Culturally Responsive Community Driven Substance Use Recovery for Black and Latinx Population

Not Applicable

Recruiting

• Conditions: Substance Use; Mental Health Issue; Medication Assisted Treatment; Opioid Use
• Interventions: Behavioral: IMANI; Behavioral: Telehealth MAT; Behavioral: Traditional MAT plus Referral and Linkage

• Registration Number: NCT05260047
• Lead Sponsor: Yale University

Brief Summary

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.

Detailed 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 of color. 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 Black and Latinx people 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 in Black and Latinx churches in the community. 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 Black and Latinx 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-02-11
• Study First Submitted QC: 2022-02-28
• Study First Posted: 2022-03-02
• Study Start: 2022-07-20
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-14
• Last Update Posted: 2024-05-16
• Primary Completion: 2026-10-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 525

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 30 days.
• Are interested in reducing substance use.
• Self-identify as Black or Latinx.

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Exclusion Criteria

• Participants who do not sign informed consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IMANI BREAKTHROUGH	IMANI	Participants will participate in 24-week IMANI weekly groups
IMANI BREAKTROUGH + church-based telehealth MAT option (IMANI + CTM)	Telehealth MAT	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.
IMANI BREAKTROUGH + church-based telehealth MAT option (IMANI + CTM)	IMANI	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.
IMANI BREAKTHROUGH + Traditional MAT plus Referral and Linkage	IMANI	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.
IMANI BREAKTHROUGH + Traditional MAT plus Referral and Linkage	Traditional MAT plus Referral and Linkage	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.

Primary Outcome Measures

Name	Time	Method
Overall attendance of program	Up to 24 weeks	The total number of sessions that participants attend will be used to measure continuation of program.
Overall treatment adherence	12-month	The number of participants that adhere to treatments will be measured using self-report at three time points.

Secondary Outcome Measures

Name	Time	Method
Change in substance abuse	Weekly for 24 weeks	Using urine toxicology strips the research staff will test the weekly urine provided by all participants for drugs use.

Trial Locations

Locations (7)

Mount Aery Baptist Church; 🇺🇸 Bridgeport, Connecticut, United States

Blackwell Memorial AME Church; 🇺🇸 Hartford, Connecticut, United States

Iglesia Nuevo Comienzo; 🇺🇸 Hartford, Connecticut, United States

Principe of Peace Church; 🇺🇸 Bridgeport, Connecticut, United States

Yale Program for Recovery and Community Health; 🇺🇸 New Haven, Connecticut, United States

Varick Memorial AME Church; 🇺🇸 New Haven, Connecticut, United States

Casa de Oracion y Adoracion; 🇺🇸 New Haven, Connecticut, United States