NCT03396458

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2017

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 11, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

3 years

First QC Date

December 15, 2017

Last Update Submit

January 23, 2020

Conditions

Hepatitis B

Keywords

Hepatitis BDisease prevalenceScreeningMigrantTurkishBelgium

Outcome Measures

Primary Outcomes (1)

  • Seroprevalence of current HBV infection in the Turkish population

    Serum HBsAg

    1 day

Secondary Outcomes (2)

  • Seroprevalence of protective antibodies against HBV infection in the Turkish population

    1 day

  • Assess risk factors for past or current HBV infecion in the Turkish population

    1 day

Study Arms (1)

Hepatitis B group

Hepatitis B serology and questionnaire

Diagnostic Test: Hepatitis B serologyOther: Questionnaire

Interventions

Hepatitis B serologyDIAGNOSTIC_TEST

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

Hepatitis B group
QuestionnaireOTHER

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.

Hepatitis B group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Turkish population

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

RECRUITING

Related Publications (1)

  • 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.

    PMID: 31045797DERIVED

MeSH Terms

Conditions

Hepatitis B

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Geert Robaeys, M.D., Ph.D.

    Hasselt University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Geert Robaeys, M.D., Ph.D.

CONTACT

+3289326505geert.robaeys@zol.be

Özgür Koc, M.D.

CONTACT

+3289321519ozgur.koc@zol.be

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

December 15, 2017

First Posted

January 11, 2018

Study Start

September 1, 2017

Primary Completion

August 31, 2020

Study Completion

August 31, 2020

Last Updated

January 27, 2020

Record last verified: 2020-01

Locations

BE(1)