NCT06658678

Brief Summary

Chronic hepatitis B remains the leading cause of liver related mortality and morbidity globally and locally. Countries have been formulating initiatives to meet the WHO target of eliminating viral hepatitis by 2030. However, data on the most important aspect of management of chronic hepatitis B, namely linkage to care and treatment, remains scarce. In order to achieve the WHO goal, treatment rate of eligible patients should reach 80%.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
803

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

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

April 3, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 26, 2024

Completed
Last Updated

October 26, 2024

Status Verified

October 1, 2024

Enrollment Period

9 months

First QC Date

June 25, 2024

Last Update Submit

October 23, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • The effect of education intervention on rate of retention in care in chronic hepatitis B patients identified from a territory wide screening program

    12 months

Secondary Outcomes (4)

  • The treatment rate in chronic hepatitis B patients up to 5 years after diagnosis

    5 years

  • The rate of viral suppression in chronic hepatitis B patients up to 5 years after diagnosis

    5 years

  • The rate of complication in chronic hepatitis B patients up to 5 years after diagnosis

    5 years

  • Factors affecting rate of retention in care from patient perspective in the form of questionnaire survey

    12 months

Study Arms (2)

Receiving an educational intervention

EXPERIMENTAL

Receiving the educational video link on their mobile device

Other: Receiving an educational intervention

No educational intervention

NO INTERVENTION

Interventions

Patient not receiving any educational intervention

Also known as: No educational intervention
Receiving an educational intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • CHB (HBV DNA+ or HBsAg+ for more than 6 months)
  • Age \>18
  • Treatment naive at initial presentation

You may not qualify if:

  • Prior HBV treatment
  • Organ transplant or other immunosuppression
  • HIV, HDV, HCV co-infection
  • Decompensated or HCC patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medicine and Department of Surgery, The University of Hong Kong, Queen Mary Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

June 25, 2024

First Posted

October 26, 2024

Study Start

April 3, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2022

Last Updated

October 26, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations