Chronic Hepatitis BHBVCareNCT07540637
Assessment of Treatment Adherence and Associated Factors in Chronic HepB Patients Supported by HBVCare
A study testing HBVCare Mobile App in people with Chronic Hepatitis B, run by Institute of Gastroenterology and Hepatology, Vietnam at 2 sites in Vietnam.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- HBVCare Mobile App
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesVietnam
- Study dates
- 15 Apr 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam2 sites, 2 recruiting
- Recruiting
Hanoi Medical University Hospital
Hanoi, 100000
- Recruiting
Institute of Gastroenterology and Hepatology
Hanoi, 100000
About this study
Official title: Assessment of Treatment Adherence and Associated Factors in Chronic Hepatitis B Patients With Supported Management by the HBVCare Application.
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.
- Conditions
- Chronic Hepatitis B
- Being tested
- HBVCare Mobile App
- Keywords
- Chronic Hepatitis B, Digital health, mobile application, medication adherence
- Medical subject headings
- Hepatitis B, Chronic, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBVCare Mobile AppOther
Using the smartphone application HBVCare (with detailed instructions provided during recruitment)
| Study group | Role | What they receive |
|---|---|---|
| Using HBVCare | Experimental | Using the mobile phone application HBVCare (with detailed instructions provided during recruitment) Receives: Other: HBVCare Mobile App |
| Not using HBVCare | No intervention | Not using the smartphone application HBVCare |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with good treatment adherence at 3 months
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.
Measured: 3 months after recruitment
Secondary outcomes (11)
Changes in Clinical Symptoms
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.
Measured: Baseline and 3 months after recruitment
Mean Usability Metric for User Experience-Lite (UMUX-Lite) Score at 3 Months
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).
Measured: 3 months after recruitment
Mean Patient Satisfaction Scores for HBVCare App Features at 3 Months
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.
Measured: 3 months after recruitment
Mean Change from Baseline in concentrations of Serum Liver Enzyme Levels (Units per Liter) at 3 Months.
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).
Measured: Baseline and 3 months after recruitment
Mean Change from Baseline in concentrations of Serum Bilirubin Levels (Milligrams per deciliter) at 3 Months
Evaluation of bilirubin processing, including Total Bilirubin and Direct Bilirubin.
Unit of Measure: Milligrams per deciliter (mg/dL)
Measured: Baseline and 3 months after recruitment
Mean Change from Baseline in concentration of Serum Albumin (Grams per deciliter) at 3 Months.
Assessment of hepatic synthetic function by measuring the concentration of serum albumin.
Unit of Measure: Grams per deciliter (g/dL).
Measured: Baseline and 3 months after recruitment
Mean Change from Baseline in Platelet Count (Thousands per microliter) at 3 Months.
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).
Measured: Baseline and 3 months after recruitment
Mean Change from Baseline in International Normalized Ratio (INR) at 3 Months.
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).
Measured: Baseline and 3 months after recruitment
Mean Change from Baseline in Serum Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Viral Load in International Units per milliliter at 3 Months
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)
Measured: Baseline and 3 months after recruitment
Mean Change from Baseline in Quantitative Hepatitis B Surface Antigen (qHBsAg) in International Units per milliliter (IU/mL) at 3 Months
Evaluation of the change in serum concentration of Hepatitis B Surface Antigen (HBsAg).
Unit of Measure: International Units per milliliter (IU/mL)
Measured: Baseline and 3 months after recruitment
Number of Participants Achieving Hepatitis B envelope Antigen (HBeAg) Seroclearance at 3 Months
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
Measured: Baseline and 3 months after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start15 Apr 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Gastroenterology and Hepatology, Vietnam
- Sponsor type
- University, hospital or other
- Collaborators
- Hanoi Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07540637
- Sponsor's protocol ID
- HC2604
- Acronym
- HBVCare
- Status last verified
- May 2026
- First submitted
- 4 Apr 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Treatment Adherence and Associated Factors in Chronic Hepatitis B Patients With Supported Management by the HBVCare Application.
- ClinicalTrials.gov ID
- NCT07540637
- Acronym / sponsor ID
- HBVCare / HC2604
- Conditions
- Chronic Hepatitis B
- Keywords
- Chronic Hepatitis B, Digital health, mobile application, medication adherence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Institute of Gastroenterology and Hepatology, VietnamUniversity, hospital or other
- Collaborators
- Hanoi Medical University
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Using HBVCare | Experimental | Other: HBVCare Mobile AppUsing the mobile phone application HBVCare (with detailed instructions provided during recruitment) |
| Not using HBVCare | No intervention | –Not using the smartphone application HBVCare |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HBVCare Mobile AppUsing the smartphone application HBVCare (with detailed instructions provided during recruitment) | Other | Using HBVCare |
Primary outcome
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.
11 secondary outcomes
Changes in Clinical Symptoms
Time frame: Baseline and 3 months after recruitment
Mean Usability Metric for User Experience-Lite (UMUX-Lite) Score at 3 Months
Time frame: 3 months after recruitment
Mean Patient Satisfaction Scores for HBVCare App Features at 3 Months
Time frame: 3 months after recruitment
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
Mean Change from Baseline in concentrations of Serum Bilirubin Levels (Milligrams per deciliter) at 3 Months
Time frame: Baseline and 3 months after recruitment
Mean Change from Baseline in concentration of Serum Albumin (Grams per deciliter) at 3 Months.
Time frame: Baseline and 3 months after recruitment
Mean Change from Baseline in Platelet Count (Thousands per microliter) at 3 Months.
Time frame: Baseline and 3 months after recruitment
Mean Change from Baseline in International Normalized Ratio (INR) at 3 Months.
Time frame: Baseline and 3 months after recruitment
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
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
Number of Participants Achieving Hepatitis B envelope Antigen (HBeAg) Seroclearance at 3 Months
Time frame: Baseline and 3 months after recruitment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HBVCare Mobile App in people with Chronic Hepatitis B, run by Institute of Gastroenterology and Hepatology, Vietnam at 2 sites in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trung Quoc Vu (+84796262002, vuquoctrung0305@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with good treatment adherence at 3 months (time frame: 3 months after recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.