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临床试验/NCT07241962
NCT07241962尚未招募不适用

Prevalence of Hepatitis B and C Within the Chinese Community Residing in Milan

IRCCS Ospedale San Raffaele0 个研究点目标入组 1,000 人开始时间: 2025年12月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
1,000
主要终点
Detection rate of HBV and/or HCV infections

研究概览

简要总结

The goal of this observational study is to assess the effectiveness of targeted screening for Hepatitis B (HBV) and Hepatitis C (HCV) infections in adults aged 18 to 50 from the Chinese community residing in Milan.

The main questions it aims to answer are:

  • Does community-based, culturally sensitive screening increase the detection of undiagnosed HBV and HCV infections in this high-risk population?
  • What is the level of adherence, satisfaction and awareness regarding rapid testing methods in this community?

Participants will:

  • Receive pre-test counseling in Italian or Chinese with the help of an interpreter
  • Complete a brief, anonymous questionnaire on demographics, risk factors and awareness of HBV/HCV
  • Undergo capillary rapid testing for HBV and/or HCV
  • Receive test results during the same visit
  • Complete a short post-test satisfaction questionnaire

The study will be conducted in public spaces within Milan's Chinatown, during monthly sessions, until 1,000 participants are enrolled. Each session will last approximately 30-60 minutes per participant.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18 to 50 years
  • Self-identified as part of the Chinese community residing in Milan
  • Willing and able to provide informed consent
  • Willing to undergo HBV and/or HCV rapid screening (capillary blood test)
  • Able to complete an anonymous questionnaire on demographics, risk factors and awareness of HBV and HCV infections
  • Able to communicate in Italian or Chinese (with interpreter assistance, if needed)

排除标准

  • Age under 18 or over 50 years
  • Not from the Chinese community or not residing in Milan
  • Unable to provide informed consent
  • Currently undergoing treatment for HBV or HCV, or with previously confirmed diagnosis of HBV or HCV
  • Severe mental or physical illness impairing participation or understanding of consent
  • Unable to respond to the questionnaire, even with interpreter assistance
  • Pregnant women

结局指标

主要结局

Detection rate of HBV and/or HCV infections

时间窗: Day 1 (during the screening session)

Proportion of participants from the Chinese community residing in Milan who test positive for Hepatitis B surface antigen (HBsAg) and/or anti-HCV antibodies using capillary rapid tests during the screening session

次要结局

  • Adherence to rapid HBV/HCV testing(Day 1)
  • Demographic profile and risk factors of screened individuals(Day 1)
  • Acceptability of rapid testing methods(Day 1)
  • Awareness of HBV and HCV infections(Day 1)

研究者

发起方
IRCCS Ospedale San Raffaele
申办方类型
Other
责任方
Principal Investigator
主要研究者

Federica Invernizzi

Doctor

IRCCS Ospedale San Raffaele

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