NCT07467018 Mobile Vehicle-Based Delivery of Lenacapavir Pre-Exposure Prophylaxis in Los Angeles County

Trial Parameters

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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 L

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