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

NCT ID: NCT06966908

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 16000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-03
• Study Completion Date: 2026-01-15

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.

Conditions

Chronic Hepatitis B

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

HBsAg-positive patients in non-hepatology/non-infectious disease departments

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

Intervention Type: OTHER

After visiting the hospital, high-risk HBV patients are prescribed HBsAg testing by their primary physician. If HBsAg positivity is detected in patients from non-infectious disease departments, their lab reports will include a reminder to visit the Hepatitis B Health Clinic. Some primary physicians may also request an infectious disease consultation or recommend patient referral. Additionally, within two weeks, the Hepatitis B Specialist Assistant will contact the patients by phone to provide referral recommendations. Once referred to the Hepatitis B Health Clinic, physicians will conduct health education, complete liver function and virological assessments, and develop individualized treatment and follow-up plans.

Interventions

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

After visiting the hospital, high-risk HBV patients are prescribed HBsAg testing by their primary physician. If HBsAg positivity is detected in patients from non-infectious disease departments, their lab reports will include a reminder to visit the Hepatitis B Health Clinic. Some primary physicians may also request an infectious disease consultation or recommend patient referral. Additionally, within two weeks, the Hepatitis B Specialist Assistant will contact the patients by phone to provide referral recommendations. Once referred to the Hepatitis B Health Clinic, physicians will conduct health education, complete liver function and virological assessments, and develop individualized treatment and follow-up plans.

Intervention Type: OTHER

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Liang Peng

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liang Peng

Role: PRINCIPAL_INVESTIGATOR

Third Affiliated Hospital, Sun Yat-Sen University

Zhongsi Hong

Role: PRINCIPAL_INVESTIGATOR

Fifth Affiliated Hospital, Sun Yat-Sen University

Fangfang Wei

Role: PRINCIPAL_INVESTIGATOR

Sixth Affiliated Hospital, Sun Yat-sen University

Locations

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

The Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, China

Countries

China

Other Identifiers

PL19

Identifier Type: -

Identifier Source: org_study_id