PrEP4U: Assessing the Effectiveness of Integrated Same-Day Lenacapavir Initiation and Follow-up Choice on PrEP Persistence
Massachusetts General Hospital
Summary
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.
Description
Since the introduction of oral PrEP over a decade ago, more than 1.3 million HIV infections occur globally each year, far exceeding the UNAIDS 2030 target of \< 335,000 cases. UNAIDS estimated that only 2.3 million people used PrEP in 2023, far below the target of 10 million by 2025. Oral PrEP persistence remains low, with many individuals discontinuing within 6-12 months. Factors contributing to low uptake and persistence include pill fatigue, stigma, access barriers, and medical mistrust. The gap is especially stark in sub-Saharan Africa and Latin America, where PrEP coverage lags behind epi…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
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…
Interventions
- OtherChoice of follow up
Randomization to either standard clinic follow up or choice of where follow up takes place
- OtherFollow up via standard clinic
Follow up will take place at the clinic where the first dose was administered.
Location
- Massachusetts General Hospital Sexual Health ClinicBoston, Massachusetts