The World Health Organization (WHO) has set a target to eliminate viral hepatitis by 2030, aiming for a 90% diagnosis rate and an 80% treatment rate for chronic hepatitis B (CHB). However, as of 2024, only 26.1% of CHB infections globally have been diagnosed, and only 14.6% have received treatment, with treatment coverage falling far short of the target. A large number of patients are in a "Diagnosed-but-Untreated (DBU)" state, with major barriers including: low disease awareness, concerns about medication side effects, fragmented healthcare pathways, and poor physician-patient communication. Traditional hospital-based follow-up models are constrained by human resources and the capacity for health information system integration, making them difficult to scale widely in primary care settings.
Supported by the National Key R\&D Program of China, our team has successfully developed the world's first infectious disease agent (Union-Agent) after more than two years of research. This study aims to conduct a multicenter, prospective, two-cohort observational and interventional investigation to identify the reasons why DBU patients fail to initiate treatment and to explore whether an intervention using the Union-Agent can significantly increase the rate of antiviral treatment initiation within six months among DBU patients who meet the antiviral indications according to the 2022 Chinese guidelines for the prevention and treatment of chronic hepatitis B. The study hypothesizes that, compared to baseline, the Union-Agent can enable 50%-60% of treatment-eligible DBU patients to initiate antiviral therapy within six months.
Aged ≥18 years with persistent HBsAg positivity for ≥6 months (diagnosed as chronic hepatitis B [CHB] per the latest Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis B).
Treatment-naïve to nucleos(t)ide analogues (NUCs), or previous NUC treatment with no medication for the past 6 months (diagnosed-but-untreated [DBU] status).
Capable of using a smartphone independently or with family member assistance.
Voluntarily provides written informed consent (electronic version) and agrees to study procedures and follow-up.
Severe mental or cognitive impairment that impairs study cooperation.
Current participation in other interventional clinical trials that may influence HBV treatment decisions.
Inability to use a smartphone even with assistance.
Refusal to sign the informed consent form.
Single group
Agent Intelligence education
Other interventionPatients, while receiving usual care, will also receive four services from Union-Agent: (i) guideline-based educational modules tailored to patients' baseline knowledge of hepatitis B; (ii) personalized medication reminders with real-time adherence records; (iii) semantic follow-up that converts patient-reported symptoms into structured data and generates early risk alerts; and (iv) algorithm-driven referral suggestions aligned with China's three-tiered healthcare referral system.
Proportion of DBU patients initiating antiviral treatment
6-month antiviral treatment initiation rate in DBU patients meeting 2022 Chinese CHB guideline indications: * Absolute increase: ≥10 percentage points from baseline. * Relative increase: 50% from baseline.
Multilevel Barriers to Antiviral Treatment in DBU CHB Patients
Identification of multilevel barriers (individual, healthcare system, societal) to antiviral treatment in diagnosed-but-untreated (DBU) chronic hepatitis B (CHB) patients, via Union-Agent's built-in structured questionnaire and clinical record review
Proportion of DBU Patients with Correct Recognition of Core HBV Knowledge
Proportion of DBU CHB patients who achieve ≥80% correct answers on the Union-Agent HBV Knowledge Assessment Scale (a validated, 20-item scale).
Change in Average Review Intervals in DBU Patients with Irregular Follow-Up History
Change from baseline in average review intervals of DBU CHB patients with a history of irregular follow-up, assessed via Union-Agent follow-up logs.
Proportion of Real-Time High-Risk Event Detection in DBU Patients
Proportion of high-risk events (ALT flares \[defined as ALT \>2× upper limit of normal\], HBV DNA rebound \[defined as HBV DNA increase \>1 log10 IU/mL from nadir\], incipient cirrhosis \[assessed by FibroScan and FIB-4 formula \]) detected in real time via the Union-Agent risk stratification module
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead sponsor
The First Affilated Hospital of the Medical College, Shihezi University
Collaborator
Taihe Hospital in Shiyan
Collaborator
Yichang Central People's Hospital
Collaborator
The Second Hospital of Anhui Medical University
Collaborator
Wuhan Jinyintan Hospital
Collaborator
Zigui County People's Hospital
Collaborator
Shanghai Zhongshan Hospital
Collaborator
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