Clinical trial NCT03772002: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatitis C, Chronic
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2018-12-11
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The percentage of patients in non-infectious departments who had positive HCV antibody testing but failed to get HCV RNA test.
timeFrame: 1 years
measure: The percentage of HCV-RNA positivity among patients with the presence of anti-HCV antibody in non-infectious departments after Non-ID HCV screening.
timeFrame: 1 years
measure: The percentage of HCV-RNA positivity linkage to care consensus guideline shaped.
timeFrame: 1 years
Secondary outcomes:
measure: The percentage of CHC patients linked to care in non-infectious departments.
timeFrame: 1 years
measure: The treatment timeliness as embodied as time period from diagnosis to engagement to anti-HCV DAA treatment.
timeFrame: 1 years
measure: The referral rate of identified HCV infected patients.
timeFrame: 1 years
Other outcomes:
Locations:
city: Changzhou
country: China
facility: The Third Hospital of Changzhou
state: Jiangsu
city: Nanjing
country: China
facility: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
state: Jiangsu
Study officials:
References: