NCT03425513

Brief Summary

The aim of this study was to evaluate the current prevalence and risk factors of hepatitis B virus (HBV) infection in a multi-ethnic neighbourhood situated in Middle Limburg, Belgium. Additionally, the investigators will determine linkage of care in hepatitis B surface antigen (HBsAg) positive subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,131

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

May 12, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 7, 2018

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

7 months

First QC Date

February 1, 2018

Last Update Submit

January 23, 2020

Conditions

Hepatitis B

Keywords

BelgiumPrevalenceRisk factorEthnicityLinkage of care

Outcome Measures

Primary Outcomes (2)

  • Seroprevalence of current HBV infection in the Middle Limburg population

    Serum HBsAg

    1 day

  • Seroprevalence of past or current HBV infection in the Middle Limburg population

    Serum anti-HBc antibodies

    1 day

Secondary Outcomes (2)

  • Assess risk factors for current HBV infection in the Middle Limburg population

    1 day

  • Assess risk factors for past or current HBV infection in the Middle Limburg population

    1 day

Study Arms (1)

Hepatitis B group

Diagnostic Test: Hepatitis B serologyOther: Questionnaire

Interventions

Hepatitis B serologyDIAGNOSTIC_TEST

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

Hepatitis B group
QuestionnaireOTHER

Participants will be asked to fill in a questionnaire regarding demographic characteristics, known viral hepatitis status and risk factors for HBV infection.

Hepatitis B group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients between the age of 18 and 70 who presented at the emergency department of Ziekenhuis Oost-Limburg, a large hospital in Genk, situated in Middle Limburg.

You may qualify if:

  • Age between 18 and 70
  • Males and females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

Location

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

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

February 1, 2018

First Posted

February 7, 2018

Study Start

May 12, 2017

Primary Completion

November 27, 2017

Study Completion

November 27, 2017

Last Updated

January 27, 2020

Record last verified: 2020-01

Locations

BE(1)