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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
First received
Last updated
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
Health authority
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.

Study Design


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
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