Towards HCV Elimination: Evaluation of an Integrated Model of HCV Care Targeting People Who Inject Drugs in Hai Phong, Vietnam
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 979
- 试验地点
- 2
- 主要终点
- Proportion of all patients in success of the model of care
研究概览
简要总结
The study aims to assess the effectiveness of a model of hepatitis C screening and integrated care, targeting people who inject drugs (PWIDs) in Hai Phong, Vietnam. In a wider perspective, this model linked to mass screening through repeated Respondent Driven Sampling (RDS) surveys, to simplified treatment protocol, and to large community-based support to improve referral to care, retention in care, adherence to treatment and prevention of reinfection, may have the potential to eliminate HCV among PWIDs in this city.
详细描述
Objectives :
The primary objective of this study is to assess the effectiveness of a model of hepatitis C screening and integrated care targeting PWIDs in Hai Phong, Vietnam.
This model will encompass all steps involved in achieving HCV cure among PWIDs:
i) Mass detection of hepatitis C infection among PWIDs: in the community through a large community-based Respondent Driven Sampling survey (RDS); and in HIV out-patient clinics and methadone treatment centers where serological testing should have been made, but not HCV RNA to confirm hepatitis C infection.
ii) a community-based support to improve referral to specific care for those with hepatitis C infection; iii) a HCV care system delivery integrated within the existing health system with a simplified treatment protocol taking into account PWIDs specificities such as frequent HIV co-infection and methadone treatment; iv) an optimized treatment adherence through a combination of health care therapeutic education and CBO support; v) an increase in harm reduction activities to encompass HCV risk transmission and to prevent HCV reinfection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
All patients
All patients will receive sofosbuvir 400-mg and daclatasvir 60-mg (1 tablet each per day) during 12 weeks.
干预措施: Sofosbuvir 400 mg and Daclatasvir 60 mg (Drug)
HIV/HCV co-infected patients
For HIV/HCV co-infected patients receiving efavirenz or nevirapine, daclatasvir dose will be increased to 90-mg per day (sofosbuvir 400 mg and daclatasvir 90 mg)
干预措施: Sofosbuvir 400 mg and Daclatasvir 90 mg (Drug)
Cirrhosis
In case of cirrhosis : ribavirin will be added to sofosbuvir / daclatasvir 12 weeks
干预措施: Ribavirin (Drug)
Cirrhosis with ribavirin contra-indication
In case of cirrhosis with ribavirin contra-indication : sofosbuvir and daclatasvir for 24 weeks
干预措施: Sofosbuvir and Daclatasvir for 24 weeks (Drug)
结局指标
主要结局
Proportion of all patients in success of the model of care
时间窗: Week 48
Proportion of patients with HCV RNA \< 15 IU/mL at the end of the study among patients who have signed the informed consent.
次要结局
- Proportion of patients cured(Week 24)
- Rate of mortality(Week 48)
- Factors associated with HCV treatment failure(Week 24)
- Rate of reinfection(Week 48)
- Frequency, type and time to drug-related clinical or biological adverse reactions(Week 48)
- Factors associated with HCV reinfection(Week 48)
- Proportion of patients enrolled in care(Pre-inclusion visit)
- Adherence assessment(Week 12)
- Proportion of patients initiating DAA treatment(Initiation treatment visit)
- Incremental cost-effectiveness ratio (ICER)(Week 48)
- Proportion of patients with detectable HCV RNA(Screening pre-inclusion)
- Frequency, type and time to grade 3 or 4 adverse clinical or biological events.(Week 48)
- Effect of the HCV treatment intervention(Week 48)