PrEP4U: Assessing the Effectiveness of Integrated Same-Day Lenacapavir Initiation and Follow-up Choice on PrEP Persistence

Starting soon · Not applicable

Conditions studied: HIV Pre-exposure Prophylaxis Use

In brief

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.

Key facts

Study ID

NCT07335289

Run by

Massachusetts General Hospital

People needed

400

Starts

2026-06-30

Expected to finish

2027-02-01

Last updated by the study team

2026-06-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital Sexual Health Clinic — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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