Simplification and Test and Treat Strategies Towards Hepatitis C Eliminationplatform" in China(STAT)

Sponsor

Huashan Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05906459

Collaborator

(none)

20,000

Enrollment

Locations

Anticipated Duration (Months)

5000

Patients Per Site

415.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The present study aims to establish a " one-sample testing platform " and assess the prevalence of hepatitis C in individuals taking routine physical examination or outpatient visit in mainland China.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C Virus Infection	Diagnostic Test: Anti-HCV antibody and HCV core antigen testing

Detailed Description

Investigators intend to establish a one-sample testing platform to improve diagnosis and linkage to care process in participants under routine physical examination or outpatient visit. The platform is based on rapid diagnostic tests (RDTs) for HCV screening and HCV core antigen for confirmation. RDTs was used to screen for anti-HCV antibodies. The result of RDT will be interpreted within 15 minutes with the sensitivity of 98.9% (95%CI, 94.5% to 99.8%) and specificity of 98.9% (95%CI, 97.5% to 99.9%) using whole blood or finger-stick blood sample [3-5]. HCV core antigen is a marker of HCV replication and has a good correlation with HCV RNA in HCV-positive patients (R=0.98). A recent study suggested HCV core antigen testing could be used alternative testing for HCV RNA testing for diagnosis when HCV RNA testing was unavailable. The process of HCV core antigen test only takes 2-3 hours. "one-sample" means only one drop (10ul) of finger-stick blood or residual blood samples from other routine tests collected from patients was needed for anti-HCV antibody testing and HCV core antigen testing, which means they will not have to take another venepuncture. In addition, the use of RDT and HCV core antigen are also less costly. This approach might improve access to care, particularly in low-income and middle-income countries.

The present study aims to establish a " one-sample testing platform " in several medical institution to assess the prevalence of hepatitis C in individuals taking routine physical examination and further promote rapid diagnosis platform in mainland China, so as to achieve the goal in 2030.

Study Design

Study Type:

Observational

Anticipated Enrollment :

20000 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Establishment of Rapid Diagnostic Procedure of "HCV Single-sample Detection Platform" in China

Anticipated Study Start Date :

Jun 30, 2023

Anticipated Primary Completion Date :

Dec 30, 2023

Anticipated Study Completion Date :

Jun 30, 2024

Outcome Measures

Primary Outcome Measures

Completion rate of rapid diagnostic processesplatform,and [1day]
Completion rate of rapid diagnostic processes

Secondary Outcome Measures

The prevalence of HCV infection [1 day]
The prevalence of HCV infection in the population attending each center (including physical examination)
The proportion of abnormal fibroscan results, liver function, blood routine, and ultrasound data in HCV-infected people [30 days]
For example, the confirmed rate of HCV infection in the screening population was much higher than that of HCV infection in the region in the epidemiological survey, and the degree of liver fibrosis and cirrhosis assessed by the confirmed population through this process was significantly lower than the mean HCV population reported in the literature, which indirectly reflected the potential benefit of rapid diagnosis process in helping to detect HCV infection missed in routine visits (including physical examination).
Additional time required by the testing process [1 day]
Additional time required by the testing process
The feedback and evaluation from study participants [1 day]
The feedback and evaluation from study participants (including whether it affects routine visits (including physical examination) procedures, and the acceptance of this process, etc.)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

1. 18 years of age and older, regardless of age or gender.
1. The residual blood sample needs to be not less than 1ml.
1. Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.

Exclusion Criteria:

1. Pregnant, lactating female and who is planning pregnancy during study period.
1. History of tumor or other severe, life-threating diseases.
1. Samples not meet collection requirements.
1. repeated enrollment.
1. HCV infection has been diagnosed.
1. Recent HCV RNA testing confirmed that there is no HCV infection.

Termination criteria:

1. Subject asked to withdraw consent.
1. Subjects may suffer adverse impact from the study at investigator's discretion.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The fifth People's Hospital Of Shanghai	Shanghai	Shanghai	China	200240
2	Central Hospital of Minhang District, Shanghai	Shanghai	Shanghai	China	201199
3	The First People's Hospital Of YunNan	Kunming	Yunnan	China	650100
4	Yunnan Provincial Infectious Disease Hospital, Yunnan AIDS Care Center	Kunming	Yunnan	China	650399