PRIDE III Prison Interventions and HIV Prevention Collaboration

Yale University

Status: Enrolling

Conditions: Opioid Use; Hiv

Treatments: Behavioral: Opioid Agonist Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06962033

2000037393

2R01DA029910-11A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Aim 1- Implementation

Experimental group

Description:

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.

Treatment:

Behavioral: Opioid Agonist Therapy

Aim 2- Scale-Up

Experimental group

Description:

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.

Treatment:

Behavioral: Opioid Agonist Therapy