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.
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
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
Massachusetts General Hospital
Lead sponsor
Brigham and Women's Hospital
Collaborator