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NOT YET RECRUITING
NCT07258251
PHASE4

Strengthening Hepatitis B Screening, Linkage to Care and Long-Term Monitoring in Phichit Province, Thailand: A Birth Bohort Approach

Sponsor: The Task Force for Global Health

View on ClinicalTrials.gov

Summary

This study in Phichit province, Thailand, aims to find and support adults born before 1992 who are at high risk for hepatitis B infection. Many people in this group were born before the universal hepatitis B vaccine was available and may not know they are infected. The study will invite nearly 240,000 eligible adults for free hepatitis B screening. Those who test positive will be linked to care at one of 12 district hospitals. Doctors will use simplified 2024 World Health Organization (WHO) guidelines to decide who needs treatment. Eligible individuals will receive a safe, effective daily medicine (tenofovir alafenamide). The study will use community health volunteers and phone reminders to help patients stay in care and take their medication regularly. Over three years, the study will track improvements in liver health and virus levels, aiming to prevent liver cirrhosis and cancer.

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

6000

Start Date

2026-01-01

Completion Date

2028-12-31

Last Updated

2025-12-02

Healthy Volunteers

Yes

Interventions

DRUG

Tenofovir Alafenamide (TAF)

HBsAg-positive individuals meeting WHO 2024 treatment eligibility criteria will receive daily oral TAF. Tenofovir disoproxil fumarate (TDF) may be used if TAF is unavailable.

BEHAVIORAL

Community-Based Support

Interventions to improve linkage to care, retention, and treatment adherence. This includes telephone calls, home visits by community health volunteers, and phone/SMS reminders for appointments.

DIAGNOSTIC_TEST

Simplified WHO 2024 Criteria

HBsAg-positive individuals will be evaluated for treatment eligibility using simplified 2024 WHO guidelines, including APRI score, as an alternative to HBV DNA testing.

Locations (1)

Phichit Provincial Hospital, Phichit / 12 District Hospitals in Phichit Province

Phichit, Changwat Phichit, Thailand