NCT03772002

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

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 School·ClinicalTrials.gov·diagnostic test
View on ClinicalTrials.gov
Study focus
Disease/Condition
Hepatitis C, Chronic
Drug/Device/Intervention
HCV screening
Study type
Interventional
Intervention type
diagnostic test
Sponsor & location
Primary sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Location
Changzhou,Nanjing, China
Timeline & enrollment
Phase
N/A
Start date
Jan 01, 2019
End date
Dec 31, 2020
Enrollment
600 participants
Primary outcome

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.

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.

ICD-10 classifications
Chronic viral hepatitis CAcute hepatitis CChronic hepatitis, unspecifiedChronic viral hepatitisChronic viral hepatitis, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT03772002
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT03772002 through Pure Global AI's free database. This phase not specified trial is sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School and is currently status unknown. The study focuses on Hepatitis C, Chronic. Target enrollment is 600 participants.

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