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Chronic Hepatitis BPhase 4HBV-PHICHITNCT07258251

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

A Phase 4 study testing Tenofovir Alafenamide (TAF), Community-Based Support and Simplified WHO 2024 Criteria in people with Chronic Hepatitis B and Hepatitis B Virus Infection, run by The Task Force for Global Health at 1 site in Thailand.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
What is being tested?
Tenofovir Alafenamide (TAF), Community-Based Support and Simplified WHO 2024 Criteria
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6,000 participants
Where
1 siteThailand
Study dates
1 Jan 2026to 31 Dec 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Subjects who withdraw consent

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dr. Gibril Ndow contact

+1 404 907 9954

gndow@taskforce.org

Dr. Wisit Apisitwitaya contact

wisitapisit1@gmail.com

Thailand1 site

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

    Phichit, Changwat Phichit

    Dr. Wisit Apisitwitaya, 0864456330, wisitapisit1@gmail.com

Other trials in Thailand

About this study

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.

Read the 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.

Being tested
Tenofovir Alafenamide (TAF), Community-Based Support, Simplified WHO 2024 Criteria
Medical subject headings
Hepatitis B, Chronic, Hepatitis B

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 SupportBehavioural

    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 CriteriaDiagnostic 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.

Study groups in NCT07258251
Study groupRoleWhat they receive
Implementation CohortExperimentalImplementation 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.
Receives: Drug: Tenofovir Alafenamide (TAF); Behavioral: Community-Based Support; Diagnostic Test: Simplified WHO 2024 Criteria

What is being measured

The primary outcome is the main question the study is designed to answer.

  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%)

    Measured: 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.

    Measured: 36 months

  3. Treatment Initiation

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

    Measured: 36 months

Secondary outcomes (8)

  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)

    Measured: 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)

    Measured: 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.

    Measured: 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

    Measured: 36 Months

  5. Virologic Response

    Change in HBV DNA viral load from baseline among treated patients

    Measured: Baseline, 12 Months, 24 Months, 36 Months

  6. Biochemical Response

    Proportion of treated patients achieving ALT normalization

    Measured: Baseline and every 6 months for 36 months

  7. Fibrosis/Inflammation Response

    Change in APRI score from baseline among treated patients

    Measured: Baseline and every 6 months for 36 months

  8. HBsAg Serometrics

    Change in quantitative HBsAg (qHBsAg) from baseline

    Measured: Baseline, 12 Months, 24 Months, 36 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2025
  2. Study start1 Jan 2026 (estimated)
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07258251
Sponsor's protocol ID
CREC102_68BT-MED35_COR-HEPB
Acronym
HBV-PHICHIT
Status last verified
Nov 2025
First submitted
20 Nov 2025
Last updated
2 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tenofovir Alafenamide (TAF), Community-Based Support and Simplified WHO 2024 Criteria in people with Chronic Hepatitis B and Hepatitis B Virus Infection, run by The Task Force for Global Health at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dr. Gibril Ndow (+1 404 907 9954, gndow@taskforce.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HBsAg Screening Uptake (time frame: 36 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07258251.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.

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