Optimizing a Bio-behavioral Intervention for Sustained Viral Suppression

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.

Conditions

• HIV Viremia

Interventions

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

Sponsors & Collaborators

• University of California, San Francisco

  collaborator OTHER

• Centro de Integracion Juvenil

  collaborator UNKNOWN

• El Centro Ambulatorio para la Prevención y Atención en SIDA e Infecciones de Transmisión Sexual

  collaborator UNKNOWN

• University of Texas, El Paso

  lead OTHER

Principal Investigators

• Julia Lechuga · The University of Texas at El Paso

• John A Sauceda · The University of California San Francisco

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-05-10

Primary Completion

2026-07-31

Completion

2026-07-31

Countries

• Mexico

Study Locations