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

A cluster-randomized RCT 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 1,350 people who inject drugs (PWID) receiving MMT from 15 regions (clusters) and 45 clinical settings using a stratified, phase-in, cluster-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; and To conduct a cost-effectiveness analysis (CEA) of integrating HIV/MMT into PC sites, with or without P4P, compared to a control group of specialized MMT sites.

QHIs are composed of equally weighted sub-scores, with the following numerators over 12 months: Number of patients who received general blood examination, Number of patients who measured blood pressure, Number of patients who have had urinalysis, Number of 40 years and older patients who had a cardiogram, Number of female patients who received a mammogram, Number of female patients who received screening for cervix cancer, Number of patients tested for HBV, Number of patients tested for HCV, Number of patients tested for liver function, Number of patients who received screening for mental health. The denominator for each of the sub-scores will be the total number of patients treated during the 12 months prior to the start of the review period. The outcome will be a score between 0-10, with higher scores indicating more services received, therefore a better outcome.

The HIV QHI is made up of equally weighted sub-scores composed of: patients tested for HIV/patients with unknown or negative status, patients tested for CD4/HIV+, patients not on ART, patients tested for VL/patients on ART, Patients on ART/Patients with HIV. Then, each of these sub-scores are added together to form an overall score, which will then be used to compared the site to other sites in the trial. The outcome will be a score between 0-5, with a higher score indicating more services received, and therefore a better outcome.

The MMT Composite QHI is composed of the following proportions: Number of patients receiving >=80mg of methadone, Number of patients receiving medication by prescription or for take-home, Number of patients in the 6-month cohort who continue treatment 6 months after enrollment, all divided by the total number of patients. Then, each of these sub-scores are added together to form an overall score, which will then be used to compared the site to other sites in the trial. The outcome will be a score between 0-3, with a higher score indicating a better outcome.

The TB composite QHI is composed of the following proportions: Number of patients screened for TB , patients with positive TB screening result who underwent further evaluation by a Phthisiatrician, Number of patients with positive screening result on TB defined as latent who received Isoniazid therapy, over total positive TB patients. Then, each of these sub-scores are added together to form an overall score, which will then be used to compared the site to other sites in the trial. The outcome will be a score between 0-3, with a higher score indicating a better outcome.

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