Bringing long-acting lenacapavir PrEP to people who are unstably housed in Los Angeles County
Mobile Vehicle-Based Delivery of Lenacapavir Pre-Exposure Prophylaxis in Los Angeles County (MOVE-LA)
This project will try giving long-acting injectable lenacapavir as HIV prevention from UCLA's mobile health vans to adults who are unhoused or facing housing instability in Los Angeles County.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 1 site (Santa Monica, California) |
| Trial ID | NCT07467018 on ClinicalTrials.gov |
What this trial studies
This observational implementation project partners with the UCLA Health Homeless Healthcare Collaborative mobile vans to offer point-of-care HIV testing and on-site lenacapavir (LEN) PrEP to unstably housed adults in community settings such as shelters, encampments, and transitional housing. Eligible participants are adults reached by the vans who are HIV-negative or of unknown status, speak English or Spanish, and are judged at risk for HIV by clinicians. The study will document uptake, continuation, and implementation outcomes using Andersen's behavioral model and Proctor et al.'s implementation outcome framework. Data collection focuses on barriers, facilitators, and real-world delivery metrics rather than a randomized efficacy comparison.
Who should consider this trial
Good fit: Adults (≥18) in Los Angeles County who are reached by UCLA HHC mobile vans, speak English or Spanish, are HIV-negative or of unknown status, are considered at risk for HIV, and can provide informed consent are ideal candidates.
Not a fit: People with known hypersensitivity to lenacapavir or its formulation, those judged unsuitable due to clinical or psychosocial conditions, individuals already on other PrEP who refuse to discontinue, or those below the protocol's BMI cutoff may not receive benefit from this program.
Why it matters
Potential benefit: If successful, this approach could increase access to long-acting PrEP and reduce new HIV infections among people who are unhoused in Los Angeles County.
How similar studies have performed: Other long-acting injectable PrEP approaches such as cabotegravir have reduced HIV incidence in clinical trials, and lenacapavir has promising early data, but mobile community delivery of LEN PrEP is relatively untested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Santa Monica, California
- UCLA Health Homeless Healthcare Collaborative — Santa Monica, California, United States (Recruiting)
Study contacts
- Study coordinator: Risa Hoffman, MD, MPH
- Email: rhoffman@mednet.ucla.edu
- Phone: 310-206-6766
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.