Phase 4
N=44
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
Bottom Line
View on ClinicalTrials.gov: NCT04982445 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Number of Participants Who Agree or Completely Agree (a Score of 4 or Higher) Across All Items on the Feasibility of Intervention Measure (FIM) — 31 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- CABENUVA (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ViiV Healthcare
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Agree or Completely Agree (a Score of 4 or Higher) Across All Items on the Feasibility of Intervention Measure (FIM) |
31 | — |
| SECONDARY 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 |
37; 31 | — |
| SECONDARY 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 |
1; 1; 0 | — |
| SECONDARY 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 |
50; 19; 11 | — |
| SECONDARY Change in FIM Score Over Time in Participants at Month 3 and 8 |
0.06; -0.03 | — |
| SECONDARY Change in FIM Score Over Time in HIV Care Providers at Month 4 and 8 |
0.33; 0.38 | — |
| SECONDARY Change in FIM Score Over Time in IC/ ASA Staff at Month 3 and 8 |
-0.04; -0.20 | — |
| SECONDARY Number of Participants Assessed for Feasibility of CABENUVA Administration by Other Quantitative Questionnaires at Month 1 |
19; 7; 6; 4; 4; 3 | — |
| SECONDARY Number of Participants Assessed for Feasibility of CABENUVA Administration (Concern About Continuing to Receive CABENUVA) by Other Quantitative Questionnaires at Month 3 and 8 |
3; 33; 5; 3; 34; 1 | — |
| SECONDARY Number of Participants Assessed for Feasibility of CABENUVA Administration by Other Quantitative Questionnaires at Month 3 and 8 |
1; 1; 1; 1; 1; 1 | — |
| SECONDARY Number of HIV Care Providers Assessed for Feasibility of CABENUVA Administration in Participants by Other Quantitative Questionnaires at Month 1 |
1; 1; 1; 0; 0; 0 | — |
| SECONDARY Number of HIV Care Providers Assessed for Feasibility of CABENUVA Administration in Participants by Other Quantitative Questionnaires at Month 4 |
0; 0; 3; 0; 0; 0 | — |
| SECONDARY Number of HIV Care Providers Assessed for Feasibility of CABENUVA Administration in Participants by Other Quantitative Questionnaires at Month 8 |
0; 0; 1; 1; 0; 1 | — |
| SECONDARY Number of IC/ASA Staff Assessed for Feasibility of CABENUVA Administration in Participants by Other Quantitative Questionnaires Prior to Month 1 |
9; 16; 17; 37; 33; 1 | — |
| SECONDARY Number of IC/ASA Staff Assessed for Feasibility of CABENUVA Administration in Participants Assessed by Other Quantitative Questionnaires at Month 3 |
0; 5; 14; 7; 8; 4 | — |
| SECONDARY Number of IC/ASA Staff Assessed for Feasibility of CABENUVA Administration in Participants by Other Quantitative Questionnaires at Month 8 |
1; 6; 4; 3; 6; 6 | — |
| SECONDARY Number of Participants Assessed for Feasibility of CABENUVA Administration by Qualitative Interviews at Month 8 |
8; 23; 2; 14; 4; 1 | — |
| SECONDARY Number of HIV Care Providers Assessed for Feasibility of CABENUVA Administration in Participants by Qualitative Interviews at Month 8 |
1; 1 | — |
| SECONDARY Number of IC/ASA Staff Assessed for Feasibility of CABENUVA Administration in Participants by Qualitative Interviews at Month 8 |
12; 3; 12; 1; 2; 4 | — |
| SECONDARY Composite Score of Feasibility Process Indications |
80.8 | — |
| SECONDARY Change in Composite Score and Each Item of Composite Score Over Time |
84.7; 52.3; 93.6; 92.7 | — |
| SECONDARY 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) |
1; 2; 1 | — |
| SECONDARY Number of Participants Who Agree or Completely Agree (a Score of 4 or Higher) Across All Items on the AIM |
35; 32; 33 | — |
| SECONDARY Number of IC/ ASA Staff Who Agree or Completely Agree (a Score of 4 or Higher) Across All Items on the AIM |
47; 13; 13 | — |
| SECONDARY Change in AIM Score Over Time in HIV Care Providers at Month 4 and 8 |
0.33; 0.25 | — |
| SECONDARY Change in AIM Score Over Time in Participants at Month 3 and 8 |
0.03; 0.00 | — |
| SECONDARY Change in AIM Score Over Time in IC/ ASA Staff at Month 3 and 8 |
-0.24; -0.03 | — |
| SECONDARY 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 |
1; 0; 0; 0; 1; 0 | — |
| SECONDARY Number of Participants Assessed for Acceptability of CABENUVA Administration at IC/ ASA by Other Quantitative Questionnaire in at Months 1, 3 and 8 |
34; 6; 0; 2; 0; 1 | — |
| SECONDARY Number of IC/ ASA Staff Assessed for Acceptability of CABENUVA Administration in Participants at IC/ ASA by Other Quantitative Questionnaire Prior to Month 1 |
6; 13; 22; 21; 51; 0 | — |
| SECONDARY 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 |
0; 0; 5; 6; 22; 1 | — |
| SECONDARY Number of Participants Assessed for Acceptability of CABENUVA Administration at IC/ASA by Qualitative Interviews at Month 8 |
8; 23; 2; 14; 4; 1 | — |
| SECONDARY Number of HIV Care Providers Assessed for Acceptability of CABENUVA Administration in Participants at IC/ASA by Qualitative Interviews at Month 8 |
2 | — |
| SECONDARY Number of IC/ASA Staff Assessed for Acceptability of CABENUVA Administration in Participants at IC/ASA by Qualitative Interviews at Month 8 |
2; 1; 2; 4; 4 | — |
| SECONDARY Number of Expert Panel That Agree or Completely Agree (a Score of 4 or Higher) Across All Items on the FIM Scale |
5; 5; 5 | — |
| SECONDARY Number of Expert Panel That Agree or Completely Agree (a Score of 4 or Higher) Across All Items on the AIM Scale |
6; 6; 6 | — |
| SECONDARY Change in FIM Score of Expert Panel Over Time Through Month 6 |
4.00; 4.46 | — |
| SECONDARY Change in AIM Score of Expert Panel Over Time Through Month 6 |
4.22; 4.46 | — |
| SECONDARY 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 |
4; 2; 1; 1; 0; 6 | — |
| SECONDARY 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 |
5; 2; 1; 0; 0; 0 | — |
| SECONDARY 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 |
0; 0; 0; 1; 1; 2 | — |
| SECONDARY Number of Expert Panel Members Assessed for Feasibility, Acceptability and Process of Referring Participants for CABENUVA Administration by Quantitative Questionnaires Prior to Month 1 |
5; 2; 1; 0; 0; 0 | — |
| SECONDARY 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 |
0; 0; 1; 0; 0; 1 | — |
| SECONDARY 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 |
0; 0; 1; 0; 0; 0 | — |
| SECONDARY Number of Expert Panel Members Assessed for Feasibility, Acceptability and Process of CABENUVA Administration in Participants by Qualitative Interviews Prior to Month 1 |
2; 4; 3; 2; 1; 2 | — |
| SECONDARY Number of Expert Panel Members Assessed for Feasibility, Acceptability and Process of CABENUVA Administration in Participants by Qualitative Interviews at Month 6 |
2; 3; 2; 1; 4; 5 | — |
| SECONDARY Number of Participants Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration With Other Quantitative Questionnaires at Month 1 |
12; 7; 4; 3; 17; 1 | — |
| SECONDARY Number of Participants Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration With Other Quantitative Questionnaires (Q 1) at Month 3 and 8 |
1; 34; 1; 5; 1; 34 | — |
| SECONDARY Number of Participants Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration With Other Quantitative Questionnaires (Q 2) at Months 3 and 8 |
0; 0; 0; 1; 0; 0 | — |
| SECONDARY Number of Participants Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration With Other Quantitative Questionnaires (Q 3) at Months 3 and 8 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration With Other Quantitative Questionnaires (Q 4) at Months 3 and 8 |
28; 6; 2; 0; 0; 0 | — |
| SECONDARY Number of Participants Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration With Other Quantitative Questionnaires (Q 5) at Months 3 and 8 |
25; 10; 0; 1; 0; 0 | — |
| SECONDARY Number of Participants Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration With Other Quantitative Questionnaires (Q 6) at Months 3 and 8 |
30; 6; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration With Other Quantitative Questionnaires (Q 7) at Months 3 and 8 |
25; 9; 1; 1; 0; 0 | — |
| SECONDARY Number of Participants Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration With Other Quantitative Questionnaires (Q 8) at Months 3 and 8 |
20; 7; 3; 1; 2; 3 | — |
| SECONDARY Number of Participants Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration With Other Quantitative Questionnaires (Q 9) at Months 3 and 8 |
9; 12; 9; 5; 0; 6 | — |
| SECONDARY Number of Participants Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration With Other Quantitative Questionnaires (Q 10) at Months 3 and 8 |
18; 15; 9; 0; 0; 0 | — |
| SECONDARY Number of Participants Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration With Other Quantitative Questionnaires (Q 11) at Months 3 and 8 |
2; 5; 6; 1; 22; 5 | — |
| SECONDARY 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 |
6; 24; 16; 46; 15; 6 | — |
| SECONDARY Number of IC/ASA Staff Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration in Participants With Other Quantitative Questionnaires at Month 3 |
2; 2; 7; 6; 2; 0 | — |
| SECONDARY Number of IC/ASA Staff Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration in Participants With Other Quantitative Questionnaires at Month 8 |
2; 2; 4; 1; 1; 1 | — |
| SECONDARY Number of HIV Care Providers Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration in Participants With Quantitative Questionnaires at Month 1 |
1; 1; 1; 0; 0; 0 | — |
| SECONDARY Number of HIV Care Providers Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration in Participants With Quantitative Questionnaires at Month 4 |
0; 0; 3; 0; 0; 0 | — |
| SECONDARY Number of HIV Care Providers Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration in Participants With Quantitative Questionnaires at Month 8 |
0; 0; 1; 1; 0; 1 | — |
| SECONDARY Number of Participants Assessed for Facilitators of CABENUVA Administration by Qualitative Interviews at Month 8 |
8; 3; 5; 4; 1; 7 | — |
| SECONDARY Number of IC/ASA Staff Assessed for Barriers/Concerns of CABENUVA Administration in Participants by Qualitative Interviews at Month 8 |
12; 1; 2; 4 | — |
| SECONDARY Number of HIV Care Providers Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration in Participants by Qualitative Interviews at Month 8 |
1; 1; 1; 1; 1; 1 | — |
| SECONDARY Number of Participants Assessed for Preference on the Location to Receive CABENUVA With Other Quantitative Questionnaires at Months 1, 3 and 8 |
28; 8; 5; 2; 0; 1 | — |
| SECONDARY Number of Participants Assessed for Preference on the Location to Receive CABENUVA by Qualitative Interviews at Month 8 |
20; 5; 8 | — |
| SECONDARY Number of Participants Assessed for Advantages of Receiving CABENUVA at IC/ ASA by Other Quantitative Questionnaires at Month 1 |
22; 21; 19; 17; 13; 12 | — |
| SECONDARY Number of Participants Assessed for Advantages of Receiving CABENUVA at IC/ ASA by Other Quantitative Questionnaires at Months 3 and 8 |
20; 19; 17; 17; 13; 10 | — |
| SECONDARY 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 |
3; 1; 1; 1; 1; 1 | — |
| SECONDARY Number of Participants Assessed for Advantages of Receiving CABENUVA at IC/ ASA by Qualitative Interviews at Month 8 |
16; 9; 14 | — |
| SECONDARY Number of HIV Care Providers Assessed for Advantages of Participants Receiving CABENUVA at IC/ ASA by Qualitative Interviews at Month 8 |
2; 2 | — |
| SECONDARY Number of Participants Assessed for Disadvantages of Receiving CABENUVA at IC/ ASA by Other Quantitative Questionnaires at Month 1 |
23; 8; 5; 4; 4; 3 | — |
| SECONDARY Number of Participants Assessed for Disadvantages of Receiving CABENUVA at IC/ ASA by Other Quantitative Questionnaires at Months 3 and 8 |
16; 7; 1; 3; 6; 7 | — |
| SECONDARY 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 |
3; 2; 2; 1; 1; 1 | — |
| SECONDARY 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 |
1; 1; 1; 0; 0; 1 | — |
| SECONDARY Number of Participants Assessed for Disadvantages of Receiving CABENUVA at IC/ ASA by Qualitative Interviews at Month 8 |
17; 3; 8 | — |
| SECONDARY Number of HIV Care Providers Assessed for Disadvantages for Participants Receiving CABENUVA at IC/ ASA by Qualitative Interviews at Month 8 |
2; 1 | — |
| SECONDARY Number of Participants Assessed for Acceptability of the Process of Receiving Injections at ICs/ ASAs by Other Quantitative Questionnaires at Month 1 |
34; 6; 0; 2; 0; 1 | — |
| SECONDARY Number of Participants Assessed for Acceptability of the Process of Receiving Injections at ICs/ ASAs by Other Quantitative Questionnaires at Month 3 |
24; 9; 1; 0; 0; 1 | — |
| SECONDARY Number of Participants Assessed for Acceptability of the Process of Receiving Injections at ICs/ ASAs by Other Quantitative Questionnaires at Month 8 |
23; 8; 1; 4; 0; 1 | — |
| SECONDARY 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 |
1; 17; 15; 2; 1; 5 | — |
| SECONDARY 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 |
1; 0; 0; 1; 0; 0 | — |
| SECONDARY Number of Participants Assessed for Acceptability of the Process of Receiving Injections at ICs/ ASAs by Qualitative Interviews at Month 8 |
8; 23; 2; 14; 4; 1 | — |
| SECONDARY Number of HIV Care Providers Assessed for Acceptability of the Process of Participants Receiving Injections at ICs/ ASAs by Qualitative Interviews at Month 8 |
1; 1 | — |
| SECONDARY Number of IC/ASA Staff Assessed for Usefulness of the Blueprint Intervention With Other Quantitative Questionnaires Prior to Month 1 |
— | — |
| SECONDARY Number of IC/ASA Staff Assessed for Usefulness of the Blueprint Intervention With Other Quantitative Questionnaires at Month 3 and 8 |
2; 6; 7; 4; 0; 1 | — |
| SECONDARY Number of HIV Care Providers Assessed for Usefulness of Plan of Treatment (POT) by Other Quantitative Questionnaires at Months 4 and 8 |
0; 2; 0; 0; 0; 0 | — |
| SECONDARY Number of IC/ASA Staff Assessed for Usefulness of the Blueprint Intervention and POT Assessed by Qualitative Interviews at Month 8 |
2; 3; 7; 1; 11 | — |
| SECONDARY Number of HIV Care Providers Assessed for Usefulness of the Blueprint Intervention and POT by Qualitative Interviews at Month 8 |
1; 1; 0; 2 | — |
| SECONDARY 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 |
14; 21; 21; 37; 15; 3 | — |
| SECONDARY 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 |
35; 5; 1; 1; 1; 0 | — |
| SECONDARY Number of HIV Care Providers Assessed for Overall Opinion of Referring the Participant to an IC/ ASA by Other Quantitative Questionnaires at Month 1 |
0; 1; 1; 1; 0; 0 | — |
| SECONDARY Number of HIV Care Providers Assessed for Overall Opinion of Referring the Participant to an IC/ ASA by Other Quantitative Questionnaires at Month 4 |
2; 1; 0; 0; 0; 0 | — |
| SECONDARY Number of HIV Care Providers Assessed for Overall Opinion of Referring the Participant to an IC/ ASA by Other Quantitative Questionnaires at Month 8 |
0; 2; 0; 0; 0; 0 | — |
| SECONDARY 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 |
0; 1; 1; 0; 0; 0 | — |
| SECONDARY Number of Participants Assessed for Overall Opinion of Receiving the Injection at an IC/ ASA by Qualitative Interview at Month 8 |
5; 11; 5; 13; 5; 4 | — |
| SECONDARY Number of HIV Care Providers Assessed for Overall Opinion of Referring Patients to an IC/ ASA by Qualitative Interview at Month 8 |
1; 2; 1; 1; 1 | — |
| SECONDARY Number of IC/ASA Staff Assessed for Overall Opinion of Administering the Injection at an IC/ ASA by Qualitative Interview at Month 8 |
12; 1 | — |
| SECONDARY Number of Injections Occurring Within Target Window From Target Date |
0; 3; 37; 27; 9; 36 | — |
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
Data sourced from ClinicalTrials.gov (NCT04982445). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.