RecruitingNot ApplicableNCT05377463

Optimizing a Bio-behavioral Intervention for Sustained Viral Suppression

Optimizing a Bio-behavioral Intervention to Promote Viral Suppression Among HIV+ People Who Inject Drugs on the U.S.-Mexico Border


Sponsor

University of Texas, El Paso

Enrollment

220 participants

Start Date

May 10, 2023

Study Type

INTERVENTIONAL

Conditions

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 suppression. The study design is a 2-to-the-2 factorial experiment. The 2 represents the level of each component: 0 (receive) or 1 (don't receive). The 2 represents the number of components being tested. The four components are: 1) receiving (or not receiving) peer support services for medication-assisted treatment (MAT) uptake and persistence and 2) behavioral activation therapy for depression (BAT). Therefore, in order to test which combination of components produce the best outcome, this factorial design randomizes people to 1 of 4 conditions. Each condition represents a possible combination of the 2 components above. All participants will receive patient navigation for care engagement.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a program that combines counseling support and medication-assisted treatment to help people living with HIV who also use drugs to better stick to their HIV medications (antiretroviral therapy) and keep their viral levels undetectable. **You may be eligible if...** - You are 18 or older, living in Mexico - You are HIV positive and eligible for free HIV care - You have injected drugs in the past 30 days - You are not currently on methadone treatment - You screen positive for depression - You are willing to discuss medication-assisted treatment with a peer counselor - You speak Spanish and plan to stay in the area for the next 12 months - You are currently not taking HIV medication as prescribed **You may NOT be eligible if...** - You are currently on methadone replacement therapy - You do not speak Spanish - You plan to move out of the study area within the next year Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALPeer support to promote uptake and persistence of medication assisted treatment (MAT)

Participants will be assigned to receive peer support to promote uptake of MAT and persistence. This component will consist of two informational sessions, a tailored recovery plan, and on-going support from a peer for the first 6 months.

BEHAVIORALBehavioral Activation Treatment (BAT) to reduce depression

Participants will be assigned to receive BAT treatment for depression. This component will consist of 8 sessions where participants will identify short and long-term goals, values, and the activities unrelated to substance use that were previously enjoyed or are likely to increase a feeling of well-being. This intervention component focuses on making a plan to troubleshoot barriers to re-engage in these activities. Sessions are delivered weekly. The content includes psycho-education about what depression is, the intervention rationale, and the activities and monitoring of activities, building social contracts to engage networks, and discussion of potential barriers to following through with activities.

BEHAVIORALNo Intervention Components

Participants not assigned to components 1 and 2


Locations(1)

Programa Compañeros

Ciudad Juárez, Chihuahua, Mexico

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NCT05377463


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