Simplified HCV Integrated Management Model in Methadone Clinics in Ukraine

NCT07569211 | Completed

• 1 other identifier: 127-2022
• Study Type: interventional
• Target: 616
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HCV; Opioid Use Disorder

Keywords

implementation science; Ukraine; Eastern Europe; Hepatitis C; HCV treatment cascade; Opioid agonist maintenance therapy

Outcome Measures

Primary Outcomes (1)

• Sustained virologic response

  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 Outcomes (5)

• Completion of all pretreatment diagnostic assessments

  Through study completion, an average of 2 weeks after baseline

• Treatment initiation

  Through study completion, an average of 4 weeks after baseline

• Treatment completion

  Through study completion, an average of 14 weeks after baseline

• SVR assessment completion

  Up to 24 weeks after treatment completion

• HCV reinfection

  12 months after treatment completion

Study Arms (3)

Case Management and Referral

ACTIVE COMPARATOR

structured referral to off-site specialist clinics for HCV treatment

Other: Case Management and Referral

Simplified HCV Integrated Management

EXPERIMENTAL

simplified onsite HCV testing, evaluation, treatment, and follow-up delivered by OAMT physicians

Other: Simplified HCV Integrated Management

Simplified HCV Integrated Management + Pay-for-performance

EXPERIMENTAL

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; Other: Pay-for-performance

Interventions

Simplified HCV Integrated Management OTHER

simplified onsite HCV testing, evaluation, treatment, and follow-up delivered by OAMT physicians

Simplified HCV Integrated Management; Simplified HCV Integrated Management + Pay-for-performance

Pay-for-performance OTHER

provider incentives linked to completion of key cascade milestones

Simplified HCV Integrated Management + Pay-for-performance

Case Management and Referral OTHER

structured referral to off-site specialist clinics for HCV treatment

Case Management and Referral

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ukrainian Institute on Public Health Policy: lead
• The Western-Eastern European Partnership Initiative on HIV, Viral Hepatitis and TB: collaborator

Study Sites (1)

Ukrainian Institute on Public Health Policy

Kyiv, 01054, Ukraine

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Hepatitis C

Interventions

Reimbursement, Incentive; Case Management; Referral and Consultation

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Reimbursement Mechanisms; Insurance, Health, Reimbursement; Financing, Organized; Economics; Health Care Economics and Organizations; Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration; Professional Practice; Organization and Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: May 6, 2026
• Study Start: March 4, 2023
• Primary Completion: October 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: January 1, 2026 - June 30, 2029
• Access Criteria: Reasonable request to the principal investigator

Locations

UA (1)