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

NCT07258251 | Not Yet Recruiting Phase 4

• 1 other identifier: CREC102_68BT-MED35_COR-HEPB
• Study Type: interventional
• Target: 6,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Hepatitis B; Hepatitis B Virus Infection

Outcome Measures

Primary Outcomes (3)

• 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%)

  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.

  36 months

• Treatment Initiation

  Percentage of HBsAg-positive individuals identified as eligible for treatment (per WHO 2024 guidelines) who successfully initiate antiviral therapy

  36 months

Secondary Outcomes (8)

• 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

Study Arms (1)

Implementation Cohort

EXPERIMENTAL

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

Interventions

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.

Implementation Cohort

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.

Implementation Cohort

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.

Implementation Cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Subjects who withdraw consent

Sponsors & Collaborators

• The Task Force for Global Health: lead
• 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

Study Sites (1)

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

Phichit, Changwat Phichit, Thailand

Location

MeSH Terms

Conditions

Hepatitis B, Chronic; Hepatitis B

Interventions

tenofovir alafenamide

Condition Hierarchy (Ancestors)

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

Study Officials

• Professor Tawasek Tawandee

  Mahidol University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Gibril Ndow

CONTACT

+1 404 907 9954; gndow@taskforce.org

Dr. Wisit Apisitwitaya

CONTACT

wisitapisit1@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 2, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

TH (1)