An interventional study of Opioid Agonist Therapy in Hiv and Opioid Use, sponsored by Yale University. Recruiting at 5 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Yale University · Not applicable, Interventional, and Prevention
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).
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.
3,035 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 306 are open to participants now.
This study's planned enrollment of 300 is above the median of 96 across 2,251 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →Yale University is the lead sponsor of 1,770 studies on the registry; 294 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 129 (58%) have results posted.
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Aim 1:
Quantitative surveys for prison OAT providers
Aim 2:
Quantitative surveys for people in probation
Quantitative surveys for probation and prison officers
Focus Groups (People in probation)
Focus Groups (Probation and prison officers)
Exclusion Criteria:
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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.
Behavioral: Opioid Agonist Therapy
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.
Behavioral: Opioid Agonist Therapy
Opioid Agonist Therapy (OAT) as HIV prevention
Number of participants receiving opioid agonist therapy (OAT)
Number of patients receiving opioid agonist therapy (OAT) per OAT site.
Time frame: baseline up to 4 years
Adherence to NIATx protocol
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).
Time frame: baseline up to 4 years
Plan to share: No
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Acquired Immunodeficiency Syndrome →