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NCT Number: NCT07258251

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

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.

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Key information

Conditions

Chronic Hepatitis B Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B Virus Infection Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Phichit, Changwat Phichit, Thailand

Location contact

Dr. Wisit Apisitwitaya

CONTACT

[email protected]

0864456330

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tenofovir Alafenamide (TAF)

Drug

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.

Community-Based Support

Behavioral

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.

Simplified WHO 2024 Criteria

Diagnostic Test

HBsAg-positive individuals will be evaluated for treatment eligibility using simplified 2024 WHO guidelines, including APRI score, as an alternative to HBV DNA testing.

Primary outcomes

  1. 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%)

  2. 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.

  3. 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

Secondary outcomes

  1. 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)

  2. 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)

  3. 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.

  4. 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

  5. Virologic Response

    Time frame: Baseline, 12 Months, 24 Months, 36 Months

    Change in HBV DNA viral load from baseline among treated patients

  6. Biochemical Response

    Time frame: Baseline and every 6 months for 36 months

    Proportion of treated patients achieving ALT normalization

  7. Fibrosis/Inflammation Response

    Time frame: Baseline and every 6 months for 36 months

    Change in APRI score from baseline among treated patients

  8. HBsAg Serometrics

    Time frame: Baseline, 12 Months, 24 Months, 36 Months

    Change in quantitative HBsAg (qHBsAg) from baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Gibril Ndow

CONTACT

[email protected]

+1 404 907 9954

Dr. Wisit Apisitwitaya

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

The Task Force for Global Health

Other

Collaborators

  • Liver Foundation Thailand
  • Ministry of Health, Thailand
  • Phichit Provincial Hospital
  • Phichit Provincial Public Health Office, Ministry of Public Health, Thailand (Host institution)
  • Siriraj Hospital
  • Thai Association for the Study of the Liver

Registry information

Acronym: HBV-PHICHIT

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Dec 2, 2025
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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