NCT05579470 · Yale University
Expanding Medication-Assisted Therapies in Central Asia
(ExMAT CA)
What this study is about
Central Asia (CA) represents the most rapidly growing HIV epidemic region worldwide, concentrated in people who inject drugs (PWID) and their sexual partners, and scaling up opioid agonist therapies (OAT) in this region is the most cost-effective strategy to prevent new HIV infections, and more effective when combined with antiretroviral therapy (ART).
View original scientific description
Central Asia (CA) represents the most rapidly growing HIV epidemic region worldwide, concentrated in people who inject drugs (PWID) and their sexual partners, and scaling up opioid agonist therapies (OAT) in this region is the most cost-effective strategy to prevent new HIV infections, and more effective when combined with antiretroviral therapy (ART). The investigators propose to use the Network for the Improvement of Addiction Treatment (NIATx) implementation strategy to scale-up OAT in three diverse Central Asian countries (Kazakhstan, Kyrgyzstan, Tajikistan) and guided by the Exploration-Planning-Implementation-Sustainment (EPIS) framework. Understanding the trajectories of implementation and scale-up in this context may emerge through creating communities of practice, especially when cohesion and competence evolves, and may guide other healthcare delivery challenges in the region (e.g., HIV, TB); as well as build important regional expertise and understanding implementation trajectories should help support OAT program sustainability.
Interventions
BEHAVIORAL
NIATx
For each country, the learning collaborative will be comprised of a Chief Narcologist from each region where the investigators will initially train them and the coaches using all the tools from the NIATx Academy (2-3-day training). The national coach for each country will receive ongoing and in-depth coaching from a US-based super coach. A nationwide Nominal Group Technique (NGT) will be conducted to assess barriers and potential targets to guide decision-making about changes. At the end of the initial meeting, each Chief Narcologist (CN) will be able to identify a change target for Plan, Do, Study, Act (PDSA) (entry, retention) and create a Change Project Form to state what will be done (e.g. flowcharting), who is involved (team), what are the measures and timeframe (\<4 weeks).
Primary outcome measures
OAT Census
Time frame: 36 months
Absolute number of patients on OAT per country
OAT Census per Oblast
Time frame: 36 months
Absolute number of patients on OAT per oblast
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- i. Aim 1: The inclusion criteria for Aim 1 Consists of:
- Quantitative surveys for PWID
- 18 years or older
- Meeting DSM-V criteria for opioid dependence
- Be either treatment naïve and seeking OAT or be on OAT for \< 90 days
- Organizational Assessments for OAT Delivery Staff
- 18 years or older
- Currently working as an OAT delivery professional at an OAT delivery site
- Focus Groups (PWID on OAT)
- 18 years or older
- Meeting DSM-V criteria for opioid dependence
- Be either treatment naïve and seeking OAT or be on OAT for \< 90 days
- Focus Groups (PWID not on OAT)
- 18 years or older
- Meeting Diagnostic and Statistical Manual of Mental Disorders(DSM)-V criteria for opioid dependence
- Be OAT naïve (defined as never having been on OAT or having not received treatment for \> 1 year)
- Focus Groups (OAT delivery staff)
- 18 years or older
- Currently working as an OAT delivery professional at an OAT delivery site ii. Aim 2: The inclusion criteria for Aim 2 consists of:
- 18 years or older
- Currently assigned as a Chief Narcologist for an Oblast iii. Aim 3: The inclusion criteria for Aim 3 consists of:
- 18 years or older
- Authorized as a professional to work at an OAT delivery site
Exclusion criteria
- Not willing to provide consent
Where
- New Haven, Connecticut
Collaborators
Den Sooluk Nuru, Institute for International Health and Education, Global Health Research Center of Central Asia, National Institute on Drug Abuse (NIDA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
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How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 22, 2025 · Source of record for eligibility and locations