Actively Recruiting

Age: 18Years +
All Genders
NCT07467018

Mobile Vehicle-Based Delivery of Lenacapavir Pre-Exposure Prophylaxis in Los Angeles County

Led by University of California, Los Angeles · Updated on 2026-04-23

100

Participants Needed

1

Research Sites

88 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This project evaluates the implementation strategy of the delivery of lenacapavir pre-exposure prophylaxis (LEN PrEP) - a newly available long-acting, injectable medication for human immunodeficiency virus (HIV) prevention - via a mobile health van model for people who are unstably housed in Los Angeles County (LAC). People who are unhoused or are facing housing instability experience significant barriers to accessing HIV prevention care in traditional clinic settings. In 2022, approximately 13% of newly diagnosed HIV cases in LAC were experiencing homelessness, a 36% increase over the prior period. The study will work with the University of California, Los Angeles (UCLA) Health's Homeless Healthcare Collaborative (HHC), which operates mobile health vans staffed by clinicians, social workers, and community health workers, to bring LEN PrEP directly to community settings, such as shelters, encampments, community centers, and transitional housing facilities. This study has three primary aims: 1. Characterize uptake of LEN PrEP among unstably housed people in LAC receiving health services via HHC's mobile program. 2. Evaluate how many study participants stay on LEN PrEP through 52 weeks. 3. Understand costs, acceptability, and sustainability of the mobile LEN PrEP delivery model.

CONDITIONS

Official Title

Mobile Vehicle-Based Delivery of Lenacapavir Pre-Exposure Prophylaxis in Los Angeles County

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Being reached for mobile health services by a UCLA HHC mobile van
  • 18 years of age or older
  • Able to provide informed consent
  • English or Spanish-speaking
  • Willing and able to comply with study procedures
  • HIV unknown or negative status confirmed by rapid 4th generation Ag/Ab test on enrollment day
  • At risk for HIV based on clinician assessment including any individual requesting PrEP
  • Pregnant and breastfeeding women/people can be offered LEN with counseling about benefits and risks
Not Eligible

You will not qualify if you...

  • Any clinical or psychosocial condition or prior therapy that makes the participant unsuitable or unable to take LEN PrEP
  • Known hypersensitivity to lenacapavir, its metabolites, or formulation excipient
  • Body mass index less than 35 kg/m2 (77 pounds)
  • Currently on oral or other long-acting PrEP and unwilling to discontinue
  • Already taking lenacapavir for HIV prevention
  • Known HIV diagnosis or positive 4th generation HIV Ab/Ag test on enrollment day or later confirmatory testing

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

UCLA Health Homeless Healthcare Collaborative

Santa Monica, California, United States, 90404

Actively Recruiting

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Research Team

R

Risa Hoffman, MD, MPH

CONTACT

D

Daisy Walker, MPH

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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