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

NCT07467018 | Recruiting FDA Drug

• 1 other identifier: IN-US-974-7769
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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. 1.Characterize uptake of LEN PrEP among unstably housed people in LAC receiving health services via HHC's mobile program.
2. 2.Evaluate how many study participants stay on LEN PrEP through 52 weeks.
3. 3.Understand costs, acceptability, and sustainability of the mobile LEN PrEP delivery model.

Conditions

HIV Prevention

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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).

  3 months after enrollment

Secondary Outcomes (5)

• Predictors of uptake

  3 months after enrollment

• Persistence on LEN PrEP at 26 and 52 weeks [+/- 14 days])

  52 weeks

• Acceptability

  52 weeks

• Predictors of persistence

  52 weeks

• Costs of mobile delivery of LEN PrEP

  52 weeks

Study Arms (1)

Primary Cohort

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

Other: Community-based healthcare delivery; Drug: Lenacapavir

Interventions

Lenacapavir DRUG

Mobile, community-based delivery of lenacapavir

Primary Cohort

Community-based healthcare delivery OTHER

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

Primary Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Health Homeless Healthcare Collaborative

Santa Monica, California, 90404, United States

RECRUITING

MeSH Terms

Interventions

lenacapavir

Central Study Contacts

Risa Hoffman, MD, MPH

CONTACT

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

Daisy Walker, MPH

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Medicine

Study Record Dates

• First Submitted: March 7, 2026
• First Posted: March 12, 2026
• Study Start: April 21, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available once all primary and secondary analyses have been completed (estimated to be January 2028)
• Access Criteria: Anonymized data can be shared after all primary and secondary study analyses have been completed and with appropriate ethical approval and agreement permissions. Study leadership will review requests for data-sharing on a case-by-case basis. Data sharing format will be determined at the time of request based on type(s) of data requested.

Locations

US (1)