Simplified HCV Integrated Management Model in Methadone Clinics in Ukraine

NCT07569211 — Not applicable, Completed, 616 participants, Ukrainian Institute on Public Health Policy
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RegistryNCT07569211, acronym SHIM
StatusCompleted
PhaseNot applicable
Study typeInterventional; non randomized, parallel, masking: none, health services research
Enrollment616 (Actual)
SponsorUkrainian Institute on Public Health Policy (Other); collaborators: The Western-Eastern European Partnership Initiative on HIV, Viral Hepatitis and TB
ConditionsHCV, Opioid Use Disorder
InterventionsSimplified HCV Integrated Management, Pay-for-performance, Case Management and Referral (Other)
Datesstart 2023-03-04, primary completion 2025-10-31, completion 2025-12-31, first posted 2026-05-06, last updated 2026-09-16
Locations1 site in Ukraine

Related Papers Related Patents Related Grants Related Experts
All trials for HCV All trials for Opioid Use Disorder All trials of Simplified HCV Integrated Management All trials of Pay-for-performance

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Case Management and ReferralActive comparatorOther: Case Management and Referralstructured referral to off-site specialist clinics for HCV treatment
Simplified HCV Integrated ManagementExperimentalOther: Simplified HCV Integrated Managementsimplified onsite HCV testing, evaluation, treatment, and follow-up delivered by OAMT physicians
Simplified HCV Integrated Management + Pay-for-performanceExperimentalOther: Simplified HCV Integrated Management; Other: Pay-for-performancesimplified onsite HCV testing, evaluation, treatment, and follow-up delivered by OAMT physicians with provider incentives linked to completion of key cascade milestones
  • Simplified HCV Integrated Management (Other): simplified onsite HCV testing, evaluation, treatment, and follow-up delivered by OAMT physicians
  • Pay-for-performance (Other): provider incentives linked to completion of key cascade milestones
  • Case Management and Referral (Other): structured referral to off-site specialist clinics for HCV treatment

+Outcome measures

Primary outcomes

  • Sustained virologic response [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

Secondary outcomes

  • Completion of all pretreatment diagnostic assessments [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
  • Treatment initiation [Through study completion, an average of 4 weeks after baseline]: Number of participants who are prescribed treatment for HCV infection based on clinical records
  • Treatment completion [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
  • SVR assessment completion [Up to 24 weeks after treatment completion]: Number of participants who complete HCV RNA testing for SVR confirmation based on clinical records
  • HCV reinfection [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

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

FacilityCityCountryStatus
Ukrainian Institute on Public Health PolicyKyivUkraine

+Study documents