Status:
RECRUITING
Optimizing a Bio-behavioral Intervention for Sustained Viral Suppression
Lead Sponsor:
University of Texas, El Paso
Collaborating Sponsors:
University of California, San Francisco
Centro de Integracion Juvenil
Conditions:
HIV Viremia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study will test two behavioral intervention components to identify the combination of the two components that best supports people who inject drugs to achieve and sustain HIV viral load suppressio...
Detailed Description
Participants will be randomly assigned to one of 4 experimental conditions. Each condition will represents every possible combination of 2 components (e.g., 1 only, 2 only, 1-2, none). Participants co...
Eligibility Criteria
Inclusion
- be at least 18 years of age
- be able to provide informed consent
- be eligible to receive free HIV care services in Mexico
- be HIV positive
- have injected drugs in the last 30 days
- not be on methadone replacement therapy
- be willing to discuss MAT uptake with a peer
- sign a medical release form to have medical data abstracted
- agree to submit and describe locator information
- agree to return to follow-up visits
- able to communicate in Spanish
- screen positive for depression on the PHQ-2
- have no plans of moving outside the study area in the next 12-months
- meet one of the following:
- not currently in possession of ART or not taking ART but prescribed ART or
- sub-optimal ART adherence as at least one 4-day treatment interruption in the past 90 days or
- sub-optimal retention in HIV care - never engaged or disengaged from HIV care as 2 or more missed clinic appointments in the last 9 months or
- no viral load test done in the past six months or
- self-reports a detectable viral load within the past 6 months
Exclusion
- has not injected drugs in the last 30 days or do not have a verifiable opioid use disorder
- is not HIV positive
- is receiving methadone
- is unwilling to discuss methadone uptake with a peer
- does not screen positive for depression
- is not able to provide informed consent
- does not speak Spanish
- has plans to move out of the city
- does not qualify to receive free HIV care services in Mexico
- has an appearance of psychological disturbance or severe cognitive impairment that could limit understanding of study procedures as determined by study staff
Key Trial Info
Start Date :
May 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT05377463
Start Date
May 10 2023
End Date
July 31 2026
Last Update
September 3 2024
Active Locations (1)
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1
Programa Compañeros
Ciudad Juárez, Chihuahua, Mexico, 32330