Hospital-based program to improve care for people with chronic hepatitis B

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

This project tests whether hospital screening, automated alerts, and a dedicated referral pathway can increase referrals, treatment starts, and follow-up for people with chronic hepatitis B identified outside liver or infectious disease clinics.

Quick facts

• Study type: Observational
• Enrollment: 16300 (estimated)
• Sex: All
• Sponsor: Third Affiliated Hospital, Sun Yat-Sen University (other)
• Locations: 3 sites (Guangzhou, Guangdong and 2 other locations)
• Trial ID: NCT06966908 on ClinicalTrials.gov

What this trial studies

The project expands a hospital-based management system across three affiliated hospitals to centralize identification, referral, treatment, and follow-up for HBsAg-positive patients. It uses automated extraction of positive HBsAg results, alert notes on reports, a designated Hepatitis B Specialist Assistant, and a Hepatitis B Health Clinic to streamline linkage to care. The primary target is to raise referral rates from non-hepatology/non-infectious departments to 50% and to increase treatment among diagnosed-but-untreated patients, while collecting cost-effectiveness and clinical outcome data. A prospective patient-reported outcomes (PRO) sub-study enrolls treatment-naïve adults who meet national treatment criteria to measure symptoms, quality of life, and care experience.

Who should consider this trial

Good fit: Ideal candidates are HBsAg-positive adults seen in non-hepatology/non-infectious disease departments at the three participating hospitals, especially treatment-naïve patients who meet the Chinese guideline treatment criteria and can consent and complete PRO questionnaires.

Not a fit: Patients already under regular follow-up in infectious disease/hepatology clinics or those already on long-term antiviral therapy (and those with other chronic liver diseases excluded from the PRO sub-study) are unlikely to benefit from the linkage interventions in this project.

Why it matters

Potential benefit: If successful, more people with chronic hepatitis B would be identified and linked to specialist care and appropriate antiviral treatment sooner, potentially reducing disease progression and complications.

How similar studies have performed: Similar in-hospital alert-and-referral programs and linkage-to-care interventions have improved referral and treatment uptake in other settings, though multicenter hospital cohorts with integrated PRO and cost-effectiveness analyses are less common.

Eligibility criteria

Inclusion Criteria:

* HBsAg-positive patients attending non-infectious disease/hepatology departments at three study centers.

Additional inclusion criteria for the PRO sub-study:

* Age ≥ 18 years;
* Treatment-naïve HBV-infected patients;
* Meet the treatment criteria according to the "Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis B" (2022 version);
* Be able to understand the study content, willing to participate, and sign the informed consent;
* Have the ability to complete questionnaires independently or with assistance.

Exclusion Criteria:

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

Additional exclusion criteria for the PRO sub-study:

* History of chronic liver diseases other than chronic HBV infection, including but not limited to: alcoholic liver disease, autoimmune liver disease, hereditary metabolic liver disease, etc. Co-infection with HCV, HDV, or HIV. Presence of other severe conditions that may affect HRQoL (such as severe cardiovascular and cerebrovascular diseases, uncontrolled mental illnesses, malignant tumors, etc.);
* Pregnant or lactating women;
* Use of pegylated interferon during the study;
* Failure to complete all follow-up visits;
* Other conditions that the investigator deems inappropriate for participation.

Where this trial is running

Guangzhou, Guangdong and 2 other locations

• The Third Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (RECRUITING)
• The Sixth Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (COMPLETED)
• The Fifth Affiliated Hospital of Sun Yat-sen University — Zhuhai, Guangdong, China (COMPLETED)

Study contacts

• Principal investigator: Liang Peng — Third Affiliated Hospital, Sun Yat-Sen University
• Study coordinator: Liang Peng

Conditions: Chronic Hepatitis B, linkage to care, management, patient reported outcome