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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
4 sites in 4 countries
United States1 site
- Active, not recruiting
Yale University
New Haven, Connecticut, 06510
Kazakhstan1 site, 1 recruiting
- 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
Kyrgyzstan1 site, 1 recruiting
- Recruiting
Den Sooluk Nuru
Bishkek
Dinara Madybaeva, dinara.madybaeva@afew.kg
Natalia Shumskaya
Tajikistan1 site, 1 recruiting
- Recruiting
Institute for International Health and Education
Dushanbe
Arash Alaei, MD, alaeiarash@gmail.com
Arash Alaei, MD
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:
- 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.
- 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.
- 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).
- Conditions
- Opioid Use Disorder
- 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 group | Role | What they receive |
|---|---|---|
| NIATx Model | Other | Receiving NIATx Coaching Receives: Behavioral: NIATx |
What is being measured
The primary outcome is the main question the study is designed to answer.
OAT Census
Absolute number of patients on OAT per country
Measured: 36 months
OAT Census per Oblast
Absolute number of patients on OAT per oblast
Measured: 36 months
Secondary outcomes (4)
New Patients
Total number of newly enrolled patients into OAT services, per country
Measured: 36 months
New Patients per Oblast
Total number of newly enrolled patients into OAT services, per oblast
Measured: 36 months
Dropout
Total number of patients dropping out of OAT services, per country
Measured: 36 months
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.
- First posted13 Oct 2022
- Study start7 Aug 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- 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
- Investigators
- Frederick L Altice, MD, Principal investigator, Yale University
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding Medication-Assisted Therapies in Central Asia
- ClinicalTrials.gov ID
- NCT05579470
- Acronym / sponsor ID
- ExMAT CA / 2000031029
- Conditions
- Opioid Use Disorder
- Keywords
- HIV, OUD, OAT, Central Asia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Den Sooluk Nuru, Institute for International Health and Education, Global Health Research Center of Central Asia, National Institute on Drug Abuse (NIDA)
- Study start
- 7 Aug 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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.
- 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).
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| NIATx Model | Other | Behavioral: NIATxReceiving NIATx Coaching |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Aim 1: The inclusion criteria for Aim 1 Consists of:
- Quantitative surveys for PWID
- Organizational Assessments for OAT Delivery Staff
- Focus Groups (PWID on OAT)
- Focus Groups (PWID not on OAT)
Key exclusion criteria (1 listed)
- Not willing to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIATxFor 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). | Behavioural | NIATx Model |
Primary outcome
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
4 secondary outcomes
New Patients
Time frame: 36 months
New Patients per Oblast
Time frame: 36 months
Dropout
Time frame: 36 months
Dropout per Oblast
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Frederick L Altice, MD principal investigator
Yale University
4 sites in 4 countries: see every site and its status.
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.