This is a double-blind, randomized placebo-controlled trial (RCT) of a prophylaxis-for-all
approach to prevention of mother-to-child transmission (PMTCT) of hepatitis B virus (HBV) in
the Democratic Republic of Congo (DRC). HBV-infected pregnant women will be randomized to
either receive tenofovir or placebo beginning at 28-32 weeks' gestation and continuing
through 12 weeks' postpartum. Women will be followed every 4-6 weeks throughout the prenatal
and postpartum period to evaluate for side effects related to the medication. Infants will
receive a birth-dose of HBV vaccine, ideally within 24 hours. Participants will be followed
longitudinally through 6 months' postpartum.
Phase:
Phase 4
Details
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborators:
Abbott Albert Einstein College of Medicine Doris Duke Charitable Foundation Université Protestant au Congo