HIV PreventionMOVE-LANCT07467018
Mobile Vehicle-Based Delivery of Lenacapavir Pre-Exposure Prophylaxis in Los Angeles County
An observational study of HIV Prevention, run by University of California, Los Angeles at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Prevention
- What is being tested?
- Community-based healthcare delivery and Lenacapavir
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UCLA Health Homeless Healthcare Collaborative
Santa Monica, California, 90404
Brian Zunner-Keating, RN, PHNA-BC, 310-562-1871, BZunner@mednet.ucla.edu
About this study
Official title: Mobile Vehicle-Based Delivery of Lenacapavir Pre-Exposure Prophylaxis in Los Angeles County (MOVE-LA)
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:
- Characterize uptake of LEN PrEP among unstably housed people in LAC receiving health services via HHC's mobile program.
- Evaluate how many study participants stay on LEN PrEP through 52 weeks.
- Understand costs, acceptability, and sustainability of the mobile LEN PrEP delivery model.
Read the detailed description
Access to HIV prevention services for unstably housed people in LAC has been limited due to barriers in seeking care at health facilities. Unstably housed people face barriers including competing life priorities (such as seeking food, shelter, and employment), low health literacy, particularly around HIV prevention, and comorbidities such as substance use and mental health disorders. A mobile healthcare service that offers LEN PrEP is ideal to help overcome these barriers by providing a low-complexity biomedical PrEP option in locations where unstably housed people congregate (i.e., shelters, encampments, community centers, and transitional housing facilities). The UCLA Health HHC was founded in January 2022 and currently operates six mobile vans, which deliver urgent care, primary care, behavioral health services, and medication-assisted treatment for substance use disorders. At least one mobile van is in the field offering services every day of the week, including weekends. The van is staffed by clinicians and community health workers, who link clients to social services. HHC recently began providing point-of-care HIV and sexually transmitted infection (STI) testing and is well-positioned to integrate LEN PrEP into their program.
Based on Andersen's behavioral model (3) and using Proctor et al's implementation outcomes (4), the investigators propose the following:
Aim 1. Characterize uptake of LEN PrEP among unstably housed people in LAC receiving health services via HHC's mobile program. People without HIV receiving health services via the HHC mobile unit (n=100) will be offered LEN PrEP. A baseline survey will be performed (sociodemographics, clinical information, HIV risk, PrEP knowledge, self-efficacy for health care, and acceptability of mobile PrEP offer). The primary outcome will be uptake, defined as receiving a first injection of LEN PrEP and both oral doses on days 1 and 2. All participants will have the option to receive an Apple AirTag to enable directly observed therapy (DOT) for the second oral LEN dose and for follow-up LEN PrEP injections.
Aim 2. Evaluate LEN PrEP persistence through 52 weeks. Participants who initiate LEN PrEP will receive ongoing visits from the HHC mobile unit for HIV/STI testing every 3 months and HIV testing and LEN injections every 6 months. The study will estimate the share of initiators who receive LEN PrEP through week 52 ("persistence" defined as completing the third dose on-time [+/-14 days]). Surveys will be performed with all individuals who can be reached at 52 weeks (both persisters and non-persisters), to understand acceptability of mobile LEN PrEP, barriers to this care, and satisfaction with care.
Aim 3. Understand costs and sustainability of the mobile LEN PrEP delivery model. Costs will be collected from the health system perspective. The study will calculate the cost per person who initiates LEN PrEP, and cost per person persisting over 52 weeks.
The investigators will additionally perform in-depth interviews with stakeholders, including HHC leadership and van staff, public health leaders, and community leaders (n=25) to understand acceptability and feasibility of this model, and service- and system-level factors hypothesized to be associated with scalability and sustainability of the program.
- Conditions
- HIV Prevention
- Being tested
- Community-based healthcare delivery, Lenacapavir
- Keywords
- lenacapavir, community-based health delivery, HIV prevention, homelessness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community-based healthcare deliveryOther
This study evaluates the implementation strategy of community-based delivery of HIV biomedical prevention with lenacapavir.
LenacapavirDrug
Mobile, community-based delivery of lenacapavir
| Study group | Role | What they receive |
|---|---|---|
| Primary Cohort | Unstably housed adults without HIV being reached for healthcare by the UCLA Health Homeless Healthcare Collaborative Receives: Other: Community-based healthcare delivery; Drug: Lenacapavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months after enrollment
Secondary outcomes (5)
Predictors of uptake
Surveys will be performed at baseline to measure sociodemographic factors, HIV risk perception, PrEP knowledge, PrEP self-efficacy, and clinical factors.
Measured: 3 months after enrollment
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)
Measured: 52 weeks
Acceptability
Acceptability of the mobile delivery of LEN PrEP
Measured: 52 weeks
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.
Measured: 52 weeks
Costs of mobile delivery of LEN PrEP
Costs will be collected from the health system perspective. The study will calculate the cost per person who initiates LEN and cost per person persisting on LEN PrEP over 52 weeks, in a cost-outcome analysis.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start21 Apr 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Risa Hoffman, MD, MPH, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07467018
- Sponsor's protocol ID
- IN-US-974-7769
- Acronym
- MOVE-LA
- Status last verified
- Apr 2026
- First submitted
- 7 Mar 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Vehicle-Based Delivery of Lenacapavir Pre-Exposure Prophylaxis in Los Angeles County (MOVE-LA)
- ClinicalTrials.gov ID
- NCT07467018
- Acronym / sponsor ID
- MOVE-LA / IN-US-974-7769
- Conditions
- HIV Prevention
- Keywords
- lenacapavir, community-based health delivery, HIV prevention, homelessness
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 21 Apr 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Characterize uptake of LEN PrEP among unstably housed people in LAC receiving health services via HHC's mobile program.
- Evaluate how many study participants stay on LEN PrEP through 52 weeks.
- Understand costs, acceptability, and sustainability of the mobile LEN PrEP delivery model.
Detailed description
Access to HIV prevention services for unstably housed people in LAC has been limited due to barriers in seeking care at health facilities. Unstably housed people face barriers including competing life priorities (such as seeking food, shelter, and employment), low health literacy, particularly around HIV prevention, and comorbidities such as substance use and mental health disorders. A mobile healthcare service that offers LEN PrEP is ideal to help overcome these barriers by providing a low-complexity biomedical PrEP option in locations where unstably housed people congregate (i.e., shelters, encampments, community centers, and transitional housing facilities). The UCLA Health HHC was founded in January 2022 and currently operates six mobile vans, which deliver urgent care, primary care, behavioral health services, and medication-assisted treatment for substance use disorders. At least one mobile van is in the field offering services every day of the week, including weekends. The van is staffed by clinicians and community health workers, who link clients to social services. HHC recently began providing point-of-care HIV and sexually transmitted infection (STI) testing and is well-positioned to integrate LEN PrEP into their program.
Based on Andersen's behavioral model (3) and using Proctor et al's implementation outcomes (4), the investigators propose the following:
Aim 1. Characterize uptake of LEN PrEP among unstably housed people in LAC receiving health services via HHC's mobile program. People without HIV receiving health services via the HHC mobile unit (n=100) will be offered LEN PrEP. A baseline survey will be performed (sociodemographics, clinical information, HIV risk, PrEP knowledge, self-efficacy for health care, and acceptability of mobile PrEP offer). The primary outcome will be uptake, defined as receiving a first injection of LEN PrEP and both oral doses on days 1 and 2. All participants will have the option to receive an Apple AirTag to enable directly observed therapy (DOT) for the second oral LEN dose and for follow-up LEN PrEP injections.
Aim 2. Evaluate LEN PrEP persistence through 52 weeks. Participants who initiate LEN PrEP will receive ongoing visits from the HHC mobile unit for HIV/STI testing every 3 months and HIV testing and LEN injections every 6 months. The study will estimate the share of initiators who receive LEN PrEP through week 52 ("persistence" defined as completing the third dose on-time [+/-14 days]). Surveys will be performed with all individuals who can be reached at 52 weeks (both persisters and non-persisters), to understand acceptability of mobile LEN PrEP, barriers to this care, and satisfaction with care.
Aim 3. Understand costs and sustainability of the mobile LEN PrEP delivery model. Costs will be collected from the health system perspective. The study will calculate the cost per person who initiates LEN PrEP, and cost per person persisting over 52 weeks.
The investigators will additionally perform in-depth interviews with stakeholders, including HHC leadership and van staff, public health leaders, and community leaders (n=25) to understand acceptability and feasibility of this model, and service- and system-level factors hypothesized to be associated with scalability and sustainability of the program.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary Cohort | – | Other: Community-based healthcare delivery, Drug: LenacapavirUnstably housed adults without HIV being reached for healthcare by the UCLA Health Homeless Healthcare Collaborative |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community-based healthcare deliveryThis study evaluates the implementation strategy of community-based delivery of HIV biomedical prevention with lenacapavir. | Other | Primary Cohort |
| LenacapavirMobile, community-based delivery of lenacapavir | Drug | Primary Cohort |
Primary outcome
Uptake of LEN PrEP
Time frame: 3 months after enrollment
The primary outcome will be defined as receiving a first injection of LEN (along with both oral doses on days 1 and 2).
5 secondary outcomes
Predictors of uptake
Time frame: 3 months after enrollment
Persistence on LEN PrEP at 26 and 52 weeks [+/- 14 days])
Time frame: 52 weeks
Acceptability
Time frame: 52 weeks
Predictors of persistence
Time frame: 52 weeks
Costs of mobile delivery of LEN PrEP
Time frame: 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Prevention, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Risa Hoffman, MD, MPH (310-206-6766, rhoffman@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uptake of LEN PrEP (time frame: 3 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.