Adapting the preterm birth phenotyping framework to a low-resource, rural setting and applying it to births from Migori County in western Kenya.

BACKGROUND: Preterm birth is the leading cause of neonatal and under-five mortality worldwide. It is a complex syndrome characterized by numerous etiologic pathways shaped by both maternal and fetal factors. To better understand preterm birth trends, the Global Alliance to Prevent Prematurity and Stillbirth published the preterm birth phenotyping framework in 2012 followed by an application of the model to a global dataset in 2015 by Barros, et al. Our objective was to adapt the preterm birth phenotyping framework to retrospective data from a low-resource, rural setting and then apply the adapted framework to a cohort of women from Migori, Kenya. METHODS: This was a single centre, observational, retrospective chart review of eligible births from November 2015 - March 2017 at Migori County Referral Hospital. Adaptations were made to accommodate limited diagnostic capabilities and data accuracy concerns. Prevalence of the phenotyping conditions were calculated as well as odds of adverse outcomes. RESULTS: Three hundred eighty-seven eligible births were included in our study. The largest phenotype group was none (no phenotype could be identified; 41.1%), followed by extrauterine infection (25.1%), and antepartum stillbirth (16.7%). Extrauterine infections included HIV (75.3%), urinary tract infections (24.7%), malaria (4.1%), syphilis (3.1%), and general infection (3.1%). Severe maternal condition was ranked fourth (15.6%) and included anaemia (69.5%), chronic respiratory distress (22.0%), chronic hypertension prior to pregnancy (5.1%), diabetes (3.4%), epilepsy (3.4%), and sickle cell disease (1.7%). Fetal anaemia cases were the most likely to transfer to the newborn unit (OR 5.1, 95% CI 0.8, 30.9) and fetal anomaly cases were the most likely to result in a pre-discharge mortality (OR 3.9, 95% CI 0.8, 19.2). CONCLUSIONS: Using routine data sources allowed for a retrospective analysis of an existing dataset, requiring less time and fewer resources than a prospective study and demonstrating a feasible approach to preterm phenotyping for use in low-resource settings to inform local prevention strategies.

Preterm birth is a complex syndrome, yet it is the leading cause of death in children worldwide. To help unravel the clinical complexities, preterm birth phenotyping is a framework that considers multiple diagnoses in the mother, helping to evaluate trends in causes of preterm birth in a given region. In our study, we adapted this international phenotyping framework to accommodate a rural, low-resource setting where obstetrical and neonatal technologies were limited, but preterm birth rates were high. We evaluated data from the patient records of a large hospital in Migori, Kenya, in the southwestern region of the country. By lowering the threshold of diagnostic criteria, we were able to apply this framework to our dataset and see that maternal infection and maternal chronic illness appear to be a significant driving forces of preterm birth. Given high rates of HIV and malaria in the region, this is not a surprising finding, but one that can inform antenatal care practices, mainly the need to test and treat for common infections (HIV, malaria, as well as urinary and reproductive tract infections), and to increase the frequency of antenatal care interactions per the World Health Organization recommendations.

Growth and neurodevelopmental outcomes of preterm and low birth weight infants in rural Kenya: a cross-sectional study.

OBJECTIVE: Data on long-term outcomes of preterm (PT) and low birth weight (LBW) infants in countries with high rates of neonatal mortality and childhood stunting are limited, especially from community settings. The current study sought to explore growth and neurodevelopmental outcomes of PT/LBW infants from a rural community-based setting of Kenya up to 18 months adjusted age. DESIGN: Cross-sectional study. SETTING: Migori County, Kenya. PARTICIPANTS: Three hundred and eighty-two PT/LBW infants (50.2% of those identified as eligible) from a cluster randomised control trial evaluating a package of facility-based intrapartum quality of care interventions for newborn survival consented for follow-up. OUTCOME MEASURES: Caregiver interviews and infant health, growth and neurodevelopmental assessments were completed at 6, 12 or 18 months±2 weeks. Data included sociodemographic information, medical history, growth measurements and neurodevelopmental assessment using the Ten Questions Questionnaire, Malawi Developmental Assessment Tool and Hammersmith Infant Neurological Examination. Analyses were descriptive and univariate regression models. No alterations were made to planned data collection. RESULTS: The final sample included 362 PT/LBW infants, of which 56.6% were moderate to late PT infants and 64.4% were LBW. Fewer than 2% of parents identified their child as currently malnourished, but direct measurement revealed higher proportions of stunting and underweight than in national demographic and health survey reports. Overall, 22.7% of caregivers expressed concern about their child's neurodevelopmental status. Neurodevelopmental delays were identified in 8.6% of infants based on one or more standardised tools, and 1.9% showed neurological findings indicative of cerebral palsy. CONCLUSIONS: Malnutrition and neurodevelopmental delays are common among PT/LBW infants in this setting. Close monitoring and access to early intervention programmes are needed to help these vulnerable infants thrive. TRIAL REGISTRATION NUMBER: NCT03112018.

Defining and estimating effects in cluster randomized trials: A methods comparison.

Across research disciplines, cluster randomized trials (CRTs) are commonly implemented to evaluate interventions delivered to groups of participants, such as communities and clinics. Despite advances in the design and analysis of CRTs, several challenges remain. First, there are many possible ways to specify the causal effect of interest (eg, at the individual-level or at the cluster-level). Second, the theoretical and practical performance of common methods for CRT analysis remain poorly understood. Here, we present a general framework to formally define an array of causal effects in terms of summary measures of counterfactual outcomes. Next, we provide a comprehensive overview of CRT estimators, including the t-test, generalized estimating equations (GEE), augmented-GEE, and targeted maximum likelihood estimation (TMLE). Using finite sample simulations, we illustrate the practical performance of these estimators for different causal effects and when, as commonly occurs, there are limited numbers of clusters of different sizes. Finally, our application to data from the Preterm Birth Initiative (PTBi) study demonstrates the real-world impact of varying cluster sizes and targeting effects at the cluster-level or at the individual-level. Specifically, the relative effect of the PTBi intervention was 0.81 at the cluster-level, corresponding to a 19% reduction in outcome incidence, and was 0.66 at the individual-level, corresponding to a 34% reduction in outcome risk. Given its flexibility to estimate a variety of user-specified effects and ability to adaptively adjust for covariates for precision gains while maintaining Type-I error control, we conclude TMLE is a promising tool for CRT analysis.

Cost analysis of an intrapartum quality improvement package for improving preterm survival and reinforcing best practices in Kenya and Uganda.

INTRODUCTION: Preterm birth is a leading cause of under-5 mortality, with the greatest burden in lower-resource settings. Strategies to improve preterm survival have been tested, but strategy costs are less understood. We estimate costs of a highly effective Preterm Birth Initiative (PTBi) intrapartum intervention package (data strengthening, WHO Safe Childbirth Checklist, simulation and team training, quality improvement collaboratives) and active control (data strengthening, Safe Childbirth Checklist). METHODS: In our analysis, we estimated costs incremental to current cost of intrapartum care (in 2020 $US) for the PTBi intervention package and active control in Kenya and Uganda. We costed the intervention package and control in two scenarios: 1) non-research implementation costs as observed in the PTBi study (Scenario 1, mix of public and private inputs), and 2) hypothetical costs for a model of implementation into Ministry of Health programming (Scenario 2, mostly public inputs). Using a healthcare system perspective, we employed micro-costing of personnel, supplies, physical space, and travel, including 3 sequential phases: program planning/adaptation (9 months); high-intensity implementation (15 months); lower-intensity maintenance (annual). One-way sensitivity analyses explored the effects of uncertainty in Scenario 2. RESULTS: Scenario 1 PTBi package total costs were $1.11M in Kenya ($48.13/birth) and $0.74M in Uganda ($17.19/birtth). Scenario 2 total costs were $0.86M in Kenya ($23.91/birth) and $0.28M in Uganda ($5.47/birth); annual maintenance phase costs per birth were $16.36 in Kenya and $3.47 in Uganda. In each scenario and country, personnel made up at least 72% of total PTBi package costs. Total Scenario 2 costs in Uganda were consistently one-third those of Kenya, largely driven by differences in facility delivery volume and personnel salaries. CONCLUSIONS: If taken up and implemented, the PTBi package has the potential to save preterm lives, with potential steady-state (maintenance) costs that would be roughly 5-15% of total per-birth healthcare costs in Uganda and Kenya.

Prevalence of Substance Use and Its Association with Sociodemographic and Behavioral Factors among Women Who Conduct Sex Work in Kenya.

Female sex workers (FSWs) in sub-Saharan Africa are a marginalized group with an increased morbidity risk. Psychoactive substance use among this group is common and increases the risk of adverse health consequences. The type of substance used, extent, and nature of use varies with different settings and regions. We examine the use of specific psychoactive substances among FSWs residing in an urban informal settlement in Nairobi. This cross-sectional study was conducted between April and August 2017. Structured questionnaires were administered in face-to-face interviews. Descriptive statistics and logistic regression were undertaken to examine prevalence, patterns, and factors associated with use of specific substances. Out of 301 FSWs, 98% reported current psychoactive substance use. The most used substance was alcohol with 95.6% of the study population reporting use in the past year. Of these, 151 (50.2%) met criteria for very high-risk drinkers. Reported current use was 61.5% for cannabis, 47.2% for khat, and 30.9% for tobacco. Factors independently associated with hazardous and harmful alcohol use included earning a higher monthly income (>USD50) and disclosure of sex work to close family and friends. There is an urgent need for preventive and curative interventions to address the high prevalence of substance use among FSW residing in high-risk urban informal settlements in Kenya.

Effect of a quality improvement intervention for management of preterm births on outcomes of all births in Kenya and Uganda: A secondary analysis from a facility-based cluster randomized trial.

Background: A large proportion of early neonatal deaths occur at the time or on the first day of birth. The Preterm Birth Initiative East Africa (PTBi EA) set out to decrease mortality among preterm births through improving quality of facility-based intrapartum care. The PTBi EA cluster randomized trial's primary analysis showed the package reduced intrapartum stillbirth and neonatal death among preterm infants. This secondary analysis examines the impact of the PTBi intervention package on stillbirth and predischarge newborn deaths combined, among all births in 20 participating facilities in Kenya and Uganda. Methods: Eligible facilities were pair-matched and randomly assigned (1:1) into either the intervention or the control group. All facilities received support for data strengthening and a modified World Health Organization (WHO) Safe Childbirth Checklist; facilities in the intervention group additionally received provider mentoring using PRONTO simulation and team training as well as quality improvement collaboratives. We abstracted data from maternity registers. Results: Of the total 29 442 births that were included, Kenya had 8468 and 6465 births and Uganda had 8719 and 5790 births, in the control and intervention arms, respectively. There were 935 stillbirths and predischarge newborn deaths in the control arm and 439 in the intervention arm. The adjusted odds ratio (aOR) for the effect of the intervention on the combined outcome, among all births, was 0.96 (95% confidence interval (CI) = 0.69-1.32), which was different by country: Kenya - 1.12 (95% CI = 0.72-1.73); Uganda - 0.65 (95% CI = 0.44-0.98); Pinteraction = 0.025. These trends were similar after excluding the PTBi primary cohort. Conclusions: The intervention package improved survival among all births in Uganda but not in Kenya. These results suggest the importance of context and facility differences that were observed between the two countries. Registration: This trial is registered with ClinicalTrials.gov, NCT03112018.

Implementing the WHO Safe Childbirth Checklist modified for preterm birth: lessons learned and experiences from Kenya and Uganda.

BACKGROUND: The WHO Safe Childbirth Checklist (SCC) contains 29 evidence-based practices (EBPs) across four pause points spanning admission to discharge. It has been shown to increase EBP uptake and has been tailored to specific contexts. However, little research has been conducted in East Africa on use of the SCC to improve intrapartum care, particularly for preterm birth despite its burden. We describe checklist adaptation, user acceptability, implementation and lessons learned. METHODS: The East Africa Preterm Birth Initiative (PTBi EA) modified the SCC for use in 23 facilities in Western Kenya and Eastern Uganda as part of a cluster randomized controlled trial evaluating a package of facility-based interventions to improve preterm birth outcomes. The modified SCC (mSCC) for prematurity included: addition of a triage pause point before admission; focus on gestational age assessment, identification and management of preterm labour; and alignment with national guidelines. Following introduction, implementation lasted 24 and 34 months in Uganda and Kenya respectively and was supported through complementary mentoring and data strengthening at all sites. PRONTO® simulation training and quality improvement (QI) activities further supported mSCC use at intervention facilities only. A mixed methods approach, including checklist monitoring, provider surveys and in-depth interviews, was used in this analysis. RESULTS: A total of 19,443 and 2229 checklists were assessed in Kenya and Uganda, respectively. In both countries, triage and admission pause points had the highest rates of completion. Kenya's completion was greater than 70% for all pause points; Uganda ranged from 39 to 75%. Intervention facilities exposed to PRONTO and QI had higher completion rates than control sites. Provider perceptions cited clinical utility of the checklist, particularly when integrated into patient charts. However, some felt it repeated information in other documentation tools. Completion was hindered by workload and staffing issues. CONCLUSION: This study highlights the feasibility and importance of adaptation, iterative modification and complementary activities to reinforce SCC use. There are important opportunities to improve its clinical utility by the addition of prompts specific to the needs of different contexts. The trial assessing the PTBi EA intervention package was registered at ClinicalTrials.gov NCT03112018 Registered December 2016, retrospectively registered.

Water Insecurity is Associated with Lack of Viral Suppression and Greater Odds of AIDS-Defining Illnesses Among Adults with HIV in Western Kenya.

Reliable access to safe and acceptable water in sufficient quantities (i.e., water security) is important for medication adherence and limiting pathogen exposure, yet prior studies have only considered the role of food security as a social determinant of HIV-related health. Therefore, the objective of this analysis was to assess the relationships between household water insecurity and HIV-related outcomes among adults living with HIV in western Kenya (N = 716). We conducted a cross-sectional analysis of baseline data from Shamba Maisha (NCT02815579), a cluster randomized controlled trial of a multisectoral agricultural and asset loan intervention. Baseline data were collected from June 2016 to December 2017. We assessed associations between water insecurity and HIV-related outcomes, adjusting for clinical and behavioral confounders, including food insecurity. Each five-unit higher household water insecurity score (range: 0-51) was associated with 1.21 higher odds of having a viral load ≥ 1000 copies/mL (95% CI 1.07, 1.36) and 1.26 higher odds of AIDS-defining illness (95% CI 1.11, 1.42). Household water insecurity was not associated with CD4 cell count (B: 0.27; 95% CI -3.59, 13.05). HIV treatment and support programs should consider assessing and addressing water insecurity in addition to food insecurity to optimize HIV outcomes.

RESUMEN: El acceso seguro al agua potable en cantidades suficientes (es decir, seguridad hídrica) es importante para la adherencia a la medicación y para limitar la exposición a patógenos; sin embargo, estudios anteriores solo han considerado el papel de la seguridad alimentaria como un determinante social de salud relacionado con el VIH. Por lo tanto, el objetivo de este análisis fue evaluar las relaciones entre la inseguridad hídrica en hogares y los resultados relacionados con el VIH en adultos que viven con VIH en el oeste de Kenia (N = 716). Realizamos un análisis transversal de los datos basales de la iniciativa Shamba Maisha (NCT02815579), un ensayo controlado aleatorio por conglomerados de una intervención multisectorial de créditos para insumos agrícolas. Los datos basales se recopilaron de junio de 2016 a diciembre de 2017. Evaluamos las asociaciones entre la inseguridad hídrica y resultados relacionados con el VIH, ajustando por factores de confusión clínicos y conductuales, incluyendo inseguridad alimentaria. Cada cinco unidades superiores de puntajes de inseguridad hídrica doméstica (rango: 0-51) fue asociado con 1.21 mayores probabilidades de tener una carga viral más alta ≥ 1000 copias / ml (CI 95%: 1,07-1,36) y con 1.26 mayores probabilidades de factores determinantes del SIDA (CI 95%: 1,11-1,42). La inseguridad de hídrica doméstica no se asoció con el recuento de células CD4 (B: −0,27; CI 95%: -13,59-13,05). Los programas de tratamiento y de apoyo al VIH deben considerar evaluar y abordar la inseguridad hídrica además de la inseguridad alimentaria para optimizar los resultados del VIH.

Causes of preterm and low birth weight neonatal mortality in a rural community in Kenya: evidence from verbal and social autopsy.

BACKGROUND: Under-five mortality in Kenya has declined over the past two decades. However, the reduction in the neonatal mortality rate has remained stagnant. In a country with weak civil registration and vital statistics systems, there is an evident gap in documentation of mortality and its causes among low birth weight (LBW) and preterm neonates. We aimed to establish causes of neonatal LBW and preterm mortality in Migori County, among participants of the PTBI-K (Preterm Birth Initiative-Kenya) study. METHODS: Verbal and social autopsy (VASA) interviews were conducted with caregivers of deceased LBW and preterm neonates delivered within selected 17 health facilities in Migori County, Kenya. The probable cause of death was assigned using the WHO International Classification of Diseases (ICD-10). RESULTS: Between January 2017 to December 2018, 3175 babies were born preterm or LBW, and 164 (5.1%) died in the first 28 days of life. VASA was conducted among 88 (53.7%) of the neonatal deaths. Almost half (38, 43.2%) of the deaths occurred within the first 24 h of life. Birth asphyxia (45.5%), neonatal sepsis (26.1%), respiratory distress syndrome (12.5%) and hypothermia (11.0%) were the leading causes of death. In the early neonatal period, majority (54.3%) of the neonates succumbed to asphyxia while in the late neonatal period majority (66.7%) succumbed to sepsis. Delay in seeking medical care was reported for 4 (5.8%) of the neonatal deaths. CONCLUSION: Deaths among LBW and preterm neonates occur early in life due to preventable causes. This calls for enhanced implementation of existing facility-based intrapartum and immediate postpartum care interventions, targeting asphyxia, sepsis, respiratory distress syndrome and hypothermia.

Environmental, Metabolic, and Inflammatory Factors Converge in the Pathogenesis of Moderate Acute Malnutrition in Children: An Observational Cohort Study.

Acute malnutrition affects more than 50 million children worldwide. These children are at an increased risk of morbidity and mortality from infectious disease. However, the pathogenesis of acute malnutrition and mechanisms underlying the increased risk and poor outcomes from infection are not well understood. Our objective was to identify differences in inflammation and inflammatory responses between children with moderate acute malnutrition (MAM) and healthy controls (HCs), and search for environmental, pathophysiological, and metabolic factors that may influence this response. Sixteen children with MAM and 16 HCs aged 18-36 months were studied in Nairobi, Kenya. None of the children had symptoms of an infectious disease (fever, diarrhea, or cough) in the 2 weeks before enrollment and sample collection. Demographic and health data were provided by their primary caregivers. Blood samples were collected to measure various biomarkers and the response to an inflammatory stimulus. Children with MAM were more frequently from households with contaminated water, crowding, and unstable income sources. They also had increases in basal inflammation, circulating bacterial lipopolysaccharide (LPS), markers of intestinal damage, and an exaggerated whole blood inflammatory response to LPS. Metabolic changes in children with MAM led to increased plasma levels of long-chain fatty acids, which were found to contribute to the pro-inflammatory state. These exploratory findings suggest convergence of multiple factors to promote dysregulated inflammatory responses and prompt several mechanistic hypotheses that can be pursued to better understand the pathogenesis of MAM.

Household Water and Food Insecurity Are Positively Associated with Poor Mental and Physical Health among Adults Living with HIV in Western Kenya.

BACKGROUND: Household food insecurity (FI) and water insecurity (WI) are prevalent public health issues that can co-occur. Few studies have concurrently assessed their associations with health outcomes, particularly among people living with HIV. OBJECTIVES: We aimed to investigate the associations between FI and WI and how they relate to physical and mental health. METHODS: Food-insecure adult smallholder farmers living with HIV in western Kenya were recruited to participate in a cluster-randomized controlled trial of a multisectoral agricultural and asset loan intervention. We used baseline data on experiences of FI (using the Household Food Insecurity Access Scale, range: 0-27) and WI (using a modified scale developed for this region, range: 0-51) in the prior month (n = 716). Outcomes included probable depression (using the Hopkins Symptom Checklist), fatigue and diarrhea in the prior month, and overall mental and physical health (using the Medical Outcomes Study HIV Health Survey, range: 0-100). We first assessed Pearson correlations between FI, WI, and sociodemographic characteristics. We then developed 3 regressions for each health outcome (control variables and FI; control variables and WI; control variables, FI, and WI) and compared model fit indexes. RESULTS: Correlations between household FI, WI, and wealth were low, meaning they measure distinct constructs. FI and WI were associated with numerous physical and mental health outcomes; accounting for both resource insecurities typically provided the best model fit. For instance, when controlling for FI, each 10-point higher WI score was associated with a 6.42-point lower physical health score (P < 0.001) and 2.92 times greater odds of probable depression (P < 0.001). CONCLUSIONS: Assessing both FI and WI is important for correctly estimating their relation with health outcomes. Interventions that address food- and water-related issues among persons living with HIV concurrently will likely be more effective at improving health than those addressing a single resource insecurity. This trial was registered at clinicaltrials.gov as NCT02815579.

Implementing an intrapartum package of interventions to improve quality of care to reduce the burden of preterm birth in Kenya and Uganda.

BACKGROUND: Quality of care during the intrapartum and immediate postnatal period for maternal and newborn health remains a major challenge due to the multiple health system bottlenecks in low-income countries. Reports of complex interventions that have been effective in reducing maternal and newborn mortality in these settings are usually limited in description, which inhibits learning and replication. We present a detailed account of the Preterm Birth Initiative (PTBi) implementation process, experiences and lessons learnt to inform scale-up and replication. METHODS: Using the TiDieR framework, we detail how the PTBi implemented an integrated package of interventions through a pair-matched cluster randomized control trial in 20 health facilities in Migori County, Kenya, and the Busoga region in east central Uganda from 2016 to 2019. The package aimed to improve quality of care during the intrapartum and immediate postnatal period with a focus on preterm birth. The package included data strengthening (DS) and introduction of a modified WHO Safe Childbirth Checklist (mSCC), simulation-based training and mentoring (PRONTO), and a Quality Improvement (QI) Collaborative. RESULTS: In 2016, DS and mSCC were introduced to improve existing data processes and increase the quality of data for measures needed to evaluate study impact. PRONTO and QI interventions were then rolled out sequentially. While package components were implemented with fidelity, some implementation processes required contextual adaptation to allow alignment with national priorities and guidelines, and flexibility to optimize uptake. CONCLUSION: Lessons learned included the importance of synergy between interventions, the need for local leadership engagement, and the value of strengthening local systems and resources. Adaptations of individual elements of the package to suit the local context were important for effective implementation, and the TIDieR framework provides the guidance needed in detailed description to replicate such a complex intervention in other settings. Detailed documentation of the implementation process of a complex intervention with mutually synergistic components can help contextualize trial results and potential for scale-up. The trial is registered at ClinicalTrials.gov NCT03112018 , registered December 2016, posted April 2017.

Working with what you have: How the East Africa Preterm Birth Initiative used gestational age data from facility maternity registers.

OBJECTIVE: Preterm birth is the primary driver of neonatal mortality worldwide, but it is defined by gestational age (GA) which is challenging to accurately assess in low-resource settings. In a commitment to reducing preterm birth while reinforcing and strengthening facility data sources, the East Africa Preterm Birth Initiative (PTBi-EA) chose eligibility criteria that combined GA and birth weight. This analysis evaluated the quality of the GA data as recorded in maternity registers in PTBi-EA study facilities and the strength of the PTBi-EA eligibility criteria. METHODS: We conducted a retrospective analysis of maternity register data from March-September 2016. GA data from 23 study facilities in Migori, Kenya and the Busoga Region of Uganda were evaluated for completeness (variable present), consistency (recorded versus calculated GA), and plausibility (falling within the 3rd and 97th birth weight percentiles for GA of the INTERGROWTH-21st Newborn Birth Weight Standards). Preterm birth rates were calculated using: 1) recorded GA <37 weeks, 2) recorded GA <37 weeks, excluding implausible GAs, 3) birth weight <2500g, and 4) PTBi-EA eligibility criteria of <2500g and between 2500g and 3000g if the recorded GA is <37 weeks. RESULTS: In both countries, GA was the least recorded variable in the maternity register (77.6%). Recorded and calculated GA (Kenya only) were consistent in 29.5% of births. Implausible GAs accounted for 11.7% of births. The four preterm birth rates were 1) 14.5%, 2) 10.6%, 3) 9.6%, 4) 13.4%. CONCLUSIONS: Maternity register GA data presented quality concerns in PTBi-EA study sites. The PTBi-EA eligibility criteria of <2500g and between 2500g and 3000g if the recorded GA is <37 weeks accommodated these concerns by using both birth weight and GA, balancing issues of accuracy and completeness with practical applicability.

Effect of a quality improvement package for intrapartum and immediate newborn care on fresh stillbirth and neonatal mortality among preterm and low-birthweight babies in Kenya and Uganda: a cluster-randomised facility-based trial.

BACKGROUND: Although gains in newborn survival have been achieved in many low-income and middle-income countries, reductions in stillbirth and neonatal mortality have been slow. Prematurity complications are a major driver of stillbirth and neonatal mortality. We aimed to assess the effect of a quality improvement package for intrapartum and immediate newborn care on stillbirth and preterm neonatal survival in Kenya and Uganda, where evidence-based practices are often underutilised. METHODS: This unblinded cluster-randomised controlled trial was done in western Kenya and eastern Uganda at facilities that provide 24-h maternity care with at least 200 births per year. The study assessed outcomes of low-birthweight and preterm babies. Eligible facilities were pair-matched and randomly assigned (1:1) into either the intervention group or the control group. All facilities received maternity register data strengthening and a modified WHO Safe Childbirth Checklist; facilities in the intervention group additionally received provider mentoring using PRONTO simulation and team training as well as quality improvement collaboratives. Liveborn or fresh stillborn babies who weighed between 1000 g and 2500 g, or less than 3000 g with a recorded gestational age of less than 37 weeks, were included in the analysis. We abstracted data from maternity registers for maternal and birth outcomes. Follow-up was done by phone or in person to identify the status of the infant at 28 days. The primary outcome was fresh stillbirth and 28-day neonatal mortality. This trial is registered with ClinicalTrials.gov, NCT03112018. FINDINGS: Between Oct 1, 2016, and April 30, 2019, 20 facilities were randomly assigned to either the intervention group (n=10) or the control group (n=10). Among 5343 eligible babies in these facilities, we assessed outcomes of 2938 newborn and fresh stillborn babies (1447 in the intervention and 1491 in the control group). 347 (23%) of 1491 infants in the control group were stillborn or died in the neonatal period compared with 221 (15%) of 1447 infants in the intervention group at 28 days (odds ratio 0·66, 95% CI 0·54-0·81). No harm or adverse effects were found. INTERPRETATION: Fresh stillbirth and neonatal mortality among low-birthweight and preterm babies can be decreased using a package of interventions that reinforces evidence-based practices and invests in health system strengthening. FUNDING: Bill & Melinda Gates Foundation.

Agricultural and Finance Intervention Increased Dietary Intake and Weight of Children Living in HIV-Affected Households in Western Kenya.

We tested whether a multisectoral household agricultural and finance intervention increased the dietary intake and improved the nutritional status of HIV-affected children. Two hospitals in rural Kenya were randomly assigned to be either the intervention or the control arm. The intervention comprised a human-powered water pump, microfinance loan for farm commodities, and training in sustainable farming practices and financial management. In each arm, 100 children (0-59 mo of age) were enrolled from households with HIV-infected adults 18-49 y old. Children were assessed beginning in April 2012 and every 3 mo for 1 y for dietary intake and anthropometry. Children in the intervention arm had a larger increase in weight (ß: 0.025 kg/mo, P = 0.030), overall frequency of food consumption (ß: 0.610 times · wk-1 · mo-1, P = 0.048), and intakes of staples (ß: 0.222, P = 0.024), fruits and vegetables (ß: 0.425, P = 0.005), meat (ß: 0.074, P < 0.001), and fat (ß: 0.057, P = 0.041). Livelihood interventions have potential to improve the nutrition of HIV-affected children. This trial was registered at clinicaltrials.gov as NCT01548599.

Prevalence of parental bereavement among female sex workers (FSW) in Kibra, Kenya.

Female sex workers (FSW) residing in Kibra, Kenya experience elevated exposure to adverse events, yet the prevalence of parental bereavement is not well characterized. This cross-sectional pilot study on 301 FSWs residing in Kibra, Kenya found that 67.7% of these women were parentally bereaved. Significantly fewer parentally bereaved women reported historical use of condoms and emergency contraception compared to non-bereaved women, and older age of paternal bereavement was significantly associated with current contraceptive use. Prevalence rates of bereavement among this cohort are well over the national Kenyan average, and further research on the specific impact of bereavement is warranted.

Clinical cascades as a novel way to assess physical readiness of facilities for the care of small and sick neonates in Kenya and Uganda.

BACKGROUND: Globally, there were 2.7 million neonatal deaths in 2015. Significant mortality reduction could be achieved by improving care in low- and middle-income countries (LMIC), where the majority of deaths occur. Determining the physical readiness of facilities to identify and manage complications is an essential component of strategies to reduce neonatal mortality. METHODS: We developed clinical cascades for 6 common neonatal conditions then utilized these to assess 23 health facilities in Kenya and Uganda at 2 time-points in 2016 and 2017. We calculated changes in resource availability over time by facility using McNemar's test. We estimated mean readiness and loss of readiness for the 6 conditions and 3 stages of care (identification, treatment, monitoring-modifying treatment). We estimated overall mean readiness and readiness loss across all conditions and stages. Finally, we compared readiness of facilities with a newborn special care unit (NSCU) to those without using the two-sample test of proportions. RESULTS: The cascade model estimated mean readiness of 26.3-26.6% across the 3 stages for all conditions. Mean readiness ranged from 11.6% (respiratory distress-apnea) to 47.8% (essential newborn care) across both time-points. The model estimated overall mean readiness loss of 30.4-31.9%. There was mild to moderate variability in the timing of readiness loss, with the majority occurring in the identification stage. Overall mean readiness was higher among facilities with a NSCU (36.8%) compared to those without (20.0%). CONCLUSION: The cascade model provides a novel approach to quantitatively assess physical readiness for neonatal care. Among 23 facilities in Kenya and Uganda, we identified a consistent pattern of 30-32% readiness loss across cascades and stages. This aggregate measure could be used to monitor and compare readiness at the facility-, health system-, or national-level. Estimates of readiness and loss of readiness may help guide strategies to improve care, prioritize resources, and promote neonatal survival in LMICs.

Demographic, psychosocial and clinical factors associated with postpartum depression in Kenyan women.

BACKGROUND: Few longitudinal studies have examined associations between risk factors during pregnancy and mental health outcomes during the postpartum period. We used a cohort study design to estimate the prevalence, incidence and correlates of significant postpartum depressive symptoms in Kenyan women. METHODS: We recruited adult women residing in an urban, resource-poor setting and attending maternal and child health clinics in two public hospitals in Nairobi, Kenya. A translated Kiswahili Edinburgh Postpartum Depression Scale was used to screen for depressive symptoms at baseline assessment in the 3rd trimester and follow up assessment at 6-10 weeks postpartum. Information was collected on potential demographic, psychosocial and clinical risk variables. Potential risk factors for postpartum depression were evaluated using multivariate logistic regression analysis. RESULTS: Out of the 171 women who were followed up at 6-10 weeks postpartum, 18.7% (95% CI: 13.3-25.5) were found to have postpartum depression using an EPDS cut off of 10. In multivariate analyses, the odds of having postpartum depression was increased more than seven-fold in the presence of conflict with partner (OR = 7.52, 95% CI: 2.65-23.13). The association between antepartum and postpartum depression was quite strong but did not reach statistical significance (OR = 3.37, 95% CI: 0.98-11.64). CONCLUSIONS: The high prevalence of significant postnatal depressive symptoms among Kenyan women underscores the need for addressing this public health burden. Depression screening and psychosocial support interventions that address partner conflict resolution should be offered as part of maternal health care.

Strengthening intrapartum and immediate newborn care to reduce morbidity and mortality of preterm infants born in health facilities in Migori County, Kenya and Busoga Region, Uganda: a study protocol for a randomized controlled trial.

BACKGROUND: Preterm birth (birth before 37 weeks of gestation) and its complications are the leading contributors to neonatal and under-5 mortality. The majority of neonatal deaths in Kenya and Uganda occur during the intrapartum and immediate postnatal period. This paper describes our study protocol for implementing and evaluating a package of facility-based interventions to improve care during this critical window. METHODS/DESIGN: This is a pair-matched, cluster randomized controlled trial across 20 facilities in Eastern Uganda and Western Kenya. The intervention facilities receive four components: (1) strengthening of routine data collection and data use activities; (2) implementation of the WHO Safe Childbirth Checklist modified for preterm birth; (3) PRONTO simulation training and mentoring to strengthen intrapartum and immediate newborn care; and (4) support of quality improvement teams. The control facilities receive both data strengthening and introduction of the modified checklist. The primary outcome for this study is 28-day mortality rate among preterm infants. The denominator will include all live births and fresh stillbirths weighing greater than 1000 g and less than 2500 g; all live births and fresh stillbirths weighing between 2501 and 3000 g with a documented gestational age less than 37 weeks. DISCUSSION: The results of this study will inform interventions to improve personnel and facility capacity to respond to preterm labor and delivery, as well as care for the preterm infant. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03112018 . Registered on 13 April 2017.