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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorThe Task Force for Global Health

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

6,000 Participants
are divided into 1 treatment group
Group A: Implementation CohortExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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
2

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
3

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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: