NCT05934591

Brief Summary

Rates of alcohol and substance misuse (ASM) in low-income, predominantly African American communities are similar to the general population. However, ASM has greater consequences (e.g., higher incarceration and HIV infection rates) for residents in these communities. We developed and optimized Community Wise (CW), a multi-level manualized behavioral intervention to decrease ASM frequency in a population of self-identified men with histories of substance use disorder (SUD) and incarceration (SUD) in Essex County, New Jersey (NJ), U.S. We propose a study to: 1) identify strategies to improve attendance and reduce ASM, and 2) to test feasibility and acceptability of CW among self-identified men and women with a history of SUD living in marginalized communities. We will achieve these aims by conducting a 23 full factorial experiment informed by MOST and CBPR. This study will identify efficient, scalable, and sustainable strategies to improve attendance and hence, maximize the interventions' effect in reducing ASM.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
166

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

July 6, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 7, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2024

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

July 2, 2025

Completed
Last Updated

July 2, 2025

Status Verified

June 1, 2025

Enrollment Period

11 months

First QC Date

June 28, 2023

Results QC Date

June 5, 2025

Last Update Submit

June 29, 2025

Conditions

Keywords

Alcohol and substance misuse treatment, treatment engagement

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Attending at Least 50% of Sessions

    We will test if different intervention delivery strategies will result in a clinically and statistically important intervention attendance with a minimum of 50% of participants attending at least 50% of the intervention

    nine weeks

Study Arms (8)

Supervision/Paid/Open Group

EXPERIMENTAL

A group of people under supervision (those on parole, drug court, probation, or methadone maintenance) will receive an incentive to attend open format groups of the Community Wise intervention.

Behavioral: Community Wise

Supervison/Paid/Closed Group

EXPERIMENTAL

A group of people under supervision (those on parole, drug court, probation, or methadone maintenance) will receive an incentive to attend closed format groups of the Community Wise intervention.

Behavioral: Community Wise

Supervision/Not Paid/Open Group

EXPERIMENTAL

A group of people under supervision (those on parole, drug court, probation, or methadone maintenance) will attend open format groups of the Community Wise intervention without receiving an incentive.

Behavioral: Community Wise

Supervision/Not Paid/Closed Group

EXPERIMENTAL

A group of people under supervision (those on parole, drug court, probation, or methadone maintenance) will attend closed format groups of the Community Wise intervention without receiving an incentive.

Behavioral: Community Wise

Not Under Supervision/Paid/Open Group

EXPERIMENTAL

A group of people not under supervision (those on parole, drug court, probation, or methadone maintenance) will receive an incentive to attend open format groups of the Community Wise intervention.

Behavioral: Community Wise

Not Under Supervision/Paid/Closed Group

EXPERIMENTAL

A group of people not under supervision (those on parole, drug court, probation, or methadone maintenance) will receive an incentive to attend closed format groups of the Community Wise intervention.

Behavioral: Community Wise

Not Under Supervision/Not Paid/Open Group

EXPERIMENTAL

A group of people not under supervision (those on parole, drug court, probation, or methadone maintenance) will attend open format groups of the Community Wise intervention without receiving an incentive.

Behavioral: Community Wise

Not Under Supervision/Not Paid/Closed Group

EXPERIMENTAL

A group of people not under supervision (those on parole, drug court, probation, or methadone maintenance) will attend closed format groups of the Community Wise intervention without receiving an incentive.

Behavioral: Community Wise

Interventions

Community WiseBEHAVIORAL

The intervention received by each group will be Community Wise, a multi-level manualized behavioral intervention to decrease alcohol and substance misuse frequency

Not Under Supervision/Not Paid/Closed GroupNot Under Supervision/Not Paid/Open GroupNot Under Supervision/Paid/Closed GroupNot Under Supervision/Paid/Open GroupSupervision/Not Paid/Closed GroupSupervision/Not Paid/Open GroupSupervision/Paid/Open GroupSupervison/Paid/Closed Group

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsEach of the 8 arms will include both men and women
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Living in St. Clair County, Illinois (IL)
  • Over 18
  • English- speaker
  • Under supervision (parole, probation, drug court or methadone maintenance)
  • Having an alcohol or substance misuse disorder

You may not qualify if:

  • Not living in St. Clair County, IL
  • Not able to speak English
  • Not able or willing to provide consent
  • Not having an alcohol or substance misuse disorder
  • Under 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Comprehensive Behavioral Health Center

East Saint Louis, Illinois, 62201, United States

Location

Results Point of Contact

Title
Dr. Liliane Windsor
Organization
University of Illinois Urbana Champaign

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 28, 2023

First Posted

July 7, 2023

Study Start

July 6, 2023

Primary Completion

May 24, 2024

Study Completion

May 24, 2024

Last Updated

July 2, 2025

Results First Posted

July 2, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations