Optimizing a Bio-behavioral Intervention for Sustained Viral Suppression

NCT05377463 | Recruiting DMC

• 1 other identifier: 1780619-1
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

HIV viral suppression

Outcome Measures

Primary Outcomes (3)

• Achievement of Viral Suppression

  Viral suppression is defined as a laboratory test result showing HIV viral load as less than 400 copies per mL. To meet our definition of achieved viral suppression, viral load must be below 400 copiers per mL at 6-month follow-up.

  Viral load below or above 400 copiers per mL at the 6-month follow-up assessment

• Viral Suppression at 9-month follow-up

  Viral suppression is defined as a laboratory test result showing HIV viral load as less than 400 copies per mL. To meet our definition of viral suppression, viral load must be below 400 copiers per mL at 6-month follow-up.

  Viral load below or above 400 copiers per mL at the 9-month follow-up assessment

• Viral Suppression at 12-month follow-up

  Viral suppression is defined as a laboratory test result showing HIV viral load as less than 400 copies per mL. To meet our definition of viral suppression, viral load must be below 400 copiers per mL.

  Viral load below or above 400 copiers per mL at the 12-month follow-up assessment

Secondary Outcomes (13)

• Drug use

  3-,6-,9-, and 12-month follow-up assessments

• Methadone uptake and persistence

  3-,6-,9-, and 12-month follow-up assessments

• Drug use frequency and severity of withdrawal and cravings

  3-,6-,9-, and 12-month follow-up assessments

• Depressive Symptoms (Clinician-assisted rating)

  3-,6-,9-, and 12-month follow-up assessments

• Depressive Symptoms (Self-report)

  3-,6-,9-, and 12-month follow-up assessments

Study Arms (4)

Condition 1: Component 1

EXPERIMENTAL

1\) Peer-Support for Medication-Assisted Treatment

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

Condition 2: Component 2

EXPERIMENTAL

2\) Behavioral Activation Therapy

Behavioral: Behavioral Activation Treatment (BAT) to reduce depression

Condition 3: Components 1 and 2

EXPERIMENTAL

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

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

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.

Behavioral: No Intervention Components

Interventions

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

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.

Condition 1: Component 1; Condition 3: Components 1 and 2

Behavioral Activation Treatment (BAT) to reduce depression BEHAVIORAL

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.

Condition 2: Component 2; Condition 3: Components 1 and 2

No Intervention Components BEHAVIORAL

Participants not assigned to components 1 and 2

Condition 4: No Components

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas, El Paso: lead
• University of California, San Francisco: collaborator
• Centro de Integracion Juvenil: collaborator
• El Centro Ambulatorio para la Prevención y Atención en SIDA e Infecciones de Transmisión Sexual: collaborator

Study Sites (1)

Programa Compañeros

Ciudad Juárez, Chihuahua, 32330, Mexico

RECRUITING

Related Publications (1)

• Sauceda JA, Lechuga J, Ramos ME, Puentes J, Ludwig-Barron N, Salazar J, Christopoulos KA, Johnson MO, Gomez D, Covarrubias R, Hernandez J, Montelongo D, Ortiz A, Rojas J, Ramos L, Avila I, Gwadz MV, Neilands TB. A factorial experiment grounded in the multiphase optimization strategy to promote viral suppression among people who inject drugs on the Texas-Mexico border: a study protocol. BMC Public Health. 2023 Feb 10;23(1):307. doi: 10.1186/s12889-023-15172-2.

  PMID: 36765309 DERIVED

MeSH Terms

Interventions

glycine N-choloyltransferase

Study Officials

• Julia Lechuga

  The University of Texas at El Paso

  PRINCIPAL INVESTIGATOR

• John A Sauceda

  The University of California San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia Lechuga, PhD

CONTACT

915-747-7221; julialec@utep.edu

John A Sauceda, PhD

CONTACT

415-502-1000; john.sauceda@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessors will be blind to the experimental condition that the participant was assigned to.
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The factorial experiment is guided by the Multiphase Optimization Strategy (MOST). The 2 intervention components are: Component 1. Peer recovery coaching to promote uptake and persistence of medication assisted treatment in the form of methadone. Component 2. Behavioral activation therapy to reduce depression. Participants will be randomly assigned to receive a total of 0 or up to 2 components. There are 4 conditions because there are 4 possible combinations of the 2 components (e.g., Condition 1 = Delivery of 1 whereas Condition 3 = Delivery of 1 and 2). All participants will receive a standard of care package which will consist of referral and patient navigation to HIV treatment services, linkage to a peer support group, and harm reduction education and materials.

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: May 17, 2022
• Study Start: May 10, 2023
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: September 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: The data will be made available as soon as possible but no later than within one year of the completion of the funded project period or upon acceptance of the data for publication, whichever is earlier.
• Access Criteria: Directions for requesting the dataset will be available at the official study website, which is to be developed. This information will be found in all publications and conference abstract presentations. An individual participant data statement noting steps to access the data is to be developed.

Locations

ME (1)