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"HBV unIversal vs Point-Of-Care-based Antiviral treatMent to Prevent Mother-to-child Transmission"

Sponsor: ANRS, Emerging Infectious Diseases • ClinicalTrials.gov ID: NCT07054359

Registry updated: 2026-10-08

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Description

To achieve global elimination of hepatitis B virus (HBV), it is crucial to eliminate HBV mother-to-child transmission (MTCT) by ensuring high coverage of birth dose vaccine and expanding the adoption of peripartum antiviral prophylaxis (PAP) by tenofovir. Current international guidelines require hepatitis B surface antigen (HBsAg)-positive pregnant women to undergo viral load (VL) quantification to identify those at high risk (VL ≥200,000 IU/mL) who should receive PAP. However, VL testing remains inaccessible in many low- and middle-income countries (LMICs), particularly in rural areas. Consequently, in the forthcoming guidelines, the WHO is going to issue a conditional recommendation for administering PAP to all HBsAg-positive women lacking access to VL testing. Although this universal strategy may appear promising for simplifying the diagnostic process, it may result in overtreating the majority of HBsAg-positive pregnant women, estimated at 85% in Africa and 70% in Asia, for whom birth dose vaccine is likely sufficient. Moreover, the real-world applicability of this strategy in LMICs has never been formally tested. As an innovative alternative, the adoption of a rapid point-of-care test for hepatitis B core-related antigen (HBcrAg-RDT) is proposed to identify women eligible for PAP.This test requires only a drop of capillary blood, eliminating the need for electricity or centrifugation, and can provide a reliable result within 45 minutes. Compared to the universal strategy, HBcrAg-RDT strategy is expected to be less expensive and could prevent unnecessary tenofovir exposure for both women and their fetuses. Our aim is to establish the non-inferiority of the HBcrAg-RDT strategy, in comparison to the universal strategy, in terms of effectiveness, defined as the reduction in maternal VL at the time of childbirth, a main driver of the MTCT risk. This will be approached through a multidisciplinary framework integrating health economics, implementation science, and health policy analysis.

Interventions

HBsAg RDT Women (Diagnostic test)
HBsAg will be screened using finger-stick capillary blood during the ANC visit, simultaneously with the HIV test
Treatment by TDF if HBcrAg RDT positive (Drug)
300mg per day or 300 mg every 2 days (if créatinine clearance is 30-50ml/min)
Treatment by TDF (Drug)
300mg per day or 300 mg every 2 days (if créatinine clearance is 30-50ml/min)
Social sciences component (Other)
The social sciences component only in Cambodia and Ivory Coast. 3 key sub-studies: i) a socio-economic and behavioral study ii) a health economic evaluation study, and iii) a health policy study. A mixed-methods approach will be used, including qualitative interviews and quantitative questionnaires among pregnant women and healthcare workers
HBsAg RDT Infants (Diagnostic test)
At 9 months, all infants will be tested for HBsAg; HBsAg-positive infants will undergo HBV DNA testing, and DBS will be collected for biobank storage.

Eligibility criteria

Inclusion Criteria: 1. ≥18 years old, or ≥ the legal age of majority as defined by each country, on the day of inclusion. 2. Pregnancy. 3. Intention to attend antenatal care visits in the Primary Health Center or the Rural Hospital 4. Living in an area covered by the Primary Health Center or the Rural Hospital on the start date of the trial 5. Positive HBsAg identified during the screening phase of the study 6. Free, informed, and written consent, signed by the person and the investigator at the latest on the day of inclusion and before any examination carried out as part of the study. Exclusion Criteria: 1. HIV co-infection. 2. HBV treatment ongoing on the day of inclusion. 3. Having at least one of the following criteria indicatives of the third trimester of pregnancy: * Gestational Age-Based Exclusion: The reported gestational age is ≥28 weeks, based on the last menstrual period (LMP) if known. * Ultrasound-Based Exclusion: Fetal biometry (e.g., head circumference, femur length) on ultrasound suggests a gestational age of ≥28 weeks. * Fundal Height-Based Exclusion: Symphysis-fundal height (SFH) measurement of ≥ 28 cm which corresponds to approximately 28 weeks of gestation. 4. Severe gravid disease at inclusion, which poses a life-threatening risk to the mother and/or child 5. Any concomitant medical condition that, according to the clinical site investigator, would contraindicate participation in the study. 6. Concurrent participation in any other study (unless approved in writing by the Global Principal Investigators).

Conditions

HBV Infection Pregnancy

Locations

Tien lang District Health center — Haiphong, Vietnam

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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