NCT07335289

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
6mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Feb 2026Nov 2026

First Submitted

Initial submission to the registry

January 5, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 13, 2026

Completed
20 days until next milestone

Study Start

First participant enrolled

February 2, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

9 months

First QC Date

January 5, 2026

Last Update Submit

January 5, 2026

Conditions

HIV Pre-exposure Prophylaxis Use

Keywords

HIV PrEPInjectable PrEPLenacapavir

Outcome Measures

Primary Outcomes (1)

  • PrEP persistence at 6 months

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

    26 weeks

Secondary Outcomes (3)

  • Safety of same-day initiation based on rapid HIV testing

    26 weeks

  • Acceptability of same-day initiation and follow-up models

    26 weeks

  • Participant costs associated with PrEP delivery models

    26 weeks

Other Outcomes (3)

  • HIV Incidence by Study Arm

    26 weeks

  • Lenacapavir Resistance in HIV Seroconverters

    26 weeks

  • Subgroup Analyses of Persistence

    26 weeks

Study Arms (2)

PrEP Clinic

ACTIVE COMPARATOR

The PrEP Clinic arm will be randomized to receive follow up at the clinic

Other: Follow up via standard clinic

PrEP Choice

EXPERIMENTAL

The PrEP Choice arm allows participants to choose where they receive their follow up

Other: Choice of follow up

Interventions

Choice of follow upOTHER

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

PrEP Choice
Follow up via standard clinicOTHER

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

PrEP Clinic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital Sexual Health Clinic

Boston, Massachusetts, 02114, United States

Location

Study Officials

  • Ruanne V Barnabas, MBChB, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Meighan Krows

CONTACT

617-726-2000mkrows@mgb.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Division of Infectious Diseases

Study Record Dates

First Submitted

January 5, 2026

First Posted

January 13, 2026

Study Start

February 2, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

January 13, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Interested parties may contact the central contact with requests for data. Data sets will be provided based on approval of request/concept by protocol team.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Once analysis of the study objectives is complete. Tentatively January 2027
Access Criteria
The protocol team will review all data requests. Upon approval of requests the data analyst will work with the requester to provide the data in an acceptable format, using a secure access link.

Locations

US(1)