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临床试验/NCT03794791
NCT03794791已完成不适用

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

Hong Ren1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2019年2月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10,000
试验地点
1
主要终点
Evaluate value of HCV education

研究概览

简要总结

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.

详细描述

  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

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • HBsAg(+) patients

排除标准

  • 未提供

结局指标

主要结局

Evaluate value of HCV education

时间窗: 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.

次要结局

  • Awareness of HCV infection(1 Year)
  • Prevalence of HCV co-infection(1 Year)

研究者

发起方
Hong Ren
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hong Ren

Principal Investigator

The Second Affiliated Hospital of Chongqing Medical University

研究点 (1)

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