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

The Task Force for Global Health

Status and phase: Not yet enrolling; Phase 4

Conditions: Chronic Hepatitis B; Hepatitis B Virus Infection

Treatments: Drug: Tenofovir Alafenamide (TAF); Behavioral: Community-Based Support; Diagnostic Test: Simplified WHO 2024 Criteria

Study type: Interventional

Funder types: Other

Identifiers

NCT07258251

CREC102_68BT-MED35_COR-HEPB

Details and patient eligibility

About

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.

Full description

Chronic hepatitis B virus (HBV) infection is a significant cause of liver cirrhosis and hepatocellular carcinoma (HCC) in Thailand. While Thailand's universal infant vaccination program, implemented in 1992, has been successful, adults born before this date remain a high-risk population with an estimated 2-3 million chronic infections.

Despite free access to HBsAg screening and treatment (including TAF/TDF), barriers such as the lack of reimbursement for HBV DNA testing and poor linkage to care have hampered progress toward WHO 2030 elimination targets.

This study is a pragmatic implementation research project designed to scale up HBsAg screening, linkage to care, and long-term monitoring in Phichit Province. It targets the birth cohort of adults born before 1992 (approx. 238,786 people).

The study will develop and evaluate tools to identify unscreened individuals, improve linkage to dedicated viral hepatitis clinics, and support long-term adherence. A key component is the implementation of simplified WHO 2024 treatment criteria, which utilize non-invasive markers like the APRI score as an alternative to HBV DNA testing to determine treatment eligibility.

Enrollment: 6,000 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults born before January 1, 1992
• Residing in Phichit Province
• Individuals who test positive for HBsAg will be invited to participate in the follow-up cohort
• HBsAg positive patients who are already under care will also be invited to participate

Exclusion criteria

• Subjects who withdraw consent

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6,000 participants in 1 patient group

Implementation Cohort

Experimental group

Description:

Implementation Cohort (Single Arm) Interventions: 1. 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. 2. Behavioral: Community-Based Support Interventions to improve linkage to care, retention, and treatment adherence4646. This includes telephone calls, home visits by community health volunteers, and phone/SMS reminders for appointments. 3. 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.

Treatment:

Diagnostic Test: Simplified WHO 2024 Criteria

Behavioral: Community-Based Support

Drug: Tenofovir Alafenamide (TAF)