceptability of CABENUVA Administration at IC/ ASA by Other Quantitative Questionnaire in at Months 1, 3 and 8
timeFrame: At Months 1, 3 and 8
measure: Number of IC/ ASA Staff Assessed for Acceptability of CABENUVA Administration in Participants at IC/ ASA by Other Quantitative Questionnaire Prior to Month 1
timeFrame: Prior to Month 1 (Baseline)
measure: 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
timeFrame: At Months 3 and 8
measure: Number of Participants Assessed for Acceptability of CABENUVA Administration at IC/ASA by Qualitative Interviews at Month 8
timeFrame: At Month 8
measure: Number of HIV Care Providers Assessed for Acceptability of CABENUVA Administration in Participants at IC/ASA by Qualitative Interviews at Month 8
timeFrame: At Month 8
measure: Number of IC/ASA Staff Assessed for Acceptability of CABENUVA Administration in Participants at IC/ASA by Qualitative Interviews at Month 8
timeFrame: At Month 8
measure: Number of Expert Panel That Agree or Completely Agree (a Score of 4 or Higher) Across All Items on the FIM Scale
timeFrame: Prior to Month 1 (Baseline), and at Month 3 and 6
measure: Number of Expert Panel That Agree or Completely Agree (a Score of 4 or Higher) Across All Items on the AIM Scale
timeFrame: Prior to Month 1 (Baseline), and at Month 3 and 6
measure: Change in FIM Score of Expert Panel Over Time Through Month 6
timeFrame: Prior to Month 1 (Baseline) and Up to Month 6
measure: Change in AIM Score of Expert Panel Over Time Through Month 6
timeFrame: Prior to Month 1 (Baseline) and Up to Month 6
measure: 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
timeFrame: Prior to Month 1 (Baseline)
measure: 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
timeFrame: Prior to Month 1 (Baseline)
measure: 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
timeFrame: Prior to Month 1 (Baseline)
measure: Number of Expert Panel Members Assessed for Feasibility, Acceptability and Process of Referring Participants for CABENUVA Administration by Quantitative Questionnaires Prior to Month 1
timeFrame: Prior to Month 1 (Baseline)
measure: 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
timeFrame: At Month 3
measure: 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
timeFrame: At Month 6
measure: Number of Expert Panel Members Assessed for Feasibility, Acceptability and Process of CABENUVA Administration in Participants by Qualitative Interviews Prior to Month 1
timeFrame: Prior to Month 1 (Baseline)
measure: Number of Expert Panel Members Assessed for Feasibility, Acceptability and Process of CABENUVA Administration in Participants by Qualitative Interviews at Month 6
timeFrame: At Month 6
measure: Number of Participants Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration With Other Quantitative Questionnaires at Month 1
timeFrame: At Month 1
measure: Number of Participants Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration With Other Quantitative Questionnaires (Q 1) at Month 3 and 8
timeFrame: At Month 3 and 8
measure: Number of Participants Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration With Other Quantitative Questionnaires (Q 2) at Months 3 and 8
timeFrame: At Months 3 and 8
measure: Number of Participants Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration With Other Quantitative Questionnaires (Q 3) at Months 3 and 8
timeFrame: At Months 3 and 8
measure: Number of Participants Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration With Other Quantitative Questionnaires (Q 4) at Months 3 and 8
timeFrame: At Months 3 and 8
measure: Number of Participants Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration With Other Quantitative Questionnaires (Q 5) at Months 3 and 8
timeFrame: At Months 3 and 8
measure: Number of Participants Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration With Other Quantitative Questionnaires (Q 6) at Months 3 and 8
timeFrame: At Months 3 and 8
measure: Number of Participants Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration With Other Quantitative Questionnaires (Q 7) at Months 3 and 8
timeFrame: At Months 3 and 8
measure: Number of Participants Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration With Other Quantitative Questionnaires (Q 8) at Months 3 and 8
timeFrame: At Months 3 and 8
measure: Number of Participants Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration With Other Quantitative Questionnaires (Q 9) at Months 3 and 8
timeFrame: At Months 3 and 8
measure: Number of Participants Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration With Other Quantitative Questionnaires (Q 10) at Months 3 and 8
timeFrame: At Months 3 and 8
measure: Number of Participants Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration With Other Quantitative Questionnaires (Q 11) at Months 3 and 8
timeFrame: At Months 3 and 8
measure: 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
timeFrame: Prior to Month 1 (Baseline)
measure: Number of IC/ASA Staff Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration in Participants With Other Quantitative Questionnaires at Month 3
timeFrame: At Month 3
measure: Number of IC/ASA Staff Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration in Participants With Other Quantitative Questionnaires at Month 8
timeFrame: At Month 8
measure: Number of HIV Care Providers Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration in Participants With Quantitative Questionnaires at Month 1
timeFrame: At Month 1
measure: Number of HIV Care Providers Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration in Participants With Quantitative Questionnaires at Month 4
timeFrame: At Month 4
measure: Number of HIV Care Providers Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration in Participants With Quantitative Questionnaires at Month 8
timeFrame: At Month 8
measure: Number of Participants Assessed for Facilitators of CABENUVA Administration by Qualitative Interviews at Month 8
timeFrame: At Month 8
measure: Number of IC/ASA Staff Assessed for Barriers/Concerns of CABENUVA Administration in Participants by Qualitative Interviews at Month 8
timeFrame: At Month 8
measure: Number of HIV Care Providers Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration in Participants by Qualitative Interviews at Month 8
timeFrame: At Month 8
measure: Number of Participants Assessed for Preference on the Location to Receive CABENUVA With Other Quantitative Questionnaires at Months 1, 3 and 8
timeFrame: At Month 1, 3 and 8
measure: Number of Participants Assessed for Preference on the Location to Receive CABENUVA by Qualitative Interviews at Month 8
timeFrame: At Month 8
measure: Number of Participants Assessed for Advantages of Receiving CABENUVA at IC/ ASA by Other Quantitative Questionnaires at Month 1
timeFrame: At Month 1
measure: Number of Participants Assessed for Advantages of Receiving CABENUVA at IC/ ASA by Other Quantitative Questionnaires at Months 3 and 8
timeFrame: At Months 3 and 8
measure: 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
timeFrame: At Months 1, 4 and 8
measure: Number of Participants Assessed for Advantages of Receiving CABENUVA at IC/ ASA by Qualitative Interviews at Month 8
timeFrame: At Month 8
measure: Number of HIV Care Providers Assessed for Advantages of Participants Receiving CABENUVA at IC/ ASA by Qualitative Interviews at Month 8
timeFrame: At Month 8
measure: Number of Participants Assessed for Disadvantages of Receiving CABENUVA at IC/ ASA by Other Quantitative Questionnaires at Month 1
timeFrame: At Month 1
measure: Number of Participants Assessed for Disadvantages of Receiving CABENUVA at IC/ ASA by Other Quantitative Questionnaires at Months 3 and 8
timeFrame: At Months 3 and 8
measure: 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
timeFrame: At Month 1
measure: 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
timeFrame: At Months 4 and 8
measure: Number of Participants Assessed for Disadvantages of Receiving CABENUVA at IC/ ASA by Qualitative Interviews at Month 8
timeFrame: At Month 8
measure: Number of HIV Care Providers Assessed for Disadvantages for Participants Receiving CABENUVA at IC/ ASA by Qualitative Interviews at Month 8
timeFrame: At Month 8
measure: Number of Participants Assessed for Acceptability of the Process of Receiving Injections at ICs/ ASAs by Other Quantitative Questionnaires at Month 1
timeFrame: At Month 1
measure: Number of Participants Assessed for Acceptability of the Process of Receiving Injections at ICs/ ASAs by Other Quantitative Questionnaires at Month 3
timeFrame: At Month 3
measure: Number of Participants Assessed for Acceptability of the Process of Receiving Injections at ICs/ ASAs by Other Quantitative Questionnaires at Month 8
timeFrame: At Month 8
measure: 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
timeFrame: At Months 3 and 8
measure: 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
timeFrame: At Months 1, 4 and 8
measure: Number of Participants Assessed for Acceptability of the Process of Receiving Injections at ICs/ ASAs by Qualitative Interviews at Month 8
timeFrame: At Month 8
measure: Number of HIV Care Providers Assessed for Acceptability of the Process of Participants Receiving Injections at ICs/ ASAs by Qualitative Interviews at Month 8
timeFrame: At Month 8
measure: Number of IC/ASA Staff Assessed for Usefulness of the Blueprint Intervention With Other Quantitative Questionnaires Prior to Month 1
timeFrame: Prior to Month 1 (Baseline)
measure: Number of IC/ASA Staff Assessed for Usefulness of the Blueprint Intervention With Other Quantitative Questionnaires at Month 3 and 8
timeFrame: At Months 3 and 8
measure: Number of HIV Care Providers Assessed for Usefulness of Plan of Treatment (POT) by Other Quantitative Questionnaires at Months 4 and 8
timeFrame: At Months 4 and 8
measure: Number of IC/ASA Staff Assessed for Usefulness of the Blueprint Intervention and POT Assessed by Qualitative Interviews at Month 8
timeFrame: Month 8
measure: Number of HIV Care Providers Assessed for Usefulness of the Blueprint Intervention and POT by Qualitative Interviews at Month 8
timeFrame: Month 8
measure: 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
timeFrame: Prior to Month 1 (Baseline) and Months 3 and 8
measure: 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
timeFrame: At Months 1, 3 and 8
measure: Number of HIV Care Providers Assessed for Overall Opinion of Referring the Participant to an IC/ ASA by Other Quantitative Questionnaires at Month 1
timeFrame: At Month 1
measure: Number of HIV Care Providers Assessed for Overall Opinion of Referring the Participant to an IC/ ASA by Other Quantitative Questionnaires at Month 4
timeFrame: At Month 4
measure: Number of HIV Care Providers Assessed for Overall Opinion of Referring the Participant to an IC/ ASA by Other Quantitative Questionnaires at Month 8
timeFrame: At Month 8
measure: 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
timeFrame: At Month 8
measure: Number of Participants Assessed for Overall Opinion of Receiving the Injection at an IC/ ASA by Qualitative Interview at Month 8
timeFrame: At Month 8
measure: Number of HIV Care Providers Assessed for Overall Opinion of Referring Patients to an IC/ ASA by Qualitative Interview at Month 8
timeFrame: At Month 8
measure: Number of IC/ASA Staff Assessed for Overall Opinion of Administering the Injection at an IC/ ASA by Qualitative Interview at Month 8
timeFrame: At Month 8
measure: Number of Injections Occurring Within Target Window From Target Date
timeFrame: Up to and including Month 8
Other outcomes:
Locations:
city: Evans
country: United States
facility: GSK Investigational Site
state: Georgia
city: East Lansing
country: United States
facility: GSK Investigational Site
state: Michigan
city: Novi
country: United States
facility: GSK Investigational Site
state: Michigan
city: Plymouth
country: United States
facility: GSK Investigational Site
state: Minnesota
city: Charlotte
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Greensboro
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Charleston
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Florence
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Summerville
country: United States
facility: GSK Investigational Site
state: South Carolina
city: West Columbia
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Fort Worth
country: United States
facility: GSK Investigational Site
state: Texas
city: Kingwood
country: United States
facility: GSK Investigational Site
state: Texas
city: North Richland Hills
country: United States
facility: GSK Investigational Site
state: Texas
city: Plano
country: United States
facility: GSK Investigational Site
state: Texas
Study officials:
affiliation: ViiV Healthcare
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: