Simplified HCV Integrated Management Model in Methadone Clinics in Ukraine (SHIM)

April 28, 2026 updated by: Ukrainian Institute on Public Health Policy

The goal of this pragmatic, quasi-experimental cluster trial is to evaluate whether simplified, onsite hepatitis C virus (HCV) treatment integrated into opioid agonist maintenance therapy (OAMT) clinics improves cure rates compared with referral-based care in Ukraine . The study includes adults (18 years and older) receiving OAMT with confirmed chronic HCV infection and no prior HCV treatment.

The main questions it aims to answer are:

  • Does onsite Simplified HCV Integrated Management (SHIM) increase the proportion of patients achieving sustained virologic response 12 weeks after treatment completion (SVR12) compared with case management and referral (CMR) to specialist clinics?
  • Does adding provider pay-for-performance (P4P) incentives to SHIM further improve progression along the HCV treatment cascade and SVR12 rates?

Researchers compared three models of care across 13 OAMT clinics in 12 Ukrainian cities:

  • Case Management and Referral (CMR): structured referral to off-site specialist clinics for HCV treatment
  • SHIM: simplified onsite HCV testing, evaluation, treatment, and follow-up delivered by OAMT physicians
  • SHIM + P4P: SHIM with provider incentives linked to completion of key cascade milestones All SHIM clinics were supported by Project ECHO telementoring to strengthen clinician capacity . The study used nationally procured direct-acting antivirals (DAAs) under routine program conditions and did not reimburse diagnostic costs.

Between February 2023 and December 2024, 616 eligible patients were enrolled .

Participants:

  • Completed confirmatory HCV RNA testing
  • Underwent simplified pretreatment clinical and laboratory assessment
  • Received 12 weeks of pan-genotypic DAA treatment either onsite (SHIM arms) or at specialist clinics (CMR arm)
  • Attended follow-up visits during treatment for adherence assessment and counseling
  • Were prescribed HCV RNA testing 12 weeks after treatment completion to confirm cure (SVR12) The primary outcome was SVR12. Secondary outcomes included completion of pretreatment evaluation, treatment initiation, treatment completion, and completion of SVR assessment.

This study evaluates HCV care under real-world conditions during ongoing national treatment scale-up in Ukraine. The findings inform whether integrating simplified HCV treatment into OAMT clinics-and aligning provider incentives-can improve cure rates and accelerate progress toward HCV elimination in high-burden populations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

616

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ukraine
      • Kyiv, Ukraine, 01054
        • Ukrainian Institute on Public Health Policy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • currently receiving treatment at the selected OAT site (implying a diagnosis of opioid dependence according to ICD 10);
  • aged 18 years or older;
  • residing within the study catchment area; and
  • having a positive HCV antibody test documented in the medical chart

Exclusion Criteria:

  • previous HCV treatment history;
  • active tuberculosis (assessed using 4-item screening questionnaire and confirmed according to the current national protocol);
  • pregnant or planning pregnancy in the next 6 months;
  • planning to move to another city in the next 6 months;
  • unwillingness to undergo confirmatory HCV RNA PCR test at their own expense and treat HCV

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Case Management and Referral
structured referral to off-site specialist clinics for HCV treatment
Other: Case Management and Referral
structured referral to off-site specialist clinics for HCV treatment
Experimental: Simplified HCV Integrated Management
simplified onsite HCV testing, evaluation, treatment, and follow-up delivered by OAMT physicians
Other: Simplified HCV Integrated Management
simplified onsite HCV testing, evaluation, treatment, and follow-up delivered by OAMT physicians
Experimental: Simplified HCV Integrated Management + Pay-for-performance
simplified onsite HCV testing, evaluation, treatment, and follow-up delivered by OAMT physicians with provider incentives linked to completion of key cascade milestones
Other: Simplified HCV Integrated Management
simplified onsite HCV testing, evaluation, treatment, and follow-up delivered by OAMT physicians
Other: Pay-for-performance
provider incentives linked to completion of key cascade milestones

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sustained virologic response
Time Frame: Up to 24 weeks after treatment completion
Number of participants who have HCV RNA below the limit of quantitation (≤50 IU/mL) based on clinical records
Up to 24 weeks after treatment completion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completion of all pretreatment diagnostic assessments
Time Frame: Through study completion, an average of 2 weeks after baseline
Number of participants who complete all pretreatment diagnostic assessments according to the SHIM algorithm (complete blood count, basic metabolic panel (including creatinine), hepatic function panel, fibrosis assessment, and HBsAg testing) based on clinical records
Through study completion, an average of 2 weeks after baseline
Treatment initiation
Time Frame: Through study completion, an average of 4 weeks after baseline
Number of participants who are prescribed treatment for HCV infection based on clinical records
Through study completion, an average of 4 weeks after baseline
Treatment completion
Time Frame: Through study completion, an average of 14 weeks after baseline
Number of participants who complete the full course of HCV treatment as prescribed based on clinical records
Through study completion, an average of 14 weeks after baseline
SVR assessment completion
Time Frame: Up to 24 weeks after treatment completion
Number of participants who complete HCV RNA testing for SVR confirmation based on clinical records
Up to 24 weeks after treatment completion
HCV reinfection
Time Frame: 12 months after treatment completion
Number of participants who receive a positive result of HCV RNA test at 12 months after treatment completion, based on clinical records
12 months after treatment completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ukrainian Institute on Public Health Policy

Collaborators

The Western-Eastern European Partnership Initiative on HIV, Viral Hepatitis and TB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2023

Primary Completion (Actual)

October 31, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

February 27, 2026

First Submitted That Met QC Criteria

April 28, 2026

First Posted (Actual)

May 6, 2026

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 127-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

January 1, 2026 - June 30, 2029

IPD Sharing Access Criteria

Reasonable request to the principal investigator

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Study Data/Documents

  1. Study Protocol
  2. Informed Consent Form

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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