Strengthening Hepatitis B Screening, Linkage to Care and Long-Term Monitoring in Phichit Province, Thailand: A Birth Bohort Approach
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 6,000
- 试验地点
- 1
- 主要终点
- HBsAg Screening Uptake
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Subjects who withdraw consent
研究组 & 干预措施
Implementation Cohort
Implementation Cohort (Single Arm)
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 adherence4646. 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.
干预措施: Tenofovir Alafenamide (TAF) (Drug)
Implementation Cohort
Implementation Cohort (Single Arm)
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 adherence4646. 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.
干预措施: Community-Based Support (Behavioral)
Implementation Cohort
Implementation Cohort (Single Arm)
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 adherence4646. 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.
干预措施: Simplified WHO 2024 Criteria (Diagnostic Test)
结局指标
主要结局
HBsAg Screening Uptake
时间窗: 36 months
Percentage of the target population (adults born before Jan 1, 1992, in Phichit province) who are successfully screened for HBsAg. (Target: 90%)
Linkage to Care
时间窗: 36 months
Percentage of individuals who test positive for HBsAg and are successfully linked to care for clinical assessment and treatment evaluation.
Treatment Initiation
时间窗: 36 months
Percentage of HBsAg-positive individuals identified as eligible for treatment (per WHO 2024 guidelines) who successfully initiate antiviral therapy
次要结局
- Treatment Eligibility (Simplified Criteria)(36 months)
- Treatment Adherence(12 Months and 24 Months)
- Retention in Care(12 Months, 24 Months, and 36 Months)
- Effectiveness of Community-Based Support(36 Months)
- Virologic Response(Baseline, 12 Months, 24 Months, 36 Months)
- Biochemical Response(Baseline and every 6 months for 36 months)
- Fibrosis/Inflammation Response(Baseline and every 6 months for 36 months)
- HBsAg Serometrics(Baseline, 12 Months, 24 Months, 36 Months)