Optimizing a Bio-behavioral Intervention for Sustained Viral Suppression

The University of Texas System (UT)

Status: Enrolling

Conditions: HIV Viremia

Treatments: Behavioral: Behavioral Activation Treatment (BAT) to reduce depression; Behavioral: No Intervention Components; Behavioral: Peer support to promote uptake and persistence of medication assisted treatment (MAT)

Study type: Interventional

Funder types: Other

Identifiers

NCT05377463

1780619-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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220 participants in 4 patient groups

Condition 1: Component 1

Experimental group

Description:

1) Peer-Support for Medication-Assisted Treatment

Treatment:

Behavioral: Peer support to promote uptake and persistence of medication assisted treatment (MAT)

Condition 2: Component 2

Experimental group

Description:

2) Behavioral Activation Therapy

Treatment:

Behavioral: Behavioral Activation Treatment (BAT) to reduce depression

Condition 3: Components 1 and 2

Experimental group

Description:

Participants assigned to a combination of: 1. Peer-Support for Medication-Assisted Treatment 2. Behavioral Activation Therap

Treatment:

Behavioral: Peer support to promote uptake and persistence of medication assisted treatment (MAT)

Behavioral: Behavioral Activation Treatment (BAT) to reduce depression

Condition 4: No Components

Experimental group

Description:

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.

Treatment:

Behavioral: No Intervention Components