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BackgroundAntiretroviral regimens with simplified dosing and better safety are needed to maximize the efficiency of antiretroviral delivery in resource-limited settings. We investigated the efficacy and safety of antiretroviral regimens with once-daily compared to twice-daily dosing in diverse areas of the world.Methods and findings1,571 HIV-1-infected persons (47% women) from nine countries in four continents were assigned with equal probability to open-label antiretroviral therapy with efavirenz plus lamivudine-zidovudine (EFV+3TC-ZDV), atazanavir plus didanosine-EC plus emtricitabine (ATV+DDI+FTC), or efavirenz plus emtricitabine-tenofovir-disoproxil fumarate (DF) (EFV+FTC-TDF). ATV+DDI+FTC and EFV+FTC-TDF were hypothesized to be non-inferior to EFV+3TC-ZDV if the upper one-sided 95% confidence bound for the hazard ratio (HR) was ≤1.35 when 30% of participants had treatment failure. An independent monitoring board recommended stopping study follow-up prior to accumulation of 472 treatment failures. Comparing EFV+FTC-TDF to EFV+3TC-ZDV, during a median 184 wk of follow-up there were 95 treatment failures (18%) among 526 participants versus 98 failures among 519 participants (19%; HR 0.95, 95% CI 0.72-1.27; p = 0.74). Safety endpoints occurred in 243 (46%) participants assigned to EFV+FTC-TDF versus 313 (60%) assigned to EFV+3TC-ZDV (HR 0.64, CI 0.54-0.76; p

Abstract: Maternal undernutrition and mortality remain high in several African countries. Key nutrition and health interventions improve maternal and birth outcomes. Evidence is scarce on how to strengthen health systems to ensure pregnant women and newborns are reached with these interventions. We conducted three quasi‐experimental nonrandomized Community Based Maternal and Neonatal Health and Nutrition projects in regions of Ethiopia, Senegal, and Kenya to demonstrate how proven nutrition interventions could be integrated into health programs to improve knowledge and practices during pregnancy, birth, and postpartum. We evaluated impact on knowledge and practices related to maternal and neonatal care using logistic regression and repeated‐measures models with districts as a fixed variable and adjusted for covariates. Combined country analyses show significant positive effects of the intervention on women receiving first antenatal care visit (ANC) during first trimester (OR = 1.44; p < .001), those consuming any iron and folic acid supplement during their latest pregnancy (OR = 1.60; p = .005), those whose <6 months infants were exclusively breastfed (OR = 2.01; p=.003), those whose delivery was facility based (OR = 1.48; p=.031), and those whose postnatal care was facility based (OR = 2.15; p<.001). There was no significant differences between intervention and control groups regarding one or more and four or more ANC visits, women consuming iron and folic acid for ≥90 days, and early initiation of breastfeeding. We conclude that integrating proven nutrition interventions into health programs at community level improved components of access to and use of ANC, delivery services, and postnatal care by women in three African countries. [ABSTRACT FROM AUTHOR]

Abstract: Maternal and neonatal mortality are unacceptably high in developing countries. Essential nutrition interventions contribute to reducing this mortality burden, although nutrition is poorly integrated into health systems. Universal health coverage is an essential prerequisite to decreasing mortality indices. However, provision and utilization of nutrition and health services for pregnant women and their newborns are poor and the potential for improvement is limited where health systems are weak. The Community‐Based Maternal and Neonatal Health and Nutrition project was established as a set of demonstration projects in 4 countries in Africa with varied health system contexts where there were barriers to safe maternal health care at individual, community and facility levels. We selected project designs based on the need, context, and policies under consideration. A theory driven approach to programme implementation and evaluation was used involving developing of contextual project logic models that linked inputs to address gaps in quality and uptake of antenatal care; essential nutrition actions in antenatal care, delivery, and postnatal care; delivery with skilled and trained birth attendant; and postnatal care to outcomes related to improvements in maternal health service utilization and reduction in maternal and neonatal morbidity and mortality. Routine monitoring and impact evaluations were included in the design. The objective of this paper is to describe the rationale and methods used in setting up a multi‐country study that aimed at designing the key maternal and neonatal health interventions and identifying indicators related to inputs, outcomes, and impact that were measured to track change associated with our interventions. [ABSTRACT FROM AUTHOR]

A process evaluation of nurses' implementation of an infant-feeding counseling protocol was conducted for the Breastfeeding, Antiretroviral and Nutrition (BAN) Study, a prevention of mother-to-child transmission of HIV clinical trial in Lilongwe, Malawi. Six trained nurses counseled HIV-infected mothers to exclusively breastfeed for 24 weeks postpartum and to stop breastfeeding within an additional four weeks. Implementation data were collected via direct observations of 123 infant feeding counseling sessions (30 antenatal and 93 postnatal) and interviews with each nurse. Analysis included calculating a percent adherence to checklists and conducting a content analysis for the observation and interview data. Nurses were implementing the protocol at an average adherence level of 90% or above. Although not detailed in the protocol, nurses appropriately counseled mothers on their actual or intended formula milk usage after weaning. Results indicate that nurses implemented the protocol as designed. Results will help to interpret the BAN Study's outcomes.