HIPOCAMP
HBV unIversal vs Point-Of-Care-based Antiviral treatMent to Prevent mother-to child transmission: a multi-country cluster-randomized non-inferiority trial (social sciences component)
The main objective is to evaluate whether a targeted strategy using an innovative point-of-care test in HBV-infected pregnant women followed up at the primary health center level is non-inferior to a universal approach, where all HBV-infected women receive tenovofir (TDF) prophylaxis, in terms of retention in care and reduction in maternal HBV DNA levels at the time of delivery.
The social science component aims to:
- Compare the acceptability, appropriateness, uptake and feasibility of the two strategies.
- Assess women's HBV knowledge, empowerment and health skills through the development and implementation of a set of HBV information and counseling tools.
- Assess the link with postpartum care and identify barriers and facilitators.
- Investigate women's willingness to share their HBV status with their partners and children, as well as their experiences of sharing status and screening partners and children for HBV.
Project period
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Main investigator
Yusuke Shimakawa (Institut Pasteur Paris), Didier Ekouevi (université Lomé), Olivier Ségéral (hopitaux universitaires de Genêve)
SESSTIM member(s) of the project:
Non-SESSTIM member(s) of the project
Kim RATTANA (National Maternal and Child Health Center, Cambodia); GUINGANE Nanelin Alice (Centre de Recherche Internationale pour la Santé (CRIS, Burkina Faso)); PHAM Minh Khue (Faculty of Public Health Haiphong University of Medicine and Pharmacy Vietnam); Raoul MOH (PACCI, Côte d'Ivoire); TZEUTON Christian (Faculty of Medicine and Pharmaceutical Sciences of Douala University of Douala, Cameroun); Gwenaëlle MARADAN (ORS-PACA)
Sponsors:
ANRS-MIE
Partners:
Institut Pasteur Paris; université Lomé; hopitaux universitaire de Genêve; National Maternal and Child Health Center; Centre de Recherche Internationale pour la Santé (CRIS); Faculty of Public Health Haiphong University of Medicine and Pharmacy; PACCI; Faculty of Medicine and Pharmaceutical Sciences of Douala University of Douala;ORS-PACA
Research question:
The overall aim of the HIPOCAMP project is to prevent the transmission of hepatitis B virus (HBV) from mother to child. Currently, international guidelines require pregnant women carrying hepatitis B surface antigen (HBsAg) to be tested for HBV DNA. This identifies those at high risk who require a drug called tenofovir (TDF). However, in many places where resources are limited, this test is not readily available, especially in rural areas. As a result, the WHO recommends that all HBsAg-positive pregnant women receive TDF, even without having been tested. This may sound promising for simplifying management, but it means that many women will receive a drug they may not need. We don't yet know whether this approach will work in real life, or how it might affect costs.We propose an alternative via a simple test requiring only a small amount of blood, the result of which is available in less than an hour. We believe that this test could identify women who really need TDF, which could save money and avoid unnecessary medication in pregnant women.
Method:
This is a two-arm cluster randomized non-inferiority trial comparing two strategies for preventing mother-to-child transmission of hepatitis B in 6 countries (Vietnam, Cambodia, Cameroon, Côte d'Ivoire, Togo and Burkina Faso).
The social sciences component includes:
- a quantitative socio-economic and behavioral component, with face-to-face questionnaires with pregnant women and caregivers
- a qualitative socio-behavioral component, with interviews conducted with pregnant women and caregivers
- a qualitative component on health policies
- a cost-effectiveness study
Research prospects:
This study will tell us whether the test investigated in this study is as good as the universal approach recommended by the WHO to prevent mother-to-child transmission of HBV. It will also tell us whether it reduces costs. This information will be useful for organizations funding the fight against infectious diseases in developing countries, as they will be able to make informed, evidence-based decisions about where to invest their money. In short, we want to find the best way to prevent the transmission of HBV from mother to child, avoiding unnecessary medication and saving money. This research could help save lives and protect the health of mothers and their children.
