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

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.

Conditions

• Chronic Hepatitis B
• Hepatitis B Virus Infection

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.

Sponsors & Collaborators

• Phichit Provincial Public Health Office, Ministry of Public Health, Thailand (Host institution)

  collaborator UNKNOWN

• Division of Gastroenterology, Department of Medicine Siriraj Hospital, Mahidol University

  collaborator UNKNOWN

• Ministry of Health, Thailand

  collaborator OTHER_GOV

• Phichit Provincial Hospital

  collaborator UNKNOWN

• Liver Foundation Thailand

  collaborator UNKNOWN

• Thai Association for the Study of the Liver

  collaborator UNKNOWN

• The Task Force for Global Health

  lead OTHER

Principal Investigators

• Professor Tawasek Tawandee · Mahidol University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-01-01

Primary Completion

2028-12-31

Completion

2028-12-31

Countries

• Thailand

Study Locations