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

RecruitingNAAges 18 Years - 50 YearsFemaleANRS, Emerging Infectious Diseases
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In plain words

What the trial is, and whether it could suit you

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 โ‰ฅ200,000 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 th

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. โ‰ฅ18 years old, or โ‰ฅ 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 โ‰ฅ28 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 โ‰ฅ28 weeks. * Fundal Height-Based Exclusion: Symphysis-fundal height (SFH) measurement of โ‰ฅ 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).
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What it tests

  • HBsAg RDT Women
  • Treatment by TDF if HBcrAg RDT positive
  • Treatment by TDF
  • Social sciences component
  • HBsAg RDT Infants
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Where

1 site
Tien lang District Health center
Haiphong, Vietnam
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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