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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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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