Expanding Medication-Assisted Therapies in Central Asia (ExMAT CA)
Primary Purpose
Opioid Use Disorder
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
NIATx
Sponsored by
About this trial
This is an interventional health services research trial for Opioid Use Disorder focused on measuring HIV, OUD, OAT, Central Asia
Eligibility Criteria
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
Sites / Locations
- Yale University
- Columbia University Global Health Research Center of Central AsiaRecruiting
- AIDS Foundation East West of KyrgyzstanRecruiting
- Institute for International Health and EducationRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
NIATx Model
Arm Description
Receiving NIATx Coaching
Outcomes
Primary Outcome Measures
OAT Census
Absolute number of patients on OAT per country
OAT Census per Oblast
Absolute number of patients on OAT per oblast
Secondary Outcome Measures
New Patients
Total number of newly enrolled patients into OAT services, per country
New Patients per Oblast
Total number of newly enrolled patients into OAT services, per oblast
Dropout
Total number of patients dropping out of OAT services, per country
Dropout per Oblast
Total number of patients dropping out of OAT services, per oblast
Full Information
NCT ID
NCT05579470
First Posted
October 10, 2022
Last Updated
August 9, 2023
Sponsor
Yale University
Collaborators
AIDS Foundation East-West (AFEW) Kyrgyzstan, Institute for International Health and Education, Columbia University Global Health Research Center of Central Asia, National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT05579470
Brief Title
Expanding Medication-Assisted Therapies in Central Asia
Acronym
ExMAT CA
Official Title
Expanding Medication-Assisted Therapies in Central Asia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 7, 2023 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
AIDS Foundation East-West (AFEW) Kyrgyzstan, Institute for International Health and Education, Columbia University Global Health Research Center of Central Asia, National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use Disorder
Keywords
HIV, OUD, OAT, Central Asia
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
900 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NIATx Model
Arm Type
Other
Arm Description
Receiving NIATx Coaching
Intervention Type
Behavioral
Intervention Name(s)
NIATx
Intervention Description
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 Measure Information:
Title
OAT Census
Description
Absolute number of patients on OAT per country
Time Frame
36 months
Title
OAT Census per Oblast
Description
Absolute number of patients on OAT per oblast
Time Frame
36 months
Secondary Outcome Measure Information:
Title
New Patients
Description
Total number of newly enrolled patients into OAT services, per country
Time Frame
36 months
Title
New Patients per Oblast
Description
Total number of newly enrolled patients into OAT services, per oblast
Time Frame
36 months
Title
Dropout
Description
Total number of patients dropping out of OAT services, per country
Time Frame
36 months
Title
Dropout per Oblast
Description
Total number of patients dropping out of OAT services, per oblast
Time Frame
36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frederick L Altice, MD
Phone
203-623-2634
Email
frederick.altice@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederick L Altice, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Columbia University Global Health Research Center of Central Asia
City
Almaty
Country
Kazakhstan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sholpan Primbetova, MSW
Phone
+7-701-930-0281
Email
sholpan.primbetova@ghrcca.org
First Name & Middle Initial & Last Name & Degree
Assel Terlikbayeva, MD
Facility Name
AIDS Foundation East West of Kyrgyzstan
City
Bishkek
Country
Kyrgyzstan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ainura Kurmanalieva
Phone
+996-550-181-181
Email
ainura.kurmanalieva@afew.kg
First Name & Middle Initial & Last Name & Degree
Natalia Shumskaya
Facility Name
Institute for International Health and Education
City
Dushanbe
Country
Tajikistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arash Alaei, MD
Email
alaeiarash@gmail.com
First Name & Middle Initial & Last Name & Degree
Arash Alaei, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Expanding Medication-Assisted Therapies in Central Asia
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