HCV, Opioid Use Disorder
Conditions
Keywords
implementation science, Ukraine, Eastern Europe, Hepatitis C, HCV treatment cascade, Opioid agonist maintenance therapy
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.
Interventions
OTHERSimplified HCV Integrated Management
simplified onsite HCV testing, evaluation, treatment, and follow-up delivered by OAMT physicians
OTHERPay-for-performance
provider incentives linked to completion of key cascade milestones
OTHERCase Management and Referral
structured referral to off-site specialist clinics for HCV treatment
Sponsors
Ukrainian Institute on Public Health Policy
The Western-Eastern European Partnership Initiative on HIV, Viral Hepatitis and TB
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Ukraine
Outcome results
None listed