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.
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
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
The subject population consists of adults 18 years and older being reached for care by the UCLA Health Homeless Healthcare Collaborative (HHC) and offered lenacapavir for HIV prevention.
Cohort
Prospective
Community-based healthcare delivery
Other interventionThis study evaluates the implementation strategy of community-based delivery of HIV biomedical prevention with lenacapavir.
Lenacapavir
DrugMobile, community-based delivery of lenacapavir
Uptake of LEN PrEP
The primary outcome will be defined as receiving a first injection of LEN (along with both oral doses on days 1 and 2).
Predictors of uptake
Surveys will be performed at baseline to measure sociodemographic factors, HIV risk perception, PrEP knowledge, PrEP self-efficacy, and clinical factors.
Persistence on LEN PrEP at 26 and 52 weeks [+/- 14 days])
Persistence defined by receiving the injection at each timepoint on-time (+/- 14 days from target due date)
Acceptability
Acceptability of the mobile delivery of LEN PrEP
Predictors of persistence
Surveys will be performed at baseline to measure sociodemographic factors, HIV risk perception, PrEP knowledge, PrEP self-efficacy, and clinical factors. These will be used to explore factors associated with persistence on LEN at 26 and 52 weeks.
Click on the lead sponsor to view all of their trials.
