NCT07834853 · American University
El Camino HIV Prevention and Care Study
(El Camino)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Camino Intervention
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.
Primary outcome measures
HIV testing within the past 6 months
Time frame: 18 months
Survey data and medical records will be used to assess HIV testing within the past 6 months among participants not living with HIV.
PrEP Uptake
Time frame: 18 months
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.
HIV Care Visit Attendance
Time frame: 18 months
Medical records will be used to assess HIV care visit attendance among participants living with HIV.
Antiretroviral Therapy Adherence
Time frame: 18 months
Medical records and survey data will be used to assess adherence to antiretroviral therapy (ART) among participants living with HIV who are prescribed ART.
HIV Viral Load
Time frame: 18 months
Medical records will be used to assess HIV viral load among participants living with HIV.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- Younger than 18 years
- Does not meet the inclusion criteria above
Where
- Berkeley, California
- Washington D.C., District of Columbia
Collaborators
National Institute of Mental Health (NIMH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 22, 2026 · Source of record for eligibility and locations