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A Prospective Cohort Study Evaluating the Impact of Rapid Point-of-Care Testing for HBV Markers on HBV Screening, Diagnosis, Treatment, and Follow-up

A Prospective Cohort Study Evaluating the Impact of Rapid Point-of-Care Testing for HBV Markers on HBV Screening, Diagnosis, Treatment, and Follow-up

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600128901
Enrollment
Unknown
Registered
2026-07-28
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B

Interventions

Observation group:None

Sponsors

Southern Medical University Southern Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Participants must be aged 18 years or above, with no restriction on gender; 2.Individuals requiring HBV screening, diagnosis, treatment, and follow-up; 3.Voluntary participation in this study and signed informed consent form prior to the study;

Exclusion criteria

Exclusion criteria: 1.Prior confirmed diagnosis of non-HBV infection; 2.Inability to understand the study procedures or to independently provide informed consent, and having no legally authorized representative; 3.Any other condition deemed by the investigator to make the individual inappropriate for the study;

Design outcomes

Primary

MeasureTime frame
The completion rate of HBV diagnosis within 2 years for populations requiring further diagnosis;The completion rate of standardized follow-up within 2 years for populations enrolled in routine management;The initiation rate of antiviral therapy within 2 years for populations meeting antiviral treatment indications;The completion rate of HBsAg test within 2 years for populations requiring HBV screening;

Secondary

MeasureTime frame
Time interval between enrollment and completion of the first HBV marker test among participants;Health economic evaluation;Liver function normalization rate;Implementation science evaluation;Social psychosocial evaluation;Number of HBV marker tests completed by participants during the 2-year follow-up period;HBV DNA clearance rate;

Countries

China

Contacts

Public ContactXueru Yin

Southern Medical University Southern Hospital

evonneyin@163.com+86 20 6278 7432

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026