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

Primary Purpose

Substance Use, Mental Health Issue, Opioid Use

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IMANI
Telehealth MAT
Traditional MAT plus Referral and Linkage
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Mount Aery Baptist Church
  • Principe of Peace Church
  • Blackwell Memorial AME Church
  • Iglesia Nuevo ComienzoRecruiting
  • Varick Memorial AME ChurchRecruiting
  • Yale Program for Recovery and Community Health
  • Casa de Oracion y Adoracion

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

IMANI BREAKTHROUGH

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

IMANI BREAKTHROUGH + Traditional MAT plus Referral and Linkage

Arm Description

Participants will participate in 24-week IMANI weekly groups

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.

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.

Outcomes

Primary Outcome Measures

Overall attendance of program
The total number of sessions that participants attend will be used to measure continuation of program.
Overall treatment adherence
The number of participants that adhere to treatments will be measured using self-report at three time points.
Overall treatment adherence
The number of participants that adhere to treatments will be measured using self-report at three time points.
Overall treatment adherence
The number of participants that adhere to treatments will be measured using self-report at three time points.

Secondary Outcome Measures

Change in substance abuse
Using urine toxicology strips the research staff will test the weekly urine provided by all participants for drugs use.

Full Information

First Posted
February 11, 2022
Last Updated
October 11, 2023
Sponsor
Yale University
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT05260047
Brief Title
Culturally Responsive Community Driven Substance Use Recovery for Black and Latinx Population
Acronym
IMANI U
Official Title
Culturally Responsive Community Driven Substance Use Recovery for Black and Latinx Population
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 11, 2022 (Actual)
Primary Completion Date
October 1, 2026 (Anticipated)
Study Completion Date
October 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use, Mental Health Issue, Opioid Use, Medication Assisted Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
525 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IMANI BREAKTHROUGH
Arm Type
Active Comparator
Arm Description
Participants will participate in 24-week IMANI weekly groups
Arm Title
IMANI BREAKTROUGH + church-based telehealth MAT option (IMANI + CTM)
Arm Type
Experimental
Arm Description
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.
Arm Title
IMANI BREAKTHROUGH + Traditional MAT plus Referral and Linkage
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
IMANI
Intervention Description
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
Intervention Name(s)
Telehealth MAT
Intervention Description
Describe what is the Telehealth MAT briefly
Intervention Type
Behavioral
Intervention Name(s)
Traditional MAT plus Referral and Linkage
Intervention Description
Describe what he traditional MAT plus referral and linkage briefly
Primary Outcome Measure Information:
Title
Overall attendance of program
Description
The total number of sessions that participants attend will be used to measure continuation of program.
Time Frame
Up to 24 weeks
Title
Overall treatment adherence
Description
The number of participants that adhere to treatments will be measured using self-report at three time points.
Time Frame
Baseline
Title
Overall treatment adherence
Description
The number of participants that adhere to treatments will be measured using self-report at three time points.
Time Frame
6-month
Title
Overall treatment adherence
Description
The number of participants that adhere to treatments will be measured using self-report at three time points.
Time Frame
12-month
Secondary Outcome Measure Information:
Title
Change in substance abuse
Description
Using urine toxicology strips the research staff will test the weekly urine provided by all participants for drugs use.
Time Frame
Weekly for 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kimberly D Blackman, BA
Phone
2037648694
Email
Kimberly.blackman@yale.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Luz S Ocasio
Phone
2037648692
Email
luz.ocasio@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chyrell Bellamy, Ph.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ayana Jordan, PhD.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Aery Baptist Church
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06604
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Bennett
Phone
203-334-2757
Facility Name
Principe of Peace Church
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06605
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moises Mercedes
Phone
203-330-9135
Email
drmoisesmercedes@gmail.com
Facility Name
Blackwell Memorial AME Church
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06002
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robyn Anderson
Phone
860-242-9859
Facility Name
Iglesia Nuevo Comienzo
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06602
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amarillys Castro
Phone
860-461-1187
Email
iarnuevocomienzo.ct@gmail.com
Facility Name
Varick Memorial AME Church
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelcy G Steele
Phone
203-624-6245
Facility Name
Yale Program for Recovery and Community Health
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06513
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kimberly D Blackman, BSW
Phone
203-764-8694
Email
Kimberly.blackman@yale.edu
First Name & Middle Initial & Last Name & Degree
Luz S Ocasio
Phone
203-764-8692
Email
luz.ocasio@yale.edu
Facility Name
Casa de Oracion y Adoracion
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hector Caraballo
Phone
203-498-1461

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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