Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05377463

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

Led by University of Texas, El Paso · Updated on 2024-09-03

220

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Texas, El Paso

Lead Sponsor

U

University of California, San Francisco

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating two behavioral intervention components to find the best combination to help people who inject drugs achieve and maintain HIV viral load suppression. This study uses a 2x2 factorial design that tests whether receiving peer support for medication-assisted treatment (MAT) and/or behavioral activation therapy (BAT) for depression helps participants. The goal is to understand which combination most effectively supports sustained viral suppression among HIV-positive individuals who inject drugs. Participants are randomly assigned to one of four groups, representing all possible combinations of the two components: peer support only, BAT only, both, or neither. All participants receive patient navigation to support care engagement. The peer support involves informational sessions and ongoing support to promote MAT uptake and persistence over six months. The BAT intervention includes eight weekly sessions focusing on goal setting, engaging in positive activities, and managing barriers to those activities. Participants complete surveys at baseline and follow-up visits at 3, 6, 9, and 12 months to assess outcomes such as viral suppression, drug use, depression symptoms, and adherence to HIV treatment. Viral load is measured at 6, 9, and 12 months to determine sustained suppression. Researchers also track methadone uptake, withdrawal severity, HIV care retention, and engagement barriers. The study includes ongoing monitoring and assessments to understand the effects of the interventions over a year.

CONDITIONS

Brief Title

Optimizing a Bio-behavioral Intervention for Sustained Viral Suppression

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Be at least 18 years old
  • Able to provide informed consent
  • Eligible to receive free HIV care services in Mexico
  • HIV positive
  • Injected drugs in the last 30 days
  • Not currently on methadone replacement therapy
  • Willing to discuss medication-assisted treatment (MAT) uptake with a peer
  • Signed medical release form to allow medical data collection
  • Agree to provide locator information for follow-up
  • Agree to return for follow-up visits
  • Able to communicate in Spanish
  • Screen positive for depression on the PHQ-2
  • No plans to move outside the study area in the next 12 months
  • Meet at least one of the following regarding ART or viral load:
    1. Not currently possessing ART or not taking ART but prescribed
    2. Sub-optimal ART adherence with at least one 4-day treatment interruption in past 90 days
    3. Sub-optimal retention in HIV care with 2 or more missed clinic appointments in last 9 months
    4. No viral load test in past 6 months
    5. Self-reports detectable viral load within past 6 months
Not Eligible

You will not qualify if you...

  • Has not injected drugs in the last 30 days or lacks verifiable opioid use disorder
  • Not HIV positive
  • Receiving methadone treatment
  • Unwilling to discuss methadone uptake with a peer
  • Does not screen positive for depression
  • Unable to provide informed consent
  • Does not speak Spanish
  • Plans to move out of the city
  • Not eligible to receive free HIV care services in Mexico
  • Shows psychological disturbance or severe cognitive impairment limiting understanding of study procedures as determined by staff

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 6 months

Participants complete a baseline survey and are assigned to receive one or both behavioral intervention components, or no intervention. Components include peer support for medication-assisted treatment over 6 months and/or behavioral activation therapy with weekly sessions.

Weekly visits for the Behavioral Activation Therapy sessions and ongoing contact for peer support within the first 6 months

Follow-up

Duration - Up to 12 months from baseline

Participants complete follow-up assessments to measure viral suppression and other behavioral and clinical outcomes at multiple time points after treatment ends.

Follow-up assessments at 3, 6, 9, and 12 months post-baseline

Trial Site Locations

Total: 1 location

1

Programa Compañeros

Ciudad Juárez, Chihuahua, Mexico, 32330

Actively Recruiting

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Research Team

J

Julia Lechuga, PhD

J

John A Sauceda, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

4

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Published Research Related To This Trial

A factorial experiment grounded in the multiphase optimization strategy to promote viral suppression among people who inject drugs on the Texas-Mexico border: a study protocol.

John A Sauceda, Julia Lechuga, Maria Elena Ramos...

https://pubmed.ncbi.nlm.nih.gov/36765309