🌐 EnglishEN

AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

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

RecruitingNAAges 18 Years - anyAllMassachusetts General Hospital
NCT07335289 on ClinicalTrials.gov ↗
💬

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

Sign in
📋 Eligibility rules (as published)
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
💊

What it tests

  • Choice of follow up
  • Follow up via standard clinic
📍

Where

2 sites
Massachusetts General Hospital Sexual Health Clinic
Boston, United States
Brigham and Women's Hospital
Boston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy