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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Mexico
Programa Compañeros
RECRUITING
Ciudad Juárez
Contact Information
Primary
Julia Lechuga, PhD
julialec@utep.edu
915-747-7221
Backup
John A Sauceda, PhD
john.sauceda@ucsf.edu
415-502-1000
Time Frame
Start Date: 2023-05-10
Estimated Completion Date: 2026-07-31
Participants
Target number of participants: 220
Treatments
Experimental: Condition 1: Component 1
1\) Peer-Support for Medication-Assisted Treatment
Experimental: Condition 2: Component 2
2\) Behavioral Activation Therapy
Experimental: Condition 3: Components 1 and 2
Participants assigned to a combination of:~1. Peer-Support for Medication-Assisted Treatment~2. Behavioral Activation Therap
Experimental: Condition 4: No Components
Participants not assigned to any of the 2 components. They are placed on a wait list and will receive components after the primary data collection period.
Related Therapeutic Areas
Sponsors
Collaborators: Centro de Integracion Juvenil, University of California, San Francisco, El Centro Ambulatorio para la Prevención y Atención en SIDA e Infecciones de Transmisión Sexual
Leads: University of Texas, El Paso

This content was sourced from clinicaltrials.gov