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

NCT ID: NCT05260047

Last Updated: 2025-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

525 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-20

Study Completion Date

2026-10-01

Brief Summary

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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

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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.

Conditions

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Substance Use Mental Health Issue Opioid Use Medication Assisted Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IMANI BREAKTHROUGH

Participants will participate in 24-week IMANI weekly groups

Group Type ACTIVE_COMPARATOR

IMANI

Intervention Type BEHAVIORAL

For the intervention, the study will introduce and offer Medication Assisted Treatment. Those participants wishing to receive MAT will be randomized to one of two intervention IMANI + church-based telehealth MAT or IMANI + Traditional MAT + Referral and Linkage. Those who do not wish to partake of MAT services will remain in the IMANI alone.

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

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.

Group Type EXPERIMENTAL

IMANI

Intervention Type BEHAVIORAL

For the intervention, the study will introduce and offer Medication Assisted Treatment. Those participants wishing to receive MAT will be randomized to one of two intervention IMANI + church-based telehealth MAT or IMANI + Traditional MAT + Referral and Linkage. Those who do not wish to partake of MAT services will remain in the IMANI alone.

Telehealth MAT

Intervention Type BEHAVIORAL

Describe what is the Telehealth MAT briefly

IMANI BREAKTHROUGH + 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.

Group Type EXPERIMENTAL

IMANI

Intervention Type BEHAVIORAL

For the intervention, the study will introduce and offer Medication Assisted Treatment. Those participants wishing to receive MAT will be randomized to one of two intervention IMANI + church-based telehealth MAT or IMANI + Traditional MAT + Referral and Linkage. Those who do not wish to partake of MAT services will remain in the IMANI alone.

Traditional MAT plus Referral and Linkage

Intervention Type BEHAVIORAL

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Interventions

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IMANI

For the intervention, the study will introduce and offer Medication Assisted Treatment. Those participants wishing to receive MAT will be randomized to one of two intervention IMANI + church-based telehealth MAT or IMANI + Traditional MAT + Referral and Linkage. Those who do not wish to partake of MAT services will remain in the IMANI alone.

Intervention Type BEHAVIORAL

Telehealth MAT

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Intervention Type BEHAVIORAL

Traditional MAT plus Referral and Linkage

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Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chyrell Bellamy, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Ayana Jordan, PhD.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Mount Aery Baptist Church

Bridgeport, Connecticut, United States

Site Status NOT_YET_RECRUITING

Principe of Peace Church

Bridgeport, Connecticut, United States

Site Status NOT_YET_RECRUITING

Blackwell Memorial AME Church

Hartford, Connecticut, United States

Site Status NOT_YET_RECRUITING

Iglesia Nuevo Comienzo

Hartford, Connecticut, United States

Site Status RECRUITING

Spottswood AME

New Britain, Connecticut, United States

Site Status RECRUITING

Varick Memorial AME Church

New Haven, Connecticut, United States

Site Status RECRUITING

Yale Program for Recovery and Community Health

New Haven, Connecticut, United States

Site Status NOT_YET_RECRUITING

Casa de Oracion y Adoracion

New Haven, Connecticut, United States

Site Status NOT_YET_RECRUITING

Countries

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United States

Central Contacts

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Kimberly D Blackman, BA

Role: CONTACT

2037648694

Luz S Ocasio

Role: CONTACT

2037648692

Facility Contacts

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Anthony Bennett

Role: primary

203-334-2757

Moises Mercedes

Role: primary

203-330-9135

Robyn Anderson

Role: primary

860-242-9859

Amarillys Castro

Role: primary

860-461-1187

Johnathon Counts, Pastor

Role: primary

860-223-8554

Kelcy G Steele

Role: primary

203-624-6245

Kimberly D Blackman, BSW

Role: primary

203-764-8694

Luz S Ocasio

Role: backup

203-764-8692

Hector Caraballo

Role: primary

203-498-1461

Other Identifiers

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1U01OD033241-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000031168

Identifier Type: -

Identifier Source: org_study_id

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