El Camino HIV Prevention and Care Study
El Camino
Evaluating the Camino Intervention to Reduce HIV Risk and Poor Care Outcomes Among Latin Americans
1 other identifier
interventional
50
1 country
2
Brief Summary
The Camino Study evaluates a status-neutral, multi-level pilot intervention designed to improve HIV prevention and care engagement among Latin Americans with unmet HIV prevention and care needs. The intervention combines legal services with peer navigation to reduce fear of healthcare engagement, reduce stress, and improve access to HIV prevention and care services. The study will enroll 50 Latin American participants in the Washington, DC, and Oakland, California areas. Using a quasi-experimental wait-list control design, the study will compare HIV outcomes among participants who receive the Camino intervention with those on a rolling waitlist over 18 months. Primary outcomes include HIV testing within the past six months and uptake of pre-exposure prophylaxis (PrEP), as well as HIV care visit attendance, antiretroviral therapy (ART) adherence, and viral load among people living with HIV. The study will also examine legal, social, and mental health factors associated with HIV prevention and care engagement and assess the feasibility of testing the intervention at a larger scale.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hiv-infections
Started Jul 2026
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 16, 2026
CompletedFirst Submitted
Initial submission to the registry
September 17, 2026
CompletedFirst Posted
Study publicly available on registry
September 22, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2029
September 22, 2026
September 1, 2026
2.6 years
September 17, 2026
September 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
HIV testing within the past 6 months
Survey data and medical records will be used to assess HIV testing within the past 6 months among participants not living with HIV.
18 months
PrEP Uptake
Survey data and medical records will be used to assess initiation of pre-exposure prophylaxis (PrEP) among participants who are HIV-negative and eligible for PrEP.
18 months
HIV Care Visit Attendance
Medical records will be used to assess HIV care visit attendance among participants living with HIV.
18 months
Antiretroviral Therapy Adherence
Medical records and survey data will be used to assess adherence to antiretroviral therapy (ART) among participants living with HIV who are prescribed ART.
18 months
HIV Viral Load
Medical records will be used to assess HIV viral load among participants living with HIV.
18 months
Study Arms (1)
Camino Intervention
EXPERIMENTALParticipants receive the Camino intervention, which includes peer navigation to support engagement in HIV prevention and care and legal services. Peer navigation begins immediately after enrollment. Participants receive the individual legal consultation when an attorney becomes available; therefore, the timing of receipt of the legal consultation varies across participants. Participants are followed for 18 months.
Interventions
Camino is a multicomponent intervention designed to improve engagement in HIV prevention and care. Participants receive culturally and linguistically appropriate peer navigation beginning after enrollment to help identify and address barriers to HIV prevention and care and connect participants with relevant health and social services. The intervention also includes individualized consultation with an attorney and legal services and navigation. Because attorney availability varies, participants receive the individual legal consultation at different times during follow-up.
Eligibility Criteria
You may qualify if:
- Age 18 years or older
- Assigned male sex at birth
- Identifies as a Latin American man who has sex with men, transgender woman, or nonbinary person on the feminine spectrum
- Not a U.S. citizen
- Speaks Spanish or English
- Resides in the Washington, DC metropolitan area or San Francisco Bay Area
- Willing to receive health and/or supportive services through participating study partners
- Willing to allow the study to obtain relevant medical record information
- Meets one of the following HIV prevention or care criteria:
- Living with HIV and either not linked to HIV care, has missed an HIV care appointment within the past year, is not taking antiretroviral therapy (ART), or has a detectable viral load; or Not living with HIV, is sexually active, and is either not taking pre-exposure prophylaxis (PrEP) or has not received an HIV test within the past 6 months
You may not qualify if:
- Younger than 18 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- American Universitylead
- National Institute of Mental Health (NIMH)collaborator
Study Sites (2)
Oasis Legal Services
Berkeley, California, 94704, United States
La ClĂnica del Pueblo
Washington D.C., District of Columbia, 20009, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thespina J Yamanis, Ph.D., MPH
American University
- PRINCIPAL INVESTIGATOR
Erin Wilson, DrPH
San Francisco Department of Public Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2026
First Posted
September 22, 2026
Study Start
July 16, 2026
Primary Completion (Estimated)
February 1, 2029
Study Completion (Estimated)
February 1, 2029
Last Updated
September 22, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data and supporting documentation will be submitted and made available in accordance with NIMH Data Archive submission and sharing timelines and will remain available according to NDA policies.
- Access Criteria
- Data will be available through the NIMH Data Archive to authorized researchers who meet NDA access requirements. Researchers must submit a formal data access request and agree to NDA data use and confidentiality requirements.
De-identified individual participant data collected during the study will be shared through the NIMH Data Archive (NDA) for secondary research use in accordance with NIH and NIMH data-sharing requirements.