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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT07335289
Status
Not Yet Recruiting

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Conditions

  • HIV Pre-exposure Prophylaxis Use

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

Start date
Feb 2, 2026
Status verified
Jan 2026
Primary completion
Nov 1, 2026
Completion
Nov 1, 2026

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Active Comparator: PrEP Clinic
    The PrEP Clinic arm will be randomized to receive follow up at the clinic
  • Experimental: PrEP Choice
    The PrEP Choice arm allows participants to choose where they receive their follow up

Primary Outcome Measure

PrEP persistence at 6 months [ Time Frame: 26 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General Hospital Sexual Health ClinicBostonMassachusetts02114
Kevin Ard, MD
[email protected]
617 726 2748
Kevin Ard, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Massachusetts General Hospital Sexual Health Clinic· Boston, MA

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