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

NANot yet recruitingINTERVENTIONAL
Enrollment

3,200

Participants

Timeline

Start Date

November 30, 2025

Primary Completion Date

November 30, 2026

Study Completion Date

January 31, 2028

Conditions
HBV InfectionPregnancy
Interventions
DIAGNOSTIC_TEST

HBsAg RDT Women

HBsAg will be screened using finger-stick capillary blood during the ANC visit, simultaneously with the HIV test

DRUG

Treatment by TDF if HBcrAg RDT positive

300mg per day or 300 mg every 2 days (if créatinine clearance is 30-50ml/min)

DRUG

Treatment by TDF

300mg per day or 300 mg every 2 days (if créatinine clearance is 30-50ml/min)

OTHER

Social sciences component

"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"

DIAGNOSTIC_TEST

HBsAg RDT Infants

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.

All Listed Sponsors
collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

lead

ANRS, Emerging Infectious Diseases

OTHER_GOV

NCT07054359 - "HBV unIversal vs Point-Of-Care-based Antiviral treatMent to Prevent Mother-to-child Transmission" | Biotech Hunter | Biotech Hunter