Hepatitis B Prevalence in the Turkish Population Living in Middle Limburg (HBVTR)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03396458|
Recruitment Status : Recruiting
First Posted : January 11, 2018
Last Update Posted : January 27, 2020
|Condition or disease||Intervention/treatment|
|Hepatitis B||Diagnostic Test: Hepatitis B serology Other: Questionnaire|
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 Type :||Observational|
|Estimated Enrollment :||1000 participants|
|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, 2020|
|Estimated Study Completion Date :||August 31, 2020|
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).
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.
- Seroprevalence of current HBV infection in the Turkish population [ Time Frame: 1 day ]Serum HBsAg
- Seroprevalence of protective antibodies against HBV infection in the Turkish population [ Time Frame: 1 day ]Serum anti-HBs
- 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
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
|Contact: Geert Robaeys, M.D., Ph.D.||+email@example.com|
|Contact: Özgür Koc, M.D.||+firstname.lastname@example.org|
|Principal Investigator:||Geert Robaeys, M.D., Ph.D.||Hasselt University|