Clinical trial NCT06966908: Hospital-Based Management of Patients With Chronic Hepatitis B Virus Infection
Official title: Hospital-Based Management of Patients With Chronic Hepatitis B Virus Infection
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Chronic Hepatitis B
Keywords: Chronic Hepatitis B
linkage to care
management
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 16000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HBsAg-positive patients attending non-infectious disease/hepatology departments.

Brief summary: Starting in 2022, the Third Affiliated Hospital of Sun Yat-sen University implemented the "Hot Wave Project," an integrated HBV infection prevention and control system encompassing patient education, screening, referral, treatment, and follow-up. This system is now being expanded to the Sixth Affiliated Hospital and Fifth Affiliated Hospital of Sun Yat-sen University. Additionally, a multicenter, in-hospital cohort study on HBV management has been initiated.The primary aim of this study is to increase the referral rate from to 50% for HBsAg-positive patients from non-hepatology/non-infectious disease departments. The secondary objective is to improve the treatment rates of HBV-infected individuals in non-hepatology/non-infectious disease departments, especially the population diagnosed but untreated (DBU). Additionally, the study seeks to analyze the cost-effectiveness and clinical benefits of the in-hospital HBV screening and management strategy.

Detailed description: The "Hot wave Project" aims to establish a multicenter management cohort for HBsAg-positive patients within hospitals. Led by infectious disease specialists, the program conducts regular hepatitis B training sessions for hospital staff to enhance their understanding of HBV prevention and control. This initiative seeks to increase HBsAg screening rates overall and encourage patients from non-infectious disease departments to seek referrals to specialized care.

For all paper reports containing HBsAg test results, a remark is added stating: "HBsAg (+) - Recommended to visit the Hepatitis B Health Clinic in the Infectious Disease Department." Positive HBsAg results are automatically extracted by the information system and sent to a dedicated computer in the Hepatitis B Health Clinic, enabling centralized digital patient management.

Additionally, the Infectious Disease Department appoints a "Hepatitis B Specialist Assistant" responsible for reviewing HBsAg screening results, notifying HBsAg-positive patients or their attending physicians, and establishing follow-up records for all patients. A "Hepatitis B Health Clinic" is also set up within the department, managed by a specialized medical team that handles the diagnosis, treatment, and education for referred chronic hepatitis B patients.

Eligibility criteria: Inclusion Criteria:

* HBsAg-positive patients attending non-infectious disease/hepatology departments at three study centers between January 2025 and December 2025.

Exclusion Criteria:

* HBsAg-positive patients already under regular follow-up in infectious disease/hepatology clinics.
* Chronic HBV patients on regular antiviral treatment.

Primary outcomes:
measure: Referral rate
timeFrame: 2 weeks
Secondary outcomes:
measure: Antiviral treatment rate
timeFrame: 2 weeks
measure: The cost-effectiveness of in-hospital HBV screening and management strategies
timeFrame: 5 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Zhuhai
country: China
facility: The Fifth Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Third Affiliated Hospital, Sun Yat-Sen University
name: Liang Peng
role: PRINCIPAL_INVESTIGATOR
affiliation: Fifth Affiliated Hospital, Sun Yat-Sen University
name: Zhongsi Hong
role: PRINCIPAL_INVESTIGATOR
affiliation: Sixth Affiliated Hospital, Sun Yat-sen University
name: Fangfang Wei
role: PRINCIPAL_INVESTIGATOR
References: