Hepatitis B Prevalence in the Turkish Population Living in Middle Limburg

Hepatitis B Clinical Trial

— HBVTR  

Official title:

Prevalence and Risk Factors of Hepatitis B Viral Infection in the Turkish Population Living in Belgium

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03396458
• Other study ID #: HBVTR-1.0
• Status: Recruiting
• Start date: September 1, 2017
• Est. completion date: August 31, 2020

Study information

• Verified date: January 2020
• Source: Hasselt University
• Contact: Geert Robaeys, M.D., Ph.D.
• Phone: +3289326505
• Email: geert.robaeys[@]zol.be
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Turkish origin, defined as one of the parents born in Turkey

• Having a signed informed consent form

Exclusion Criteria:

/

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

Diagnostic Test:
• Hepatitis B serology
A serum specimen will be taken and assessed for hepatitis B serology (HBsAg, anti-HBs and anti-HBc).

Other:
• Questionnaire
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.

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Hasselt University

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seroprevalence of current HBV infection in the Turkish population	Serum HBsAg	1 day
Secondary	Seroprevalence of protective antibodies against HBV infection in the Turkish population	Serum anti-HBs	1 day
Secondary	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	1 day