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临床试验/NCT03772002
NCT03772002Unknown不适用

Hepatitis C Surveillance With Linkage to Care of Patients From Non-infectious Departments in Tertiary Hospitals From Jiangsu, China

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2019年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
600
试验地点
2
主要终点
The percentage of HCV-RNA positivity linkage to care consensus guideline shaped.

研究概览

简要总结

Due to the occult nature of hepatitis C virus (HCV), it is estimated that less than 5% of people with chronic hepatitis C (CHC) infection knowing their status. The major challenges are that awareness is lacking, reliable diagnostics and testing services are not sufficiently available, and laboratory capacity is weak. In the context of major tertiary hospitals, the well-functioning laboratories would ensure the high-quality HCV testing, which facilitate the identification of inpatients who are unaware of HCV infection. However, given the preliminary data, diagnostic rate of inpatients from non-infectious (non-ID) departments is disturbingly low. A recent study from a major hospital in Jilin province of China showed that 3.36% of inpatients were anti-HCV positive; however, HCV RNA confirmatory testing was not further performed in this study.

From the retrospective cohort in non-ID departments of a tertiary hospital of Jiangsu during 2016 to 2017, only 25.9% (71/273) of patients with anti-HCV antibody (Ab) further had HCV RNA confirmatory test, while 40% (29/71) were identified as CHC. The previous data indicates that insufficient anti-HCV Ab testing and insufficient follow-up of patients with positive anti-HCV Ab from non-ID departments. Indeed, compared to hospitals in Western countries, the infectious department in Chinese hospitals are relative independent from non-ID departments, meanwhile the knowledge of HCV infection is relatively lacking for non-ID physicians. Therefore, an appropriate clinical pathway for integration and linkage of non-ID department and ID departments for diagnosis and care delivery of CHC patients is urgently needed. The investigator aim to establish a feasible clinical pathway and consensus guideline to enhance HCV testing surveillance with linkage to care in non-ID departments. Moreover, the participants with anti-HCV Ab also will be enrolled in the HCV prospective cohort, in which the intervention and clinical outcome of hepatitis will be longitudinally monitored in the future study.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

入选标准

  • Retrospective cohort:
  • ≥ 18 years of age.
  • Inpatients from non-infectious department.
  • Documentation of laboratory test indicating positive HCV antibody.
  • Prospective cohort:
  • ≥ 18 years of age.
  • Inpatients from non-infectious departments.
  • Patients who meet the requirement of HCV antibody screening:
  • patients with high risk possibility of HCV infection.
  • patients who will have special or invasive medical operation.
  • patients with unexplained abnormal liver biochemical laboratory results.

排除标准

  • Retrospective cohort: Duplicated subjects.
  • Prospective cohort:Inability or unwillingness to provide informed consent or abide by the requirements of the study.

研究组 & 干预措施

HCV screening

Experimental

干预措施: HCV screening (Diagnostic Test)

结局指标

主要结局

The percentage of HCV-RNA positivity linkage to care consensus guideline shaped.

时间窗: 1 years

The percentage of patients in non-infectious departments who had positive HCV antibody testing but failed to get HCV RNA test.

时间窗: 1 years

The percentage of HCV-RNA positivity among patients with the presence of anti-HCV antibody in non-infectious departments after Non-ID HCV screening.

时间窗: 1 years

次要结局

  • The percentage of CHC patients linked to care in non-infectious departments.(1 years)
  • The referral rate of identified HCV infected patients.(1 years)
  • The treatment timeliness as embodied as time period from diagnosis to engagement to anti-HCV DAA treatment.(1 years)

研究者

发起方
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chao Wu

Prof.

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

研究点 (2)

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