Hepatitis B and C Within the Chinese Community in Milan

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

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 Overview

• Status: Not yet recruiting
• Conditions: HCV Infection; HBV (Hepatitis B Virus)

• Study Type: Observational
• Enrollment (Estimated): 1000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adults aged 18 to 50 years who self-identify as part of the Chinese community residing in Milan. Participants must be able to provide informed consent, complete a short questionnaire and undergo rapid testing for HBV and/or HCV. Both males and females are eligible. The study aims to reach individuals who may face cultural, linguistic or systemic barriers to healthcare access.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection rate of HBV and/or HCV infections	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	Day 1 (during the screening session)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to rapid HBV/HCV testing	Proportion of participants who complete the full screening process, including pre-test counseling, informed consent, questionnaire and rapid testing	Day 1
Acceptability of rapid testing methods	Participant satisfaction and perceived acceptability of the capillary rapid testing process, measured through a standardized post-test questionnaire	Day 1
Demographic profile and risk factors of screened individuals	Distribution of age, sex and self-reported risk factors among participants who undergo screening	Day 1
Awareness of HBV and HCV infections	Proportion of participants who report prior awareness or knowledge of HBV and/or HCV infections in the pre-test questionnaire	Day 1

Collaborators and Investigators

• Sponsor: IRCCS Ospedale San Raffaele

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 21, 2025

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Infections; RNA Virus Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Communicable Diseases; DNA Virus Infections; Flaviviridae Infections; Hepadnaviridae Infections; Hepatitis; Hepatitis B; Hepatitis C
• Other Study ID Numbers: OBS-CHN-2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No