Recruiting

Lenacapavir

Sponsor:

Massachusetts General Hospital

Code:

NCT07335289

Conditions

HIV Pre-exposure Prophylaxis Use

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Choice of follow up

Follow up via standard clinic

Study Details

Brief summary:

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.

Conditions

HIV Pre-exposure Prophylaxis Use

Study ID

NCT07335289

Start date

Jul 17, 2026

Status verified date

Jun, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

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

Interventions

Choice of follow up

Randomization to either standard clinic follow up or choice of where follow up takes place

Follow up via standard clinic

Follow up will take place at the clinic where the first dose was administered.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Meighan Krows

617-726-2000mkrows@mgb.org

Locations

Massachusetts General Hospital Sexual Health Clinic

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Kevin Ard, MD

617 726 2748kard@mgh.harvard.edu

Principal Investigator:

Kevin Ard, MD

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Jennifer Manne-Goehler, MD

6177325500jmanne@bwh.harvard.edu

Principal Investigator:

Jennifer Manne-Goehler, MD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Sep 23, 2026

Last verified

Jun, 2026

Keywords

  • HIV PrEP
  • Injectable PrEP
  • Lenacapavir

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-09-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.