Mobile Vehicle-Based Delivery of Lenacapavir Pre-Exposure Prophylaxis in Los Angeles County (NCT07467018) | Clinical Trial Compass
RecruitingNot Applicable
Mobile Vehicle-Based Delivery of Lenacapavir Pre-Exposure Prophylaxis in Los Angeles County
United States100 participantsStarted 2026-04-21
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Being reached for mobile health services by a UCLA HHC mobile van
* ≥18 years of age
* Able to provide informed consent
* English or Spanish-speaking
* Willing and able to comply with study procedures
* HIV unknown or negative status and HIV negative based on rapid 4th generation Ag/Ab test on the day of enrollment
* At-risk for HIV, based on clinician assessment (based on CDC guidelines; includes any individual requesting PrEP, regardless of reported risk factors for HIV)
* Pregnant and breastfeeding women/people can be offered LEN with counseling about benefits and risks.
Exclusion Criteria:
* Any clinical or psychosocial condition or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study or unable to take LEN PrEP
* Known hypersensitivity to the study drug, the metabolites, or formulation excipient
* BMI \<35 kg/m2 (77 pounds)
* On oral or other long-acting PrEP and unwilling to discontinue
* Already taking LEN for HIV prevention
* Known HIV diagnosis or positive 4th generation HIV Ab/Ag test (on day of enrollment) or subsequent lab-based confirmatory testing.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.