Expanding Medication-Assisted Therapies in Central Asia

NCT05579470 | Recruiting DMC

• 2 other identifiers: 20000310291R01DA054851-01A1
• Study Type: interventional
• Target: 900
• Locations: 4 countries
• Sites: 4

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.

Conditions

Opioid Use Disorder

Keywords

HIV; OUD; OAT; Central Asia

Outcome Measures

Primary Outcomes (2)

• OAT Census

  Absolute number of patients on OAT per country

  36 months

• OAT Census per Oblast

  Absolute number of patients on OAT per oblast

  36 months

Secondary Outcomes (4)

• New Patients

  36 months

• New Patients per Oblast

  36 months

• Dropout

  36 months

• Dropout per Oblast

  36 months

Study Arms (1)

NIATx Model

OTHER

Receiving NIATx Coaching

Behavioral: NIATx

Interventions

NIATx BEHAVIORAL

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).

NIATx Model

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Quantitative surveys for PWID
• 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
• years or older
• Currently working as an OAT delivery professional at an OAT delivery site
• Focus Groups (PWID on OAT)
• 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)
• 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)

You may not qualify if:

• Not willing to provide consent

Sponsors & Collaborators

• Yale University: lead
• Den Sooluk Nuru: collaborator
• Institute for International Health and Education: collaborator
• Global Health Research Center of Central Asia: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (4)

Yale University

New Haven, Connecticut, 06510, United States

ACTIVE NOT RECRUITING

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

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Frederick L Altice, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frederick L Altice, MD

CONTACT

203-623-2634; frederick.altice@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: October 13, 2022
• Study Start: August 7, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); TA (1); KY (1); KA (1)