NCT07335289Recruiting
PrEP4U: Assessing the Effectiveness of Integrated Same-Day Lenacapavir Initiation and Follow-up Choice on PrEP Persistence
Source: ClinicalTrials.gov · Last updated 23 Sept 2026
Brief summary (registry, in English)
PrEP4U is designed as a pragmatic, randomized implementation trial to test strategies that could directly inform real-world roll-out of lenacapavir. By integrating: * Same-day initiation based on rapid HIV testing, and * Choice of follow-up delivery location (home, community, or clinic) the study addresses two of the most pressing implementation questions for long-acting injectable PrEP. The primary hypothesis is that giving participants choice in follow-up location will improve PrEP persistence compared to a clinic-only model. Secondary analyses will evaluate safety of rapid testing, acceptability, and participant costs. Exploratory analyses will assess HIV incidence and resistance. Findings from PrEP4U will provide essential evidence to guide scalable, equitable, person-centered delivery models for lenacapavir PrEP in the U.S. and globally.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 5 Jan 2026
- Start date
- 17 Jul 2026
- Primary completion date
- 1 Jul 2027
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- HIV
- NCT number
- NCT07335289
What you commit to
- Study type: Interventional
- Planned participants: 400
- From 17 Jul 2026 to the primary completion date, 1 Jul 2027
- 2 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.
Other illness
- Known HIV infection at baseline
- Contraindication to lenacapavir injection (e.g., hypersensitivity, significant drug interactions)
- Participation in another interventional HIV prevention study
- Any condition judged by the investigator to compromise safety or study integrity
Other
- Pregnancy at baseline (participants who become pregnant during the trial may remain enrolled if they choose)
Who the study is looking for
- HIV negative
- Eligible for HIV PrEP per CDC guidelines
- Able and willing to provide informed consent
- Willing to receive injectable lenacapavir and adhere to study procedures
- Residing inMassachusetts with expected availability for 6-month follow-up
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Sexual Health Clinic Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.