Integrating Addiction Treatment and HIV Services Into Primary Care Clinics in Ukraine

NCT04927091 | Completed

• 2 other identifiers: 20000200671R01DA043125-01
• Study Type: interventional
• Target: 1,458
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized controlled trial to:

1. 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. 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.

Conditions

Hiv; Opioid-use Disorder

Outcome Measures

Primary Outcomes (1)

• Average percentage of recommended Quality Health Indicator services accessed by participants to assess efficacy

  The total average percentage of the 17 recommended Quality Health Indicator screenings and services that were accessed by participants to assess efficacy. Recommended QHI screenings are as follows: General medical examination; blood analysis; urine analysis; cardiogram; mammogram; cervical cancer screening; prostate cancer screening; hepatitis B screening; hepatitis C screening; HIV screening; CD4 or viral load; ART treatment; TB screening; TB treatment; received take-home MMT; adequate MMT dose; on MMT for 12 months.

  every 6 months up to 24 months

Secondary Outcomes (3)

• Average percentage of recommended HIV Quality Health Indicator services accessed to assess efficacy

  every 6 months up to 24 months

• Average percentage of recommended MMT Quality Health Indicator services accessed to assess efficacy

  every 6 months up to 24 months

• Average percentage of recommended TB Quality Health Indicator services accessed to assess efficacy

  every 6 months up to 24 months

Study Arms (3)

Specialty Addiction Clinic

NO INTERVENTION

ECHO-IC/QI-enhanced primary care clinic

EXPERIMENTAL

Other: Integration of HIV and PWID services

ECHO-IC/QI-enhanced primary care clinic with Pay for Performance

ACTIVE COMPARATOR

Other: Integration of HIV and PWID services

Interventions

Integration of HIV and PWID services OTHER

Co-location of clinical services for HIV and PWID patients

ECHO-IC/QI-enhanced primary care clinic; ECHO-IC/QI-enhanced primary care clinic with Pay for Performance

Eligibility Criteria

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

You may qualify if:

• PWID
• Interested in MMT
• Meets DSM-V criteria for Opioid Dependence

You may not qualify if:

• Not willing to consent

Sponsors & Collaborators

• Yale University: lead
• Ukrainian Institute on Public Health Policy: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

European Institute for Public Health Policy

Kyiv, Ukraine

Location

Related Publications (2)

• Machavariani E, Esserman D, Dumchev K, Filippovych M, Pykalo I, Ivasiy R, Madden LM, Bromberg DJ, Haddad M, Morozova O, Oliveros D, Ahmad B, Dvoriak S, Altice FL. Integrating Methadone Services Into Primary Care in Ukraine: Two-Year Outcomes From a Randomized Trial. Ann Intern Med. 2025 Dec 9. doi: 10.7326/ANNALS-25-01764. Online ahead of print.

  PMID: 41359964 DERIVED

• 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.

  PMID: 36962514 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Frederick Altice, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: June 15, 2021
• Study Start: May 1, 2017
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: July 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

UA (1)