Prevalence of Hepatitis B and C Within the Chinese Community Residing in Milan
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 1,000
- Primary Endpoint
- Detection rate of HBV and/or HCV infections
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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)
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Detection rate of HBV and/or HCV infections
Time Frame: 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
Secondary Outcomes
- 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)
Investigators
Federica Invernizzi
Doctor
IRCCS Ospedale San Raffaele