Integrating Addiction Treatment and HIV Services Into Primary Care Clinics in Ukraine
NCT ID: NCT04927091
Last Updated: 2024-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1458 participants
INTERVENTIONAL
2017-05-01
2024-06-30
Brief Summary
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1. To compare both primary (composite quality health indicator (QHI) scores) and secondary (individual HIV/methadone maintenance treatment (MMT)/TB/primary care QHI scores, quality of life, and stigma) outcomes in an anticipated 1,350 people who inject drugs (PWID) receiving MMT from 13 regions (clusters) and 39 clinical settings using a stratified, phase-in, controlled design over 24 months. After stratifying PWIDs based on their current receipt of MMT, they will be randomized to receive MMT in specialty addiction clinics (N=450) or in an ECHO-IC/QI-enhanced primary care clinic with (N=450) or without (N=450) pay for performance (P4P) incentives.
2. Using a multi-level implementation science framework, to examine the contribution of client, clinician and organizational factors that contribute to the comprehensive composite (primary outcome) and individual (secondary) QHI scores.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Specialty Addiction Clinic
No interventions assigned to this group
ECHO-IC/QI-enhanced primary care clinic
Integration of HIV and PWID services
Co-location of clinical services for HIV and PWID patients
ECHO-IC/QI-enhanced primary care clinic with Pay for Performance
Integration of HIV and PWID services
Co-location of clinical services for HIV and PWID patients
Interventions
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Integration of HIV and PWID services
Co-location of clinical services for HIV and PWID patients
Eligibility Criteria
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Inclusion Criteria
* Interested in MMT
* Meets DSM-V criteria for Opioid Dependence
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Ukrainian Institute on Public Health Policy
OTHER
National Institute on Drug Abuse (NIDA)
NIH
Yale University
OTHER
Responsible Party
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Principal Investigators
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Frederick Altice, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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European Institute for Public Health Policy
Kyiv, , Ukraine
Countries
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References
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Pashchenko O, Bromberg DJ, Dumchev K, LaMonaca K, Pykalo I, Filippovych M, Esserman D, Polonsky M, Galvez de Leon SJ, Morozova O, Dvoriak S, Altice FL. Preliminary analysis of self-reported quality health indicators of patients on opioid agonist therapy at specialty and primary care clinics in Ukraine: A randomized control trial. PLOS Glob Public Health. 2022 Nov 2;2(11):e0000344. doi: 10.1371/journal.pgph.0000344. eCollection 2022.
Other Identifiers
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2000020067
Identifier Type: -
Identifier Source: org_study_id
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