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Opioid Use DisorderExMAT CANCT05579470

Expanding Medication-Assisted Therapies in Central Asia

A study testing NIATx in people with Opioid Use Disorder, run by Yale University at 4 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Opioid Use Disorder
What is being tested?
NIATx
Could I receive a placebo?
No, everyone receives an active treatment
How many people
900 participants
Where
4 sitesin 4 countries
Study dates
7 Aug 2023to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 25Show fewer
  • 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
  • Aim 2: The inclusion criteria for Aim 2 consists of:
  • 18 years or older
  • Currently assigned as a Chief Narcologist for an Oblast
  • 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

Who cannot join

  • Not willing to provide consent

Trial locations and contacts

4 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Frederick L Altice, MD contact

203-623-2634

frederick.altice@yale.edu

4 sites in 4 countries

United States1 site
  • Yale University

    New Haven, Connecticut, 06510

    Active, not recruiting

Other trials in United States

Kazakhstan1 site, 1 recruiting
  • Columbia University Global Health Research Center of Central Asia

    Almaty

    Sholpan Primbetova, MSW, +7-701-930-0281, sholpan.primbetova@ghrcca.org

    Assel Terlikbayeva, MD

    Recruiting

Other trials in Kazakhstan

Kyrgyzstan1 site, 1 recruiting
  • Den Sooluk Nuru

    Bishkek

    Dinara Madybaeva, dinara.madybaeva@afew.kg

    Natalia Shumskaya

    Recruiting

Other trials in Kyrgyzstan

Tajikistan1 site, 1 recruiting
  • Institute for International Health and Education

    Dushanbe

    Arash Alaei, MD, alaeiarash@gmail.com

    Arash Alaei, MD

    Recruiting

About this study

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).

Being tested
NIATx
Keywords
HIV, OUD, OAT, Central Asia
Medical subject headings
Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NIATxBehavioural

    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).

Study groups in NCT05579470
Study groupRoleWhat they receive
NIATx ModelOtherReceiving NIATx Coaching
Receives: Behavioral: NIATx

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. OAT Census

    Absolute number of patients on OAT per country

    Measured: 36 months

  2. OAT Census per Oblast

    Absolute number of patients on OAT per oblast

    Measured: 36 months

Secondary outcomes (4)
  1. New Patients

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

    Measured: 36 months

  2. New Patients per Oblast

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

    Measured: 36 months

  3. Dropout

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

    Measured: 36 months

  4. Dropout per Oblast

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

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2022
  2. Study start7 Aug 2023
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Model description
THe investigators propose a quasi-experimental, pretest-posttest design to evaluate the effect of the NIATx strategy on OAT scale-up for three CA countries. Specifically interested in assessing how the introduction of a NIATx model affects two primary outcomes: (1) rate of entry onto OAT, and (2) retention on OAT. Though the implementation science field is rapidly evolving, such an approach is limited by its assumption that existing data were collected and recorded in a manner that adheres to the fidelity of the measures - a noted innovation in this proposal. This limitation is addressed prospectively recording OAT entry and attrition over an extended time period (36 months) and, as part of Aim 3, collect inner and outer context and bridging and innovation of EBP factors as repeated measures to examine trajectories and factors that are associated with them.
Masking
None (open label)
Enrolment
900 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05579470
Sponsor's protocol ID
2000031029
Other IDs
1R01DA054851-01A1
Acronym
ExMAT CA
Status last verified
Oct 2026
First submitted
10 Oct 2022
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing NIATx in people with Opioid Use Disorder, run by Yale University at 4 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States, Kazakhstan, Kyrgyzstan, Tajikistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Frederick L Altice, MD (203-623-2634, frederick.altice@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

OAT Census (time frame: 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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