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Not yet recruitingNCT07241962Updated Nov 21, 2025

Hepatitis B and C Within the Chinese Community in Milan

An observational study in HBV (Hepatitis B Virus) and HCV Infection, sponsored by IRCCS Ospedale San Raffaele. Not yet recruiting. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-21.

Sponsored by IRCCS Ospedale San Raffaele · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
1,000
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • HBV (Hepatitis B Virus)
  • HCV Infection
03

In context

Hepatitis B

1,045 studies on the registry are indexed under Hepatitis B; 139 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 365 across 251 observational studies indexed under Hepatitis B.

Browse Hepatitis B studies →

Lead sponsor

IRCCS Ospedale San Raffaele is the lead sponsor of 36 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults aged 18 to 50 years
  • Self-identified as part of the Chinese community residing in Milan
  • Willing and able to provide
  • Willing to undergo and/or 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

Exclusion Criteria:

  • Age under 18 or over 50 years
  • Not from the Chinese community or not residing in Milan
  • Unable to provide
  • Currently undergoing treatment for or , 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
1,000 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes
06

What researchers measure

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

    Time frame: Day 1 (during the screening session)

Secondary outcomes

  1. 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

    Time frame: Day 1

  2. Acceptability of rapid testing methods

    Participant satisfaction and perceived acceptability of the capillary rapid testing process, measured through a standardized post-test questionnaire

    Time frame: Day 1

  3. Demographic profile and risk factors of screened individuals

    Distribution of age, sex and self-reported risk factors among participants who undergo screening

    Time frame: Day 1

  4. 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

    Time frame: Day 1

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07241962
Lead sponsor
IRCCS Ospedale San Raffaele
Responsible party
Federica Invernizzi (Doctor, IRCCS Ospedale San Raffaele) — Principal investigator
First posted
Nov 21, 2025
Start date
Dec 2025 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Nov 21, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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