Simplified HCV Integrated Management Model in Methadone Clinics in Ukraine

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

Interventions

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

OTHER

Case Management and Referral

structured referral to off-site specialist clinics for HCV treatment

Sponsors & Collaborators

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

  collaborator UNKNOWN

• Ukrainian Institute on Public Health Policy

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-03-04

Primary Completion

2025-10-31

Completion

2025-12-31

Countries

• Ukraine

Study Locations