Hepatitis C Surveillance With Linkage to Care of Patients From Non-ID Departments in Jiangsu
Primary Purpose
Hepatitis C, Chronic
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
HCV screening
Sponsored by
About this trial
This is an interventional screening trial for Hepatitis C, Chronic
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Retrospective cohort: Duplicated subjects.
Prospective cohort:Inability or unwillingness to provide informed consent or abide by the requirements of the study.
Sites / Locations
- The Third Hospital of Changzhou
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HCV screening
Arm Description
Outcomes
Primary Outcome Measures
The percentage of patients in non-infectious departments who had positive HCV antibody testing but failed to get HCV RNA test.
The percentage of HCV-RNA positivity among patients with the presence of anti-HCV antibody in non-infectious departments after Non-ID HCV screening.
The percentage of HCV-RNA positivity linkage to care consensus guideline shaped.
Secondary Outcome Measures
The percentage of CHC patients linked to care in non-infectious departments.
The treatment timeliness as embodied as time period from diagnosis to engagement to anti-HCV DAA treatment.
The referral rate of identified HCV infected patients.
Full Information
NCT ID
NCT03772002
First Posted
December 9, 2018
Last Updated
December 11, 2018
Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborators
Gilead Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03772002
Brief Title
Hepatitis C Surveillance With Linkage to Care of Patients From Non-ID Departments in Jiangsu
Official Title
Hepatitis C Surveillance With Linkage to Care of Patients From Non-infectious Departments in Tertiary Hospitals From Jiangsu, China
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Anticipated)
Primary Completion Date
June 30, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborators
Gilead Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HCV screening
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
HCV screening
Intervention Description
HCV antibody and HCV RNA surveillance, anti-HCV treatment assessment
Primary Outcome Measure Information:
Title
The percentage of patients in non-infectious departments who had positive HCV antibody testing but failed to get HCV RNA test.
Time Frame
1 years
Title
The percentage of HCV-RNA positivity among patients with the presence of anti-HCV antibody in non-infectious departments after Non-ID HCV screening.
Time Frame
1 years
Title
The percentage of HCV-RNA positivity linkage to care consensus guideline shaped.
Time Frame
1 years
Secondary Outcome Measure Information:
Title
The percentage of CHC patients linked to care in non-infectious departments.
Time Frame
1 years
Title
The treatment timeliness as embodied as time period from diagnosis to engagement to anti-HCV DAA treatment.
Time Frame
1 years
Title
The referral rate of identified HCV infected patients.
Time Frame
1 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Retrospective cohort: Duplicated subjects.
Prospective cohort:Inability or unwillingness to provide informed consent or abide by the requirements of the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chao Wu, M.D, Ph.D.
Phone
86-25-83105890
Email
dr.wu@nju.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yuxin Chen, Ph.D.
Phone
86-25-83105890
Email
yuxin_chen2015@163.com
Facility Information:
Facility Name
The Third Hospital of Changzhou
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213001
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Longgen Liu
Facility Name
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chao Wu, M.D, Ph.D
Phone
86-25-83105890
Email
dr.wu@nju.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Hepatitis C Surveillance With Linkage to Care of Patients From Non-ID Departments in Jiangsu
We'll reach out to this number within 24 hrs