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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

6000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2028-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Hepatitis B Hepatitis B Virus Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Implementation Cohort

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.

Group Type EXPERIMENTAL

Tenofovir Alafenamide (TAF)

Intervention Type DRUG

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.

Community-Based Support

Intervention Type BEHAVIORAL

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.

Simplified WHO 2024 Criteria

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type BEHAVIORAL

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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