Adverse birth outcome case definitions associated with maternal HIV and antiretroviral drug use in pregnancy: a scoping review protocol.

INTRODUCTION: The global antiretroviral therapy era has led to a decline in the number of children newly acquiring HIV and an increase in the number of children who are HIV-exposed and uninfected (HEU). This shift has prompted extensive research focussing on health and survival outcomes of children who are HEU. Study findings, particularly in relation to adverse birth outcomes, have been disparate, inconclusive and have not always been generalisable. Thus, the objectives of this scoping review are (1) to identify and extract definitions used for the adverse birth outcome terms 'low birth weight', 'small for gestational age', 'stillbirth' and 'preterm birth'; (2) to compare the characteristics of studies from which birth outcome definitions were extracted by (a) temporal periods and (b) study country setting (high-income vs low-income and middle-income countries); (3) to use content analysis to map and describe the temporal and geographic distribution of the definitions used and construct a logical model of their evolution. METHODS AND ANALYSIS: The online databases of PubMed/MEDLINE, Scopus, Web of Science, Cochrane Library and CINHAL/EBSCOhost will be used to identify published and grey literature from 2011 to 2022 to identify definitions for the adverse birth outcome terms 'low birth weight', 'small for gestational age', 'stillbirth' and 'preterm birth'. A three-step process of (1) duplicate removal, (2) title and abstract screening and (3) full text screening will be used to select included studies. The extracted data will be used to conduct a comparative analysis, content analysis and construct a logic model. ETHICS AND DISSEMINATION: This review will be used to inform a consensus process around the development of harmonised definitions for the specified adverse birth outcomes. Our dissemination plan includes presentations, publications as well as the development infographics and a resource hub. The study is approved by the Human Research Ethics Committee of Stellenbosch University.

Protocol for a systematic review and meta-analysis of fractional dose compared with standard dose inactivated polio vaccination in children.

INTRODUCTION: WHO recommends the introduction of at least one single dose of inactivated polio vaccine (IPV) in routine immunisation schedules. Thus, there has been an increased demand and concurrent supply shortages of IPV worldwide. One of the strategies to improve access is the use of fractional instead of full doses of IPV. We aim to compare the effects of fractional with standard doses of IPV. METHODS AND ANALYSIS: We will include randomised trials, non-randomised trials, case-control studies and cohort studies that compared fractional with full doses of IPV among children aged 5 years or younger. We will search for eligible studies among published and grey literature. Two authors will independently screen the results of the search, select studies, extract data and assess risk of bias. We will stratify analyses by study design, type of poliovirus, type of outcome measure and number of IPV doses given. For each type of poliovirus, we will pool the outcome data from studies using random-effects meta-analyses. Statistical heterogeneity will be assessed using the χ2 test of homogeneity and quantified using the I2 statistic. To investigate statistical heterogeneity, subgroup analyses will be performed based on the timing of the first fractional dose, age of administration, immunisation schedules and country income status. Sensitivity analyses will be used to assess if the effect of IPV fractional dosing is affected by study design, risk of bias and methods of meta-analysis. ETHICS AND DISSEMINATION: We obtained approval from the University of Cape Town Human Research Ethics Committee (HREC REF: 412/2018). The findings of this review will provide evidence for decision-making with regards to IPV dosage, eventually improving access to the vaccine by stretching vaccine supplies. The results will be published in the University of Cape Town online library and in a peer reviewed journal. PROSPERO REGISTRATION NUMBER: CRD42018092647.