Recruiting

Lenacapavir

Sponsor:

UCLA

Code:

NCT07467018

Conditions

HIV Prevention

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Community-based healthcare delivery

Lenacapavir

Study Details

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.

Conditions

HIV Prevention

Study ID

NCT07467018

Start date

Apr 21, 2026

Status verified date

Apr, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Primary Cohort

Unstably housed adults without HIV being reached for healthcare by the UCLA Health Homeless Healthcare Collaborative

Interventions

Community-based healthcare delivery

This study evaluates the implementation strategy of community-based delivery of HIV biomedical prevention with lenacapavir.

Lenacapavir

Mobile, community-based delivery of lenacapavir

Primary outcome measure

  • Uptake of LEN PrEP [ Time Frame: 3 months after enrollment ]

Central Contacts and Locations

Central contacts

Risa Hoffman, MD, MPH

310-206-6766rhoffman@mednet.ucla.edu

Daisy Walker, MPH

424-832-6674DaisyWalker@mednet.ucla.edu

Locations

UCLA Health Homeless Healthcare Collaborative

Recruiting

Santa Monica, California, United States, 90404

Contacts

Brian Zunner-Keating, RN, PHNA-BC

310-562-1871BZunner@mednet.ucla.edu

More Information

Sponsor

University of California, Los Angeles

Last update posted

Apr 23, 2026

Last verified

Apr, 2026

Keywords

  • lenacapavir
  • community-based health delivery
  • HIV prevention
  • homelessness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2026-04-23.