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Recruiting NCT06962033

PRIDE III Prison Interventions and HIV Prevention Collaboration

No phase Interventional Hiv Opioid Use

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Opioid Agonist Therapy.
Who it may be relevant to
Registry conditions: Hiv, Opioid Use. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Georgia, Kyrgyzstan, Moldova, Tajikistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Behavioral Opioid Agonist Therapy
    Opioid Agonist Therapy (OAT) as HIV prevention

Primary outcome measures

  • Number of participants receiving opioid agonist therapy (OAT) [Time frame: baseline up to 4 years]
Secondary outcome measures (1)
  • Adherence to NIATx protocol [Time frame: baseline up to 4 years]

Eligibility criteria

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

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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Yale University — New Haven
Georgia · 1 center
  • Alternative Georgia — Tbilisi
Kyrgyzstan · 1 center
  • AIDS Foundation East-West (AFEW) — Bishkek
Moldova · 1 center
  • NGO AFI — Chisinau
Tajikistan · 1 center
  • Institute for International Health and Education (IIHE) — Dushanbe

Identifiers

NCT: NCT06962033 · 2000037393 · 2R01DA029910-11A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗