About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Subjects who withdraw consent
Trial design
Single group
Treatments tested in this trial
Tenofovir Alafenamide (TAF)
DrugHBsAg-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
BehavioralInterventions 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
Diagnostic testHBsAg-positive individuals will be evaluated for treatment eligibility using simplified 2024 WHO guidelines, including APRI score, as an alternative to HBV DNA testing.
Treatment groups
Trial outcomes
Primary outcomes
HBsAg Screening Uptake
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
Percentage of individuals who test positive for HBsAg and are successfully linked to care for clinical assessment and treatment evaluation.
Treatment Initiation
Percentage of HBsAg-positive individuals identified as eligible for treatment (per WHO 2024 guidelines) who successfully initiate antiviral therapy
Secondary outcomes
Treatment Eligibility (Simplified Criteria)
Proportion of HBsAg-positive individuals eligible for treatment based on simplified WHO 2024 criteria without HBV DNA results (e.g., using APRI score)
Treatment Adherence
Proportion of patients on treatment with good compliance, defined as taking \& 80% of prescribed medication, measured by pill count and the 8-item Morisky Medication Adherence Scale (MMAS-8)
Retention in Care
Proportion of all HBsAg-positive individuals (treated and untreated) who maintain scheduled 6-monthly follow-up appointments.
Effectiveness of Community-Based Support
Assessed by measuring the impact of iinterventions (e.g., health volunteers, phone reminders) on linkage and retention rates
Sponsors and contacts
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The Task Force for Global Health
Lead sponsor
Phichit Provincial Public Health Office, Ministry of Public Health, Thailand (Host institution)
Collaborator
Division of Gastroenterology, Department of Medicine Siriraj Hospital, Mahidol University
Collaborator
Ministry of Health, Thailand
Collaborator
Phichit Provincial Hospital
Collaborator
Liver Foundation Thailand
Collaborator
Thai Association for the Study of the Liver
Collaborator
This trial is not recruiting at the moment. You can still explore other options: