Clinical trial NCT05260047: Culturally Responsive Community Driven Substance Use Recovery for Black and Latinx Population
Official title: Culturally Responsive Community Driven Substance Use Recovery for Black and Latinx Population
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Substance Use
Mental Health Issue
Opioid Use
Medication Assisted Treatment
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2022-03-02
Enrollment: 525
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall attendance of program
timeFrame: Up to 24 weeks
measure: Overall treatment adherence
timeFrame: Baseline
measure: Overall treatment adherence
timeFrame: 6-month
measure: Overall treatment adherence
timeFrame: 12-month
Secondary outcomes:
measure: Change in substance abuse
timeFrame: Weekly for 24 weeks
Other outcomes:
Locations:
city: Bridgeport
country: United States
facility: Mount Aery Baptist Church
state: Connecticut
city: Bridgeport
country: United States
facility: Principe of Peace Church
state: Connecticut
city: Hartford
country: United States
facility: Blackwell Memorial AME Church
state: Connecticut
city: Hartford
country: United States
facility: Iglesia Nuevo Comienzo
state: Connecticut
city: New Haven
country: United States
facility: Varick Memorial AME Church
state: Connecticut
city: New Haven
country: United States
facility: Yale Program for Recovery and Community Health
state: Connecticut
city: New Haven
country: United States
facility: Casa de Oracion y Adoracion
state: Connecticut
Study officials:
affiliation: Yale University
name: Chyrell Bellamy, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Ayana Jordan, PhD.
role: PRINCIPAL_INVESTIGATOR
References: