Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 4 study that has completed, run by ViiV Healthcare. The registered enrollment target is 287 participants.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05374525
The ClinicalTrials.gov registry entry for NCT05374525 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 287 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ViiV Healthcare, which has 182 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which APRETUDE is the first listed.
NCT05374525 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.