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Background: Pregnancy and polymorphisms in drug disposition genes alter the clearance of key antiretrovirals used as part of regimens for prevention of mother-to-child transmission of HIV (PMTCT). The clinical significance of these in women initiating therapy late in pregnancy has not been investigated. The primary objective of the Viral and Antiretroviral Dynamics in HIV Mother-To-Child Transmission Fluids (VADICT) study is to investigate viral and antiretroviral dynamics in matrices associated with mother-to-child transmission (MTCT) (plasma, genital fluid and breastmilk) in women (stratified by CYP2B6 genotypes) who initiate antiretroviral therapy (ART) before or early in pregnancy versus late in pregnancy or early postpartum. Methods: A cohort of HIV-1 infected women who initiated ART containing 600 mg efavirenz before or early in pregnancy (n = 120), during the third trimester (n = 60), or early postpartum (n = 60) will be studied. Eligible patients will be recruited from four hospitals in Benue State, North Central Nigeria and followed until the end of breastfeeding. Procedures at follow up visits will include sample collection for drug quantification and HIV-1 RNA and DNA in plasma, genital fluid and breastmilk; adherence monitoring; and newborn and infant assessment. Using newborn exposure to maternal efavirenz at birth for validation, prenatal pharmacogenetics of efavirenz will be explored using physiologically-based pharmacokinetic modelling. Three integrated methods will be used to monitor patterns and correlates of adherence across pregnancy and the breastfeeding period. A population pharmacokinetic-pharmacodynamic model will be developed to describe the observed data and simulate what to expect in women initiating ART containing 400 mg efavirenz (recently approved for non-pregnant adults) late in pregnancy or early postpartum. Discussion: This study will help in understanding residual MTCT in women receiving ART and reasons for the rise in MTCT risk during the breastfeeding period. Trial registration: ClinicalTrials.gov: NCT03284645 (15/09/2017)

BACKGROUND: COVID-19 is disrupting health services for mothers and newborns, particularly in low- and middle-income countries (LMIC). Preterm newborns are particularly vulnerable. We undertook analyses of the benefits of kangaroo mother care (KMC) on survival among neonates weighing ≤2000 g compared with the risk of SARS-CoV-2 acquired from infected mothers/caregivers. METHODS: We modelled two scenarios over 12 months. Scenario 1 compared the survival benefits of KMC with universal coverage (99%) and mortality risk due to COVID-19. Scenario 2 estimated incremental deaths from reduced coverage and complete disruption of KMC. Projections were based on the most recent data for 127 LMICs (~90% of global births), with results aggregated into five regions. FINDINGS: Our worst-case scenario (100% transmission) could result in 1,950 neonatal deaths from COVID-19. Conversely, 125,680 neonatal lives could be saved with universal KMC coverage. Hence, the benefit of KMC is 65-fold higher than the mortality risk of COVID-19. If recent evidence of 10% transmission was applied, the ratio would be 630-fold. We estimated a 50% reduction in KMC coverage could result in 12,570 incremental deaths and full disruption could result in 25,140 incremental deaths, representing a 2·3-4·6% increase in neonatal mortality across the 127 countries. INTERPRETATION: The survival benefit of KMC far outweighs the small risk of death due to COVID-19. Preterm newborns are at risk, especially in LMICs where the consequences of disruptions are substantial. Policymakers and healthcare professionals need to protect services and ensure clearer messaging to keep mothers and newborns together, even if the mother is SARS-CoV-2-positive. FUNDING: Eunice Kennedy Shriver National Institute of Child Health & Human Development; Bill & Melinda Gates Foundation; Elma Philanthropies; Wellcome Trust; and Joint Global Health Trials scheme of Department of Health and Social Care, Department for International Development, Medical Research Council, and Wellcome Trust.

Background This research prioritization aimed to identify major research gaps in mater-nal, newborn, child and adolescent health (MNCAH) to help mitigate the direct and indi-rect effects of the COVID-19 pandemic.Methods We adapted the Child Health and Nutrition Research Initiative methodology. Wedefined scope, domains, themes and scoring criteria. We approached diverse global expertsvia email to submit their research ideas in MNCAH and MNCAH-related cross-cutting/health systems area. We curated the research ideas as research questions (RQs) and sentthem to the consenting experts for scoring via the online link. For each RQ, the researchpriority score (RPS) was calculated as an average of individual criterion scores and rankedbased on RPS in each area.Results We identified top-ranked 10 RQs in each maternal, newborn, and child and ado-lescent health and 5 in the cross-cutting/health systems area. In maternal health, indirecteffects on care, measures to improve care, health risks and outcomes, and preventing andmanaging SARS-CoV-2 infection/COVID-19 disease were priority RQs. In newborn health,clinical characterization and managing SARS-CoV-2 infection/COVID-19 disease, mode oftransmission and interventions to prevent transmission were the focus. For child and ado-lescent health, top-ranked RQs were indirect effects on care, clinical status and outcomes,interventions to protect against SARS-CoV-2 infection/COVID-19 disease, and educationalinstitute-related RQs. The cross-cutting RQs were the effects of the pandemic on availabili-ty, access, care-seeking and utilization of MNCAH services and potential solutions.Conclusions We call on partners, including governments, non-governmental organizations,research institutes, and donors, to address this urgent research agenda.

Background: Three randomized open-label clinical trials [Simplified Antibiotic Therapy Trial (SATT) Bangladesh, SATT Pakistan and African Neonatal Sepsis Trial (AFRINEST)] were developed to test the equivalence of simplified antibiotic regimens compared with the standard regimen of 7 days of parenteral antibiotics. These trials were originally conceived and designed separately; subsequently, significant efforts were made to develop and implement a common protocol and approach. Previous articles in this supplement briefly describe the specific quality control methods used in the individual trials; this article presents additional information about the systematic approaches used to minimize threats to validity and ensure quality across the trials. Methods: A critical component of quality control for AFRINEST and SATT was striving to eliminate variation in clinical assessments and decisions regarding eligibility, enrollment and treatment outcomes. Ensuring appropriate and consistent clinical judgment was accomplished through standardized approaches applied across the trials, including training, assessment of clinical skills and refresher training. Standardized monitoring procedures were also applied across the trials, including routine (day-to-day) internal monitoring of performance and adherence to protocols, systematic external monitoring by funding agencies and external monitoring by experienced, independent trial monitors. A group of independent experts (Technical Steering Committee/Technical Advisory Group) provided regular monitoring and technical oversight for the trials. Conclusions: Harmonization of AFRINEST and SATT have helped to ensure consistency and quality of implementation, both internally and across the trials as a whole, thereby minimizing potential threats to the validity of the trials’ results.

The aim of this cross-sectional study was to highlight the sociocultural beliefs and practices relating to the care and feeding of low-birthweight (LBW) babies in two rural communities in the south-west of Nigeria. Data from 60 mothers and their newborns and community care providers were collected using qualitative instruments. The 60 mothers [30 mothers of LBW and 30 of normal-birthweight (NBW) infants] were identified through key informants, snowball approach and information obtained from community healthcare providers. The mean weight at recruitment of the LBW and NBW babies studied was 1680 +/- 440 and 2990 +/- 450 g respectively. Only two of the 60 mothers in the study delivered in orthodox health facilities, because in most cases these facilities were unaffordable, inaccessible and incompatible with rural lifestyles/beliefs. Most of the mothers believed that exclusive breastfeeding was not adequate for the LBW babies, and so herbal mixtures believed to accelerate growth were given in addition to breast milk. The use of forced hand-feeding and feeding bottles was universal among the mothers of LBW babies in order to 'increase the volume of feeds the baby gets'. Herbal dressing was used for cord and anterior fontanel care, while the babies were kept warm by using extra clothing, lighted lanterns and shutting of the windows. Five (16.7%) LBW infants and 1 (3.3%) NBW baby died, while 12 (40%) LBW, compared with 4 (13.3%) NBW infants, were hospitalized during the study. The findings of this study serve to identify the cultural beliefs and values around the care of LBW infants. Interventions designed to improve neonatal survival must therefore, take cognizance of these beliefs, customs and practices, in order to ensure effective and proper care of the LBW infants.

Recommendations for care in the first week of a newborn's life include thermal care practices such as drying and wrapping, skin to skin contact, immediate breastfeeding and delayed bathing. This paper examines beliefs and practices related to neonatal thermal care in three African countries. Data were collected in the same way in each site and included 16-20 narrative interviews with recent mothers, eight observations of neonatal bathing, and in-depth interviews with 12-16 mothers, 9-12 grandmothers, eight health workers and 0-12 birth attendants in each site. We found similarities across sites in relation to understanding the importance of warmth, a lack of opportunities for skin to skin care, beliefs about the importance of several baths per day and beliefs that the Vernix caseosa was related to poor maternal behaviours. There was variation between sites in beliefs and practices around wrapping and drying after delivery, and the timing of the first bath with recent behavior change in some sites. There was near universal early bathing of babies in both Nigerian sites. This was linked to a deep-rooted belief about body odour. When asked about keeping the baby warm, respondents across the sites rarely mentioned recommended thermal care practices, suggesting that these are not perceived as salient. More effort is needed to promote appropriate thermal care practices both in facilities and at home. Programmers should be aware that changing deep rooted practices, such as early bathing in Nigeria, may take time and should utilize the current beliefs in the importance of neonatal warmth to facilitate behaviour change.