Evaluation of integrated hepatitis C management in methadone clinics in Ukraine

Grantee

Ukrainian Institute on Public Health Policy (UIPHP), Kyiv, Ukraine

Project start

August 2022

Main applicant and principal investigator

Kostyantyn Dumchev, Scientific Director, UIPHP

Deputy applicant

Sergii Dvoriak, Director, UIPHP

Collaborators

1. Prof Frederick Altice, Yale University, USA
2. Dr Patrizia Carrieri, French National Institute of Health and Medical research (INSERM), France

Background

People who inject drugs (PWID) have a high burden of hepatitis C virus infection (HCV) but suffer from lower access to life-saving treatments because of stigma and low awareness. Enrollment into opioid agonist treatment (OAT), especially in integrated settings, improves the health of PWID through reducing drug use and increasing access to medical care. Integration of OAT with HIV and TB care is well studied, including in Ukraine, however, there are only a few studies of OAT and HCV treatment integration. About 17 000 patients receive opioid agonist treatment (OAT) in Ukraine among whom 83% are HCV-infected. Considering the increasing availability of DAA medications in Ukraine, this group can be efficiently covered with treatment using a simplified integrated HCV management (SHIM) care model, which minimizes the number of required assessments and costs. Building on the successful Stage 1 project, where we demonstrated feasibility of the applied SHIM care model and high cure rates in a small sample of OAT patients, we propose a rigorous evaluation using a hybrid type 2 implementation study design.

Objective

The goal of the proposed hybrid type 2 implementation study is to scale up and evaluate the effectiveness of the SHIM algorithm in improving the HCV treatment cascade outcomes in OAT clinics in Ukraine. We will strengthen the SHIM model implementation by an evidence-based ECHO (Extension for Community Healthcare Outcomes) intervention, a collaborative telehealth learning intervention that supports and empowers clinicians to develop knowledge and self-efficacy about HCV care, which has not traditionally been part of their clinical scope. Additionally, we will study the client, clinician and organizational factors that contribute to SHIM and ECHO adoption.

Methods

A hybrid type 2 implementation study design will be applied, combining a matched cluster-randomized trial and qualitative methods. 480 HCV-infected patients from 12 clinics with matching characteristics will be randomized to three arms: standard of care (N=160) versus SHIM with (N=160) or without (N=160) ECHO facilitation. We will assess and compare HCV cascade outcomes, including treatment uptake, completion and HCV cure. Client, clinician and organizational factors that contribute to SHIM and ECHO adoption will be assessed using a qualitative multi-level implementation science framework.

Output / impact

The results of SHIM evaluation, if shown effective, will enable formal endorsement by the Ministry of Health, paving the way for scale-up to OAT clinics and non-specialized clinics in Ukraine. The results of the study will strengthen the global evidence base on integration of HCV services for PWID, which currently lacks RCT data, particularly from low- and middle-income countries. Ultimately, this will result in improved access to HCV care, improved quality of life of the many people currently living with HCV and contribute to HCV elimination.