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
AI-Summary
Brief Title
Who Can Participate
AI-Screening
Your Study Journey
Trial Site Locations
Research Team
How is the study designed?
Similar Trials
Frequently Asked Questions
Research Publications
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
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:
Not currently possessing ART or not taking ART but prescribed
Sub-optimal ART adherence with at least one 4-day treatment interruption in past 90 days
Sub-optimal retention in HIV care with 2 or more missed clinic appointments in last 9 months
No viral load test in past 6 months
Self-reports detectable viral load within past 6 months
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
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
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...