NCT05377463

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: University of Texas, El Paso · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Participants will be randomly assigned to one of 4 experimental conditions. Each condition will represents every possible combination of 2 components (e.g., 1 only, 2 only, 1-2, none). Participants complete a survey assessment at baseline, complete their assigned intervention components, and then return to complete follow-up assessment surveys at 3-, 6-,9-, and 12-months. The primary outcome is sustained viral suppression defined as viral load test results of \<400 copies per mL on all 6-,9-, and 12-month follow-up visits. Results of Aim 1 will yield estimates of the unique impact of each intervention component, as well as each combination of components, on sustained viral suppression. The research team and partners will make decisions about what constitutes the optimized intervention by judging the observed effect sizes and statistical significance against real-world constraints that go into the delivery of the interventions. The secondary aims are to test mediators to explain component 1-2 and its relationship to viral suppression. We will also test moderators of these relationship between each component and outcome of viral suppression.

Conditions

• HIV Viremia

Interventions

Type	Name	Description
BEHAVIORAL	Peer 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.
BEHAVIORAL	Behavioral 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.
BEHAVIORAL	No Intervention Components	Participants not assigned to components 1 and 2

Timeline

• Start date: 2023-05-10
• Primary completion: 2026-07-31
• Completion: 2026-07-31
• First posted: 2022-05-17
• Last updated: 2024-09-03

Locations

1 site across 1 country: Mexico