NCT07467018 Mobile Vehicle-Based Delivery of Lenacapavir Pre-Exposure Prophylaxis in Los Angeles County
| NCT ID | NCT07467018 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, Los Angeles |
| Condition | HIV Prevention |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-04-21 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2026-04-21 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07467018 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HIV Prevention. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07467018 currently recruiting?
Yes, NCT07467018 is actively recruiting participants. Contact the research team at rhoffman@mednet.ucla.edu for enrollment information.
Where is the NCT07467018 trial being conducted?
This trial is being conducted at Santa Monica, United States.
Who is sponsoring the NCT07467018 clinical trial?
NCT07467018 is sponsored by University of California, Los Angeles. The trial plans to enroll 100 participants.
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