Hepatitis BHBVTRNCT03396458
Hepatitis B Prevalence in the Turkish Population Living in Middle Limburg
An observational study of Hepatitis B, run by Hasselt University at 1 site in Belgium.
Trial summary
This study will assess HBV (HBsAg, anti-HBc and anti-HBs) prevalence in the Turkish population living in Belgium. Additionally, the investigators will determine the risk factors for HBV infection and the uptake of screening, vaccination and antiviral treatment in this hard-to-reach Turkish population. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Hepatitis B serology and Questionnaire
- Type of treatment
- Vaccines
- How many people
- 1,000 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2017to 31 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Turkish population
Who may be able to join
- Turkish origin, defined as one of the parents born in Turkey
- Having a signed informed consent form
Who cannot join
- /
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Ziekenhuis Oost-Limburg
Genk, Limburg, 3600
Özgür Koc, M.D., +3289321519, ozgur.koc@zol.be
Geert Robaeys, M.D., Ph.D., +3289326505, geert.robaeys@zol.be
About this study
Official title: Prevalence and Risk Factors of Hepatitis B Viral Infection in the Turkish Population Living in Belgium
This study will assess HBV (HBsAg, anti-HBc and anti-HBs) prevalence in the Turkish population living in Belgium. Additionally, the investigators will determine the risk factors for HBV infection and the uptake of screening, vaccination and antiviral treatment in this hard-to-reach Turkish population.
Read the detailed description
HBV infection is an important public health problem in the Turkish population, i.e. one of the largest migrant populations in Europe. With the introduction of cost-effective antiviral treatments in the past decade, there is a need to identify HBV infected patients who may benefit from treatment. This study will assess the HBV prevalence in the Turkish population living in Belgium. Additionally, the investigators will determine the risk factors of HBV infection and the uptake of screening, vaccination and antiviral treatment in this hard-to-reach Turkish population.
A cross-sectional, epidemiological trial will be conducted in the region Middle Limburg Belgium, where the Turkish adult population (subjects born in Turkey or subjects of which one of the parents is born in Turkey), 18 years of age and older, will be screened for HBsAg, anti-HBs and anti-HBc. Educational meetings concerning viral hepatitis B will be organized and there will be three ways to be screened for HBV: (1) immediately after the educational meetings, (2) at the Outpatient Hepatology Department of Ziekenhuis Oost-Limburg (ZOL) and (3) at home visits. Subsequently, participants will be asked to fill in a questionnaire regarding sociodemographic factors, migration history, risk factors for HBV infection (e.g. sharing toothbrushes, HBV infected family member) and HBV vaccination status. One year after data collection, HBsAg positive patients will be assessed whether they are under follow-up at the general practitioner or hepatologist. The investigators will also gather information regarding the uptake of vaccination in non-immunized subjects.
This study will provide information about the HBV prevalence and distribution of the stages of liver disease in the Turkish population in Belgium. By determining the risk factors for HBV infection, subgroups with an increased prevalence of HBV infection can be identified. This study will also give information on how to organize the healthcare system for screening in hard-to-reach migrant groups and to develop care paths.
- Conditions
- Hepatitis B
- Being tested
- Hepatitis B serology, Questionnaire
- Keywords
- Hepatitis B, Disease prevalence, Screening, Migrant, Turkish, Belgium
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatitis B serologyDiagnostic test
A serum specimen will be taken and assessed for hepatitis B serology (HBsAg, anti-HBs and anti-HBc).
QuestionnaireOther
Participants will be asked to fill in a questionnaire regarding sociodemographic factors, migration history, risk factors for HBV infection (e.g. sharing toothbrushes, HBV infected family member) and HBV vaccination status.
| Study group | Role | What they receive |
|---|---|---|
| Hepatitis B group | Hepatitis B serology and questionnaire Receives: Diagnostic Test: Hepatitis B serology; Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroprevalence of current HBV infection in the Turkish population
Serum HBsAg
Measured: 1 day
Secondary outcomes (2)
Seroprevalence of protective antibodies against HBV infection in the Turkish population
Serum anti-HBs
Measured: 1 day
Assess risk factors for past or current HBV infecion in the Turkish population
Combine results from (1) serum anti-HBc with (2) questionnaire regarding sociodemographic factors, migration, risk factors for HBV infection and HBV vaccination status
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2018
- Study start1 Sep 2017
- Primary completion31 Aug 2020 (estimated)
- Study completion31 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis BStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geert Robaeys, Hasselt University
- Investigators
- Geert Robaeys, M.D., Ph.D., Principal investigator, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03396458
- Sponsor's protocol ID
- HBVTR-1.0
- Acronym
- HBVTR
- Status last verified
- Jan 2020
- First submitted
- 15 Dec 2017
- Last updated
- 27 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Koc OM, Hens N, Bielen R, Van Damme P, Robaeys G. Hepatitis B virus prevalence and risk factors in hard-to-reach Turkish population living in Belgium: A protocol for screening. Medicine (Baltimore). 2019 May;98(18):e15412. doi: 10.1097/MD.0000000000015412.
PubMed 31045797
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Risk Factors of Hepatitis B Viral Infection in the Turkish Population Living in Belgium
- ClinicalTrials.gov ID
- NCT03396458
- Acronym / sponsor ID
- HBVTR / HBVTR-1.0
- Conditions
- Hepatitis B
- Keywords
- Hepatitis B, Disease prevalence, Screening, Migrant, Turkish, Belgium
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 11 Jan 2018 (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.
This study will assess HBV (HBsAg, anti-HBc and anti-HBs) prevalence in the Turkish population living in Belgium. Additionally, the investigators will determine the risk factors for HBV infection and the uptake of screening, vaccination and antiviral treatment in this hard-to-reach Turkish population.
Detailed description
HBV infection is an important public health problem in the Turkish population, i.e. one of the largest migrant populations in Europe. With the introduction of cost-effective antiviral treatments in the past decade, there is a need to identify HBV infected patients who may benefit from treatment. This study will assess the HBV prevalence in the Turkish population living in Belgium. Additionally, the investigators will determine the risk factors of HBV infection and the uptake of screening, vaccination and antiviral treatment in this hard-to-reach Turkish population.
A cross-sectional, epidemiological trial will be conducted in the region Middle Limburg Belgium, where the Turkish adult population (subjects born in Turkey or subjects of which one of the parents is born in Turkey), 18 years of age and older, will be screened for HBsAg, anti-HBs and anti-HBc. Educational meetings concerning viral hepatitis B will be organized and there will be three ways to be screened for HBV: (1) immediately after the educational meetings, (2) at the Outpatient Hepatology Department of Ziekenhuis Oost-Limburg (ZOL) and (3) at home visits. Subsequently, participants will be asked to fill in a questionnaire regarding sociodemographic factors, migration history, risk factors for HBV infection (e.g. sharing toothbrushes, HBV infected family member) and HBV vaccination status. One year after data collection, HBsAg positive patients will be assessed whether they are under follow-up at the general practitioner or hepatologist. The investigators will also gather information regarding the uptake of vaccination in non-immunized subjects.
This study will provide information about the HBV prevalence and distribution of the stages of liver disease in the Turkish population in Belgium. By determining the risk factors for HBV infection, subgroups with an increased prevalence of HBV infection can be identified. This study will also give information on how to organize the healthcare system for screening in hard-to-reach migrant groups and to develop care paths.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hepatitis B group | – | Diagnostic Test: Hepatitis B serology, Other: QuestionnaireHepatitis B serology and questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Turkish population
Key inclusion criteria (2 listed)
- Turkish origin, defined as one of the parents born in Turkey
- Having a signed informed consent form
Key exclusion criteria (1 listed)
- /
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hepatitis B serologyA serum specimen will be taken and assessed for hepatitis B serology (HBsAg, anti-HBs and anti-HBc). | Diagnostic test | Hepatitis B group |
| QuestionnaireParticipants will be asked to fill in a questionnaire regarding sociodemographic factors, migration history, risk factors for HBV infection (e.g. sharing toothbrushes, HBV infected family member) and HBV vaccination status. | Other | Hepatitis B group |
Primary outcome
Seroprevalence of current HBV infection in the Turkish population
Time frame: 1 day
Serum HBsAg
2 secondary outcomes
Seroprevalence of protective antibodies against HBV infection in the Turkish population
Time frame: 1 day
Assess risk factors for past or current HBV infecion in the Turkish population
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Derived from this study: PubMed 31045797Koc OM, Hens N, Bielen R, Van Damme P, Robaeys G. Hepatitis B virus prevalence and risk factors in hard-to-reach Turkish population living in Belgium: A protocol for screening. Medicine (Baltimore). 2019 May;98(18):e15412. doi: 10.1097/MD.0000000000015412.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Geert Robaeys, M.D., Ph.D. principal investigator
Hasselt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B, run by Hasselt University at 1 site in Belgium.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Geert Robaeys, M.D., Ph.D. (+3289326505, geert.robaeys@zol.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroprevalence of current HBV infection in the Turkish population (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03396458, which also lists 1 linked publication.
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 27 Jan 2020.