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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: pliang@mail.sysu.edu.cn
• Phone: +8613533978874

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.