Clinical trial NCT03396458: Hepatitis B Prevalence in the Turkish Population Living in Middle Limburg
Official title: Prevalence and Risk Factors of Hepatitis B Viral Infection in the Turkish Population Living in Belgium
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis B
Keywords: Hepatitis B
Disease prevalence
Screening
Migrant
Turkish
Belgium
Lead sponsor: Hasselt University
Sponsor class: OTHER
First posted: 2018-01-11
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Turkish population

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Turkish origin, defined as one of the parents born in Turkey
* Having a signed informed consent form

Exclusion Criteria:

/

Primary outcomes:
measure: Seroprevalence of current HBV infection in the Turkish population
timeFrame: 1 day
Secondary outcomes:
measure: Seroprevalence of protective antibodies against HBV infection in the Turkish population
timeFrame: 1 day
measure: Assess risk factors for past or current HBV infecion in the Turkish population
timeFrame: 1 day
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
state: Limburg
Study officials:
affiliation: Hasselt University
name: Geert Robaeys, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.