Hepatitis C: Community Testing and Treatment (CT2 Study Myanmar)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 634
- 试验地点
- 2
- 主要终点
- Proportion of Ab positive patients who receive GeneXpert HCV VL test
研究概览
简要总结
Implementation-effectiveness hybrid trial assessing acceptability, feasibility and cost-effectiveness of community-based point-of-care testing and treatment for hepatitis C. Utilises Cepheid GeneXpert HCV VL device as diagnostic tool (diagnosis of chronic infection and assessment of treatment outcome) and sofosbuvir/daclatasvir for HCV therapy (local standard of care).
详细描述
Historically, testing and treatment for hepatitis C has been confined to centralised laboratories and tertiary hospitals respectively. Recent advancements in point-of-care testing for hepatitis C (anti-HCV antibody and HCV RNA/VL) and treatment options with the introduction of direct acting antivirals allows for testing and treatment to occur in de-centralised primary care settings.
This study is an effectiveness-implementation hybrid study to assess the feasibility, acceptability, effectiveness and cost-effectiveness of a de-centralised approach to hepatitis C testing and treatment at community-based clinics in Yangon, Myanmar. Generalist doctors trained in hepatitis C treatment will prescribe direct acting antiviral therapy to eligible participants.
The study will utilise SD Bioline HCV RDT and Cepheid GeneXpert HCV VL test; and sofosbuvir/daclatasvir to treat hepatitis C. Test of cure will be performed at 12 weeks post-treatment completion to assess sustained virological response (SVR).
Study inclusion criteria prior to recruitment into study:
- Aged ≥18 years
- Attendance at study site
- Willing and able to provide written informed consent
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- 是
入选标准
- •Aged ≥18 years
- •Attendance at study site
- •Willing and able to provide written informed consent
排除标准
- •Confirmed HCV RNA positive result (chronic HCV infection) prior to study recruitment
- •Treatment experienced (either DAA or pegylated interferon)
- •Hepatitis B virus (HBV) infected
- •Human Immunodeficiency Virus (HIV) infected
- •estimated glomerular filtration rate (eGFR) <30
- •Active tuberculosis (if known active tuberculosis or as per symptom screening assessment)
- •Pregnant women
- •Serious drug-drug interaction with sofosbuvir/daclatasvir of a drug that the patient is unwilling or unable to stop taking
结局指标
主要结局
Proportion of Ab positive patients who receive GeneXpert HCV VL test
时间窗: 6-9 months of recruitment
Calculated by using Number of HCV Ab tests performed, Number of HCV RNA tests performed. Aggregate data is taken from patient-level case report forms recording results of tests performed (Clinical Case Report Form 1 \& 2).
Proportion of patients who achieve SVR12 who started on direct-acting antiviral therapy for chronic hepatitis C infection
时间窗: 9-18 months
Calculated by using Number of patients started on DAAs, Number of patients who completed treatment, Number of patients who achieve SVR12 as measured by GeneXpert HCV VL not detected 12 weeks post completion of treatment. Aggregate data is taken from patient-level case report forms recording results of tests performed and treatment plan (Clinical Case Report Form 1, 2, 3, 4 \& 5).
Proportion of patients who complete direct-acting antiviral therapy for chronic hepatitis C infection
时间窗: 9-18 months
Calculated by using Number of patients started on DAAs, Number of patients who completed treatment. Aggregate data is taken from patient-level case report forms recording results of tests performed and treatment plan (Clinical Case Report Form 1, 2, 3, 4 \& 5).
Proportion of RNA positive patients who receive direct-acting antiviral therapy for chronic hepatitis C infection
时间窗: 9-12 months of recruitment & treatment
Calculated by using Number of HCV RNA positive patients, Number of patients started on DAAs. Aggregate data is taken from patient-level case report forms recording results of tests performed and treatment plan (Clinical Case Report Form 1, 2 \& 3).
次要结局
- Costing of testing and treatment pathway at community site(6-18 months)
- Satisfaction of testing and treatment pathway among patients(6-18 months)