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NCT Number: NCT07540637

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

Adherence to chronic Hepatitis B (HBV) treatment and regular follow-up visits is essential for preventing dangerous complications, yet adherence rates in Vietnam remain low due to barriers in patient awareness and geographic conditions. Digital health solutions, particularly mobile applications, have shown potential as tools for supporting patients in proactive disease management. The HBVCare mobile application was developed to provide features such as medication reminders, storage of lab results, and health education to improve treatment adherence and clinical outcomes. The investigators are conducting a multicenter, randomized controlled trial at Hoang Long Clinic and Hanoi Medical University Hospital to evaluate the effectiveness of HBVCare. Patients are randomized into either a control group receiving standard care and an intervention group using the HBVCare app, with patient adherence and related factors assessed after three months of treatment.

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Key information

Conditions

Chronic Hepatitis B Behavior Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Health Behavior Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Medication Adherence Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hanoi Medical University Hospital, Hanoi, Vietnam

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years.
  • Diagnosis of Chronic Hepatitis B (CHB): HBsAg (+) and/or HBV DNA positive for ≥ 6 months; Or HBsAg positive and anti-HBc IgM negative.
  • Smartphone ownership (iOS or Android) with an active internet connection and the ability to install the HBVCare application.
  • Sufficient literacy to read and understand Vietnamese and respond to study questions.
  • Provision of informed consent to participate in the study.

Exclusion criteria

  • Mental health disorders, cognitive impairment, or difficulties in communication and mobile application usage.
  • Severe comorbid chronic conditions, such as heart failure, kidney failure, or respiratory failure.
  • Presence of severe complications, including gastrointestinal bleeding, liver cancer, hepatic encephalopathy, or acute liver failure.

Treatment and study plan

HBVCare Mobile App

Other

Using the smartphone application HBVCare (with detailed instructions provided during recruitment)

Primary outcomes

  1. Proportion of patients with good treatment adherence at 3 months

    Time frame: 3 months after recruitment

    Patients achieved a high level of adherence to antiviral medication (25 points on MARS-5 score) and follow-up schedules (attend the clinical follow-up within 1 week of the pre-specified schedule) as recorded through the HBVCare application.

Secondary outcomes

  1. Changes in Clinical Symptoms

    Time frame: Baseline and 3 months after recruitment

    Assessment of 8 subjective symptoms associated with chronic Hepatitis B (fatigue / tiredness, Skin or mucosal hemorrhage, loss of appetite, ascites, nausea / vomiting, pain or discomfort in the liver area, jaundice / discolored urine, peripheral edema). Symptom progression was evaluated over a 3-month follow-up period based on patient-reported outcomes: improvement, no change, worsening, new onset, or absence of symptoms.

  2. Mean Usability Metric for User Experience-Lite (UMUX-Lite) Score at 3 Months

    Time frame: 3 months after recruitment

    Evaluation of the overall perceived usability and usefulness of the HBVCare digital platform. The Usability Metric for User Experience-Lite (UMUX-Lite) consists of two items (the app is easy to use, the app meets my requirements) measured on a 7-point Likert scale (total of 14 points, higher scores indicate better perceived usability and a more positive user experience).

  3. Mean Patient Satisfaction Scores for HBVCare App Features at 3 Months

    Time frame: 3 months after recruitment

    Assessment of user satisfaction with 5 specific app features: clinical data storage, medication/follow-up reminders, health education, symptom/adherence surveys, and reporting graphs. Each feature is rated on a 5-point Likert scale (1 = Very Dissatisfied, 5 = Very Satisfied). Higher scores indicate higher levels of satisfaction with the specific feature.

  4. Mean Change from Baseline in concentrations of Serum Liver Enzyme Levels (Units per Liter) at 3 Months.

    Time frame: Baseline and 3 months after recruitment

    Liver function test results for evaluating hepatic inflammation, including concentrations of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and Gamma-glutamyl Transferase (GGT).

    Unit of Measure: Units per Liter (U/L).

  5. Mean Change from Baseline in concentrations of Serum Bilirubin Levels (Milligrams per deciliter) at 3 Months

    Time frame: Baseline and 3 months after recruitment

    Evaluation of bilirubin processing, including Total Bilirubin and Direct Bilirubin.

    Unit of Measure: Milligrams per deciliter (mg/dL)

  6. Mean Change from Baseline in concentration of Serum Albumin (Grams per deciliter) at 3 Months.

    Time frame: Baseline and 3 months after recruitment

    Assessment of hepatic synthetic function by measuring the concentration of serum albumin.

    Unit of Measure: Grams per deciliter (g/dL).

  7. Mean Change from Baseline in Platelet Count (Thousands per microliter) at 3 Months.

    Time frame: Baseline and 3 months after recruitment

    Measurement of the number of circulating platelets to monitor for portal hypertension or bone marrow suppression.

    Unit of Measure: Thousands per microliter (10^3/μL).

  8. Mean Change from Baseline in International Normalized Ratio (INR) at 3 Months.

    Time frame: Baseline and 3 months after recruitment

    Measurement of a standardized measure of prothrombin time called International Normalized Ratio (INR) to evaluate blood coagulation and liver synthetic function.

    Unit of Measure: Ratio (Unitless).

  9. Mean Change from Baseline in Serum Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Viral Load in International Units per milliliter at 3 Months

    Time frame: Baseline and 3 months after recruitment

    Quantitative measurement of Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) to evaluate the level of viral replication.

    Unit of Measure: International Units per milliliter (IU/mL)

  10. Mean Change from Baseline in Quantitative Hepatitis B Surface Antigen (qHBsAg) in International Units per milliliter (IU/mL) at 3 Months

    Time frame: Baseline and 3 months after recruitment

    Evaluation of the change in serum concentration of Hepatitis B Surface Antigen (HBsAg).

    Unit of Measure: International Units per milliliter (IU/mL)

  11. Number of Participants Achieving Hepatitis B envelope Antigen (HBeAg) Seroclearance at 3 Months

    Time frame: Baseline and 3 months after recruitment

    Number of participants who transit from Hepatitis B envelope Antigen (HBeAg)-positive at baseline to HBeAg-negative at the 3-month follow-up.

    Unit of Measure: Number of participants

Study contacts

Contact information is provided by the study sponsor or research team.

Hang Viet Dao, MD, PhD

CONTACT

[email protected]; [email protected]

+84987988075

Trung Quoc Vu

CONTACT

[email protected]

+84796262002

Sponsors and collaborators

Lead sponsor

Institute of Gastroenterology and Hepatology, Vietnam

Other

Collaborators

  • Hanoi Medical University Hospital, Vietnam

Registry information

Official study title

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

Acronym: HBVCare

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 20, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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