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 4 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.
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Safety (Pregnant Women): Number of Pregnant Women With Adverse Effects Related to Study Medications
Timeframe: Up to study close-out visit, or up to 12 months
Safety (Infants): Number of Infants with Adverse Effects Related to Study Medications
Timeframe: At delivery
Feasibility (Recruitment): Number of Eligible Participants Who Were Enrolled in the Study
Timeframe: Up to study close-out visit, or up to 12 months
Feasibility (Refusal): Number of Eligible Participants Who Refused to Enroll in the Study
Timeframe: Up to study close-out visit, or up to 12 months
Feasibility (Withdrawal): Number of Enrolled Participants Who Withdraw from the Study
Timeframe: Up to study close-out visit, or up to 12 months
Feasibility (Retention): Number of Enrolled Participants Who Remain in the Study Through 6 Months Postpartum
Timeframe: Up to study close-out visit, or up to 12 months
Feasibility (Maintenance): Proportion of Study Visits Completed Per Participant
Timeframe: Up to study close-out visit (12 months)
Acceptability (Lab Testing): Number of Mothers With Lab Testing Acceptability Scores >80%
Timeframe: Upon study close-out visit, or up to 12 months
Acceptability (Medication): Number of Mothers With Medication Acceptability Scores >80%
Timeframe: Upon study close-out visit, or up to 12 months
Preliminary Effectiveness: Number of Infants With HBV Positivity by Rapid Diagnostic Testing at 6 Months of Life to Indicate Mother-to-Child Transmission of HBV
Timeframe: Measured at 6 months after birth