El Camino HIV Prevention and Care Study

NCT07834853 — Not applicable, Recruiting, 50 participants, American University

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

RegistryNCT07834853, acronym El Camino
StatusRecruiting
PhaseNot applicable
Study typeInterventional; na, sequential, masking: none, prevention
Enrollment50 (Estimated)
SponsorAmerican University (Other); collaborators: National Institute of Mental Health (NIMH)
ConditionsHIV Infections
InterventionsCamino Intervention (Behavioral)
Datesstart 2026-07-16, primary completion 2029-02-01 (estimated), completion 2029-02-01 (estimated), first posted 2026-09-22, last updated 2026-09-22
Locations2 sites in United States

Related Papers Related Patents Related Grants Related Experts
All trials for HIV Infections All trials of Camino Intervention

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Camino InterventionExperimentalBehavioral: Camino InterventionParticipants 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.
  • 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.

+Outcome measures

Primary outcomes

  • HIV testing within the past 6 months [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 [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 [18 months]: Medical records will be used to assess HIV care visit attendance among participants living with HIV.
  • Antiretroviral Therapy Adherence [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 [18 months]: Medical records will be used to assess HIV viral load among participants living with HIV.

+Eligibility

Sex: Male, ages: 18 Years to any

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

+Locations (2)

FacilityCityCountryStatus
Oasis Legal ServicesBerkeley, CaliforniaUnited StatesNot yet recruiting
La ClĂ­nica del PuebloWashington D.C., District of ColumbiaUnited StatesRecruiting

+Investigators

+Funding

NIH grants: R34MH140638