About
In PROTECT-B, we aim to evaluate the real-world performance of the HBcrAg-RDT in identifying HBV-positive pregnant women with high viral loads (≥200,000 IU/mL) in The Gambia and Burkina Faso. This viral threshold is critical as it indicates when the risk of mother-to-child transmission (MTCT) is high and prophylactic treatment should be initiated.
As a prospective cross-sectional multicenter study started in 2024, PROTECT-B takes a holistic approach to this evaluation. Our research integrates diagnostic validation with economic, environmental, and implementation assessments to determine the potential of the HBcrAg-RDT as an accessible alternative to other HBV testing strategies.
By combining clinical validation, micro-costing, carbon footprint analysis, and mathematical modeling, we aim to provide comprehensive evidence for policy decisions regarding HBV screening strategies in resource-limited antenatal care settings.
Project objectives
Primary objective: To evaluate the real-world performance of the HBcrAg-RDT for identifying pregnant women with high HBV viral loads (≥200,000 IU/mL) eligible for antiviral prophylaxis to prevent mother-to-child transmission in The Gambia and Burkina Faso.
Secondary objectives:
- To assess the diagnostic accuracy and clinical utility of the HBcrAg-RDT compared to HBV DNA testing and Treat All strategies in antenatal care settings.
- To evaluate the operational feasibility, ease-of-use, and acceptability of HBV screening strategies among laboratory and healthcare personnel.
- To determine the financial and environmental costs of the specified HBV screening strategies.
- To develop context-specific recommendations for HBV screening implementation through mathematical modeling that incorporates facility capacity, population-level health impacts, and cost-effectiveness.
To generate comprehensive evidence to inform flexible, context-appropriate HBV screening policies in resource-limited settings.
Fundings
- ANRS/MIE
Partners
- MRC Unit The Gambia at LSHTM, Fajara, The Gambia
- Centre MURAZ, Bobo-Dioulasso, Burkina Faso
- Imperial College London, London, United Kingdom
- Unité Mixte de Recherche 1252 SESSTIM Sciences Economiques et Sociales de la Santé & Traitement de l’Information Médicale, Marseille, France
