At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 179 enrolled
Drug / intervention
Tenofovir Disoproxil Fumarate +1 moredrug
Likely dose
Tenofovir Disoproxil Fumarate 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Arresting Vertical Transmission of Hepatitis B Virus in the Democratic Republic of the Congo: The AVERT-HBV Study
In Brief
A Phase 4 clinical trial evaluating Tenofovir Disoproxil Fumarate and Monovalent HBV vaccine for Hepatitis B and Vertical Transmission of Infectious Disease. Completed, enrolled 179 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesDemocratic Republic of the Congo
CollaboratorsKinshasa School of Public Health, Ohio State University
Timeline
Phase 4CompletedFinished
20192020202120222023202420252026
First PostedJun 2018
Enrollment StartSep 2018
Primary CompletionMar 2020
Study CompletionAug 2020
TodayJul 2026
First PostedJun 25, 2018
Enrollment StartSep 24, 2018
Primary CompletionMar 6, 2020
Study CompletionAug 15, 2020
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 8.0 years ago
Interventions
Tenofovir Disoproxil Fumaratedrug
300 mg tablet of TDF once daily from 28-32 weeks gestation through 12 weeks postpartum.
Monovalent HBV vaccinebiological
Infants born to HBsAg-positive women will be given a single dose of monovalent HBV vaccine within 24 hours of life.