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

Sponsor

Yale University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04947475

Collaborator

Ukrainian Institute on Public Health Policy (Other), AFEW Kyrgyzstan (Other), AFI - Act For Involvement (Other), National Institute on Drug Abuse (NIDA) (NIH)

835

Enrollment

Locations

Arm

66.9

Anticipated Duration (Months)

278.3

Patients Per Site

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Opioid-use Disorder HIV Infections Tuberculosis Hepatitis C Hepatitis B Depression Syphilis	Behavioral: SBIRT	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

835 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

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

Actual Study Start Date :

Jan 1, 2017

Anticipated Primary Completion Date :

Jul 31, 2022

Anticipated Study Completion Date :

Jul 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Screening, Brief Intervention, & Referral to Treatment (SBIRT) Program 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.	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.

Arm

Intervention/Treatment

Experimental: Screening, Brief Intervention, & Referral to Treatment (SBIRT) Program

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.

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.

Outcome Measures

Primary Outcome Measures

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

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

18 years of age or older
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.
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.
Meets ICD-10 screening criteria for pre-incarceration opioid dependence

FOR THOSE IN PROBATION:

Living within 30 km of an OAT delivery site
Not having received OAT in the last 15 days.
Positive for OUD

Exclusion Criteria:

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

Contacts and Locations

Locations

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