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Hospital-Based Management of Patients With Chronic Hepatitis B Virus Infection

Sun Yat-sen University logo

Sun Yat-sen University

Status

Invitation-only

Conditions

Chronic Hepatitis B

Treatments

Other: Facilitate the referral of in-hospital chronic hepatitis B patients and provide treatment and follow-up in the infectious disease department.

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

16,000 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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.

Trial design

16,000 participants in 1 patient group

HBsAg-positive patients in non-hepatology/non-infectious disease departments
Treatment:
Other: Facilitate the referral of in-hospital chronic hepatitis B patients and provide treatment and follow-up in the infectious disease department.

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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