Tests choice of follow-up location for people starting HIV prevention injections
Tests whether choosing follow-up location helps adults on lenacapavir HIV prevention stay on it.
Plain-language title generated from the registry record
Registry title: PrEP4U: Assessing the Effectiveness of Integrated Same-Day Lenacapavir Initiation and Follow-up Choice on PrEP Persistence
Key facts
- Where
- Boston, United StatesSee the 2 sites
Where in United States
- Brigham and Women's HospitalBoston, United StatesTaking people
- Massachusetts General Hospital Sexual Health ClinicBoston, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Massachusetts General Hospital
- Trial code
- NCT07335289
- Record updated
- 23 September 2026
- Original description
PrEP4U is designed as a pragmatic, randomized implementation trial to test strategies that could directly inform real-world roll-out of lenacapavir. By integrating:Read full original descriptionShow less
PrEP4U: Assessing the Effectiveness of Integrated Same-Day Lenacapavir Initiation and Follow-up Choice on PrEP Persistence
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.
Inclusion: 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.
Exclusion: 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; Pregnancy at baseline (participants who become pregnant during the trial may remain enrolled if they choose).