Expanding access to opioid addiction treatment in Central Asia

Expanding Medication-Assisted Therapies in Central Asia

This study is trying to see if improving access to opioid addiction treatment can help people in Central Asia who inject drugs and are at risk for HIV.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 900 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Yale University (other)
• Locations: 4 sites (New Haven, Connecticut and 3 other locations)
• Trial ID: NCT05579470 on ClinicalTrials.gov

What this trial studies

This initiative aims to address the growing HIV epidemic in Central Asia, particularly among people who inject drugs (PWID) and their partners, by scaling up opioid agonist therapies (OAT). The study employs the Network for the Improvement of Addiction Treatment (NIATx) implementation strategy to enhance OAT delivery in Kazakhstan, Kyrgyzstan, and Tajikistan. By utilizing the Exploration-Planning-Implementation-Sustainment (EPIS) framework, the project seeks to understand and improve the implementation of OAT in these regions, ultimately aiming to create communities of practice that can tackle healthcare delivery challenges. The study will involve quantitative surveys and focus groups with PWID and OAT delivery staff to gather insights and improve treatment access.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 18 and older who meet DSM-V criteria for opioid dependence and are either treatment naïve or have been on OAT for less than 90 days.

Not a fit: Patients who are not opioid dependent or those who have been on OAT for more than 90 days may not benefit from this study.

Why it matters

Potential benefit: If successful, this initiative could significantly reduce new HIV infections among PWID in Central Asia by improving access to effective opioid addiction treatments.

How similar studies have performed: Other studies have shown success in scaling up opioid addiction treatments in similar contexts, indicating potential for positive outcomes in this initiative.

Eligibility criteria

Inclusion Criteria:

i. Aim 1: The inclusion criteria for Aim 1 Consists of:

1. Quantitative surveys for PWID

   1. 18 years or older
   2. Meeting DSM-V criteria for opioid dependence
   3. Be either treatment naïve and seeking OAT or be on OAT for \< 90 days
2. Organizational Assessments for OAT Delivery Staff

   1. 18 years or older
   2. Currently working as an OAT delivery professional at an OAT delivery site
3. Focus Groups (PWID on OAT)

   1. 18 years or older
   2. Meeting DSM-V criteria for opioid dependence
   3. Be either treatment naïve and seeking OAT or be on OAT for \< 90 days
4. Focus Groups (PWID not on OAT)

   1. 18 years or older
   2. Meeting Diagnostic and Statistical Manual of Mental Disorders(DSM)-V criteria for opioid dependence
   3. Be OAT naïve (defined as never having been on OAT or having not received treatment for \> 1 year)
5. Focus Groups (OAT delivery staff)

   1. 18 years or older
   2. Currently working as an OAT delivery professional at an OAT delivery site

ii. Aim 2: The inclusion criteria for Aim 2 consists of:

1. 18 years or older
2. Currently assigned as a Chief Narcologist for an Oblast

iii. Aim 3: The inclusion criteria for Aim 3 consists of:

1. 18 years or older
2. Authorized as a professional to work at an OAT delivery site

Exclusion Criteria:

* Not willing to provide consent

Where this trial is running

New Haven, Connecticut and 3 other locations

• Yale University — New Haven, Connecticut, United States (ACTIVE_NOT_RECRUITING)
• Columbia University Global Health Research Center of Central Asia — Almaty, Kazakhstan (RECRUITING)
• Den Sooluk Nuru — Bishkek, Kyrgyzstan (RECRUITING)
• Institute for International Health and Education — Dushanbe, Tajikistan (RECRUITING)

Study contacts

• Principal investigator: Frederick L Altice, MD — Yale University
• Study coordinator: Frederick L Altice, MD

Conditions: Opioid Use Disorder, HIV, OUD, OAT, Central Asia