NCT04371276

Brief Summary

Immunisation policies have strong influences on the epidemiology of hepatitis A and B infection. In Hong Kong, vaccines against both viruses have been available through different channels and programmes in the past 3 decades. To evaluate the changes in the prevalence of hepatitis A and B in the general population, a seroepidemiology study is conducted involving a prospective cross-sectional survey followed for serology testing. Eligible members of 1327 spatially random households would be invited to join the study by completing a questionnaire and providing blood samples, either by dried blood spots or venesection, for determining the presence of antigen and/or antibody against hepatitis B, as well as antibody against hepatitis A. The main measures comprise a set of metrics on the prevalence of hepatitis A and B. Analysis would be conducted to examine the association of risk factors with the tested markers and describe the attitudes towards viral hepatitis vaccination. The results would allow us to understand the transmission potential of hepatitis A and B in the community would be influenced by the changing disease epidemiology and coverage of vaccination, which inform the development of new vaccination strategies in Hong Kong

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,888

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2018

Typical duration 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

September 1, 2018

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 1, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

3.3 years

First QC Date

April 29, 2020

Last Update Submit

February 6, 2023

Conditions

Keywords

hepatitis Ahepatitis Bepidemiology

Outcome Measures

Primary Outcomes (2)

  • hepatitis B infection prevalence

    Proportion of individuals with positive HBsAg

    12 months

  • hepatitis A immunity prevalence

    Proportion of individuals with positive IgG against HAV

    12 months

Interventions

Blood samples will be collected from recruited subjects from invited households for testing for hepatitis B (HBsAg, anti-HBs and anti-HBc) and hepatitis A (anti-HAV)

Also known as: blood sampling for serology testing

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Residents of Building Groups from diverse geographical locations in Hong Kong selected through cluster sampling are targeted. With the building information available, three households would be randomly selected from each Building Group.

You may qualify if:

  • residents normally living in Hong Kong
  • living in domestic households randomly selected from Building Groups
  • Any age, while subjects below the age of 18 would require informed consent of their guardians for participation
  • Any gender

You may not qualify if:

  • unable to understand written Chinese or English,
  • failure to give consent for participation
  • living in institution or non-domestic housing,
  • foreign domestic helpers,
  • normally living in Hong Kong

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong, China

Location

Related Publications (1)

  • Poon CM, Chan DP, Lee SS, Wong NS. Seroepidemiology of hepatitis A and B in the general population in Hong Kong: protocol of a cross-sectional survey using spatial sampling in a highly urbanised city. BMJ Open. 2021 Mar 22;11(3):e042065. doi: 10.1136/bmjopen-2020-042065.

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood

MeSH Terms

Conditions

Hepatitis AHepatitis B

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Hepatitis, Viral, HumanVirus DiseasesInfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesBlood-Borne InfectionsCommunicable DiseasesHepadnaviridae InfectionsDNA Virus Infections

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Shui Shan Lee, MD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 29, 2020

First Posted

May 1, 2020

Study Start

September 1, 2018

Primary Completion

December 31, 2021

Study Completion

May 31, 2022

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations