HBV Universal vs Point-of-Ccare Antiviral Prophylaxis to Prevent Mother-to-Child Transmission

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This cluster-randomized trial compares two strategies for preventing HBV transmission from mother to child. The intervention arm uses a selective approach where HBV core-related antigen rapid testing determines if a pregnant woman should receive tenofovir. The control arm provides universal antiviral treatment to all HBsAg-positive pregnant women. The study includes 80 clusters (40 per arm) across multiple rural sites, enrolling about 3,200 pregnant women, with a parallel social sciences component in two countries to assess acceptability and implementation. Primary outcomes focus on MTCT rates and programmatic feasibility in LMIC settings lacking routine VL testing. The trial is open-label, non-inferiority, and cluster-randomized with primary health centers serving as the randomization units.

Why it matters

Who can join: the full rules

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).

Where it's running

• Tien lang District Health center
  Haiphong, Vietnam Recruiting

Study contacts

• Study coordinator: Olivier SEGERAL
• Email: olivier.segeral@hug.ch
• Phone: + 41 79 553 6535

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.