A Comprehensive HBsAg-positive Patients Centered Screening Strategy (CHARSET)

January 16, 2021 updated by: Hong Ren

A Comprehensive HBsAg-positive Patients Centered Screening Strategy Targeting HCV(Hepatitis C) Micro-elimination (CHARSET) in Chongqing, China Establishment of a Model Toward HCV Elimination

HBV(hepatitis B virus) /HCV(hepatitis C virus) co-infection may accelerate liver disease progression and increase the risk of HCC(Hepatocellular Carcinoma)development. It is reported HCV co-infection harmfully affects liver fibrosis in HBV patients, while decompensated cirrhosis is increased in co-infected patients compared with HBV- or HCV- mono-infected patients. One meta-analysis having pooled 39 studies performed in China reported that around 5% of HCC was associated with HCV infection alone and 6% with co-infection of HBV + HCV. However, the exact prevalence of HCV infection in HBsAg(Hepatitis B virus surface antigen)(+) cohort is actually unknown. It is estimated to be between 0.7% and 16%, a percentage that varies over a wide range among several studies from literature, mainly depending on different geographical distribution and study population. However, in regions where HBV is endemic, such as China with a HBsAg positive rate of 7.18%, the probability of co-infection increases due to a similar transmission route, especially in patients with high risk of HCV infection, like dialysis, HIV infection, organ transplantation, sex workers, drug abuser, tattoo, piercing, blood donation, history of scaling or dental filling, HCV family history and so on.

As for China, the awareness of HCV infection is much lower than HBV because the occult of HCV infection, also because governments as well as medical authorities didn't input enough resources to disease education. Up to now, the national HCV elimination in China is daunting because of barriers in HCV awareness/link to care, and lack of well-established strategies. On the contrary, HBV infection has been widely known and educated to general population. As an add-on benefit, it might be relatively easier to conduct HCV screening test among those HBsAg-positive population. HCV elimination in high-risk subgroups from the basis in HBV population can be achieved with greater possibility and such model could be further shared to health care societies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

1. Objective:

Primary objective:

Evaluate value of HCV education in HCV screening and diagnosis in HBsAg(+) patients

Secondary objectives:

  1. Evaluate prevalence of HCV co-infection in HBV cohort in Chongqing, China
  2. Assess awareness of HCV infection in HBV/HCV cohort and analysis of risk factors

2. Research methods

A. Evaluate value of HCV education in HCV screening and diagnosis in HBsAg(+) patients About 300 patients screened for HBsAg every day in the second affiliated hospital of Chongqing Medcial University. So there will be about 200,000 patients tested for HBsAg for 2 years, among which 5% is estimated to be HBsAg (+) (n=10,000) and will be informed. All of them will be asked to follow-up in Infectious Disease Department of the hospital and be divided into two groups by 1:1 randomization. Patients in the first group will not receive any disease education, but the investigators will record how many patients propose to take anti-HCV test voluntarily after those patients know the result of HBsAg test of their own (The acceptation rate of anti-HCV test is A). The second group will receive education about HCV infection as well as HBV/HCV co-infection and then be asked whether those patients are willing to do anti-HCV test or not (The acceptation rate of anti-HCV test is B). Education Methods including video playing of HCV Introduction (disease profile, risk factors for infection, outcomes, HBV/HCV coinfection, reinfection, etc) for 5 min, booklets of relative information distribution, physicians and nurses consulting in clinic. Diagnosis rate of HCV coinfection is C and D for the two groups, respectively.The investigators anticipate B will be higher than A and D will be higher than C, which reflects impact from disease education. Considering some patients with HBsAg(+) might not be willing to be involved in the randomization part or lost to follow-up, the investigators presuppose sample size to be 3,000 for each group for evaluation importance of education.

B. Evaluate prevalence of HCV co-infection in HBV Cohort in Chongqing, China Actually all patients with HBsAg(+) (n=10,000) will be tested for anti-HCV with blood samples and the positive ones will be informed and suggested to do HCV RNA test to get an actual prevalence of HCV co-infection in HBV cohort in Chongqing.The investigators estimate about 16% of patients (1600 for 2 years) with HBsAg (+) are positive for anti-HCV, among which about 1200 patients are positive for HCV RNA test. These patients will be diagnosed as HCV infection and will go genotyping as well as link to care.

C. Awareness of HCV infection in HBV/HCV Cohort and analysis of risk factors All patients who are HBsAg(+) will be asked to finish questionnaires, including basic information, demographic information, risk factors for HBV or HCV infection (dialysis, HIV infection, organ transplantation, sex workers, drug abuser, tattoo, piercing, blood donation, history of scaling or dental filling, HCV family history and so on), awareness of their own HBV or HCV infection, etc.

3. Which, if any, policymakers will be engaged and how.

A. For Government Results of this program may enable government including public health officials to identify where to strengthen efforts. The investigators will get evidence to show the difference of screening and diagnosis rate of HCV infection between HBsAg(+) patients who received disease education and the ones who didn't. Elimination of the HCV as public health threats by 2030 might need to be based on patient education.

B. For Reimbursement Bureau So far there is not enough data on epidemiology to accurately assess potential HCV infection in HBsAg(+) patients. The entire hepatitis elimination effort depends on improving the availability of reliable data to describe the epidemiology of HCV. By executing this program the investigators will get the prevalence of HCV infection in HBsAg(+) patients in Chongqing and there is big possibility that the data is much higher than in general population.The investigators want to let the reimbursement bureau know anti-HCV and RNA test in HBsAg(+) cohort may results in better cost effectiveness in HCV diagnosis and treatment. Reimbursement in such population may be considered.

C. For Other Medical Units Two press conferences will be held at the beginning and at the end of CHARSET program to advocate the importance of increasing HCV awareness, link-to-treatment and HCV elimination. The program will also be posted on social media like WEIBO/WECHAT (something like facebook/twitter in China) and website of the second affiliated hospital of Chongqing Medical University. Because of acquisition of higher HCV screening and diagnosis rate, this model could be generalized in other medical units to benefit more patients.

4. Study Duration (in months) 24 months

Study Type

Observational

Enrollment (Actual)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400010
        • The 2nd affiliated Hospital of Chongqing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

HBsAg(+) patients

Description

Inclusion Criteria:

  • HBsAg(+) patients

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
education
Education will be used to see whether or not improve the HCV screening and diagnosis in HBsAg(+) patients. Blood test ,HCV-RNA quantification test and HCV genotyping will be employed to evaluate the prevalence of HBV-HCV co-infection. Awareness of HCV infection in HBV/HCV cohort and analysis of risk factors will also be assessed.
Behavioral: education
Education Methods including video playing of HCV Introduction (disease profile, risk factors for infection, outcomes, HBV/HCV coinfection, reinfection, etc) for 5 min, booklets of relative information distribution, physicians and nurses consulting in clinic.
Other Names:
  • HCV RNA quantification test/HCV genotyping
no education
There is no education at all.Screening and diagnosis of HCV infection in HBsAg(+) patients are based on voluntary. Blood test ,HCV-RNA quantification test and HCV genotyping will still be employed to evaluate the prevalence of HBV-HCV co-infection. Awareness of HCV infection in HBV/HCV cohort and analysis of risk factors will also be assessed.
Behavioral: no education
Education Methods including video playing of HCV Introduction (disease profile, risk factors for infection, outcomes, HBV/HCV coinfection, reinfection, etc) for 5 min, booklets of relative information distribution, physicians and nurses consulting in clinic.
Other Names:
  • HCV RNA quantification test/HCV genotyping

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate value of HCV education
Time Frame: 1 Year
This patients will receive education about HCV infection as well as HBV/HCV co-infection and then be asked whether they are willing to do anti-HCV test or not. Education Methods including video playing of HCV Introduction (disease profile, risk factors for infection, outcomes, HBV/HCV coinfection, reinfection, etc) for 5 min, booklets of relative information distribution, physicians and nurses consulting in clinic.
1 Year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of HCV co-infection
Time Frame: 1 Year
All patients with HBsAg(+) (n=10,000) will be tested for anti-HCV with blood samples and the positive ones will be informed and suggested to do HCV RNA test to get an actual prevalence of HCV co-infection in HBV cohort in Chongqing. The investigators estimate about 16% of patients (1600 for 2 years) with HBsAg (+) are positive for anti-HCV, among which about 1200 patients are positive for HCV RNA test. These patients will be diagnosed as HCV infection and will go genotyping as well as link to care.
1 Year
Awareness of HCV infection
Time Frame: 1 Year
All patients who are HBsAg(+) will be asked to finish questionnaires, including basic information, demographic information, risk factors for HBV or HCV infection (dialysis, HIV infection, organ transplantation, sex workers, drug abuser, tattoo, piercing, blood donation, history of scaling or dental filling, HCV family history and so on), awareness of their own HBV or HCV infection, etc.
1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hong Ren

Collaborators

Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2019

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

January 2, 2019

First Submitted That Met QC Criteria

January 3, 2019

First Posted (Actual)

January 7, 2019

Study Record Updates

Last Update Posted (Actual)

January 20, 2021

Last Update Submitted That Met QC Criteria

January 16, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LS2018037

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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