Simplified HCV Integrated Management Model in Methadone Clinics in Ukraine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 616
- 试验地点
- 1
- 主要终点
- Sustained virologic response
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Simplified HCV Integrated Management + Pay-for-performance
simplified onsite HCV testing, evaluation, treatment, and follow-up delivered by OAMT physicians with provider incentives linked to completion of key cascade milestones
干预措施: Simplified HCV Integrated Management (Other)
Simplified HCV Integrated Management + Pay-for-performance
simplified onsite HCV testing, evaluation, treatment, and follow-up delivered by OAMT physicians with provider incentives linked to completion of key cascade milestones
干预措施: Pay-for-performance (Other)
Simplified HCV Integrated Management
simplified onsite HCV testing, evaluation, treatment, and follow-up delivered by OAMT physicians
干预措施: Simplified HCV Integrated Management (Other)
Case Management and Referral
structured referral to off-site specialist clinics for HCV treatment
干预措施: Case Management and Referral (Other)
结局指标
主要结局
Sustained virologic response
时间窗: 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
次要结局
- 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)