AI Agent to Help People With Hepatitis B Start Antiviral Treatment

Trial details

Who runs it

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Trial code

NCT07520123

Record updated

9 April 2026

Original description

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.Read full original descriptionShow less

Union-FAST: An Intelligent-Agent Intervention to Increase Antiviral Treatment Uptake in Diagnosed-but-Untreated Hepatitis B Patients：A Multicenter Prospective Study

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.

Inclusion: 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.

Exclusion: 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.

ClinicalTrials.gov NCT07520123