NCT05260047

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
525

participants targeted

Target at P75+ for not_applicable

Timeline
5mo left

Started Jul 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

8 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress90%
Jul 2022Oct 2026

First Submitted

Initial submission to the registry

February 11, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

July 20, 2022

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

June 26, 2025

Status Verified

June 1, 2025

Enrollment Period

4.2 years

First QC Date

February 11, 2022

Last Update Submit

June 20, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Overall attendance of program

    The total number of sessions that participants attend will be used to measure continuation of program.

    Up to 24 weeks

  • Overall treatment adherence

    The number of participants that adhere to treatments will be measured using self-report at three time points.

    Baseline

  • Overall treatment adherence

    The number of participants that adhere to treatments will be measured using self-report at three time points.

    6-month

  • Overall treatment adherence

    The number of participants that adhere to treatments will be measured using self-report at three time points.

    12-month

Secondary Outcomes (1)

  • Change in substance abuse

    Weekly for 24 weeks

Study Arms (3)

IMANI BREAKTHROUGH

ACTIVE COMPARATOR

Participants will participate in 24-week IMANI weekly groups

Behavioral: IMANI

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

EXPERIMENTAL

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: IMANIBehavioral: Telehealth MAT

IMANI BREAKTHROUGH + Traditional MAT plus Referral and Linkage

EXPERIMENTAL

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: IMANIBehavioral: Traditional MAT plus Referral and Linkage

Interventions

IMANIBEHAVIORAL

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 BREAKTHROUGHIMANI BREAKTHROUGH + Traditional MAT plus Referral and LinkageIMANI BREAKTROUGH + church-based telehealth MAT option (IMANI + CTM)
Telehealth MATBEHAVIORAL

Describe what is the Telehealth MAT briefly

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

Describe what he traditional MAT plus referral and linkage briefly

IMANI BREAKTHROUGH + Traditional MAT plus Referral and Linkage

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- Participants who do not sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Mount Aery Baptist Church

Bridgeport, Connecticut, 06604, United States

NOT YET RECRUITING

Principe of Peace Church

Bridgeport, Connecticut, 06605, United States

NOT YET RECRUITING

Blackwell Memorial AME Church

Hartford, Connecticut, 06002, United States

NOT YET RECRUITING

Iglesia Nuevo Comienzo

Hartford, Connecticut, 06602, United States

RECRUITING

Spottswood AME

New Britain, Connecticut, 06053, United States

RECRUITING

Varick Memorial AME Church

New Haven, Connecticut, 06511, United States

RECRUITING

Yale Program for Recovery and Community Health

New Haven, Connecticut, 06513, United States

NOT YET RECRUITING

Casa de Oracion y Adoracion

New Haven, Connecticut, 06519, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Referral and ConsultationGenetic Linkage

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services AdministrationGenetic Phenomena

Study Officials

  • Chyrell Bellamy, Ph.D.

    Yale University

    PRINCIPAL INVESTIGATOR
  • Ayana Jordan, PhD.

    Yale University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kimberly D Blackman, BA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2022

First Posted

March 2, 2022

Study Start

July 20, 2022

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

June 26, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations