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

Depression Clinical Trial

— MATLINK  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04947475
• Other study ID #: 1407014374
• Secondary ID: 2R01DA029910-06
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: July 31, 2024

Study information

• Verified date: November 2023
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 835
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Exclusion Criteria:

1. Pregnant or may become pregnant

2. FOR THOSE IN PRISON: Will be released from prison in 7 days or less.

Related Conditions & MeSH terms

• Depression
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis C
• HIV Infections
• Opioid-Related Disorders
• Opioid-use Disorder
• Syphilis
• Tuberculosis

Intervention

Behavioral:
• SBIRT
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. In our BI, we will provide evidence-based information on Opioid Agonist Therapy (OAT) that is available to them in the community upon release or in the community. We will inform them of the risks and benefits of OAT and explain to them how OAT can be accessed in the community. OAT is provided at no cost to Ukrainian, Moldovan, and Kyrgyz citizens with opioid dependence. The BI will last approximately 20 minutes and time will be made available for them to ask questions. The BI will not be audio recorded.

Locations

Country	Name	City	State
Kyrgyzstan	AIDS Foundation East-West	Bishkek
Moldova, Republic of	AFI - Act for Involvement	Chisinau
Ukraine	Ukrainian Institute for Public Health Policy	Kyiv

Sponsors (5)

Lead Sponsor	Collaborator
Yale University	AFEW Kyrgyzstan, AFI - Act For Involvement, National Institute on Drug Abuse (NIDA), Ukrainian Institute on Public Health Policy

Countries where clinical trial is conducted

Kyrgyzstan,  Moldova, Republic of,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enrollment on OAT	Total number of participants who enroll on OAT divided by the number of participants who underwent study procedures, per country.	12 months
Secondary	OAT Knowledge	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.	6 month
Secondary	OAT Attitudes	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.	6 months
Secondary	Interest in OAT	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.	6 months
Secondary	OAT Difficulty	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.	6 months
Secondary	OAT Importance	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.	6 months