Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07540637

Assessment of Treatment Adherence and Associated Factors in Chronic Hepatitis B Patients With Supported Management by the HBVCare Application

Led by Institute of Gastroenterology and Hepatology, Vietnam · Updated on 2026-05-15

70

Participants Needed

2

Research Sites

4 weeks

Total Duration

On this page

Sponsors

I

Institute of Gastroenterology and Hepatology, Vietnam

Lead Sponsor

H

Hanoi Medical University Hospital, Vietnam

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating how the HBVCare mobile application can support adults living with chronic Hepatitis B in improving their adherence to treatment and regular follow-up visits. This is important because low adherence in Vietnam is linked to patient awareness and geographic challenges, which can lead to serious complications. The study is a randomized controlled trial conducted at multiple centers in Vietnam to assess the app's impact on treatment adherence and related health outcomes. Participants are randomly assigned to one of two groups: one group uses the HBVCare app, which offers medication reminders, lab result storage, and educational content; the other group receives standard care without the app. The intervention lasts for three months, during which participants in the app group receive instructions on using HBVCare to help manage their disease proactively. During the study, participants will have their treatment adherence assessed after three months. Researchers will also monitor changes in clinical symptoms, user experience with the app, patient satisfaction, and various laboratory measures related to liver health and viral load. The primary outcome is the proportion of patients demonstrating good treatment adherence at three months, with additional data collected to evaluate the app's usability and impact on health markers.

CONDITIONS

Brief Title

Assessment of Treatment Adherence and Associated Factors in Chronic HepB Patients Supported by HBVCare

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosis of Chronic Hepatitis B for 6 months or more (HBsAg positive and/or HBV DNA positive; or HBsAg positive and anti-HBc IgM negative)
  • Own a smartphone (iOS or Android) with active internet and ability to install the HBVCare app
  • Able to read and understand Vietnamese and respond to study questions
  • Provided informed consent to participate
Not Eligible

You will not qualify if you...

  • Mental health disorders, cognitive impairment, or difficulties using mobile applications
  • Severe chronic health conditions such as heart failure, kidney failure, or respiratory failure
  • Severe complications including gastrointestinal bleeding, liver cancer, hepatic encephalopathy, or acute liver failure

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 3 months

Participants use the HBVCare mobile application or do not use it, based on random assignment, to support management of chronic Hepatitis B.

Baseline visit and 1 follow-up visit at 3 months

Trial Site Locations

Total: 2 locations

1

Hanoi Medical University Hospital

Hanoi, Vietnam, 100000

Actively Recruiting

2

Institute of Gastroenterology and Hepatology

Hanoi, Vietnam, 100000

Actively Recruiting

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Research Team

T

Trung Quoc Vu

H

Hang Viet Dao, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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