NCT06962033

Brief Summary

The primary objective of this research project is to identify barriers to scale-up of Opioid Agonist Therapy (OAT) in the justice systems (prisons and probation) in Tajikistan, Kyrgyzstan, Moldova, and Georgia, and establish a NIATx learning collaborative to scale-up OAT, and analyze scale-up utilizing latent class growth analyses in people who inject drugs (PWID).

Trial Health

83
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline
27mo left

Started Nov 2024

Longer than P75 for not_applicable hiv

Geographic Reach
5 countries

5 active sites

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Nov 2024Dec 2028

Study Start

First participant enrolled

November 5, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 8, 2025

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

September 10, 2026

Status Verified

September 1, 2026

Enrollment Period

4.1 years

First QC Date

April 29, 2025

Last Update Submit

September 9, 2026

Conditions

HivOpioid Use

Outcome Measures

Primary Outcomes (1)

  • Number of participants receiving opioid agonist therapy (OAT)

    Number of patients receiving opioid agonist therapy (OAT) per OAT site.

    baseline up to 4 years

Secondary Outcomes (1)

  • Adherence to NIATx protocol

    baseline up to 4 years

Study Arms (2)

Aim 1- Implementation

EXPERIMENTAL

Scale-up Opioid Agonist Therapy (OAT) as HIV prevention in prisons and pre-trial detention centers in EECA for individuals with Opioid Use Disorder (OUD) and link them to community treatment after release using development of NIATx learning collaboratives with prison OAT providers (addiction care specialists or primary care doctors). OAT scale-up data will be collected from each country's national OAT database, as well as administration of survey to prison narcologists.

Behavioral: Opioid Agonist Therapy

Aim 2- Scale-Up

EXPERIMENTAL

Scale-up OAT as HIV prevention in the newly formed probation system in EECA for individuals with OUD and link them to OAT treatment as part of routine care to align public safety and public health using development of NIATx learning collaboratives with probation and prison officers in Kyrgyzstan, Tajikistan, Moldova, and Georgia. OAT scale-up data will be collected from each member country's national OAT database, and administer a survey to probation officers.

Behavioral: Opioid Agonist Therapy

Interventions

Opioid Agonist TherapyBEHAVIORAL

Opioid Agonist Therapy (OAT) as HIV prevention

Aim 1- ImplementationAim 2- Scale-Up

Eligibility Criteria

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

You may qualify if:

  • Aim 1:
  • Quantitative surveys for prison OAT providers
  • Being 18 years or older
  • Being currently assigned and working as a probation OAT provider for a probation site
  • ECHO procedures
  • Aim 2:
  • Quantitative surveys for people in probation
  • Being 18 years or older
  • Screen yes to opioid injection on the online screener questionnaire
  • Currently in probation
  • Quantitative surveys for probation and prison officers
  • Being 18 years or older
  • Being currently assigned and working as a probation or prison officer at a probation site
  • Focus Groups (People in probation)
  • Being 18 years or older
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Yale University

New Haven, Connecticut, 06520, United States

NOT YET RECRUITING

Alternative Georgia

Tbilisi, Georgia

RECRUITING

AIDS Foundation East-West (AFEW)

Bishkek, Kyrgyzstan

RECRUITING

NGO AFI

Chisinau, Moldova

RECRUITING

Institute for International Health and Education (IIHE)

Dushanbe, Tajikistan

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Frederick L Altice, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David Oliveros, MPH

CONTACT

202-805-8118david.oliveros@yale.edu

Jin Hee Kim, MPH

CONTACT

jinhee.kim@yale.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Aim 1: 100 (60 prison OAT providers, 15 per country) for surveys, 40 prison OAT providers, 10 per country, for NGT) Aim 2: 200 (100 probation clients, 100 prison and probation staff (officers and leadership)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2025

First Posted

May 8, 2025

Study Start

November 5, 2024

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

September 10, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

MO(1)US(1)GE(1)KY(1)TA(1)