PrEP4U: Assessing the Effectiveness of Integrated Same-Day Lenacapavir Initiation and Follow-up Choice on PrEP Persistence
- HIV Pre-exposure Prophylaxis Use
At a glance
- Phase
- Phase not stated
- Study type
- Interventional
- Sponsor
- Massachusetts General Hospital
- Enrolment target
- 400
- Started
- 17 July 2026
- Main results due
- 1 July 2027
- Study sites
- 2
- Registry updated
- 23 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- Healthy volunteers can take part.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: * 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 Criteria: * Known HIV infection at baseline * Contraindication to lenacapavir injection (e.g., hypersensitivity, significant drug interactions) * Pregnancy at baseline (participants who become pregnant during the trial may remain enrolled if they choose) * Participation in another interventional HIV prevention study * Any condition judged by the investigator to compromise safety or study integrity
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(2)
Massachusetts General Hospital Sexual Health Clinic
Boston, Massachusetts, United States
Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, United States
Recruiting
Showing 2 of 2 sites. 2 of the 2 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07335289. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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