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NCT05374525 · ClinicalTrials.gov registry record · Phase 4
A Study Evaluating Implementation Strategies for the Delivery of Cabotegravir in Low and High-Volume PrEP Site in the United States
A Phase 4 study, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 4
- Development phase
- 287
- Enrollment target
NCT05374525: Completed Phase 4 study, sponsored by ViiV Healthcare.
NCT05374525 is a Phase 4 study that has completed, run by ViiV Healthcare. The registered enrollment target is 287 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05374525, a Phase 4 study, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 287 participants
- Enrollment target
Study 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).
Primary Outcome
The FIM-Intervention (INT) was a four-item measure for APRETUDE intervention (1. APRETUDE seems implementable in our clinic/practice 2. APRETUDE seems possible in our clinic/practice 3. APRETUDE seems doable in our clinic/practice 4. APRETUDE seems easy to use in our clinic/practice) and was measured on a five-point rating scale (1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = completely agree). The mean score ranges from 1 to 5 with 1 indicating the lea
Interventions
- DRUG APRETUDE
- DRUG Cabotegravir OLI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 287 participants |
| Start Date | 2022-05-18 |
| Est. Completion | 2024-08-08 |
| Phase | Phase 4 |
What the finished NCT05374525 record still lists
NCT05374525 is an interventional study that assigns participants to a tested intervention. The registered 287 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 2 interventions - of which APRETUDE is the first listed.
NCT05374525 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05374525 about?
NCT05374525 is a clinical study titled "A Study Evaluating Implementation Strategies for the Delivery of Cabotegravir in Low and High-Volume PrEP Site in the United States". 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 ...
What is the current status of trial NCT05374525?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 287 participants. The study started on 2022-05-18. Estimated completion is 2024-08-08.
What interventions are being tested in trial NCT05374525?
The interventions under investigation include: APRETUDE (DRUG), Cabotegravir OLI (DRUG).
Who is sponsoring clinical trial NCT05374525?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05374525's enrollment target sits among peer trials
287 301st of 2000 higher than 1,700 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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