Clinical trial NCT06962033: PRIDE III Prison Interventions and HIV Prevention Collaboration
Official title: PRIDE III Prison Interventions and HIV Prevention Collaboration
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hiv
Opioid Use
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2025-05-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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)
Primary purpose: PREVENTION

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Number of participants receiving opioid agonist therapy (OAT)
timeFrame: baseline up to 4 years
Secondary outcomes:
measure: Adherence to NIATx protocol
timeFrame: baseline up to 4 years
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Tbilisi
country: Georgia
facility: Alternative Georgia
city: Bishkek
country: Kyrgyzstan
facility: AIDS Foundation East-West (AFEW)
city: Chisinau
country: Moldova, Republic of
facility: NGO AFI
city: Dushanbe
country: Tajikistan
facility: Institute for International Health and Education (IIHE)
Study officials:
affiliation: Yale University
name: Frederick L Altice, MD
role: PRINCIPAL_INVESTIGATOR
References: