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

NCT ID: NCT03772002

Last Updated: 2018-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatitis C, Chronic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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HCV screening

Group Type EXPERIMENTAL

HCV screening

Intervention Type DIAGNOSTIC_TEST

HCV antibody and HCV RNA surveillance, anti-HCV treatment assessment

Interventions

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HCV screening

HCV antibody and HCV RNA surveillance, anti-HCV treatment assessment

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role collaborator

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role lead

Responsible Party

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Chao Wu

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Third Hospital of Changzhou

Changzhou, Jiangsu, China

Site Status

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Site Status

Countries

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China

Central Contacts

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Chao Wu, M.D, Ph.D.

Role: CONTACT

Phone: 86-25-83105890

Email: [email protected]

Yuxin Chen, Ph.D.

Role: CONTACT

Phone: 86-25-83105890

Email: [email protected]

Facility Contacts

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Longgen Liu

Role: primary

Chao Wu, M.D, Ph.D

Role: primary

Other Identifiers

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IN-CN-987-5343

Identifier Type: -

Identifier Source: org_study_id