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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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.
• Поведенческое 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.
• Диагностический тест 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.

Первичные конечные точки

• HBsAg Screening Uptake [Срок оценки: 36 months]
• Linkage to Care [Срок оценки: 36 months]
• Treatment Initiation [Срок оценки: 36 months]

Вторичные конечные точки (8)

• Treatment Eligibility (Simplified Criteria) [Срок оценки: 36 months]
• Treatment Adherence [Срок оценки: 12 Months and 24 Months]
• Retention in Care [Срок оценки: 12 Months, 24 Months, and 36 Months]
• Effectiveness of Community-Based Support [Срок оценки: 36 Months]
• Virologic Response [Срок оценки: Baseline, 12 Months, 24 Months, 36 Months]
• Biochemical Response [Срок оценки: Baseline and every 6 months for 36 months]
• Fibrosis/Inflammation Response [Срок оценки: Baseline and every 6 months for 36 months]
• HBsAg Serometrics [Срок оценки: Baseline, 12 Months, 24 Months, 36 Months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Subjects who withdraw consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Таиланд · 1 центр

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

Идентификаторы

NCT: NCT07258251 · CREC102_68BT-MED35_COR-HEPB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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