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

NCT07335289 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-01-13

No results posted yet for this study

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

Interventions

OTHER

Choice of follow up

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

OTHER

Follow up via standard clinic

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

Sponsors & Collaborators

  • Brigham and Women's Hospital

    collaborator OTHER

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Ruanne V Barnabas, MBChB, PhD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-02-02
Primary Completion
2026-11-01
Completion
2026-11-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07335289 on ClinicalTrials.gov