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NCT Number: NCT07834853

El Camino HIV Prevention and Care Study

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Oasis Legal Services, Berkeley, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Camino Intervention

Behavioral

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 outcomes

  1. 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.

  2. 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.

  3. HIV Care Visit Attendance

    Time frame: 18 months

    Medical records will be used to assess HIV care visit attendance among participants living with HIV.

  4. 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.

  5. HIV Viral Load

    Time frame: 18 months

    Medical records will be used to assess HIV viral load among participants living with HIV.

Sponsors and collaborators

Lead sponsor

American University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Evaluating the Camino Intervention to Reduce HIV Risk and Poor Care Outcomes Among Latin Americans

Acronym: El Camino

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Sep 22, 2026
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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