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

A randomized controlled trial to:

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.

Study Overview

• Status: Completed
• Conditions: Hiv; Opioid-use Disorder
• Intervention / Treatment: Other: Integration of HIV and PWID services

Detailed Description

Original outcomes were edited and Implementation outcomes were added November 2023.

• Study Type: Interventional
• Enrollment (Actual): 1458
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ukraine
  • Kyiv, Ukraine
    • European Institute for Public Health Policy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Not willing to consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Specialty Addiction Clinic
Experimental: ECHO-IC/QI-enhanced primary care clinic	Other: Integration of HIV and PWID services; Co-location of clinical services for HIV and PWID patients
Active Comparator: ECHO-IC/QI-enhanced primary care clinic with Pay for Performance	Other: Integration of HIV and PWID services; Co-location of clinical services for HIV and PWID patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average percentage of recommended HIV Quality Health Indicator services accessed to assess efficacy	The total average percentage of the 3 HIV Quality Health Indicator screenings and services that were accessed by participants to assess efficacy. Recommended QHI screenings are as follows: HIV screening; CD4 or viral load; ART treatment.	every 6 months up to 24 months
Average percentage of recommended MMT Quality Health Indicator services accessed to assess efficacy	The total average percentage of the 3 HIV Quality Health Indicator screenings and services that were accessed by participants to assess efficacy. Recommended QHI screenings are as follows: received take-home MMT; adequate MMT dose; on MMT for 12 months.	every 6 months up to 24 months
Average percentage of recommended TB Quality Health Indicator services accessed to assess efficacy	The total average percentage of the 2 HIV Quality Health Indicator screenings and services that were accessed by participants to assess efficacy. Recommended QHI screenings are as follows: TB screening; TB treatment.	every 6 months up to 24 months

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Drug Abuse (NIDA); Ukrainian Institute on Public Health Policy
• Investigators: Principal Investigator: Frederick Altice, MD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: June 10, 2021
• First Submitted That Met QC Criteria: June 10, 2021
• First Posted (Actual): June 15, 2021

Study Record Updates

• Last Update Posted (Actual): July 10, 2024
• Last Update Submitted That Met QC Criteria: July 9, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: 2000020067; 1R01DA043125-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No