The COMBAT HBV Feasibility Trial

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Abbott; Albert Einstein College of Medicine; Doris Duke Charitable Foundation; Université Protestant au Congo
• Treatments: Tenofovir; Vaccines

Criteria

Inclusion Criteria:

• Pregnant women ≥18 years of age who present for routine prenatal care between 28-32 weeks' gestation and who test HBV-positive by point-of-care hepatitis B surface antigen test. Women must intend to seek maternity and postpartum care exclusively at one of the Kinshasa-based study maternity centers.

• Infants born to enrolled women will be included in the study

Exclusion Criteria:

• Individuals with abnormal creatinine by point-of-care testing

• Any woman who plans to move outside of Kinshasa Province during the study period.

• Any HIV-positive individual, determined by routine point-of-care screening at antenatal care visits