Hepatitis C Surveillance With Linkage to Care of Patients From Non-ID Departments in Jiangsu

Hepatitis C, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03772002
• Other study ID #: IN-CN-987-5343
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: December 2018
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: Chao Wu, M.D, Ph.D.
• Phone: 86-25-83105890
• Email: dr.wu[@]nju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: December 31, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Retrospective cohort:

1. = 18 years of age.

2. Inpatients from non-infectious department.

3. Documentation of laboratory test indicating positive HCV antibody.

Prospective cohort:

1. = 18 years of age.

2. Inpatients from non-infectious departments.

3. Patients who meet the requirement of HCV antibody screening:

1. patients with high risk possibility of HCV infection.

2. patients who will have special or invasive medical operation.

3. 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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Diagnostic Test:
• HCV screening
HCV antibody and HCV RNA surveillance, anti-HCV treatment assessment

Locations

Country	Name	City	State
China	The Third Hospital of Changzhou	Changzhou	Jiangsu
China	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	Gilead Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of patients in non-infectious departments who had positive HCV antibody testing but failed to get HCV RNA test.		1 years
Primary	The percentage of HCV-RNA positivity among patients with the presence of anti-HCV antibody in non-infectious departments after Non-ID HCV screening.		1 years
Primary	The percentage of HCV-RNA positivity linkage to care consensus guideline shaped.		1 years
Secondary	The percentage of CHC patients linked to care in non-infectious departments.		1 years
Secondary	The treatment timeliness as embodied as time period from diagnosis to engagement to anti-HCV DAA treatment.		1 years
Secondary	The referral rate of identified HCV infected patients.		1 years