Birth Surveillance in Eswatini Following Transition to Dolutegravir-Based Treatment
Overview
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Eswatini
2021 - 2023
Through this study, EGPAF will conduct birth surveillance in Eswatini to contribute to the international evidence base on the incidence of neural tube defects (NTD) in children born to women on DTG or other antiretroviral regimens and in the general population. Based on the existing evidence to date, we will test the null hypothesis that there is no association between preconception DTG and NTD.
With planned broad transition of programs to DTG-based ART for first- and second-line treatment, it will be important to have in place sentinel surveillance to evaluate birth outcomes in women who become pregnant while receiving DTG or any new drug regimen. Through this effort, EGPAF will establish and support a sentinel surveillance system in four high-volume public maternities. The system will allow for the collection of data on preconception DTG exposures and birth defects by capturing deliveries from all HIV-positive and HIV-negative women, primarily using existing facility sources. This surveillance will strengthen and improve upon planned efforts by the Eswatini MOH to introduce national routine pregnancy outcome and infant monitoring, helping to ensure the sustainability of such a system to evaluate new drugs as they come to market. More detailed information will be collected through interviews with mothers whose children have been identified to have major external birth defects.