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

November 20, 2025 updated by: The Task Force for Global Health
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

6000

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Thailand
    • Changwat Phichit
      • Phichit, Changwat Phichit, Thailand
        • Phichit Provincial Hospital, Phichit / 12 District Hospitals in Phichit Province
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Implementation Cohort

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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HBsAg Screening Uptake
Time Frame: 36 months

Percentage of the target population (adults born before Jan

1, 1992, in Phichit province) who are successfully screened for HBsAg. (Target: 90%)
36 months
Linkage to Care
Time Frame: 36 months
Percentage of individuals who test positive for HBsAg and are successfully linked to care for clinical assessment and treatment evaluation.
36 months
Treatment Initiation
Time Frame: 36 months
Percentage of HBsAg-positive individuals identified as eligible for treatment (per WHO 2024 guidelines) who successfully initiate antiviral therapy
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Eligibility (Simplified Criteria)
Time Frame: 36 months
Proportion of HBsAg-positive individuals eligible for treatment based on simplified WHO 2024 criteria without HBV DNA results (e.g., using APRI score)
36 months
Treatment Adherence
Time Frame: 12 Months and 24 Months
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)
12 Months and 24 Months
Retention in Care
Time Frame: 12 Months, 24 Months, and 36 Months
Proportion of all HBsAg-positive individuals (treated and untreated) who maintain scheduled 6-monthly follow-up appointments.
12 Months, 24 Months, and 36 Months
Effectiveness of Community-Based Support
Time Frame: 36 Months
Assessed by measuring the impact of iinterventions (e.g., health volunteers, phone reminders) on linkage and retention rates
36 Months
Virologic Response
Time Frame: Baseline, 12 Months, 24 Months, 36 Months
Change in HBV DNA viral load from baseline among treated patients
Baseline, 12 Months, 24 Months, 36 Months
Biochemical Response
Time Frame: Baseline and every 6 months for 36 months
Proportion of treated patients achieving ALT normalization
Baseline and every 6 months for 36 months
Fibrosis/Inflammation Response
Time Frame: Baseline and every 6 months for 36 months
Change in APRI score from baseline among treated patients
Baseline and every 6 months for 36 months
HBsAg Serometrics
Time Frame: Baseline, 12 Months, 24 Months, 36 Months
Change in quantitative HBsAg (qHBsAg) from baseline
Baseline, 12 Months, 24 Months, 36 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Task Force for Global Health

Collaborators

Ministry of Health, Thailand
Phichit Provincial Public Health Office, Ministry of Public Health, Thailand (Host institution)
Division of Gastroenterology, Department of Medicine Siriraj Hospital, Mahidol University
Phichit Provincial Hospital
Liver Foundation Thailand
Thai Association for the Study of the Liver

Investigators

  • Principal Investigator: Professor Tawasek Tawandee, Mahidol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

November 20, 2025

First Submitted That Met QC Criteria

November 20, 2025

First Posted (Actual)

December 2, 2025

Study Record Updates

Last Update Posted (Actual)

December 2, 2025

Last Update Submitted That Met QC Criteria

November 20, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CREC102_68BT-MED35_COR-HEPB

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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