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Trial record 2 of 314 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

Hepatitis B Prevalence in the Turkish Population Living in Middle Limburg (HBVTR)

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ClinicalTrials.gov Identifier: NCT03396458
Recruitment Status : Recruiting
First Posted : January 11, 2018
Last Update Posted : January 11, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Hepatitis B Diagnostic Test: Hepatitis B serology Other: Questionnaire

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

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prevalence and Risk Factors of Hepatitis B Viral Infection in the Turkish Population Living in Belgium
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Hepatitis B group
Hepatitis B serology and questionnaire
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.


Outcome Measures

Primary Outcome Measures :
  1. Seroprevalence of current HBV infection in the Turkish population [ Time Frame: 1 day ]
    Serum HBsAg


Secondary Outcome Measures :
  1. Seroprevalence of protective antibodies against HBV infection in the Turkish population [ Time Frame: 1 day ]
    Serum anti-HBs

  2. Assess risk factors for past or current HBV infecion in the Turkish population [ Time Frame: 1 day ]
    Combine results from (1) serum anti-HBc with (2) questionnaire regarding sociodemographic factors, migration, risk factors for HBV infection and HBV vaccination status


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Turkish population
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03396458


Contacts
Contact: Geert Robaeys, M.D., Ph.D. +3289326505 geert.robaeys@zol.be
Contact: Özgür Koc, M.D. +3289321519 ozgur.koc@zol.be

Locations
Belgium
Ziekenhuis Oost-Limburg Recruiting
Genk, Limburg, Belgium, 3600
Contact: Özgür Koc, M.D.    +3289321519    ozgur.koc@zol.be   
Contact: Geert Robaeys, M.D., Ph.D.    +3289326505    geert.robaeys@zol.be   
Sponsors and Collaborators
Hasselt University
Investigators
Principal Investigator: Geert Robaeys, M.D., Ph.D. Hasselt University
More Information

Responsible Party: Geert Robaeys, Clinical Associate Professor, Hasselt University
ClinicalTrials.gov Identifier: NCT03396458     History of Changes
Other Study ID Numbers: HBVTR-1.0
First Posted: January 11, 2018    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Geert Robaeys, Hasselt University:
Hepatitis B
Disease prevalence
Screening
Migrant
Turkish
Belgium

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections