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NCT Number: NCT06962033

PRIDE III Prison Interventions and HIV Prevention Collaboration

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).

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alternative Georgia, Tbilisi, Georgia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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
  • Screen yes to opioid injection criteria on the online screener
  • Currently in probation
  • 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

-

Treatment and study plan

Opioid Agonist Therapy

Behavioral

Opioid Agonist Therapy (OAT) as HIV prevention

Primary outcomes

  1. Number of participants receiving opioid agonist therapy (OAT)

    Time frame: baseline up to 4 years

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

Secondary outcomes

  1. Adherence to NIATx protocol

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

David Oliveros, MPH

CONTACT

[email protected]

202-805-8118

Jin Hee Kim, MPH

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: PRIDE III

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
May 8, 2025
Registry last updated
May 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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