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

Study Overview
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Brief Summary
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A randomized controlled trial to: 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. 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
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Original outcomes were edited and Implementation outcomes were added November 2023.

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

Conditions
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Hiv, Opioid-use Disorder

Intervention / Treatment
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* Other: Integration of HIV and PWID services


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PWID Interested in MMT Meets DSM-V criteria for Opioid Dependence Exclusion Criteria: Not willing to consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |