Ignite Creation Date:
2024-05-06 @ 12:35 PM
Last Modification Date:
2024-10-26 @ 1:01 PM
Study NCT ID:
NCT03794791
Status:
COMPLETED
Last Update Posted:
2021-01-20
First Post:
2019-01-02
Brief Title:
A Comprehensive HBsAg-positive Patients Centered Screening Strategy
Sponsor:
Hong Ren
Organization:
The Second Affiliated Hospital of Chongqing Medical University
Study Overview
Official Title:
A Comprehensive HBsAg-positive Patients Centered Screening Strategy Targeting HCVHepatitis C Micro-elimination CHARSET in Chongqing China Establishment of a Model Toward HCV Elimination
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHARSET
Brief Summary:
HBVhepatitis B virus HCVhepatitis C virus co-infection may accelerate liver disease progression and increase the risk of HCCHepatocellular Carcinomadevelopment 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 HBsAgHepatitis B virus surface antigen cohort is actually unknown It is estimated to be between 07 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 718 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 didnt input enough resources to disease education Up to now the national HCV elimination in China is daunting because of barriers in HCV awarenesslink 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
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 didnt input enough resources to disease education Up to now the national HCV elimination in China is daunting because of barriers in HCV awarenesslink 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
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 HBVHCV 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 200000 patients tested for HBsAg for 2 years among which 5 is estimated to be HBsAg n10000 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 11 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 HBVHCV 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 HBVHCV 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 respectivelyThe 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 3000 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 n10000 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 ChongqingThe 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 HBVHCV 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 didnt 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 populationThe 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 WEIBOWECHAT something like facebooktwitter 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
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 HBVHCV 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 200000 patients tested for HBsAg for 2 years among which 5 is estimated to be HBsAg n10000 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 11 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 HBVHCV 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 HBVHCV 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 respectivelyThe 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 3000 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 n10000 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 ChongqingThe 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 HBVHCV 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 didnt 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 populationThe 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 WEIBOWECHAT something like facebooktwitter 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None