A Comprehensive HBsAg-positive Patients Centered Screening Strategy

NCT03794791 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10000

Last updated 2021-01-20

No results posted yet for this study

Summary

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.

Conditions

  • Hepatitis B and Hepatitis C (Disorder)

Interventions

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.

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.

Sponsors & Collaborators

Principal Investigators

  • HONG REN, Prof. · The Second Affiliated Hospital of Chongqing Medical University

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-20
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03794791 on ClinicalTrials.gov