Optimizing a behavioral intervention for HIV viral suppression

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

This study is testing different combinations of support and therapy to see which helps people who inject drugs keep their HIV viral load low over a year.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 220 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Texas, El Paso (other)
• Locations: 1 site (Ciudad Juárez, Chihuahua)
• Trial ID: NCT05377463 on ClinicalTrials.gov

What this trial studies

This study tests two behavioral intervention components to determine the best combination for helping people who inject drugs achieve and maintain HIV viral load suppression. Participants will be randomly assigned to one of four groups, each receiving different combinations of peer support services for medication-assisted treatment and behavioral activation therapy for depression. The primary goal is to assess sustained viral suppression through follow-up assessments over 12 months. The study also aims to explore mediators and moderators affecting the relationship between the interventions and viral suppression outcomes.

Who should consider this trial

Good fit: Ideal candidates are HIV-positive individuals aged 18 and older who have injected drugs in the last 30 days and are eligible for free HIV care services in Mexico.

Not a fit: Patients who are currently on methadone replacement therapy or do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly improve the ability of individuals with HIV who inject drugs to achieve and maintain viral suppression.

How similar studies have performed: Other studies have shown promise in using behavioral interventions for HIV management, but this specific factorial approach is relatively novel.

Eligibility criteria

Inclusion Criteria:

* 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:

  1. not currently in possession of ART or not taking ART but prescribed ART or
  2. sub-optimal ART adherence as at least one 4-day treatment interruption in the past 90 days or
  3. 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
  4. no viral load test done in the past six months or
  5. self-reports a detectable viral load within the past 6 months

Exclusion Criteria:

* 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

Where this trial is running

Ciudad Juárez, Chihuahua

• Programa Compañeros — Ciudad Juárez, Chihuahua, Mexico (RECRUITING)

Study contacts

• Principal investigator: Julia Lechuga — The University of Texas at El Paso
• Study coordinator: Julia Lechuga, PhD

Conditions: HIV Viremia, HIV viral suppression