A Phase 4 interventional study of Tenofovir Alafenamide (TAF) and Community-Based Support in Chronic Hepatitis B and Hepatitis B Virus Infection, sponsored by The Task Force for Global Health. Not yet recruiting at 1 site in Thailand. Per ClinicalTrials.gov, last updated 2025-12-02.
Sponsored by The Task Force for Global Health · Phase 4, Interventional, and Treatment
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.
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.
895 studies on the registry are indexed under Hepatitis B, Chronic; 151 are open to participants now.
This study's planned enrollment of 6,000 is above the median of 100 across 659 interventional studies indexed under Hepatitis B, Chronic.
Browse Hepatitis B, Chronic studies →The Task Force for Global Health is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Tenofovir Alafenamide (TAF) · Behavioral: Community-Based Support · Diagnostic Test: Simplified WHO 2024 Criteria
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.
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.
HBsAg-positive individuals will be evaluated for treatment eligibility using simplified 2024 WHO guidelines, including APRI score, as an alternative to HBV DNA testing.
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%)
Time frame: 36 months
Linkage to Care
Percentage of individuals who test positive for HBsAg and are successfully linked to care for clinical assessment and treatment evaluation.
Time frame: 36 months
Treatment Initiation
Percentage of HBsAg-positive individuals identified as eligible for treatment (per WHO 2024 guidelines) who successfully initiate antiviral therapy
Time frame: 36 months
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)
Time frame: 36 months
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)
Time frame: 12 Months and 24 Months
Retention in Care
Proportion of all HBsAg-positive individuals (treated and untreated) who maintain scheduled 6-monthly follow-up appointments.
Time frame: 12 Months, 24 Months, and 36 Months
Effectiveness of Community-Based Support
Assessed by measuring the impact of iinterventions (e.g., health volunteers, phone reminders) on linkage and retention rates
Time frame: 36 Months
Virologic Response
Change in HBV DNA viral load from baseline among treated patients
Time frame: Baseline, 12 Months, 24 Months, 36 Months
Biochemical Response
Proportion of treated patients achieving ALT normalization
Time frame: Baseline and every 6 months for 36 months
Fibrosis/Inflammation Response
Change in APRI score from baseline among treated patients
Time frame: Baseline and every 6 months for 36 months
HBsAg Serometrics
Change in quantitative HBsAg (qHBsAg) from baseline
Time frame: Baseline, 12 Months, 24 Months, 36 Months
Start is estimated for Jan 2026; primary completion for Dec 2028, 35 months later.
Of 46 non-industry phase 4 interventional studies under Hepatitis B, Chronic, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 83. This study's planned 35 months is below that.
Counting every sponsor, half of 63 studies reached it within 43 months; a quarter within 30 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tenofovir alafenamide
The Task Force for Global Health