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

Not Applicable

Completed

• Conditions: Opioid-use Disorder; Hiv
• Interventions: Other: Integration of HIV and PWID services

• Registration Number: NCT04927091
• Lead Sponsor: Yale University

Brief Summary

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.

Detailed Description

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-05-01
• Study First Submitted: 2021-06-10
• Study First Submitted QC: 2021-06-10
• Study First Posted: 2021-06-15
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1458

Inclusion Criteria

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

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Exclusion Criteria

• Not willing to consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ECHO-IC/QI-enhanced primary care clinic with Pay for Performance	Integration of HIV and PWID services	-
ECHO-IC/QI-enhanced primary care clinic	Integration of HIV and PWID services	-

Primary Outcome Measures

Name	Time	Method
Average percentage of recommended Quality Health Indicator services accessed by participants to assess efficacy	every 6 months up to 24 months	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.

Secondary Outcome Measures

Name	Time	Method
Average percentage of recommended HIV Quality Health Indicator services accessed to assess efficacy	every 6 months up to 24 months	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.
Average percentage of recommended MMT Quality Health Indicator services accessed to assess efficacy	every 6 months up to 24 months	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.
Average percentage of recommended TB Quality Health Indicator services accessed to assess efficacy	every 6 months up to 24 months	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.

Trial Locations

Locations (1)

European Institute for Public Health Policy; 🇺🇦 Kyiv, Ukraine