Phase 4
N=179
Arresting Vertical Transmission of Hepatitis B Virus
Hepatitis B · Vertical Transmission of Infectious Disease
Bottom Line
View on ClinicalTrials.gov: NCT03567382 ↗Enrolled (actual)
179
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Number of Participants With Lab Testing Acceptability Survey Scores >80% — 7; 41; 7; 40 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Tenofovir Disoproxil Fumarate (Drug); Monovalent HBV vaccine (Biological)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Lab Testing Acceptability Survey Scores >80% |
7; 41; 7; 40 | — |
| PRIMARY Number of Mothers With Infant Vaccination Acceptability Survey Scores >80% |
7; 42 | — |
| SECONDARY Number of Infants With HBV Positivity at 6 Months of Life to Indicate Mother-to-Child Transmission of HBV |
0; 0 | — |
| SECONDARY Number of Mothers With High-risk HBV Demonstrating Adherence to Tenofovir Therapy |
9 | — |
| SECONDARY Number of Infants Receiving Timely Birth Dose Vaccination |
8; 38 | — |
Summary
The purpose of this pilot study is to demonstrate the feasibility of adding HBV screening and treatment of pregnant women to the existing HIV PMTCT platform in order to prevent mother-to-child transmission of hepatitis B virus.
Eligibility Criteria
Inclusion criteria
- Pregnant women receiving care at Binza and Kingasani maternity centers presenting prior to 24 weeks gestation
- Infants born to HBV-positive women
Exclusion criteria
- Participants who are severely sick and who require prolonged hospitalization.
- Any women who do not intend to stay in Kinshasa for prenatal care through delivery
Data sourced from ClinicalTrials.gov (NCT03567382). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.