Health TrialsbyHealthPanel

El Camino HIV Prevention and Care Study

ConditionHIV Infections
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorAmerican University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Younger than 18 years

Does not meet the inclusion criteria above

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Camino InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
18 months
2

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.

Time frame
18 months
3

HIV Care Visit Attendance

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

Time frame
18 months
4

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.

Time frame
18 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

American University

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov
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