PrEP4U: Lenacapavir for HIV Prevention

This study, called PrEP4U, is looking at better ways to help people stick with HIV pre-exposure prophylaxis (PrEP) using an injectable medicine called lenacapavir. We want to see if giving you a choice in where you have your follow-up appointments (like at home or in the community, instead of always at the clinic) helps you continue using PrEP for longer. You can join if you are HIV-negative, eligible for PrEP, willing to receive lenacapavir injections, and live in Massachusetts. The main goal is to see how many people are still using PrEP at 6 months. We are currently unclear about the study's recruitment status, but it plans to enroll 400 people.

Study design
This is a randomized study, meaning participants will be assigned by chance to one of two groups, with 400 participants planned.
What's involved
You would receive injectable lenacapavir and follow study procedures, including follow-up appointments for 6 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for PrEP persistence at 6 months (26 weeks).

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NCT07335289

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

Not Yet Recruiting
NAAges 18+InterventionalHealth services
Massachusetts General Hospital
~400 participants
Updated 2026-06-25 on ClinicalTrials.gov
What's tested:Choice of follow upFollow up via standard clinic

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
PrEP persistence at 6 months
Measured over 26 weeks
HIV Pre-exposure Prophylaxis Use
1 sites across 1 states
Massachusetts1
  • Ruanne V Barnabas, MBChB, PhD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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
  • PrEP persistence at 6 months26 weeks

    Proportion of participants in the PrEP Choice arm versus the PrEP Clinic arm who successfully receive the second on-time injection