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RecruitingNCT05579470ExMAT CAUpdated Oct 14, 2026

Expanding Medication-Assisted Therapies in Central Asia

An interventional study of NIATx in Opioid Use Disorder, sponsored by Yale University. Recruiting at 4 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-14.

Sponsored by Yale University · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Started Aug 2023; still recruiting 3 years 3 months later.
Updated Oct 14, 2026Primary completion movedStudy completion movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
900
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

Central Asia (CA) represents the most rapidly growing HIV epidemic region worldwide, concentrated in people who inject drugs (PWID) and their sexual partners. Scaling up opioid agonist therapies (OAT) in CA is the most cost-effective strategy to prevent new HIV infections, and more effective when combined with antiretroviral therapy (ART). OAT, when adequately scaled, controls HIV epidemics through both primary and secondary prevention (increased engagement along the entire HIV treatment cascade). CA countries have especially low OAT (and ART) coverage and are uniquely impacted by their proximity to opioid trade routes, a myriad of patient, provider, healthcare and policy barriers and suboptimal implementation. CA countries share a similar Semashko healthcare system, but differ by political, cultural and economic trajectories since independence from the Soviet Union. Such healthcare systems are especially challenging for implementation of evidence-based practices (EBPs). Moreover, the HIV treatment cascade differs in Kazakhstan (KZ), Kyrgyzstan (KY) and Tajikistan (TJ) with low levels of HIV testing (71%, 61% and 48%), being on ART (\~30%) and viral suppression (20%, 18%, 22%), respectively. OAT coverage is similarly low (0.2%, 4.6% and 2.8%) for the 120,500, 25,000 and 22,500 PWID, respectively. The investigators propose to use the Network for the Improvement of Addiction Treatment (NIATx) implementation strategy to scale-up OAT in three diverse CA countries guided by the Exploration-Planning-Implementation-Sustainment (EPIS) framework.

Using the investigators experiences with NIATx to scale-up OAT in Ukraine, the EPIS framework will be used where the investigators will first assess the barriers and facilitators to OAT scale-up, including inner and outer context and bridging factors associated with OAT innovations as part of exploration/preparation. Despite its unequivocal efficacy, it was perceived as negative by both patients and providers in Ukraine. Myths surrounding OAT combined with structural factors within clinics accounted for 82% of the barriers. The investigators then implemented NIATx by training in-country coaches and used a menu of tools and quality improvement techniques to scale-up OAT to increase OAT entry and retention. EPIS relies on dynamic use of implementation to adapt to the context. Collaborative learning is key feature of NIATx that involves a transformation to adoption and scale-up of EBPs. OAT implementation, however, requires adaptation of implementation strategies to local contextual factors, including available resources, expertise, and cultural norms, which must be accomplished for successful implementation. Such adaptation, however, must be understood to promote sustainability and to install promising practices that are unique to the context. Health delivery in CA is based on vestiges of Soviet-era Semashko health systems which are siloed, rigidly vertical and do not promote teamwork. Observations from Ukraine suggest that group cohesion may emerge through collaborative learning, but it is not linear and outcomes among group members differ. Understanding the trajectories of implementation, a core feature of EPIS, may in this context emerge through creating communities of practice, especially when cohesion evolves, and may guide other healthcare delivery challenges in the region (e.g., HIV, TB). Using NIATx to build important regional expertise and understanding implementation trajectories should help support OAT program sustainability. The specific aims are:

  1. To create a socio-ecological framework for OAT delivery by conducting formative research to assess client-level, program-level and structural facilitators and barriers to entry into and retention in OAT in each country in order to create improved, sustainable models of OAT delivery that are contextually relevant, including integration of OAT into primary and HIV clinical care settings.
  2. To scale-up OAT in 3 diverse Central Asian countries by training and coaching national experts in Kazakhstan (KZ), Kyrgyzstan (KG) and Tajikistan (TJ) on the use of NIATx.
  3. To use latent class growth analyses to identify implementation trajectories of OAT, scale-up using NIATx in the Eastern Europe and Central Asia (EECA) context and explore which organizational, professional and group dynamic characteristics are associated with these trajectories and related to individual level outcomes (i.e., OAT scale-up).

As part of the implementation and sustainability plan, and consistent with NIATx, the investigators will convene stakeholder meetings to bridge inner (National and Oblast Chief Narcologists) and outer (e.g. Non-Governmental Organization (NGOs), Ministry of Health, external funders and experts) factors to guide initial implementation, review findings from the investigators studies and use information to inform policies for expanding OAT in each CA country. These meeting will inform implementation and guide structural policy changes to promote sustainability. Significance is high given CA having the most rapidly evolving HIV epidemic worldwide, concentrated in PWID and their sexual partners and where current implementation efforts have failed. Innovation is high by using NIATx and its extensive toolkit to facilitate OAT scale-up alongside an in-depth assessment of key NIATx elements that contribute to success in this context. Success is likely to be high given the experience of the US and Central Asian teams, their previous collaborative research and a common goal to control HIV in the region. Public health benefit is likely to be high given the need to simultaneously address both treatment and prevention of HIV and opioid use disorder (OUD).

02

Conditions studied

  • Opioid Use Disorder

Keywords

  • HIV
  • OUD
  • OAT
  • Central Asia
03

In context

Opioid-Related Disorders

1,472 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.

This study's planned enrollment of 900 is above the median of 63 across 1,166 interventional studies indexed under Opioid-Related Disorders.

Browse Opioid-Related Disorders studies →

Lead sponsor

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.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

Exclusion Criteria:

  • Not willing to provide consent
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
900 participants (estimated)

Study arms

  • Other
    NIATx Model

    Receiving NIATx Coaching

    Behavioral: NIATx

Interventions

  • BehavioralNIATx

    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).

06

What researchers measure

Primary outcomes

  1. OAT Census

    Absolute number of patients on OAT per country

    Time frame: 36 months

  2. OAT Census per Oblast

    Absolute number of patients on OAT per oblast

    Time frame: 36 months

Secondary outcomes

  1. New Patients

    Total number of newly enrolled patients into OAT services, per country

    Time frame: 36 months

  2. New Patients per Oblast

    Total number of newly enrolled patients into OAT services, per oblast

    Time frame: 36 months

  3. Dropout

    Total number of patients dropping out of OAT services, per country

    Time frame: 36 months

  4. Dropout per Oblast

    Total number of patients dropping out of OAT services, per oblast

    Time frame: 36 months

07

Study locations

3 of 4 sites recruiting
  • Yale University
    New Haven, Connecticut 06510, United States
    Active, not recruiting

    Not enrolling at this site.

  • 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
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Primary completion
Dec 31, 2026→Dec 31, 2027
Oct 14, 2026
Study completion
Dec 31, 2026→Dec 31, 2027
Oct 14, 2026
Show all 1 update
  1. Oct 14, 2026
    Primary completion Dec 31, 2026→Dec 31, 2027
    Study completion Dec 31, 2026→Dec 31, 2027
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05579470
Lead sponsor
Yale University
Collaborators
Den Sooluk Nuru, Institute for International Health and Education, Global Health Research Center of Central Asia, National Institute on Drug Abuse (NIDA)
Responsible party
Sponsor
First posted
Oct 13, 2022
Start date
Aug 7, 2023
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Oct 14, 2026

Study contacts

Frederick L Altice, MD
Contact
frederick.altice@yale.edu
203-623-2634
Frederick L Altice, MD
principal investigator · Yale University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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