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
Parallel
Choice of follow up
Other interventionRandomization to either standard clinic follow up or choice of where follow up takes place
Follow up via standard clinic
Other interventionFollow up will take place at the clinic where the first dose was administered.
PrEP persistence at 6 months
Proportion of participants in the PrEP Choice arm versus the PrEP Clinic arm who successfully receive the second on-time injection
Safety of same-day initiation based on rapid HIV testing
Proportion of individuals in whom rapid and laboratory Ag/Ab test results are consistent.
Acceptability of same-day initiation and follow-up models
Participant acceptability scores measured using structured surveys
Participant costs associated with PrEP delivery models
Average participant costs (financial and time) per injection visit in clinic versus community/home settings
HIV Incidence by Study Arm
HIV incidence rate (per 100 person-years) by arm
Lenacapavir Resistance in HIV Seroconverters
Proportion of HIV infections with confirmed resistance mutations
Subgroup Analyses of Persistence
Identification of populations for whom differentiated delivery has the greatest impact
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
Brigham and Women's Hospital
Collaborator
