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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 (MATLINK)

Primary Purpose

Opioid-use Disorder, HIV Infections, Tuberculosis

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
SBIRT
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Opioid-use Disorder focused on measuring HIV, OUD, Methadone, HCV, HBV, TB, Depression, Syphilis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • AIDS Foundation East-West
  • AFI - Act for Involvement
  • Ukrainian Institute for Public Health PolicyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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.

Outcomes

Primary Outcome Measures

Enrollment on OAT
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
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
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
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
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
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.

Full Information

First Posted
June 23, 2021
Last Updated
November 9, 2022
Sponsor
Yale University
Collaborators
Ukrainian Institute on Public Health Policy, AFEW Kyrgyzstan, AFI - Act For Involvement, National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT04947475
Brief 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
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
Ukrainian Institute on Public Health Policy, AFEW Kyrgyzstan, AFI - Act For Involvement, National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder, HIV Infections, Tuberculosis, Hepatitis C, Hepatitis B, Depression, Syphilis
Keywords
HIV, OUD, Methadone, HCV, HBV, TB, Depression, Syphilis

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
835 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Screening, Brief Intervention, & Referral to Treatment (SBIRT) Program
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SBIRT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Enrollment on OAT
Description
Total number of participants who enroll on OAT divided by the number of participants who underwent study procedures, per country.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
OAT Knowledge
Description
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.
Time Frame
6 month
Title
OAT Attitudes
Description
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.
Time Frame
6 months
Title
Interest in OAT
Description
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.
Time Frame
6 months
Title
OAT Difficulty
Description
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.
Time Frame
6 months
Title
OAT Importance
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samy J Galvez de Leon, MPH
Phone
4752024653
Email
samy.galvez@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederick L Altice, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Natalya Shumskaya
Organizational Affiliation
AIDS Foundation East-West
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nataliia Saishuk
Organizational Affiliation
Ukrainian Institute for Public Health Policy
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Svetlana Doltu
Organizational Affiliation
AFI - Act For Involvement
Official's Role
Study Director
Facility Information:
Facility Name
AIDS Foundation East-West
City
Bishkek
Country
Kyrgyzstan
Individual Site Status
Active, not recruiting
Facility Name
AFI - Act for Involvement
City
Chisinau
Country
Moldova, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Ukrainian Institute for Public Health Policy
City
Kyiv
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nataliia Saichuk

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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