Strategies for Hepatitis C Testing and Treatment in Aboriginal Communities That Lead to Elimination
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 4
- 主要终点
- Change in Hepatitis C prevalence
研究概览
简要总结
A community-based "test and treat" intervention integrating point-of-care HCV RNA testing, non-invasive liver disease assessment and linkage to care will lead to a reduction in HCV prevalence among people attending Aboriginal health services.
详细描述
SCALE-C is an interventional cohort study recruiting people with or at risk of HCV infection from Aboriginal health services in Australia. Participants will be screened for HCV infection using point-of-care testing (anti-HCV antibody and/or HCV RNA). People with current HCV infection (HCV RNA positive) will be offered treatment with eight or 12 weeks of pan-genotypic DAA therapy, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir, as available on the PBS.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •18 years of age or older;
- •voluntarily signed the informed consent form.
排除标准
- •Pregnant women.
研究组 & 干预措施
Fingerstick Point of Care GeneXpert HCV Test
Participants will have HCV testing using the finger-stick point of care GeneXpert quantitative HCV RNA assay.
干预措施: Fingerstick GeneXpert HCV RNA quantitative assay (Device)
Fingerstick Point of Care GeneXpert HCV Test
Participants will have HCV testing using the finger-stick point of care GeneXpert quantitative HCV RNA assay.
干预措施: sofosbuvir/velpatesvir (Drug)
Fingerstick Point of Care GeneXpert HCV Test
Participants will have HCV testing using the finger-stick point of care GeneXpert quantitative HCV RNA assay.
干预措施: glecaprevir/pibrentasvir (Drug)
Treat - SOF/VEL
Participants with active HCV infection will be offered treatment with one of two pan-genoptyic regimens available in Australia - sofosbuvir/velpatesvir
干预措施: sofosbuvir/velpatesvir (Drug)
Treat - G/P
Participants with active HCV infection will be offered treatment with one of two pan-genoptyic regimens available in Australia - glecaprevir/pibrentasvir
干预措施: glecaprevir/pibrentasvir (Drug)
结局指标
主要结局
Change in Hepatitis C prevalence
时间窗: Week 0 to week 144
Change in the proportion of people with current HCV infection (HCV RNA positive)
次要结局
- Change in Hepatitis C incidence(Week 0 to week 144)
- DAA uptake(To week 144)
- Treatment response rate (SVR12 rate)(From week 0 to Week 144)
- HCV reinfection incidence post treatment(6 monthly from end of treatment until week 144)