An interventional study of Simplified HCV Integrated Management and Pay-for-performance in HCV and Opioid Use Disorder, sponsored by Ukrainian Institute on Public Health Policy. Completed at 1 site in Ukraine. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Ukrainian Institute on Public Health Policy · Not applicable, Interventional, and Health services research
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:
Researchers compared three models of care across 13 OAMT clinics in 12 Ukrainian cities:
Between February 2023 and December 2024, 616 eligible patients were enrolled .
Participants:
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.
1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's enrollment of 616 is above the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →Ukrainian Institute on Public Health Policy is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
structured referral to off-site specialist clinics for HCV treatment
Other: Case Management and Referral
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 with provider incentives linked to completion of key cascade milestones
Other: Simplified HCV Integrated Management · Other: Pay-for-performance
simplified onsite HCV testing, evaluation, treatment, and follow-up delivered by OAMT physicians
provider incentives linked to completion of key cascade milestones
structured referral to off-site specialist clinics for HCV treatment
Sustained virologic response
Number of participants who have HCV RNA below the limit of quantitation (≤50 IU/mL) based on clinical records
Time frame: Up to 24 weeks after treatment completion
Completion of all pretreatment diagnostic assessments
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
Time frame: Through study completion, an average of 2 weeks after baseline
Treatment initiation
Number of participants who are prescribed treatment for HCV infection based on clinical records
Time frame: Through study completion, an average of 4 weeks after baseline
Treatment completion
Number of participants who complete the full course of HCV treatment as prescribed based on clinical records
Time frame: Through study completion, an average of 14 weeks after baseline
SVR assessment completion
Number of participants who complete HCV RNA testing for SVR confirmation based on clinical records
Time frame: Up to 24 weeks after treatment completion
HCV reinfection
Number of participants who receive a positive result of HCV RNA test at 12 months after treatment completion, based on clinical records
Time frame: 12 months after treatment completion
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes
Supporting information: Study protocol, Icf
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Ukrainian Institute on Public Health Policy