NCT05374525CompletedPhase 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, Randomized, Open-label, Two-arm Study Evaluating Implementation Strategies for the Delivery of Cabotegravir in Low and High-volume Pre-exposure Prophylaxis (PrEP) Sites in the U.S. for HIV Uninfected MSM and Transgender Men ≥ 18
Source: ClinicalTrials.gov · Last updated 15 Dec 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 287 (actual)
- First submitted
- 10 May 2022
- Start date
- 18 May 2022
- Primary completion date
- 8 Aug 2024
- Lead sponsor
- ViiV Healthcare
- Diseases
- HIV
- NCT number
- NCT05374525
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 287
- From 18 May 2022 to the primary completion date, 8 Aug 2024
- 17 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Accepts healthy volunteers
Sites (17)
Sites in registry order. Save your city in your profile to sort them by distance.
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.