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

Massachusetts General Hospital · with Brigham and Women's Hospital · NCT07335289

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
400
US sites recruiting
2
Study start
July 17, 2026
Record last updated
September 23, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Choice of follow up; Follow up via standard clinic

Conditions: HIV Pre-exposure Prophylaxis Use

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Massachusetts General Hospital Sexual Health Clinic

    Boston, MA 02114

    Site contact: Kevin Ard, MD · 617 726 2748 · kard@mgh.harvard.edu

  • Brigham and Women's Hospital

    Boston, MA 02115

    Site contact: Jennifer Manne-Goehler, MD · 6177325500 · jmanne@bwh.harvard.edu

Study contacts (from the official record)

  • Meighan Krows · 617-726-2000 · mkrows@mgb.org
All healthy volunteers studies in Massachusetts →
PrEP4U: Assessing the Effectiveness of Integrated Same-Day… (NCT07335289) | Bored Studies