Screening for Hepatitis C and Hepatitis B in Inpatients: A Toronto Viral Hepatitis Care Network (VIRCAN) Collaboration
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 2,920
- 试验地点
- 4
- 主要终点
- Number of HCV RNA positive participants who attend their first hepatology appointment.
研究概览
简要总结
Currently, there is a lack of literature on programs evaluating rapid screening methods to traditional venipuncture methods for sample collection during screening for viral hepatitis. Due to the relatively low diagnosis and linkage to care rate, screening programs that provide same day results for viral hepatitis infection may improve both diagnosis and enable providers to engage patients shortly after diagnosis. This stands in contrast to the multi-visit, weeks long process that normally accompanies serum testing for hepatitis C virus (HCV) and hepatitis B virus (HBV). A few American studies have examined the implementation of HCV inpatient screening programs; however, they are focused specifically on high-risk patient populations, the barriers to accessing care experienced by study participants are not relevant to the Canadian healthcare system context, and do not use rapid testing. Furthermore, there are few, if any, data on HBV inpatient screening programs and the diagnosis rate remains low. This project will provide key data on a rapid inpatient screening and linkage to care strategy as well as the prevalence of these viruses across different age bands within the population. Finally, the study will help determine whether rapid inpatient screening is a feasible and acceptable approach for screening and linkage to care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 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
- •Adults aged 18 years or older at time of consent
- •Patients admitted to GIMIUs at TGH or TWH
排除标准
- •Patients whose end of life is expected to be less than 6 months
- •Patients who are unable or decline to provide informed consent
- •Patients with confirmed, active COVID-19 infections
- •Patients with immediate life-threatening conditions where screening for chronic HCV and HBV infection may delay urgent care
结局指标
主要结局
Number of HCV RNA positive participants who attend their first hepatology appointment.
时间窗: 2 year
To determine the proportion of HCV RNA positive participants successfully linked to care from each arm. Participants will be contacted at 90 days and 1 year post-enrolment to self-report.
Number of HCV RNA positive participants who achieve a Sustained Virological Response at 12 weeks (SVR12) after treatment completion.
时间窗: 2 year
To determine the proportion of HCV RNA positive participants who successfully achieved a sustained virological response at 12 weeks (SVR12) after treatment completion. Participants will be contacted at 90 days and 1 year post-enrolment to self-report.
Number of HCV antibody positive participants who complete an HCV RNA PCR.
时间窗: 2 year
To determine the proportion of HCV antibody positive participants who complete HCV RNA PCR in each arm. Participants will be contacted at 90 days and 1 year post-enrolment to self-report progress.
次要结局
- Number of chronic hepatitis C and hepatitis B infection in the general internal medicine inpatient units.(1 year)
- Percentage of physicians, residents, and nurses who believe that hepatitis C and hepatitis B screening can be incorporated into the general internal medicine inpatient units' workflow.(1 year)
- Proportion of Cepheid Xpert® HCV Viral Load test results matching test results from the standard commercial assay for HCV RNA PCR.(1 year)
- Number of patients willing to participate in hepatitis C and hepatitis B screening in general internal medicine inpatient units.(1 year)
- Retrospective rates of HCV testing, HCV antibody positive results, and HCV RNA positive results in general internal medicine inpatient units.(1 year)
研究者
Jordan Feld
Associate Professor
University Health Network, Toronto