Project MATLINK: Development and Evaluation of a Screening, Brief Intervention, & Referral to Treatment (SBIRT) Program for Opioid Dependent Prisoners and Probationers Transitioning to the Community

Not Applicable

Active, not recruiting

• Conditions: HIV Infections; Opioid-use Disorder; Tuberculosis; Hepatitis B; Depression; Syphilis; Hepatitis C
• Interventions: Behavioral: SBIRT

• Registration Number: NCT04947475
• Lead Sponsor: Yale University

Brief Summary

The purpose of this study is to evaluate the efficacy a Screening, Brief Intervention, and Referral to Treatment (SBIRT) program for linking opioid dependent individuals currently incarcerated or in probation in Moldova, Kyrgyzstan, and Ukraine to opioid substitution therapy in the community after release or during their probation period.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2021-06-23
• Study First Submitted QC: 2021-06-23
• Study First Posted: 2021-07-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-01
• Last Update Posted: 2023-11-03
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 835

Inclusion Criteria

1. 18 years of age or older

2. Within 180 days of release or possible release (eligible for parole) to the community, but greater than 7 days to release to the community OR currently in probation.

3. FOR THOSE IN PRISON: Relocating to a location within 30 km (approximately 60-minute commute) of the referred Narcology center. Each participant will be asked the address he/she is planning to reside under that will be immediately checked on the map to determine the travel time. A participant then will be asked if he/she would be willing to travel the distance to a particular OAT site. If a person does not meet this inclusion criterion, he/she will be referred to a local harm reduction center.

4. Meets ICD-10 screening criteria for pre-incarceration opioid dependence

   FOR THOSE IN PROBATION:

5. Living within 30 km of an OAT delivery site

6. Not having received OAT in the last 15 days.

7. Positive for OUD

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Exclusion Criteria

1. Pregnant or may become pregnant
2. FOR THOSE IN PRISON: Will be released from prison in 7 days or less.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Screening, Brief Intervention, & Referral to Treatment (SBIRT) Program	SBIRT	There are two objectives to the Brief Intervention. First, the BI is designed to inform potential participants on the risks of substance misuse, abuse, and dependency by illustrating the potential hazards and adverse health consequences. Second, the BI aims to motivate potential participants to reduce risky behavior (e.g., continued drug use) and seek treatment for their substance dependence disorder.

Primary Outcome Measures

Name	Time	Method
Enrollment on OAT	12 months	Total number of participants who enroll on OAT divided by the number of participants who underwent study procedures, per country.

Secondary Outcome Measures

Name	Time	Method
OAT Importance	6 months	Overall mean change in composite score of importance of initiating OAT pre vs post intervention stratified by study groups (enrolled vs not en rolled on OAT) at the 6-month mark.
OAT Knowledge	6 month	Overall mean change in composite score of knowledge of OAT pre vs post intervention stratified by study groups (enrolled vs not en rolled on OAT) at the 6-month mark.
OAT Attitudes	6 months	Overall mean change in composite score of attitudes towards OAT pre vs post intervention stratified by study groups (enrolled vs not en rolled on OAT) at the 6-month mark.
Interest in OAT	6 months	Overall mean change in composite score of interest in initiating OAT pre vs post intervention stratified by study groups (enrolled vs not en rolled on OAT) at the 6-month mark.
OAT Difficulty	6 months	Overall mean change in composite score of difficulty in initiating OAT pre vs post intervention stratified by study groups (enrolled vs not en rolled on OAT) at the 6-month mark.

Trial Locations

Locations (3)

AIDS Foundation East-West; 🇰🇬 Bishkek, Kyrgyzstan

AFI - Act for Involvement; 🇲🇩 Chisinau, Moldova, Republic of

Ukrainian Institute for Public Health Policy; 🇺🇦 Kyiv, Ukraine