Home › NCT07335289

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

Who can join

Ages 18 and older · All sexes · Healthy volunteers welcome

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

About the study

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.

What is being tested

• Choice of follow up (other)
• Follow up via standard clinic (other)

Sponsor: Massachusetts General Hospital · Participants: 400 · Started: Jul 17, 2026

Contact the study team

• Meighan Krows · Phone: 617-726-2000

Official record on ClinicalTrials.gov — NCT07335289

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.