HBV (Hepatitis B Virus)NCT07241962
Hepatitis B and C Within the Chinese Community in Milan
An observational study of HBV (Hepatitis B Virus) and HCV Infection, run by IRCCS Ospedale San Raffaele.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- HBV (Hepatitis B Virus), HCV Infection
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Dec 2025to Dec 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
About this study
Official title: 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:
Read more
- 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
- Medical subject headings
- Hepatitis B, Hepatitis C
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1 (during the screening session)
Secondary outcomes (4)
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
Measured: 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
Measured: Day 1
Demographic profile and risk factors of screened individuals
Distribution of age, sex and self-reported risk factors among participants who undergo screening
Measured: 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
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study startDec 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HBV (Hepatitis B Virus)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- IRCCS Ospedale San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Federica Invernizzi, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07241962
- Sponsor's protocol ID
- OBS-CHN-2025
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Hepatitis B and C Within the Chinese Community Residing in Milan
- ClinicalTrials.gov ID
- NCT07241962
- Acronym / sponsor ID
- OBS-CHN-2025
- Conditions
- HBV (Hepatitis B Virus), HCV Infection
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- IRCCS Ospedale San RaffaeleUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
Adherence to rapid HBV/HCV testing
Time frame: Day 1
Acceptability of rapid testing methods
Time frame: Day 1
Demographic profile and risk factors of screened individuals
Time frame: Day 1
Awareness of HBV and HCV infections
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of HBV (Hepatitis B Virus) and HCV Infection, run by IRCCS Ospedale San Raffaele.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection rate of HBV and/or HCV infections (time frame: Day 1 (during the screening session)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.