NCT04947475

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
835

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 1, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

May 11, 2025

Status Verified

May 1, 2025

Enrollment Period

6.3 years

First QC Date

June 23, 2021

Last Update Submit

May 8, 2025

Conditions

Keywords

HIVOUDMethadoneHCVHBVTBDepressionSyphilis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • OAT Knowledge

    6 month

  • OAT Attitudes

    6 months

  • Interest in OAT

    6 months

  • OAT Difficulty

    6 months

  • OAT Importance

    6 months

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

SBIRTBEHAVIORAL

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.

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

AIDS Foundation East-West

Bishkek, Kyrgyzstan

Location

AFI - Act for Involvement

Chisinau, Moldova

Location

Ukrainian Institute for Public Health Policy

Kyiv, Ukraine

Location

MeSH Terms

Conditions

Opioid-Related DisordersHIV InfectionsTuberculosisHepatitis CHepatitis BDepressionSyphilis

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesHepatitis, Viral, HumanFlaviviridae InfectionsHepatitisLiver DiseasesDigestive System DiseasesHepadnaviridae InfectionsDNA Virus InfectionsBehavioral SymptomsBehaviorTreponemal InfectionsSpirochaetales InfectionsGram-Negative Bacterial InfectionsSexually Transmitted Diseases, Bacterial

Study Officials

  • Frederick L Altice, MD

    Yale University

    PRINCIPAL INVESTIGATOR
  • Natalya Shumskaya

    AIDS Foundation East-West

    STUDY DIRECTOR
  • Nataliia Saishuk

    Ukrainian Institute for Public Health Policy

    STUDY DIRECTOR
  • Svetlana Doltu

    AFI - Act For Involvement

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2021

First Posted

July 1, 2021

Study Start

January 1, 2017

Primary Completion

April 30, 2023

Study Completion

April 30, 2023

Last Updated

May 11, 2025

Record last verified: 2025-05

Locations