A Comprehensive HBsAg-positive Patients Centered Screening Strategy
A Comprehensive HBsAg-positive Patients Centered Screening Strategy
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.
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
Inclusion Criteria:

 -  HBsAg(+) patients

 Exclusion Criteria:

 -  none