Lenacapavir for PrEP
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Ruanne V Barnabas, MBChB, PhD
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
The PrEP4U trial is for HIV-negative individuals in Massachusetts who meet CDC guidelines for HIV PrEP, can consent to participate, are willing to receive injectable lenacapavir and follow study procedures, and will be available for a 6-month follow-up.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Same-day Initiation
Participants begin lenacapavir PrEP with rapid HIV testing and choose follow-up location
Follow-up
Participants receive follow-up care at chosen location (home, community, or clinic) to improve PrEP persistence
Monitoring and Evaluation
Participants are monitored for safety, acceptability, and persistence of PrEP
What Are the Treatments Tested in This Trial?
Interventions
- Lenacapavir
Trial Overview
This trial tests the effectiveness of same-day lenacapavir initiation with a choice of follow-up location (home, community, or clinic) on maintaining use of PrEP. It aims to inform best practices for long-acting injectable PrEP implementation.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
The PrEP Choice arm allows participants to choose where they receive their follow up
The PrEP Clinic arm will be randomized to receive follow up at the clinic
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
Brigham and Women's Hospital
Collaborator
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