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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Massachusetts General Hospital • ClinicalTrials.gov ID: NCT07335289

Registry updated: 2026-09-23
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Description

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.

Interventions

  • Choice of follow up (Other)
    Randomization to either standard clinic follow up or choice of where follow up takes place
  • Follow up via standard clinic (Other)
    Follow up will take place at the clinic where the first dose was administered.

Eligibility criteria

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

Conditions

HIV Pre-exposure Prophylaxis Use

Locations

  • Massachusetts General Hospital Sexual Health Clinic — Boston, Massachusetts, United States
  • Brigham and Women's Hospital — Boston, Massachusetts, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record