Culturally Responsive Community Driven Substance Use Recovery for Black and Latinx Population (IMANI U)

Yale University

Status: Enrolling

Conditions: Substance Use; Mental Health Issue; Medication Assisted Treatment; Opioid Use

Treatments: Behavioral: IMANI; Behavioral: Telehealth MAT; Behavioral: Traditional MAT plus Referral and Linkage

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05260047

1U01OD033241-01 (U.S. NIH Grant/Contract)

2000031168

Details and patient eligibility

About

The main goal of this current study is to develop and optimize methods for increasing access to, uptake of, and engagement in MAT (Medication Assisted Treatment) among communities of color.

Full description

The main goal of this current study is to develop and optimize methods for increasing access to, uptake of, and engagement in MAT (Medication Assisted Treatment) among communities in geographical areas with high overdose cases. Through a multilevel Community Based Participatory Research initiative and a rigorous RCT that incorporates elements of choice in participation, the study will examine whether adding a church-based telehealth MAT option to Imani (Imani + CTM) will improve outcomes for people who reside in geographical areas with high overdose rates with Alcohol Use Disorder or Opioid Use Disorder)compared to Imani + Traditional MAT Referral and Linkage (Imani + Traditional MAT R&L) in the community. Individuals who do not choose to engage in MAT will continue in the Imani group program as usual. Imani (meaning Faith in Swahili) Breakthrough was developed in 2017 through a community based participatory research process. Imani Breakthrough is a faith-based, person-centered, culturally informed harm reduction recovery program that takes place churches in the community in geographical areas with high overdose rates. This program provides an innovative approach to engaging vulnerable groups into Substance Use Disorder treatment by focusing on SAMHSA's 8 dimensions of wellness (social determinants of health), 7 domains of citizenship, culturally informed education, and referral to Medication Assisted Treatment defined as any Food and Drug Administration approved pharmacotherapy for treating Substance Use Disorder. The Community Based Participatory Research process, which incorporates learning from and partnering with the church and larger community (including providers and policymakers), aims to increase the community's understanding of Alcohol Use Disorder and Opioid Use Disorder, tackle Medication Assisted Treatment misconceptions, optimize IMANI implementation, and establish policy recommendations for the healthcare systems to better serve people with Substance Use Disorder.

The specific aims are:

Specific Aim 1: To evaluate the impact of Imani + a church-based telehealth Medicine Assisted Treatment option (Imani + CTM) compared to Imani + Traditional MAT referral and linkage option (Imani + MAT R&L) on medication for addiction treatment initiation and engagement.

Specific Aim 2: To assess whether there are changes in substance use over time for Imani+ CTM compared to Imani + Traditional MAT R&L.

Specific Aim 3: To evaluate potential mediators and moderators (e.g., choice, SDOH) of improvements in primary SUD outcomes (initiation, engagement, and decreased substance use).

Exploratory Aim 1: To assess differences in the 7 domains of citizenship and 8 dimensions of wellness (social determinants of health) comparing those enrolled in a MAT condition to those NOT enrolled in a MAT condition.

Enrollment: 525 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants must meet criteria for a DSM-5 Alcohol Use Disorder and/or Opioid Use Disorder and are currently using alcohol and/or other opioids within the last 28 days.
• Are interested in reducing substance use.
• Self-identify as living in a geographical area with high overdose case rates

Exclusion criteria

• Participants who do not sign informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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525 participants in 3 patient groups

IMANI BREAKTHROUGH

Active Comparator group

Description:

Participants will participate in 24-week IMANI weekly groups

Treatment:

Behavioral: IMANI

IMANI BREAKTROUGH + church-based telehealth MAT option (IMANI + CTM)

Experimental group

Description:

Participants will participate in the 24-week Imani weekly group. During weeks 1-4 participants will received education on MAT. Those participants randomized will receive the IMANI weekly group as well as a church based telehealth Medication Assisted Treatment option. The church based telehealth MAT will consist of participants assigned to receive MAT from addiction treatment providers via telehealth. Telehealth sessions will be provided in the church.

Treatment:

Behavioral: Telehealth MAT

Behavioral: IMANI

IMANI BREAKTHROUGH + Traditional MAT plus Referral and Linkage

Experimental group

Description:

Participants will participate in the 24-week Imani weekly group. During weeks 1-4 participants will received education on MAT. Those participants randomized will receive the IMANI weekly group as well as Traditional MAT services with Referral and Linkage to services. Participants in this arm will be provided a list of referrals and links to community MAT providers. They will choose their providers.

Treatment:

Behavioral: Traditional MAT plus Referral and Linkage

Behavioral: IMANI