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

Opioid Use Clinical Trial

— IMANI U  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05260047
• Other study ID #: 2000031168
• Secondary ID: 1U01OD033241-01
• Status: Recruiting
• Phase: N/A
• Start date: July 20, 2022
• Est. completion date: October 1, 2026

Study information

• Verified date: May 2024
• Source: Yale University
• Contact: Kimberly D Blackman, BA
• Phone: 2037648694
• Email: Kimberly.blackman[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 525
• Est. completion date: October 1, 2026
• Est. primary completion date: October 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Exclusion Criteria:

• Participants who do not sign informed consent

Related Conditions & MeSH terms

• Medication Assisted Treatment
• Mental Health Issue
• Opioid Use
• Substance Use
• Substance-Related Disorders

Intervention

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.
• Telehealth MAT
Describe what is the Telehealth MAT briefly
• Traditional MAT plus Referral and Linkage
Describe what he traditional MAT plus referral and linkage briefly

Locations

Country	Name	City	State
United States	Mount Aery Baptist Church	Bridgeport	Connecticut
United States	Principe of Peace Church	Bridgeport	Connecticut
United States	Blackwell Memorial AME Church	Hartford	Connecticut
United States	Iglesia Nuevo Comienzo	Hartford	Connecticut
United States	Casa de Oracion y Adoracion	New Haven	Connecticut
United States	Varick Memorial AME Church	New Haven	Connecticut
United States	Yale Program for Recovery and Community Health	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall attendance of program	The total number of sessions that participants attend will be used to measure continuation of program.	Up to 24 weeks
Primary	Overall treatment adherence	The number of participants that adhere to treatments will be measured using self-report at three time points.	Baseline
Primary	Overall treatment adherence	The number of participants that adhere to treatments will be measured using self-report at three time points.	6-month
Primary	Overall treatment adherence	The number of participants that adhere to treatments will be measured using self-report at three time points.	12-month
Secondary	Change in substance abuse	Using urine toxicology strips the research staff will test the weekly urine provided by all participants for drugs use.	Weekly for 24 weeks