Phase 4
N=287
A Study Evaluating Implementation Strategies for the Delivery of Cabotegravir in Low and High-Volume PrEP Site in the United States
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT05374525 ↗Enrolled (actual)
287
Serious AEs
0.5%
Results posted
Dec 2025
Primary outcome: Primary: Mean Feasibility of Intervention Measure (FIM) Score Assessed for SSPs — 4.37; 4.27 Scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- APRETUDE (Drug); Cabotegravir OLI (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- ViiV Healthcare
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Feasibility of Intervention Measure (FIM) Score Assessed for SSPs |
4.37; 4.27 | — |
| SECONDARY Change From Baseline in FIM Score Assessed for SSPs |
-0.29; 0.08; -0.01; -0.11 | — |
| SECONDARY Number of SSPs Assessed for Perceptions of Facilitators to RI, DI and Overall Implementation of PrEP Into Routine Care Through Month 12 |
5; 1; 6; 0; 5; 0 | — |
| SECONDARY Number of SSPs Assessed for Perceptions of Barriers to RI, DI and Overall Implementation of PrEP Into Routine Care Through Month 12 |
7; 3; 4; 2; 4; 2 | — |
| SECONDARY Mean FIM Score Assessed for PSPs |
4.33; 4.51; 4.35; 4.46; 4.36; 4.46 | — |
| SECONDARY Mean Acceptability of Intervention Measure (AIM) Score Assessed for PSPs |
4.46; 4.41; 4.57; 4.57; 4.61; 4.60 | — |
| SECONDARY Number of PSPs With Responses to Implementation Science Questionnaire (ISQ) Regarding Their Feelings About Taking APRETUDE |
79; 64; 19; 10; 7; 1 | — |
| SECONDARY Number of PSPs With Responses to ISQs Regarding Acceptability of Coming to Clinic for APRETUDE Injection |
60; 55; 31; 19; 10; 2 | — |
| SECONDARY Number of PSPs With Responses to the ISQs Regarding Recommending APRETUDE |
72; 49; 18; 12; 2; 0 | — |
| SECONDARY Number of PSPs With Responses to the ISQs Regarding Appointment Scheduling |
60; 46; 20; 13; 5; 3 | — |
| SECONDARY Number of PSPs With Responses to the ISQs Regarding Appointment Rescheduling |
44; 25; 14; 17; 1; 4 | — |
| SECONDARY Change From Baseline in AIM Score Assessed for PSPs |
0.17; 0.20; 0.27; 0.19 | — |
| SECONDARY Change From Baseline in FIM Score Assessed for PSPs |
0.01; 0.00; 0.01; -0.01 | — |
| SECONDARY Percentage of PSPs With Change From Baseline in ISQ Responses |
3.0; -2.8; -0.7; 1.0; -4.5; 0.3 | — |
| SECONDARY Number of PSPs Assessed for Perception of Facilitators to Feasibility and Acceptability of APRETUDE Through Month 12 |
23; 20; 14; 12; 15; 11 | — |
| SECONDARY Number of PSPs Assessed for Perception of Barriers to Feasibility and Acceptability of APRETUDE Through Month 12 |
1; 3 | — |
| SECONDARY Mean FIM Score for Telehealth Delivery Assessed for SSPs |
4.01; 3.43; 4.13; 4.08; 4.26; 4.22 | — |
| SECONDARY Mean AIM Score for Telehealth Delivery Assessed for SSPs |
4.09; 3.26; 4.16; 3.98; 4.07; 4.17 | — |
| SECONDARY Number of SSPs With Responses to the ISQs Regarding Use of Telehealth Delivery |
54; 28; 1; 0; 1; 2 | — |
| SECONDARY Number of SSPs With Responses to the ISQs Indicating Which Telehealth Services Were Used |
14; 0; 1; 0; 8; 0 | — |
| SECONDARY Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used |
10; 0; 3; 0; 1; 0 | — |
| SECONDARY Change From Baseline in FIM Score for Telehealth Delivery Assessed for SSPs |
-0.11; 0.20; -0.06; 0.16 | — |
| SECONDARY Change From Baseline in AIM Score for Telehealth Delivery Assessed for SSPs |
-0.13; 0.53; -0.38; 0.41 | — |
| SECONDARY Percentage of SSPs With Change From Baseline in ISQ Responses for Telehealth Delivery |
-39.6; -58.9; 27.6; 48.3; 11.9; 10.6 | — |
| SECONDARY Mean FIM Score for Telehealth Delivery Assessed for PSPs |
4.40; 4.15; 4.56; 4.19; 4.25; 4.38 | — |
| SECONDARY Mean AIM Score for Telehealth Delivery Assessed for PSPs |
4.32; 4.13; 4.56; 4.25; 4.21; 4.27 | — |
| SECONDARY Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE |
72; 48; 14; 10; 0; 0 | — |
| SECONDARY Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services |
12; 8; 4; 1; 1; 0 | — |
| SECONDARY Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used |
12; 8; 3; 0; 2; 1 | — |
| SECONDARY Number of PSPs With Response to the ISQs Recommending Telehealth Delivery |
29; 12; 9; 9; 1; 3 | — |
| SECONDARY Change From Baseline in FIM Score for Telehealth Delivery Assessed for PSPs |
0.08; 0.25; -0.35; 0.17 | — |
| SECONDARY Change From Baseline in AIM Score for Telehealth Delivery Assessed for PSPs |
0.09; 0.26; -0.39; 0.21 | — |
| SECONDARY Percentage of PSPs With Change From Baseline in ISQ Responses Regarding Telehealth Delivery |
-40.1; -45.8; 35.8; 35.1; 4.3; 10.8 | — |
| SECONDARY Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery |
12; 4; 3; 2; 6; 1 | — |
| SECONDARY Number of PSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery |
2; 5; 1; 5; 1; 0 | — |
| SECONDARY Mean AIM Score Assessed for SSPs |
4.69; 4.66; 4.33; 4.43; 4.41; 4.52 | — |
| SECONDARY Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE |
3; 2; 5; 4; 13; 2 | — |
| SECONDARY Change From Baseline in AIM Score Assessed for SSPs |
-0.36; -0.22; -0.33; -0.11; -0.06; -0.16 | — |
| SECONDARY Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE |
-1.4; 0.2; 0.9; -13.3; -11.4; 0.2 | — |
| SECONDARY Mean AIM Score Assessed for PSPs |
4.46; 4.41; 4.57; 4.57; 4.61; 4.60 | — |
| SECONDARY Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline |
35; 32; 27; 23; 12; 10 | — |
| SECONDARY Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6 |
28; 24; 17; 17; 18; 6 | — |
| SECONDARY Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12 |
23; 24; 26; 14; 5; 8 | — |
| SECONDARY Change From Baseline in Mean AIM Score in PSPs |
0.17; 0.20; 0.27; 0.19 | — |
| SECONDARY Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy |
-2.9; -4.6; -7.2; -3.7; 8.1; -3.8 | — |
| SECONDARY Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use |
1; 0; 3; 1; 5; 1 | — |
| SECONDARY Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use |
1; 0; 2; 1; 10; 10 | — |
| SECONDARY Number of SSPs Assessed for Perceptions of Utility of Implementation Strategies and Facilitators and Barriers to Acceptability of RI and DI |
7; 4; 11; 8; 4; 4 | — |
| SECONDARY Number of PSPs Assessed for Perceptions of Utility of Implementation Strategies Through Semi-Structured Interviews (SSIs) |
10; 9; 7; 10; 7; 12 | — |
| SECONDARY Number of Injections Occurring Within Target Window From Target Date |
103; 76; 77; 57; 66; 49 | — |
| SECONDARY Number of PSPs Completing Target Number of Injections |
81; 63 | — |
| SECONDARY Number of PSPs With Perceptions of Facilitators to Fidelity to Injections |
23; 20; 15; 10; 13; 11 | — |
| SECONDARY Number of PSPs With Perceptions of Barriers to Fidelity to Injections |
14; 11; 4; 6; 2; 5 | — |
| SECONDARY Number of SSPs With Perceptions of Facilitators to Fidelity to Injections |
7; 2; 2; 3; 1; 4 | — |
| SECONDARY Number of SSPs With Perceptions of Barriers to Fidelity to Injections |
4; 2; 2; 2; 2; 2 | — |
| SECONDARY Number of SSPs Who Administer Sexual Health Assessment (SHA) |
14; 14; 4; 20 | — |
| SECONDARY Number of Eligible PSPs for Which SHA Are Administered |
39; 35; 15; 13; 23; 15 | — |
| SECONDARY Number of Men Who Have Sex With Men (MSM) and Transgender Men (TGM) Who Take the SHA Through M12 |
73; 1; 25; 3; 36; 2 | — |
| SECONDARY Number of MSM and TGM Who Report Having Had Sex in the Last 6 Months on the SHA |
5; 1; 128; 5; 1; 0 | — |
| SECONDARY Number of PSPs Who Expressed Interest in PrEP or Never Heard of PrEP Out of Those Who Report Having Had Sex in the Last 6 Months |
70; 61; 30; 15; 7; 3 | — |
| SECONDARY Number of PSPs Who Initiate APRETUDE After Taking the SHA |
77; 65; 26; 11; 2; 1 | — |
| SECONDARY Number of PSPs With Perceptions of SHA |
16; 0; 3; 0; 4; 0 | — |
| SECONDARY Number of SSPs With Perceptions of SHA |
1; 1; 3; 8; 5; 1 | — |
| SECONDARY Number of Modifications Reported by SSPs Using FRAME-IS |
6; 3; 4; 8; 3; 0 | — |
| SECONDARY Number of Modifications for Each Category Reported by SSPs Using FRAME-IS |
12; 4; 5; 3; 22; 0 | — |
| SECONDARY Number of Modifications Made for Adaptations to Implementation Reported by SSPs Using FRAME-IS |
23; 5; 19; 8; 18; 10 | — |
| SECONDARY Number of PSPs Assessed for Perceptions of Adaptations to Implementation Strategies |
21; 20; 10; 7; 5; 7 | — |
| SECONDARY Number of PSPs With History of PrEP Use That Complete the SHA and ISQ and Start APRETUDE |
5; 1; 11; 0; 1; 0 | — |
| SECONDARY Number of PSPs With Reasons for Choosing and Switching to APRETUDE Assessed by Semi-Structured Interviews (SSIs) |
16; 11; 6; 3; 4; 5 | — |
| SECONDARY Number of PSPs With Reasons for Choosing and Switching to APRETUDE Assessed by ISQs |
66; 49; 63; 45; 55; 47 | — |
| SECONDARY Number of PSPs Assessed for Perception of Facilitators |
19; 17; 12; 6; 4; 6 | — |
| SECONDARY Number of PSPs Assessed for Perception of Barriers |
1; 3; 6; 3; 0; 4 | — |
| SECONDARY Number of SSPs Assessed for Perception of Facilitators |
11; 11; 6; 8; 4; 5 | — |
| SECONDARY Number of SSPs Assessed for Perception of Barriers |
9; 4; 2; 2 | — |
Summary
This is a two-arm study evaluating the impact of two implementation strategy conditions, dynamic implementation and routine implementation on the feasibility of delivering of Cabotegravir PrEP in low and high-volume PrEP sites in the United States for men who have sex with men (MSM) and Transgender men ≥ 18 years of age. There are two types of participants in the study. Patient Study Participants (PSPs) will refer to individuals who are enrolled in the study and who will receive commercially available Cabotegravir PrEP via prescription from the PrEP provider at the corresponding site. Staff Study Participants (SSPs) will refer to site staff who are involved in administrative and clinical aspects of offering and administering PrEP to PSPs and will participate in the staff study assessments. PSPs who choose to opt for 1-month oral lead-in (OLI) will receive cabotegravir tablets for PrEP at Month 1 followed by APPRETUDE intramuscular (IM) injections on Month 2, 3 and every two months thereafter up to Month 13. PSPs who opt for Direct to injections (DTI) will receive APPRETUDE IM injections on Month 1, 2 and every two months thereafter up to Month 12. Month 6/7 refers to Month 6 (DTI)/ Month 7 (OLI). Month 12/13 refers to Month 12 (DTI)/ Month 13 (OLI).
Eligibility Criteria
Inclusion Criteria
- Participant must be ≥ 18 years of age inclusive, at the time of signing the informed consent.
- No prior history of receiving CAB PrEP
- HIV negative test result at screening
- Capable of giving signed informed consent form
Exclusion Criteria
- HIV indeterminate or positive test result during screening and prior to initiation of CAB PrEP
- A participant of concurrent interventional clinical or implementation science study at any time during the study
Data sourced from ClinicalTrials.gov (NCT05374525). 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.