Hepatitis B and C Within the Chinese Community in Milan

NCT07241962 | Not Yet Recruiting

• 1 other identifier: OBS-CHN-2025
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HBV (Hepatitis B Virus); HCV Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Adherence to rapid HBV/HCV testing

  Day 1

• Acceptability of rapid testing methods

  Day 1

• Demographic profile and risk factors of screened individuals

  Day 1

• Awareness of HBV and HCV infections

  Day 1

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Ospedale San Raffaele: lead

MeSH Terms

Conditions

Hepatitis B; Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Flaviviridae Infections; RNA Virus Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11