CClinicalTrials.gg
Status unknownNCT03396458HBVTRUpdated Jan 27, 2020

Hepatitis B Prevalence in the Turkish Population Living in Middle Limburg

An observational study in Hepatitis B, sponsored by Hasselt University. Status unknown at 1 site in Belgium. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-27.

Sponsored by Hasselt University · Observational

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Hepatitis B

Keywords

  • Hepatitis B
  • Disease prevalence
  • Screening
  • Migrant
  • Turkish
  • Belgium
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Turkish population

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

/

04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Hepatitis B group

    Hepatitis B serology and questionnaire

    Diagnostic Test: Hepatitis B serology · Other: Questionnaire

Interventions

  • Diagnostic testHepatitis B serology

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

  • OtherQuestionnaire

    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.

05

What researchers measure

Primary outcomes

  1. Seroprevalence of current HBV infection in the Turkish population

    Serum HBsAg

    Time frame: 1 day

Secondary outcomes

  1. Seroprevalence of protective antibodies against HBV infection in the Turkish population

    Serum anti-HBs

    Time frame: 1 day

  2. 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

    Time frame: 1 day

06

Study locations

1 of 1 sites recruiting
  • Ziekenhuis Oost-Limburg
    Genk, Limburg 3600, Belgium
    Recruiting
07

References and documents

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 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03396458
Lead sponsor
Hasselt University
Responsible party
Geert Robaeys (Clinical Associate Professor, Hasselt University) — Principal investigator
First posted
Jan 11, 2018
Start date
Sep 1, 2017
Primary completion
Aug 31, 2020 (estimated)
Completion
Aug 31, 2020 (estimated)
Last update
Jan 27, 2020

Study contacts

Geert Robaeys, M.D., Ph.D.
Contact
geert.robaeys@zol.be
+3289326505
Özgür Koc, M.D.
Contact
ozgur.koc@zol.be
+3289321519
Geert Robaeys, M.D., Ph.D.
principal investigator · Hasselt University

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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