<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03794791</url>
  </required_header>
  <id_info>
    <org_study_id>LS2018037</org_study_id>
    <nct_id>NCT03794791</nct_id>
  </id_info>
  <brief_title>A Comprehensive HBsAg-positive Patients Centered Screening Strategy</brief_title>
  <acronym>CHARSET</acronym>
  <official_title>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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hong Ren</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Gilead Sciences</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>The Second Affiliated Hospital of Chongqing Medical University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      HBV(hepatitis B virus) /HCV(hepatitis C virus) co-infection may accelerate liver disease&#xD;
      progression and increase the risk of HCC(Hepatocellular Carcinoma)development. It is reported&#xD;
      HCV co-infection harmfully affects liver fibrosis in HBV patients, while decompensated&#xD;
      cirrhosis is increased in co-infected patients compared with HBV- or HCV- mono-infected&#xD;
      patients. One meta-analysis having pooled 39 studies performed in China reported that around&#xD;
      5% of HCC was associated with HCV infection alone and 6% with co-infection of HBV + HCV.&#xD;
      However, the exact prevalence of HCV infection in HBsAg(Hepatitis B virus surface antigen)(+)&#xD;
      cohort is actually unknown. It is estimated to be between 0.7% and 16%, a percentage that&#xD;
      varies over a wide range among several studies from literature, mainly depending on different&#xD;
      geographical distribution and study population. However, in regions where HBV is endemic,&#xD;
      such as China with a HBsAg positive rate of 7.18%, the probability of co-infection increases&#xD;
      due to a similar transmission route, especially in patients with high risk of HCV infection,&#xD;
      like dialysis, HIV infection, organ transplantation, sex workers, drug abuser, tattoo,&#xD;
      piercing, blood donation, history of scaling or dental filling, HCV family history and so on.&#xD;
&#xD;
      As for China, the awareness of HCV infection is much lower than HBV because the occult of HCV&#xD;
      infection, also because governments as well as medical authorities didn't input enough&#xD;
      resources to disease education. Up to now, the national HCV elimination in China is daunting&#xD;
      because of barriers in HCV awareness/link to care, and lack of well-established strategies.&#xD;
      On the contrary, HBV infection has been widely known and educated to general population. As&#xD;
      an add-on benefit, it might be relatively easier to conduct HCV screening test among those&#xD;
      HBsAg-positive population. HCV elimination in high-risk subgroups from the basis in HBV&#xD;
      population can be achieved with greater possibility and such model could be further shared to&#xD;
      health care societies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Objective:&#xD;
&#xD;
      Primary objective:&#xD;
&#xD;
      Evaluate value of HCV education in HCV screening and diagnosis in HBsAg(+) patients&#xD;
&#xD;
      Secondary objectives:&#xD;
&#xD;
        1. Evaluate prevalence of HCV co-infection in HBV cohort in Chongqing, China&#xD;
&#xD;
        2. Assess awareness of HCV infection in HBV/HCV cohort and analysis of risk factors&#xD;
&#xD;
      2. Research methods&#xD;
&#xD;
      A. Evaluate value of HCV education in HCV screening and diagnosis in HBsAg(+) patients About&#xD;
      300 patients screened for HBsAg every day in the second affiliated hospital of Chongqing&#xD;
      Medcial University. So there will be about 200,000 patients tested for HBsAg for 2 years,&#xD;
      among which 5% is estimated to be HBsAg (+) (n=10,000) and will be informed. All of them will&#xD;
      be asked to follow-up in Infectious Disease Department of the hospital and be divided into&#xD;
      two groups by 1:1 randomization. Patients in the first group will not receive any disease&#xD;
      education, but the investigators will record how many patients propose to take anti-HCV test&#xD;
      voluntarily after those patients know the result of HBsAg test of their own (The acceptation&#xD;
      rate of anti-HCV test is A). The second group will receive education about HCV infection as&#xD;
      well as HBV/HCV co-infection and then be asked whether those patients are willing to do&#xD;
      anti-HCV test or not (The acceptation rate of anti-HCV test is B). Education Methods&#xD;
      including video playing of HCV Introduction (disease profile, risk factors for infection,&#xD;
      outcomes, HBV/HCV coinfection, reinfection, etc) for 5 min, booklets of relative information&#xD;
      distribution, physicians and nurses consulting in clinic. Diagnosis rate of HCV coinfection&#xD;
      is C and D for the two groups, respectively.The investigators anticipate B will be higher&#xD;
      than A and D will be higher than C, which reflects impact from disease education. Considering&#xD;
      some patients with HBsAg(+) might not be willing to be involved in the randomization part or&#xD;
      lost to follow-up, the investigators presuppose sample size to be 3,000 for each group for&#xD;
      evaluation importance of education.&#xD;
&#xD;
      B. Evaluate prevalence of HCV co-infection in HBV Cohort in Chongqing, China Actually all&#xD;
      patients with HBsAg(+) (n=10,000) will be tested for anti-HCV with blood samples and the&#xD;
      positive ones will be informed and suggested to do HCV RNA test to get an actual prevalence&#xD;
      of HCV co-infection in HBV cohort in Chongqing.The investigators estimate about 16% of&#xD;
      patients (1600 for 2 years) with HBsAg (+) are positive for anti-HCV, among which about 1200&#xD;
      patients are positive for HCV RNA test. These patients will be diagnosed as HCV infection and&#xD;
      will go genotyping as well as link to care.&#xD;
&#xD;
      C. Awareness of HCV infection in HBV/HCV Cohort and analysis of risk factors All patients who&#xD;
      are HBsAg(+) will be asked to finish questionnaires, including basic information, demographic&#xD;
      information, risk factors for HBV or HCV infection (dialysis, HIV infection, organ&#xD;
      transplantation, sex workers, drug abuser, tattoo, piercing, blood donation, history of&#xD;
      scaling or dental filling, HCV family history and so on), awareness of their own HBV or HCV&#xD;
      infection, etc.&#xD;
&#xD;
      3. Which, if any, policymakers will be engaged and how.&#xD;
&#xD;
      A. For Government Results of this program may enable government including public health&#xD;
      officials to identify where to strengthen efforts. The investigators will get evidence to&#xD;
      show the difference of screening and diagnosis rate of HCV infection between HBsAg(+)&#xD;
      patients who received disease education and the ones who didn't. Elimination of the HCV as&#xD;
      public health threats by 2030 might need to be based on patient education.&#xD;
&#xD;
      B. For Reimbursement Bureau So far there is not enough data on epidemiology to accurately&#xD;
      assess potential HCV infection in HBsAg(+) patients. The entire hepatitis elimination effort&#xD;
      depends on improving the availability of reliable data to describe the epidemiology of HCV.&#xD;
      By executing this program the investigators will get the prevalence of HCV infection in&#xD;
      HBsAg(+) patients in Chongqing and there is big possibility that the data is much higher than&#xD;
      in general population.The investigators want to let the reimbursement bureau know anti-HCV&#xD;
      and RNA test in HBsAg(+) cohort may results in better cost effectiveness in HCV diagnosis and&#xD;
      treatment. Reimbursement in such population may be considered.&#xD;
&#xD;
      C. For Other Medical Units Two press conferences will be held at the beginning and at the end&#xD;
      of CHARSET program to advocate the importance of increasing HCV awareness, link-to-treatment&#xD;
      and HCV elimination. The program will also be posted on social media like WEIBO/WECHAT&#xD;
      (something like facebook/twitter in China) and website of the second affiliated hospital of&#xD;
      Chongqing Medical University. Because of acquisition of higher HCV screening and diagnosis&#xD;
      rate, this model could be generalized in other medical units to benefit more patients.&#xD;
&#xD;
      4. Study Duration (in months) 24 months&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 20, 2019</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Evaluate value of HCV education</measure>
    <time_frame>1 Year</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prevalence of HCV co-infection</measure>
    <time_frame>1 Year</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Awareness of HCV infection</measure>
    <time_frame>1 Year</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">10000</enrollment>
  <condition>Hepatitis B and Hepatitis C (Disorder)</condition>
  <arm_group>
    <arm_group_label>education</arm_group_label>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>no education</arm_group_label>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>education</intervention_name>
    <description>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.</description>
    <arm_group_label>education</arm_group_label>
    <other_name>HCV RNA quantification test/HCV genotyping</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>no education</intervention_name>
    <description>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.</description>
    <arm_group_label>no education</arm_group_label>
    <other_name>HCV RNA quantification test/HCV genotyping</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        HBsAg(+) patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HBsAg(+) patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>HONG REN, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Second Affiliated Hospital of Chongqing Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The 2nd affiliated Hospital of Chongqing Medical University</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>400010</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Pol S, Haour G, Fontaine H, Dorival C, Petrov-Sanchez V, Bourliere M, Capeau J, Carrieri P, Larrey D, Larsen C, Marcellin P, Pawlostky JM, Nahon P, Zoulim F, Cacoub P, de Ledinghen V, Mathurin P, Negro F, Pageaux GP, Yazdanpanah Y, Wittkop L, Zarski JP, Carrat F; French Anrs Co22 Hepather Cohort. The negative impact of HBV/HCV coinfection on cirrhosis and its consequences. Aliment Pharmacol Ther. 2017 Dec;46(11-12):1054-1060. doi: 10.1111/apt.14352. Epub 2017 Oct 9.</citation>
    <PMID>28994127</PMID>
  </reference>
  <reference>
    <citation>Wang M, Wang Y, Feng X, Wang R, Wang Y, Zeng H, Qi J, Zhao H, Li N, Cai J, Qu C. Contribution of hepatitis B virus and hepatitis C virus to liver cancer in China north areas: Experience of the Chinese National Cancer Center. Int J Infect Dis. 2017 Dec;65:15-21. doi: 10.1016/j.ijid.2017.09.003. Epub 2017 Sep 19.</citation>
    <PMID>28935244</PMID>
  </reference>
  <reference>
    <citation>Papadopoulos N, Papavdi M, Pavlidou A, Konstantinou D, Kranidioti H, Kontos G, Koskinas J, Papatheodoridis GV, Manolakopoulos S, Deutsch M. Hepatitis B and C coinfection in a real-life setting: viral interactions and treatment issues. Ann Gastroenterol. 2018 May-Jun;31(3):365-370. doi: 10.20524/aog.2018.0255. Epub 2018 Mar 28.</citation>
    <PMID>29720863</PMID>
  </reference>
  <reference>
    <citation>Wang H, Swann R, Thomas E, Innes HA, Valerio H, Hayes PC, Allen S, Barclay ST, Wilks D, Fox R, Bhattacharyya D, Kennedy N, Morris J, Fraser A, Stanley AJ, Gunson R, Mclntyre PG, Hunt A, Hutchinson SJ, Mills PR, Dillon JF. Impact of previous hepatitis B infection on the clinical outcomes from chronic hepatitis C? A population-level analysis. J Viral Hepat. 2018 Aug;25(8):930-938. doi: 10.1111/jvh.12897. Epub 2018 Apr 15.</citation>
    <PMID>29577515</PMID>
  </reference>
  <reference>
    <citation>Lazarus JV, Wiktor S, Colombo M, Thursz M; EASL International Liver Foundation. Micro-elimination - A path to global elimination of hepatitis C. J Hepatol. 2017 Oct;67(4):665-666. doi: 10.1016/j.jhep.2017.06.033. Epub 2017 Jul 29. No abstract available.</citation>
    <PMID>28760329</PMID>
  </reference>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>January 16, 2021</last_update_submitted>
  <last_update_submitted_qc>January 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>The Second Affiliated Hospital of Chongqing Medical University</investigator_affiliation>
    <investigator_full_name>Hong Ren</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>HBV</keyword>
  <keyword>HCV</keyword>
  <keyword>Co-infection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis B</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03794791
org study id: LS2018037
nct id: NCT03794791
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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
observational model: Cohort
time perspective: Prospective
measure: Evaluate value of HCV education
time frame: 1 Year
description: 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.
measure: Prevalence of HCV co-infection
time frame: 1 Year
description: 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.
measure: Awareness of HCV infection
time frame: 1 Year
description: 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.
arm group label: education
description: 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.
arm group label: no education
description: 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.
intervention type: Behavioral
intervention name: education
description: 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.
arm group label: education
other name: HCV RNA quantification test/HCV genotyping
intervention type: Behavioral
intervention name: no education
description: 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.
arm group label: no education
other name: HCV RNA quantification test/HCV genotyping
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: HONG REN, Prof.
role: Principal Investigator
affiliation: The Second Affiliated Hospital of Chongqing Medical University
facility: 
country: China
citation: Pol S, Haour G, Fontaine H, Dorival C, Petrov-Sanchez V, Bourliere M, Capeau J, Carrieri P, Larrey D, Larsen C, Marcellin P, Pawlostky JM, Nahon P, Zoulim F, Cacoub P, de Ledinghen V, Mathurin P, Negro F, Pageaux GP, Yazdanpanah Y, Wittkop L, Zarski JP, Carrat F; French Anrs Co22 Hepather Cohort. The negative impact of HBV/HCV coinfection on cirrhosis and its consequences. Aliment Pharmacol Ther. 2017 Dec;46(11-12):1054-1060. doi: 10.1111/apt.14352. Epub 2017 Oct 9.
PMID: 28994127
citation: Wang M, Wang Y, Feng X, Wang R, Wang Y, Zeng H, Qi J, Zhao H, Li N, Cai J, Qu C. Contribution of hepatitis B virus and hepatitis C virus to liver cancer in China north areas: Experience of the Chinese National Cancer Center. Int J Infect Dis. 2017 Dec;65:15-21. doi: 10.1016/j.ijid.2017.09.003. Epub 2017 Sep 19.
PMID: 28935244
citation: Papadopoulos N, Papavdi M, Pavlidou A, Konstantinou D, Kranidioti H, Kontos G, Koskinas J, Papatheodoridis GV, Manolakopoulos S, Deutsch M. Hepatitis B and C coinfection in a real-life setting: viral interactions and treatment issues. Ann Gastroenterol. 2018 May-Jun;31(3):365-370. doi: 10.20524/aog.2018.0255. Epub 2018 Mar 28.
PMID: 29720863
citation: Wang H, Swann R, Thomas E, Innes HA, Valerio H, Hayes PC, Allen S, Barclay ST, Wilks D, Fox R, Bhattacharyya D, Kennedy N, Morris J, Fraser A, Stanley AJ, Gunson R, Mclntyre PG, Hunt A, Hutchinson SJ, Mills PR, Dillon JF. Impact of previous hepatitis B infection on the clinical outcomes from chronic hepatitis C? A population-level analysis. J Viral Hepat. 2018 Aug;25(8):930-938. doi: 10.1111/jvh.12897. Epub 2018 Apr 15.
PMID: 29577515
citation: Lazarus JV, Wiktor S, Colombo M, Thursz M; EASL International Liver Foundation. Micro-elimination - A path to global elimination of hepatitis C. J Hepatol. 2017 Oct;67(4):665-666. doi: 10.1016/j.jhep.2017.06.033. Epub 2017 Jul 29. No abstract available.
PMID: 28760329
responsible party type: Sponsor-Investigator
investigator affiliation: The Second Affiliated Hospital of Chongqing Medical University
investigator full name: Hong Ren
investigator title: Principal Investigator
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis B
mesh term: Hepatitis
sharing ipd: No