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Not yet recruiting NCT07258251

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

Phase IV Interventional Chronic Hepatitis B Hepatitis B Virus Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tenofovir Alafenamide (TAF), Community-Based Support, Simplified WHO 2024 Criteria.
Who it may be relevant to
Registry conditions: Chronic Hepatitis B, Hepatitis B Virus Infection. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Thailand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed 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.

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.

Primary outcome measures

  • HBsAg Screening Uptake [Time frame: 36 months]
  • Linkage to Care [Time frame: 36 months]
  • Treatment Initiation [Time frame: 36 months]
Secondary outcome measures (8)
  • Treatment Eligibility (Simplified Criteria) [Time frame: 36 months]
  • Treatment Adherence [Time frame: 12 Months and 24 Months]
  • Retention in Care [Time frame: 12 Months, 24 Months, and 36 Months]
  • Effectiveness of Community-Based Support [Time frame: 36 Months]
  • Virologic Response [Time frame: Baseline, 12 Months, 24 Months, 36 Months]
  • Biochemical Response [Time frame: Baseline and every 6 months for 36 months]
  • Fibrosis/Inflammation Response [Time frame: Baseline and every 6 months for 36 months]
  • HBsAg Serometrics [Time frame: Baseline, 12 Months, 24 Months, 36 Months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Thailand · 1 center
  • Phichit Provincial Hospital, Phichit / 12 District Hospitals in Phichit Province — Phichit

Identifiers

NCT: NCT07258251 · CREC102_68BT-MED35_COR-HEPB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗