Preparing to introduce new maternal immunizations in low- and lower-middle-income countries: A report from the Bill & Melinda Gates Foundation convening "Allies in Maternal and Newborn Care"; May 3-4, 2018.

New strategies will be critical to reduce infant mortality and severe morbidity - there are still 5.2 million newborn deaths and stillbirths each year. The decline in newborn mortality has not kept pace with the reduction in under-five deaths and is slowest in low- and lower-middle-income countries (LMICs). Maternal immunization is a promising intervention to protect infants when they are most vulnerable - in utero and their first few months of life, before they can receive their own vaccines. Successfully introducing new vaccines for pregnant women in LMICs will require collaboration between two fields - (1) immunization and (2) maternal, newborn and child health - that use different service delivery approaches, operate under different policy and funding paradigms, and are not always integrated. In May 2018, stakeholders from these distinct communities convened to identify challenges and opportunities associated with delivering new maternal immunizations. Participants agreed that antenatal care is a logical platform. However, in many resource-constrained settings, antenatal care providers are already overburdened, and most women do not receive the recommended number of antenatal visits. Implementing maternal immunization could help increase antenatal care attendance by offering an additional safe and effective intervention that women value. Substantial effort is needed to demonstrate the benefits of maternal immunization to decision-makers and providers, and to ensure that countries and health systems are ready for introduction. To that end, participants identified the following priorities: assure coherence of policies for introducing new vaccines for pregnant women and strengthen maternal health interventions; generate demand for existing, recommended, and new maternal vaccines; conduct socio-behavioral, health systems and implementation research to shape optimal vaccine delivery strategies; and strengthen antenatal and perinatal care quality. To achieve these aims, collaboration across fields will be essential. Given that new maternal vaccines are advancing in clinical development, time is of the essence.

Contraception determinants in youths of Sierra Leone are largely behavioral.

BACKGROUND: Sexual initiation occurs early in Sierra Leone. This study aims to analyze the determinants of condom and/or contraceptive use among a representative sample of young persons (10 to 24 years) in Sierra Leone. METHODS: This is a secondary analysis of data from a study conducted to monitor the implementation of a UNFPA package of interventions directed to improve SRH in young people of Sierra Leone. This assessment was conducted in 2016 at the end of the Ebola outbreak. In consequence, determinants linked to healthy lifestyle behaviors and UNFPA interventions were explored in addition to the usual determinants: socio demographic and sexual lifestyle. This study is a household quantitative survey with open ended questions used to illustrate and complete the analysis. RESULTS: A total of 1409 young people were interviewed: of these, 216 boys and 381 girls were sexually active. Those who were pregnant or wished for pregnancy were excluded, leaving 194 boys and 268 girls for the analysis of determinants. The proportion of young people using neither condom nor other contraception at their last sexual intercourse in the whole sample was 40.5% and there was no statistically significant difference between boys and girls (42.3 vs 39.2; P = 0.504). Determinants were assessed and, after multivariable analysis, results differed between boys and girls and showed the importance of behavioral aspects. Four determinants were common to boys and girls: literacy, distance, negotiation capacity and hand washing. However, the distance factor for girls was to the health facility and for boys it was to school. Three more determinants remained in the boy's model: sleeping under a bednet, number of sexual partners and knowledge of contraceptive methods. Opinions about condoms and contraception revealed important barriers; opposition to contraceptive use was the main reason for non-use for both boys and girls, while lack of access was an important reason for boys. CONCLUSION: There is a need to reach out to the 40% of young people who are sexually active and neither pregnant nor with pregnancy desire, and are not using condom or contraception.

Stillbirths: ending preventable deaths by 2030.

Efforts to achieve the new worldwide goals for maternal and child survival will also prevent stillbirth and improve health and developmental outcomes. However, the number of annual stillbirths remains unchanged since 2011 and is unacceptably high: an estimated 2.6 million in 2015. Failure to consistently include global targets or indicators for stillbirth in post-2015 initiatives shows that stillbirths are hidden in the worldwide agenda. This Series paper summarises findings from previous papers in this Series, presents new analyses, and proposes specific criteria for successful integration of stillbirths into post-2015 initiatives for women's and children's health. Five priority areas to change the stillbirth trend include intentional leadership; increased voice, especially of women; implementation of integrated interventions with commensurate investment; indicators to measure effect of interventions and especially to monitor progress; and investigation into crucial knowledge gaps. The post-2015 agenda represents opportunities for all stakeholders to act together to end all preventable deaths, including stillbirths.

Scaling up quality care for mothers and newborns around the time of birth: an overview of methods and analyses of intervention-specific bottlenecks and solutions.

BACKGROUND: The Every Newborn Action Plan (ENAP) and Ending Preventable Maternal Mortality targets cannot be achieved without high quality, equitable coverage of interventions at and around the time of birth. This paper provides an overview of the methodology and findings of a nine paper series of in-depth analyses which focus on the specific challenges to scaling up high-impact interventions and improving quality of care for mothers and newborns around the time of birth, including babies born small and sick. METHODS: The bottleneck analysis tool was applied in 12 countries in Africa and Asia as part of the ENAP process. Country workshops engaged technical experts to complete a tool designed to synthesise "bottlenecks" hindering the scale up of maternal-newborn intervention packages across seven health system building blocks. We used quantitative and qualitative methods and literature review to analyse the data and present priority actions relevant to different health system building blocks for skilled birth attendance, emergency obstetric care, antenatal corticosteroids (ACS), basic newborn care, kangaroo mother care (KMC), treatment of neonatal infections and inpatient care of small and sick newborns. RESULTS: The 12 countries included in our analysis account for the majority of global maternal (48%) and newborn (58%) deaths and stillbirths (57%). Our findings confirm previously published results that the interventions with the most perceived bottlenecks are facility-based where rapid emergency care is needed, notably inpatient care of small and sick newborns, ACS, treatment of neonatal infections and KMC. Health systems building blocks with the highest rated bottlenecks varied for different interventions. Attention needs to be paid to the context specific bottlenecks for each intervention to scale up quality care. Crosscutting findings on health information gaps inform two final papers on a roadmap for improvement of coverage data for newborns and indicate the need for leadership for effective audit systems. CONCLUSIONS: Achieving the Sustainable Development Goal targets for ending preventable mortality and provision of universal health coverage will require large-scale approaches to improving quality of care. These analyses inform the development of systematic, targeted approaches to strengthening of health systems, with a focus on overcoming specific bottlenecks for the highest impact interventions.

Quality care during labour and birth: a multi-country analysis of health system bottlenecks and potential solutions.

BACKGROUND: Good outcomes during pregnancy and childbirth are related to availability, utilisation and effective implementation of essential interventions for labour and childbirth. The majority of the estimated 289,000 maternal deaths, 2.8 million neonatal deaths and 2.6 million stillbirths every year could be prevented by improving access to and scaling up quality care during labour and birth. METHODS: The bottleneck analysis tool was applied in 12 countries in Africa and Asia as part of the Every Newborn Action Plan process. Country workshops engaged technical experts to complete the survey tool, which is designed to synthesise and grade health system "bottlenecks", factors that hinder the scale up, of maternal-newborn intervention packages. We used quantitative and qualitative methods to analyse the bottleneck data, combined with literature review, to present priority bottlenecks and actions relevant to different health system building blocks for skilled birth attendance and basic and comprehensive emergency obstetric care. RESULTS: Across 12 countries the most critical bottlenecks identified by workshop participants for skilled birth attendance were health financing (10 out of 12 countries) and health workforce (9 out of 12 countries). Health service delivery bottlenecks were found to be the most critical for both basic and comprehensive emergency obstetric care (9 out of 12 countries); health financing was identified as having critical bottlenecks for comprehensive emergency obstetric care (9 out of 12 countries). Solutions to address health financing bottlenecks included strengthening national financing mechanisms and removing financial barriers to care seeking. For addressing health workforce bottlenecks, improved human resource planning is needed, including task shifting and improving training quality. For health service delivery, proposed solutions included improving quality of care and establishing public private partnerships. CONCLUSIONS: Progress towards the 2030 targets for ending preventable maternal and newborn deaths is dependent on improving quality of care during birth and the immediate postnatal period. Strengthening national health systems to improve maternal and newborn health, as a cornerstone of universal health coverage, will only be possible by addressing specific health system bottlenecks during labour and birth, including those within health workforce, health financing and health service delivery.

Antenatal corticosteroids for management of preterm birth: a multi-country analysis of health system bottlenecks and potential solutions.

BACKGROUND: Preterm birth complications are the leading cause of deaths for children under five years. Antenatal corticosteroids (ACS) are effective at reducing mortality and serious morbidity amongst infants born at <34 weeks gestation. WHO guidelines strongly recommend use of ACS for women at risk of imminent preterm birth where gestational age, imminent preterm birth, and risk of maternal infection can be assessed, and appropriate maternal/newborn care provided. However, coverage remains low in high-burden countries for reasons not previously systematically investigated. METHODS: The bottleneck analysis tool was applied in 12 countries in Africa and Asia as part of the Every Newborn Action Plan process. Country workshops involved technical experts to complete the survey tool, which is designed to synthesise and grade health system "bottlenecks", factors that hinder the scale up, of maternal-newborn intervention packages. We used quantitative and qualitative methods to analyse the bottleneck data, combined with literature review, to present priority bottlenecks and actions relevant to different health system building blocks for ACS. RESULTS: Eleven out of twelve countries provided data in response to the ACS questionnaire. Health system building blocks most frequently reported as having significant or very major bottlenecks were health information systems (11 countries), essential medical products and technologies (9 out of 11 countries) and health service delivery (9 out of 11 countries). Bottlenecks included absence of coverage data, poor gestational age metrics, lack of national essential medicines listing, discrepancies between prescribing authority and provider cadres managing care, delays due to referral, and lack of supervision, mentoring and quality improvement systems. CONCLUSIONS: Analysis centred on health system building blocks in which 9 or more countries (>75%) reported very major or significant bottlenecks. Health information systems should include improved gestational age assessment and track ACS coverage, use and outcomes. Better health service delivery requires clarified policy assigning roles by level of care and cadre of provider, dependent on capability to assess gestational age and risk of preterm birth, and the implementation of guidelines with adequate supervision, mentoring and quality improvement systems, including audit and feedback. National essential medicines lists should include dexamethasone for antenatal use, and dexamethasone should be integrated into supply logistics.

Basic newborn care and neonatal resuscitation: a multi-country analysis of health system bottlenecks and potential solutions.

BACKGROUND: An estimated two-thirds of the world's 2.7 million newborn deaths could be prevented with quality care at birth and during the postnatal period. Basic Newborn Care (BNC) is part of the solution and includes hygienic birth and newborn care practices including cord care, thermal care, and early and exclusive breastfeeding. Timely provision of resuscitation if needed is also critical to newborn survival. This paper describes health system barriers to BNC and neonatal resuscitation and proposes solutions to scale up evidence-based strategies. METHODS: The maternal and newborn bottleneck analysis tool was applied by 12 countries in Africa and Asia as part of the Every Newborn Action Plan process. Country workshops engaged technical experts to complete the survey tool, which is designed to synthesise and grade health system "bottlenecks" that hinder the scale up of maternal-newborn intervention packages. We used quantitative and qualitative methods to analyse the bottleneck data, combined with literature review, to present priority bottlenecks and actions relevant to different health system building blocks for BNC and neonatal resuscitation. RESULTS: Eleven of the 12 countries provided grading data. Overall, bottlenecks were graded more severely for resuscitation. The most severely graded bottlenecks for BNC were health workforce (8 of 11 countries), health financing (9 out of 11) and service delivery (7 out of 9); and for neonatal resuscitation, workforce (9 out of 10), essential commodities (9 out of 10) and service delivery (8 out of 10). Country teams from Africa graded bottlenecks overall more severely. Improving workforce performance, availability of essential commodities, and well-integrated health service delivery were the key solutions proposed. CONCLUSIONS: BNC was perceived to have the least health system challenges among the seven maternal and newborn intervention packages assessed. Although neonatal resuscitation bottlenecks were graded more severe than for BNC, similarities particularly in the workforce and service delivery building blocks highlight the inextricable link between the two interventions and the need to equip birth attendants with requisite skills and commodities to assess and care for every newborn. Solutions highlighted by country teams include ensuring more investment to improve workforce performance and distribution, especially numbers of skilled birth attendants, incentives for placement in challenging settings, and skills-based training particularly for neonatal resuscitation.

Kangaroo mother care: a multi-country analysis of health system bottlenecks and potential solutions.

BACKGROUND: Preterm birth is now the leading cause of under-five child deaths worldwide with one million direct deaths plus approximately another million where preterm is a risk factor for neonatal deaths due to other causes. There is strong evidence that kangaroo mother care (KMC) reduces mortality among babies with birth weight <2000 g (mostly preterm). KMC involves continuous skin-to-skin contact, breastfeeding support, and promotion of early hospital discharge with follow-up. The World Health Organization has endorsed KMC for stabilised newborns in health facilities in both high-income and low-resource settings. The objectives of this paper are to: (1) use a 12-country analysis to explore health system bottlenecks affecting the scale-up of KMC; (2) propose solutions to the most significant bottlenecks; and (3) outline priority actions for scale-up. METHODS: The bottleneck analysis tool was applied in 12 countries in Africa and Asia as part of the Every Newborn Action Plan process. Country workshops involved technical experts to complete the survey tool, which is designed to synthesise and grade health system "bottlenecks", factors that hinder the scale-up, of maternal-newborn intervention packages. We used quantitative and qualitative methods to analyse the bottleneck data, combined with literature review, to present priority bottlenecks and actions relevant to different health system building blocks for KMC. RESULTS: Marked differences were found in the perceived severity of health system bottlenecks between Asian and African countries, with the former reporting more significant or very major bottlenecks for KMC with respect to all the health system building blocks. Community ownership and health financing bottlenecks were significant or very major bottlenecks for KMC in both low and high mortality contexts, particularly in South Asia. Significant bottlenecks were also reported for leadership and governance and health workforce building blocks. CONCLUSIONS: There are at least a dozen countries worldwide with national KMC programmes, and we identify three pathways to scale: (1) champion-led; (2) project-initiated; and (3) health systems designed. The combination of all three pathways may lead to more rapid scale-up. KMC has the potential to save lives, and change the face of facility-based newborn care, whilst empowering women to care for their preterm newborns.

Treatment of neonatal infections: a multi-country analysis of health system bottlenecks and potential solutions.

BACKGROUND: Around one-third of the world's 2.8 million neonatal deaths are caused by infections. Most of these deaths are preventable, but occur due to delays in care-seeking, and access to effective antibiotic treatment with supportive care. Understanding variation in health system bottlenecks to scale-up of case management of neonatal infections and identifying solutions is essential to reduce mortality, and also morbidity. METHODS: A standardised bottleneck analysis tool was applied in 12 countries in Africa and Asia as part of the development of the Every Newborn Action Plan. Country workshops involved technical experts to complete a survey tool, to grade health system "bottlenecks" hindering scale up of maternal-newborn intervention packages. Quantitative and qualitative methods were used to analyse the data, combined with literature review, to present priority bottlenecks and synthesise actions to improve case management of newborn infections. RESULTS: For neonatal infections, the health system building blocks most frequently graded as major or significant bottlenecks, irrespective of mortality context and geographical region, were health workforce (11 out of 12 countries), and community ownership and partnership (11 out of 12 countries). Lack of data to inform decision making, and limited funding to increase access to quality neonatal care were also major challenges. CONCLUSIONS: Rapid recognition of possible serious bacterial infection and access to care is essential. Inpatient hospital care remains the first line of treatment for neonatal infections. In situations where referral is not possible, the use of simplified antibiotic regimens for outpatient management for non-critically ill young infants has recently been reported in large clinical trials; WHO is developing a guideline to treat this group of young infants. Improving quality of care through more investment in the health workforce at all levels of care is critical, in addition to ensuring development and dissemination of national guidelines. Improved information systems are needed to track coverage and adequately manage drug supply logistics for improved health outcomes. It is important to increase community ownership and partnership, for example through involvement of community groups.

Inpatient care of small and sick newborns: a multi-country analysis of health system bottlenecks and potential solutions.

BACKGROUND: Preterm birth is the leading cause of child death worldwide. Small and sick newborns require timely, high-quality inpatient care to survive. This includes provision of warmth, feeding support, safe oxygen therapy and effective phototherapy with prevention and treatment of infections. Inpatient care for newborns requires dedicated ward space, staffed by health workers with specialist training and skills. Many of the estimated 2.8 million newborns that die every year do not have access to such specialised care. METHODS: The bottleneck analysis tool was applied in 12 countries in Africa and Asia as part of the Every Newborn Action Plan process. Country workshops involved technical experts to complete the survey tool, which is designed to synthesise and grade health system "bottlenecks" (or factors that hinder the scale up) of maternal-newborn intervention packages. For this paper, we used quantitative and qualitative methods to analyse the bottleneck data, and combined these with literature review, to present priority bottlenecks and actions relevant to different health system building blocks for inpatient care of small and sick newborns. RESULTS: Inpatient care of small and sick newborns is an intervention package highlighted by all country workshop participants as having critical health system challenges. Health system building blocks with the highest graded (significant or major) bottlenecks were health workforce (10 out of 12 countries) and health financing (10 out of 12 countries), followed by community ownership and partnership (9 out of 12 countries). Priority actions based on solution themes for these bottlenecks are discussed. CONCLUSIONS: Whilst major bottlenecks to the scale-up of quality inpatient newborn care are present, effective solutions exist. For all countries included, there is a critical need for a neonatal nursing cadre. Small and sick newborns require increased, sustained funding with specific insurance schemes to cover inpatient care and avoid catastrophic out-of-pocket payments. Core competencies, by level of care, should be defined for monitoring of newborn inpatient care, as with emergency obstetric care. Rather than fatalism that small and sick newborns will die, community interventions need to create demand for accessible, high-quality, family-centred inpatient care, including kangaroo mother care, so that every newborn can survive and thrive.

Implementation of the Every Newborn Action Plan: Progress and lessons learned.

Progress in reducing newborn mortality has lagged behind progress in reducing maternal and child deaths. The Every Newborn Action Plan (ENAP) was launched in 2014, with the aim of achieving equitable and high-quality coverage of care for all women and newborns through links with other global and national plans and measurement and accountability frameworks. This article aims to assess country progress and the mechanisms in place to support country implementation of the ENAP. A country tracking tool was developed and piloted in October-December 2014 to collect data on the ENAP-related national milestones and implementation barriers in 18 high-burden countries. Simultaneously, a mapping exercise involving 47 semi-structured interviews with partner organizations was carried out to frame the categories of technical support available in countries to support care at and around the time of birth by health system building blocks. Existing literature and reports were assessed to further supplement analysis of country progress. A total of 15 out of 18 high-burden countries have taken concrete actions to advance newborn health; four have developed specific action plans with an additional six in process and a further three strengthening newborn components within existing plans. Eight high-burden countries have a newborn mortality target, but only three have a stillbirth target. The ENAP implementation in countries is well-supported by UN agencies, particularly UNICEF and WHO, as well as multilateral and bilateral agencies, especially in health workforce training. New financial commitments from development partners and the private sector are substantial but tracking of national funding remains a challenge. For interventions with strong evidence, low levels of coverage persists and health information systems require investment and support to improve quality and quantity of data to guide and track progress. Some of the highest burden countries have established newborn health action plans and are scaling up evidence based interventions. Further progress will only be made with attention to context-specific implementation challenges, especially in areas that have been neglected to date such as quality improvement, sustained investment in training and monitoring health worker skills, support to budgeting and health financing, and strengthening of health information systems.

Every Newborn: health-systems bottlenecks and strategies to accelerate scale-up in countries.

Universal coverage of essential interventions would reduce neonatal deaths by an estimated 71%, benefit women and children after the first month, and reduce stillbirths. However, the packages with the greatest effect (care around birth, care of small and ill newborn babies), have low and inequitable coverage and are the most sensitive markers of health system function. In eight of the 13 countries with the most neonatal deaths (55% worldwide), we undertook a systematic assessment of bottlenecks to essential maternal and newborn health care, involving more than 600 experts. Of 2465 bottlenecks identified, common constraints were found in all high-burden countries, notably regarding the health workforce, financing, and service delivery. However, bottlenecks for specific interventions might differ across similar health systems. For example, the implementation of kangaroo mother care was noted as challenging in the four Asian country workshops, but was regarded as a feasible aspect of preterm care by respondents in the four African countries. If all high-burden countries achieved the neonatal mortality rates of their region's fastest progressing countries, then the mortality goal of ten or fewer per 1000 livebirths by 2035 recommended in this Series and the Every Newborn Action Plan would be exceeded. We therefore examined fast progressing countries to identify strategies to reduce neonatal mortality. We identified several key factors: (1) workforce planning to increase numbers and upgrade specific skills for care at birth and of small and ill newborn babies, task sharing, incentives for rural health workers; (2) financial protection measures, such as expansion of health insurance, conditional cash transfers, and performance-based financing; and (3) dynamic leadership including innovation and community empowerment. Adapting from the 2005 Lancet Series on neonatal survival and drawing on this Every Newborn Series, we propose a country-led, data-driven process to sharpen national health plans, seize opportunities to address the quality gap for care at birth and care of small and ill newborn babies, and systematically scale up care to reach every mother and newborn baby, particularly the poorest.

Voluntary medical male circumcision: a framework analysis of policy and program implementation in eastern and southern Africa.

BACKGROUND: Following confirmation of the effectiveness of voluntary medical male circumcision (VMMC) for HIV prevention, the World Health Organization and the Joint United Nations Programme on HIV/AIDS issued recommendations in 2007. Less than 5 y later, priority countries are at different stages of program scale-up. This paper analyzes the progress towards the scale-up of VMMC programs. It analyzes the adoption of VMMC as an additional HIV prevention strategy and explores the factors may have expedited or hindered the adoption of policies and initial program implementation in priority countries to date. METHODS AND FINDINGS: VMMCs performed in priority countries between 2008 and 2010 were recorded and used to classify countries into five adopter categories according to the Diffusion of Innovations framework. The main predictors of VMMC program adoption were determined and factors influencing subsequent scale-up explored. By the end of 2010, over 550,000 VMMCs had been performed, representing approximately 3% of the target coverage level in priority countries. The "early adopter" countries developed national VMMC policies and initiated VMMC program implementation soon after the release of the WHO recommendations. However, based on modeling using the Decision Makers' Program Planning Tool (DMPPT), only Kenya appears to be on track towards achievement of the DMPPT-estimated 80% coverage goal by 2015, having already achieved 61.5% of the DMPPT target. None of the other countries appear to be on track to achieve their targets. Potential predicators of early adoption of male circumcision programs include having a VMMC focal person, establishing a national policy, having an operational strategy, and the establishment of a pilot program. CONCLUSIONS: Early adoption of VMMC policies did not necessarily result in rapid program scale-up. A key lesson is the importance of not only being ready to adopt a new intervention but also ensuring that factors critical to supporting and accelerating scale-up are incorporated into the program. The most successful program had country ownership and sustained leadership to translate research into a national policy and program. Please see later in the article for the Editors' Summary.

Male circumcision for HIV prevention: current research and programmatic issues.

Randomized controlled trials in sub-Saharan Africa have shown that adult male circumcision reduces the risk of HIV acquisition in men by about 60%. In this article, we review recent data on the association of male circumcision and HIV/sexually transmitted infection in men and women. This includes a summary of data showing some evidence of an effect of male circumcision against genital ulcer disease, HSV-2 infection, human papillomavirus and Trichomonas vaginalis, but not Chlamydia trachomatis or Neisseria gonorrhoea in men. Longitudinal studies among HIV discordant couples suggest that male circumcision may provide some direct long-term benefit to women, which may start after complete wound healing. Circumcision may also protect against HIV acquisition in men who have sex with men (MSM) and those who practice unprotected anal intercourse (either exclusively or predominantly), although these data are not consistent. To date, there is little evidence from the few studies available of either unsafe practices or reported increases in risky behaviour, or adverse changes in sexual satisfaction and function. As countries in southern and eastern Africa scale up services, operational research will likely be useful to iteratively improve programme delivery and impact while identifying the best methods of integrating safe male circumcision services into HIV prevention strategies and strengthening health systems.