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

June 20, 2025 updated by: Yale University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Estimated)

525

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Connecticut
      • Bridgeport, Connecticut, United States, 06604
        • Not yet recruiting
        • Mount Aery Baptist Church
        • Contact:
          • Anthony Bennett
          • Phone Number: 203-334-2757
      • Bridgeport, Connecticut, United States, 06605
        • Not yet recruiting
        • Principe of Peace Church
        • Contact:
      • Hartford, Connecticut, United States, 06002
        • Not yet recruiting
        • Blackwell Memorial AME Church
        • Contact:
          • Robyn Anderson
          • Phone Number: 860-242-9859
      • Hartford, Connecticut, United States, 06602
      • New Britain, Connecticut, United States, 06053
      • New Haven, Connecticut, United States, 06511
        • Recruiting
        • Varick Memorial AME Church
        • Contact:
          • Kelcy G Steele
          • Phone Number: 203-624-6245
      • New Haven, Connecticut, United States, 06513
        • Not yet recruiting
        • Yale Program for Recovery and Community Health
        • Contact:
        • Contact:
      • New Haven, Connecticut, United States, 06519
        • Not yet recruiting
        • Casa de Oracion y Adoracion
        • Contact:
          • Hector Caraballo
          • Phone Number: 203-498-1461

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: IMANI BREAKTHROUGH
Participants will participate in 24-week IMANI weekly groups
Behavioral: 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.
Experimental: 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.
Behavioral: 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.
Behavioral: Telehealth MAT
Describe what is the Telehealth MAT briefly
Experimental: 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.
Behavioral: 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.
Behavioral: Traditional MAT plus Referral and Linkage
Describe what he traditional MAT plus referral and linkage briefly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall attendance of program
Time Frame: Up to 24 weeks
The total number of sessions that participants attend will be used to measure continuation of program.
Up to 24 weeks
Overall treatment adherence
Time Frame: Baseline
The number of participants that adhere to treatments will be measured using self-report at three time points.
Baseline
Overall treatment adherence
Time Frame: 6-month
The number of participants that adhere to treatments will be measured using self-report at three time points.
6-month
Overall treatment adherence
Time Frame: 12-month
The number of participants that adhere to treatments will be measured using self-report at three time points.
12-month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in substance abuse
Time Frame: Weekly for 24 weeks
Using urine toxicology strips the research staff will test the weekly urine provided by all participants for drugs use.
Weekly for 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Chyrell Bellamy, Ph.D., Yale University
  • Principal Investigator: Ayana Jordan, PhD., Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2022

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

February 11, 2022

First Submitted That Met QC Criteria

February 28, 2022

First Posted (Actual)

March 2, 2022

Study Record Updates

Last Update Posted (Actual)

June 26, 2025

Last Update Submitted That Met QC Criteria

June 20, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000031168
  • 1U01OD033241-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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