PRIDE III Prison Interventions and HIV Prevention Collaboration

Not Applicable

Recruiting

• Conditions: Hiv; Opioid Use

• Registration Number: NCT06962033
• Lead Sponsor: Yale University

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).

Detailed Description

Aim 1 consists of the development of NIATx learning collaboratives with prison OAT providers (addiction care specialists or primary care doctors). This aim is an implementation science aim involving the collection of OAT scale-up data from each country's national OAT database, as well as administration of survey to prison narcologists every 6 months.

Aim 2 consists of the development of NIATx learning collaboratives with probation and prison officers in Kyrgyzstan, Tajikistan, Moldova, and Georgia. Investigators will collect OAT scale-up data from each member country's national OAT database, and administer a survey to probation officers every 6 months. Investigators will also observe and interview probation clients and staff using ethnographic methods.

Study Timeline

• Study Start: 2024-11-05
• Study First Submitted: 2025-04-29
• Study First Submitted QC: 2025-04-29
• Status Verified: 2025-05
• Study First Posted: 2025-05-08
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-11
• Primary Completion: 2028-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Aim 1:

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

2. ECHO procedures

Aim 2:

1. Quantitative surveys for people in probation

   • Being 18 years or older
   • Screen yes to opioid injection on the online screener questionnaire
   • Currently in probation

2. 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

3. Focus Groups (People in probation)

   • Being 18 years or older
   • Screen yes to opioid injection criteria on the online screener
   • Currently in probation

4. Focus Groups (Probation and prison officers)

   • Being 18 years or older
   • Being currently assigned and working as a probation or prison officer at a probation
   • Has more than 3 months of field experience
   • Works at a probation site within 25 kilometers of an OAT site

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of participants receiving opioid agonist therapy (OAT)	baseline up to 4 years	Number of patients receiving opioid agonist therapy (OAT) per OAT site.

Secondary Outcome Measures

Name	Time	Method
Adherence to NIATx protocol	baseline up to 4 years	Adherence to NIATx protocol: using the NIATx fidelity scale, a 19-item assesment to measure adherence to the NIATx model on a 5-point scale from 1 (No evidence) to 5 (Extensive evidence).

Trial Locations

Locations (5)

Yale University; 🇺🇸 New Haven, Connecticut, United States

Alternative Georgia; 🇬🇪 Tbilisi, Georgia

AIDS Foundation East-West (AFEW); 🇰🇬 Bishkek, Kyrgyzstan

NGO AFI; 🇲🇩 Chisinau, Moldova, Republic of

Institute for International Health and Education (IIHE); 🇹🇯 Dushanbe, Tajikistan