Recruiting

HIV Prevention

Sponsor:

American University

Code:

NCT07834853

Conditions

HIV Infections

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Camino Intervention

Study Details

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.

Conditions

HIV Infections

Study ID

NCT07834853

Start date

Jul 16, 2026

Status verified date

Sep, 2026

Completion date

Feb, 2029

Anticipated

Primary completion date

Feb, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Camino Intervention

Participants 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 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 measure

  • HIV testing within the past 6 months [ Time Frame: 18 months ]
  • PrEP Uptake [ Time Frame: 18 months ]
  • HIV Care Visit Attendance [ Time Frame: 18 months ]
  • Antiretroviral Therapy Adherence [ Time Frame: 18 months ]
  • HIV Viral Load [ Time Frame: 18 months ]

Central Contacts and Locations

Locations

La Clínica del Pueblo

Recruiting

Washington D.C., District of Columbia, United States, 20009

Contacts

Angela Suarez

(202) 462-4788asuarez@lcdp.org

More Information

Sponsor

American University

Last update posted

Sep 22, 2026

Last verified

Sep, 2026

Keywords

  • HIV prevention
  • HIV care
  • Pre-exposure prophylaxis (PrEP)
  • Peer navigation
  • Legal services
  • Latin Americans
  • Medical-legal partnership

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by American University on 2026-09-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.