Union-FAST: An Intelligent-Agent Intervention to Increase Antiviral Treatment Uptake in Diagnosed-but-Untreated Hepatitis B Patients：A Multicenter Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Proportion of DBU patients initiating antiviral treatment
研究概览
简要总结
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.
详细描述
- Study Overview 1.1 Study Title An Intelligent-Agent Intervention (Union-FAST) to increase antiviral treatment uptake in diagnosed-but-untreated hepatitis B patients: a multicenter prospective study 1.2 Study Rationale The World Health Organization (WHO) 2016 Global Hepatitis Strategy targets ≥90% diagnostic coverage and ≥80% treatment coverage for chronic hepatitis B (CHB) by 2030 [1]. However, global progress remains sluggish: in 2024, only 26.1% of CHB patients were diagnosed and 14.6% received antiviral treatment, with merely 13% of infected individuals aware of their status and <3% on therapy by the end of 2022 [2-3]. China, the country with the highest HBV burden globally, faces the same gap-antiviral uptake at Union Hospital Wuhan only rose from 55% to 62% after the 2022 Chinese national guidelines, still far below the WHO target [4].
Diagnosed-but-untreated (DBU) CHB patients face key barriers including limited disease knowledge, concerns about adverse drug effects, fragmented care pathways, and inadequate physician-patient communication. Traditional hospital-based follow-up relies on integrated hospital information systems, limiting scalability to secondary and community care [5]. In contrast, AI-based intelligent-agent models enable web/mobile-delivered education, dynamic follow-up, and risk assessment, with mature applications in CHB management (e.g., 95% diagnostic concordance, real-time guideline-concordant plan generation) [6].
This study evaluates Union-Agent-a cloud-based AI assistant developed under China's National Key R&D Program (2022YFC2305100), integrating speech recognition, natural language processing, knowledge-graph retrieval, and large-language-model reasoning-for DBU CHB patients. The Union-FAST framework (Find DBU patients, Analyze barriers, Strategize interventions, Tool implementation) aims to address care gaps and improve antiviral treatment initiation.
1.3 Study Objectives Primary Objectives To evaluate whether Union-Agent increases the 6-month antiviral treatment initiation rate in DBU CHB patients meeting the 2022 Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis B by at least 10 percentage points (or a 50% relative increase) from baseline.
Secondary Objectives
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
patients diagnosed with Chronic Hepatitis B but Untreated
A multicenter, prospective, dual-cohort (observational + interventional) study with a self-controlled baseline design. The study includes two core phases:
- Baseline cross-sectional survey: Characterize DBU patients, identify treatment barriers, and establish stratification variables for intervention.
- Prospective interventional cohort: Patients receive routine care plus four Union-Agent-driven services, with real-time data collection to evaluate treatment uptake and clinical outcomes.
Core Services for Patients
-
Guideline-based personalized education;
-
Standardized treatment recommendations; ③ Individualized medication reminders; ④ Semantic follow-up and risk assessment; ⑤ Automated scheduling: Reminders for routine reviews, lab tests, and appointment booking; support for uploading lab results for physician review.
干预措施: Agent Intelligence education (Other)
结局指标
主要结局
Proportion of DBU patients initiating antiviral treatment
时间窗: from enrollment to six months post-enrollment
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.
次要结局
- Multilevel Barriers to Antiviral Treatment in DBU CHB Patients(From baseline assessment until 6 months of intervention, assessed at baseline and 6 months of intervention via Union-Agent's built-in structured questionnaire and clinical record review.)
- Proportion of DBU Patients with Correct Recognition of Core HBV Knowledge(From baseline assessment until 6 months of intervention, assessed at baseline and 6 months of intervention using the Union-Agent HBV Knowledge Assessment Scale.)
- Change in Average Review Intervals in DBU Patients with Irregular Follow-Up History(From the start of Union-Agent intervention until 6 months of intervention, assessed up to 6 months via Union-Agent follow-up logs to determine changes in average review intervals.)
- Proportion of Real-Time High-Risk Event Detection in DBU Patients(From the start of Union-Agent intervention until 6 months of intervention, assessed up to 6 months via the Union-Agent risk stratification module to detect high-risk events in real time.)
研究者
Xin Zheng
Professor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology