Parental experiences of the impacts of Covid-19 on the care of young children; qualitative interview findings from the Nairobi Early Childcare in Slums (NECS) project.

INTRODUCTION: The Covid-19 pandemic, and societal attempts to control it, have touched almost every aspect of people's lives around the world, albeit in unequal ways. In particular, there is considerable concern about the way that stringent 'lockdowns', as implemented in Kenya and many other countries, affected young children, especially those living in informal settlements. However, to date, there has been little research attempting to unpack and understand how the pandemic has impacted on the care of young children. METHODS: In-depth telephone interviews were conducted with 21 parents/carers of children aged under five years living in three Nairobi slums between May and September 2021 exploring the ways in which Covid-19, and policies to control the pandemic, impacted on their household and the care of their child/children. RESULTS: The impacts of Covid-19 control measures on the care of children have been widely felt, deep and multiple. The impact of economic hardship has been significant, reportedly undermining food security and access to services including healthcare and childcare. Respondents reported an associated increase in domestic and community violence. Many people relied on help from others; this was most commonly reported to be in the form of variable levels of flexibility from landlords and help from other community members. No direct harms from Covid-19 disease were reported by respondents. CONCLUSION: The impacts of Covid-19 control measures on the care of young children in informal settlements have been indirect but dramatic. Given the breadth and depth of these reported impacts, and the particular vulnerability of young children, deeper consideration ought to inform decisions about approaches to implementation of stringent disease control measures in future. In addition, these findings imply a need for both short- and long-term policy responses to ameliorate the impacts described.

Effect of the SPRING home visits intervention on early child development and growth in rural India and Pakistan: parallel cluster randomised controlled trials.

Introduction: Almost 250 million children fail to achieve their full growth or developmental potential, trapping them in a cycle of continuing disadvantage. Strong evidence exists that parent-focussed face to face interventions can improve developmental outcomes; the challenge is delivering these on a wide scale. SPRING (Sustainable Programme Incorporating Nutrition and Games) aimed to address this by developing a feasible affordable programme of monthly home visits by community-based workers (CWs) and testing two different delivery models at scale in a programmatic setting. In Pakistan, SPRING was embedded into existing monthly home visits of Lady Health Workers (LHWs). In India, it was delivered by a civil society/non-governmental organisation (CSO/NGO) that trained a new cadre of CWs. Methods: The SPRING interventions were evaluated through parallel cluster randomised trials. In Pakistan, clusters were 20 Union Councils (UCs), and in India, the catchment areas of 24 health sub-centres. Trial participants were mother-baby dyads of live born babies recruited through surveillance systems of 2 monthly home visits. Primary outcomes were BSID-III composite scores for psychomotor, cognitive and language development plus height for age z-score (HAZ), assessed at 18 months of age. Analyses were by intention to treat. Results: 1,443 children in India were assessed at age 18 months and 1,016 in Pakistan. There was no impact in either setting on ECD outcomes or growth. The percentage of children in the SPRING intervention group who were receiving diets at 12 months of age that met the WHO minimum acceptable criteria was 35% higher in India (95% CI: 4-75%, p = 0.023) and 45% higher in Pakistan (95% CI: 15-83%, p = 0.002) compared to children in the control groups. Discussion: The lack of impact is explained by shortcomings in implementation factors. Important lessons were learnt. Integrating additional tasks into the already overloaded workload of CWs is unlikely to be successful without additional resources and re-organisation of their goals to include the new tasks. The NGO model is the most likely for scale-up as few countries have established infrastructures like the LHW programme. It will require careful attention to the establishment of strong administrative and management systems to support its implementation.

Parental experiences of childcare in an informal urban settlement: qualitative interview findings from the Nairobi Early Childcare in Slums (NECS) project.

OBJECTIVES: To gain an in-depth understanding of parent/carers' perspectives on, and decision-making about, early childhood care in general, and paid childcare specifically, in informal settlements in Nairobi. DESIGN: In-depth telephone interviews, conducted using a topic guide, were analysed through a combination of deductive and inductive thematic analysis and regular reflexivity meetings. We explored parents' childcare needs and experiences over time, and their perspectives on the provision of paid childcare in the slums. SETTING: Three informal settlements or slums in Nairobi: Kibera; Kawangware; and Mukuru-Viwandani. PARTICIPANTS: A purposively selected sample of 21 parental and non-parental carers of children aged under 5 years who were currently living in three Nairobi slums, including men and women, and users and non-users of paid childcare. RESULTS: Childcare is complex, with a plurality of approaches being used. Common strategies include family member provided care (often but not exclusively by mothers, at home or at a place of work), paid childcare and informal or ad hoc arrangements with neighbours. Childcare decision-making in these settings is constrained by economics and the broader context of living in the slum. Paid childcare is frequently used, but is widely understood to be lacking in quality, especially for the poorest. Quality of childcare is understood to comprise a combination of structural factors, such as the physical space, play and learning resources and processes such as interactions between the care provider and children or parents. CONCLUSIONS: These findings suggest a need, and opportunity, to improve early childhood care in slums. Understanding parental perspectives on both the deficiencies and valued features of childcare is likely to be vital to informing efforts to improve childcare in these settings.

Non-specific effects of BCG and DTP vaccination on infant mortality: An analysis of birth cohorts in Ghana and Tanzania.

BACKGROUND: Vaccines may induce non-specific effects on survival and health outcomes, in addition to protection against targeted pathogens or disease. Observational evidence suggests that infant Baccillus Calmette-Guérin (BCG) vaccination may provide non-specific survival benefits, while diphtheria-tetanus-pertussis (DTP) vaccination may increase the risk of mortality. Non-specific vaccine effects have been hypothesized to modify the effect of neonatal vitamin A supplementation (NVAS) on mortality. METHODS: 22,955 newborns in Ghana and 31,999 newborns in Tanzania were enrolled in two parallel, randomized, double-blind, placebo-controlled trials of neonatal vitamin A supplementation from 2010 to 2014 and followed until 1-year of age. Cox proportional hazard models were used to estimate associations of BCG and DTP vaccination with infant survival. RESULTS: BCG vaccination was associated with a decreased risk of infant mortality after controlling for confounders in both countries (Ghana adjusted hazard ratio (aHR): 0.51, 95% CI: 0.38-0.68; Tanzania aHR: 0.08, 95% CI: 0.07-0.10). Receiving a DTP vaccination was associated with a decreased risk of death (Ghana aHR: 0.39, 95% CI: 0.26-0.59; Tanzania aHR: 0.19, 95% CI: 0.16-0.22). There was no evidence of interaction between BCG or DTP vaccination status and infant sex or NVAS. CONCLUSION: We demonstrated that BCG and DTP vaccination were associated with decreased risk of infant mortality in Ghana and Tanzania with no evidence of interaction between DTP or BCG vaccination, NVAS, and infant sex. Our study supports global recommendations on BCG and DTP vaccination and programmatic efforts to ensure all children have access to timely vaccination. CLINICAL TRIALS REGISTRATION: Ghana (Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12610000582055) and Tanzania (ANZCTR: ACTRN12610000636055).

Associations Between Maternal Depression, Antidepressant Use During Pregnancy, and Adverse Pregnancy Outcomes: An Individual Participant Data Meta-analysis.

OBJECTIVE: To evaluate the associations of depressive symptoms and antidepressant use during pregnancy with the risks of preterm birth, low birth weight, small for gestational age (SGA), and low Apgar scores. DATA SOURCES: MEDLINE, EMBASE, ClinicalTrials.gov, and PsycINFO up to June 2016. METHODS OF STUDY SELECTION: Data were sought from studies examining associations of depression, depressive symptoms, or use of antidepressants during pregnancy with gestational age, birth weight, SGA, or Apgar scores. Authors shared the raw data of their studies for incorporation into this individual participant data meta-analysis. TABULATION, INTEGRATION, AND RESULTS: We performed one-stage random-effects meta-analyses to estimate odds ratios (ORs) with 95% CIs. The 215 eligible articles resulted in 402,375 women derived from 27 study databases. Increased risks were observed for preterm birth among women with a clinical diagnosis of depression during pregnancy irrespective of antidepressant use (OR 1.6, 95% CI 1.2-2.1) and among women with depression who did not use antidepressants (OR 2.2, 95% CI 1.7-3.0), as well as for low Apgar scores in the former (OR 1.5, 95% CI 1.3-1.7), but not the latter group. Selective serotonin reuptake inhibitor (SSRI) use was associated with preterm birth among women who used antidepressants with or without restriction to women with depressive symptoms or a diagnosis of depression (OR 1.6, 95% CI 1.0-2.5 and OR 1.9, 95% CI 1.2-2.8, respectively), as well as with low Apgar scores among women in the latter group (OR 1.7, 95% CI 1.1-2.8). CONCLUSION: Depressive symptoms or a clinical diagnosis of depression during pregnancy are associated with preterm birth and low Apgar scores, even without exposure to antidepressants. However, SSRIs may be independently associated with preterm birth and low Apgar scores. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42016035711.

Direct maternal morbidity and the risk of pregnancy-related deaths, stillbirths, and neonatal deaths in South Asia and sub-Saharan Africa: A population-based prospective cohort study in 8 countries.

BACKGROUND: Maternal morbidity occurs several times more frequently than mortality, yet data on morbidity burden and its effect on maternal, foetal, and newborn outcomes are limited in low- and middle-income countries. We aimed to generate prospective, reliable population-based data on the burden of major direct maternal morbidities in the antenatal, intrapartum, and postnatal periods and its association with maternal, foetal, and neonatal death in South Asia and sub-Saharan Africa. METHODS AND FINDINGS: This is a prospective cohort study, conducted in 9 research sites in 8 countries of South Asia and sub-Saharan Africa. We conducted population-based surveillance of women of reproductive age (15 to 49 years) to identify pregnancies. Pregnant women who gave consent were include in the study and followed up to birth and 42 days postpartum from 2012 to 2015. We used standard operating procedures, data collection tools, and training to harmonise study implementation across sites. Three home visits during pregnancy and 2 home visits after birth were conducted to collect maternal morbidity information and maternal, foetal, and newborn outcomes. We measured blood pressure and proteinuria to define hypertensive disorders of pregnancy and woman's self-report to identify obstetric haemorrhage, pregnancy-related infection, and prolonged or obstructed labour. Enrolled women whose pregnancy lasted at least 28 weeks or those who died during pregnancy were included in the analysis. We used meta-analysis to combine site-specific estimates of burden, and regression analysis combining all data from all sites to examine associations between the maternal morbidities and adverse outcomes. Among approximately 735,000 women of reproductive age in the study population, and 133,238 pregnancies during the study period, only 1.6% refused consent. Of these, 114,927 pregnancies had morbidity data collected at least once in both antenatal and in postnatal period, and 114,050 of them were included in the analysis. Overall, 32.7% of included pregnancies had at least one major direct maternal morbidity; South Asia had almost double the burden compared to sub-Saharan Africa (43.9%, 95% CI 27.8% to 60.0% in South Asia; 23.7%, 95% CI 19.8% to 27.6% in sub-Saharan Africa). Antepartum haemorrhage was reported in 2.2% (95% CI 1.5% to 2.9%) pregnancies and severe postpartum in 1.7% (95% CI 1.2% to 2.2%) pregnancies. Preeclampsia or eclampsia was reported in 1.4% (95% CI 0.9% to 2.0%) pregnancies, and gestational hypertension alone was reported in 7.4% (95% CI 4.6% to 10.1%) pregnancies. Prolonged or obstructed labour was reported in about 11.1% (95% CI 5.4% to 16.8%) pregnancies. Clinical features of late third trimester antepartum infection were present in 9.1% (95% CI 5.6% to 12.6%) pregnancies and those of postpartum infection in 8.6% (95% CI 4.4% to 12.8%) pregnancies. There were 187 pregnancy-related deaths per 100,000 births, 27 stillbirths per 1,000 births, and 28 neonatal deaths per 1,000 live births with variation by country and region. Direct maternal morbidities were associated with each of these outcomes. CONCLUSIONS: Our findings imply that health programmes in sub-Saharan Africa and South Asia must intensify their efforts to identify and treat maternal morbidities, which affected about one-third of all pregnancies and to prevent associated maternal and neonatal deaths and stillbirths. TRIAL REGISTRATION: The study is not a clinical trial.

Who actually cares for children in slums? Why we need to think, and do, more about paid childcare in urbanizing sub-Saharan Africa.

The early years are critical and inform the developmental trajectory of children. This is justifiably attracting growing policy attention. Much of this attention is focused on interventions and policies directed at parents, especially mothers. Yet emerging evidence suggests that increasing numbers of children in rapidly urbanizing low- and middle-income countries are now spending much of their day with other formal and informal childcare providers, including largely unregulated paid childcare providers. This paper summarizes the limited literature about the use of such paid childcare in low- and middle-income countries in sub-Saharan Africa, before considering possible reasons behind the lack of research evidence. Finally, key research gaps and their implications for public health practice are explored, with reference to the ongoing British Academy funded Nairobi Early Childcare in Slums research programme in Nairobi, Kenya. We argue that improving childcare may be an under-explored strategy to help some of the world's most disadvantaged children in the most important period of their lives, and that interventions in this largely informal market should be built on a rigorous research base. This article is part of the theme issue 'Multidisciplinary perspectives on social support and maternal-child health'.

Using the Mothers Object Relations Scale for early childhood development research in rural India: Findings from the Early Life Stress Sub-study of the SPRING Cluster Randomised Controlled Trial (SPRING-ELS).

Background: The World Health Organization and others promote responsive caregiving to support all children to thrive, particularly in low- and middle-income countries. The 14-item Mother's Object Relations Scales - Short Form (MORS-SF) may be of use in research and public health programmes because of its basis in attachment theory and ability to capture parental feelings towards their child. Methods: We culturally adapted the MORS-SF for use with mothers in the SPRING home visits trial when their infants were 12 months old. The same dyads were assessed using the HOME inventory concurrently and Bayley Scales of Infant Development III (BSID-III) at 18 months of age. Mixed effects linear regression was used to examine associations between MORS-SF (explanatory variable) and HOME-IT, and the cognitive, language and motor domains of BSID-III (outcome variables). Results: 1273 dyads completed all assessments. For the motor and language BSID-III scales and for HOME-IT there were strong and positive associations with the MORS-SF warmth sub-scale, and strong and negative associations with the invasion sub-scale. Important but less strong associations were seen with the BSID-III cognitive scale. Evidence of interaction suggested that both are individually important for child development. Conclusions: This is the first time MORS-SF has been used in India where optimising responsive caregiving is of importance in supporting all children to reach their potential. It is also the first time that the tool has been used in relation to child development. MORS-SF could be a valuable addition to evaluation in early childhood development.

Nairobi Early Childcare in Slums (NECS) Study Protocol: a mixed-methods exploration of paid early childcare in Mukuru slum, Nairobi.

INTRODUCTION: The early years are critical. Early nurturing care can lay the foundation for human capital accumulation with lifelong benefits. Conversely, early adversity undermines brain development, learning and future earning.Slums are among the most challenging places to spend those early years and are difficult places to care for a child. Shifting family and work structures mean that paid, largely informal, childcare seems to be becoming the 'new normal' for many preschool children growing up in rapidly urbanising Africa. However, little is known about the quality of this childcare. AIMS: To build a rigorous understanding what childcare strategies are used and why in a typical Nairobi slum, with a particular focus on provision and quality of paid childcare. Through this, to inform evaluation of quality and design and implementation of interventions with the potential to reach some of the most vulnerable children at the most critical time in the life course. METHODS AND ANALYSIS: Mixed methods will be employed. Qualitative research (in-depth interviews and focus group discussions) with parents/carers will explore need for and decision-making about childcare. A household survey (of 480 households) will estimate the use of different childcare strategies by parents/carers and associated parent/carer characteristics. Subsequently, childcare providers will be mapped and surveyed to document and assess quality of current paid childcare. Semistructured observations will augment self-reported quality with observable characteristics/practices. Finally, in-depth interviews and focus group discussions with childcare providers will explore their behaviours and motivations. Qualitative data will be analysed through thematic analysis and triangulation across methods. Quantitative and spatial data will be analysed through epidemiological methods (random effects regression modelling and spatial statistics). ETHICS AND DISSEMINATION: Ethical approval has been granted in the UK and Kenya. Findings will be disseminated through journal publications, community and government stakeholder workshops, policy briefs and social media content.

Testing the assumptions of an indicator of unmet need for obstetric surgery in Ghana: A cross-sectional study of linked hospital and population-based delivery data.

BACKGROUND: The Unmet Obstetric Need (UON) indicator has been widely used to estimate unmet need for life-saving surgery at birth; however, its assumptions have not been verified. The objective of this study was to test two UON assumptions: (a) Absolute maternal indications (AMIs) require surgery for survival and (b) 1%-2% of deliveries develop AMIs, implying that rates of surgeries for AMIs below this threshold indicate excess mortality from these complications. METHODS: We used linked hospital and population-based data in central Ghana. Among hospital deliveries, we calculated the percentage of deliveries with AMIs who received surgery, and mortality among AMIs who did not. At the population level, we assessed whether the percentage of deliveries with surgeries for AMIs was inversely associated with mortality from these complications, stratified by education. RESULTS: A total of 380 of 387 (98%) hospital deliveries with recorded AMIs received surgery; an additional eight women with no AMI diagnosis died of AMI-related causes. Among the 50 148 deliveries in the population, surgeries for AMIs increased from 0.6% among women with no education to 1.9% among women with post-secondary education (P < .001). However, there was no association between AMI-related mortality and education (P = .546). Estimated AMI prevalence was 0.84% (95% CI: 0.76%-0.92%), below the assumed 1% minimum threshold. DISCUSSION: Obstetric providers consider AMIs absolute indications for surgery. However, low rates of surgeries for AMIs among less educated women were not associated with higher mortality. The UON indicator should be used with caution in estimating the unmet need for life-saving obstetric surgery; innovative approaches are needed to identify unmet need in the context of rising cesarean rates.

Impact of adversity on early childhood growth & development in rural India: Findings from the early life stress sub-study of the SPRING cluster randomised controlled trial (SPRING-ELS).

INTRODUCTION: Early childhood development is key to achieving the Sustainable Development Goals and can be negatively influenced by many different adversities including violence in the home, neglect, abuse and parental ill-health. We set out to quantify the extent to which multiple adversities are associated with impaired early childhood growth & development. METHODS: This was a substudy of the SPRING cluster randomised controlled trial covering the whole population of 120 villages of rural India. We assessed all children born from 18 June 2015 for adversities in the first year of life and summed these to make a total cumulative adversity score, and four subscale scores. We assessed the association of each of these with weight-for-age z-score, length-for-age z-score, and the motor, cognitive and language developmental scales of the Bayley Scales of Infant Development III assessed at 18 months. RESULTS: We enrolled 1726 children soon after birth and assessed 1273 of these at both 12 and 18 months of age. There were consistent and strongly negative relationships between all measures of childhood adversity and all five child growth & development outcome measures at 18 months of age. For the Bayley motor scale, each additional adversity was associated with a 1.1 point decrease (95%CI -1.3, -0.9); for the cognitive scales this was 0.8 points (95%CI -1.0, -0.6); and for language this was 1.4 points (95%CI -1.9, -1.1). Similarly for growth, each additional adversity was associated with a -0.09 change in weight-for-age z-score (-0.11, -0.06) and -0.12 change in height-for-age z-score (-0.14, -0.09). DISCUSSION: Our results are the first from a large population-based study in a low/middle-income country to show that each increase in adversity in multiple domains increases risk to child growth and development at a very early age. There is an urgent need to act to improve these outcomes for young children in LMICs and these findings suggest that Early Childhood programmes should prioritise early childhood adversity because of its impact on developmental inequities from the very start.

Sustained effectiveness and cost-effectiveness of the Healthy Activity Programme, a brief psychological treatment for depression delivered by lay counsellors in primary care: 12-month follow-up of a randomised controlled trial.

BACKGROUND: The Healthy Activity Programme (HAP), a brief behavioural intervention delivered by lay counsellors, enhanced remission over 3 months among primary care attendees with depression in peri-urban and rural settings in India. We evaluated the sustainability of the effects after treatment termination, the cost-effectiveness of HAP over 12 months, and the effects of the hypothesized mediator of activation on clinical outcomes. METHODS AND FINDINGS: Primary care attendees aged 18-65 years screened with moderately severe to severe depression on the Patient Health Questionnaire 9 (PHQ-9) were randomised to either HAP plus enhanced usual care (EUC) (n = 247) or EUC alone (n = 248), of whom 95% completed assessments at 3 months, and 91% at 12 months. Primary outcomes were severity on the Beck Depression Inventory-II (BDI-II) and remission on the PHQ-9. HAP participants maintained the gains they showed at the end of treatment through the 12-month follow-up (difference in mean BDI-II score between 3 and 12 months = -0.34; 95% CI -2.37, 1.69; p = 0.74), with lower symptom severity scores than participants who received EUC alone (adjusted mean difference in BDI-II score = -4.45; 95% CI -7.26, -1.63; p = 0.002) and higher rates of remission (adjusted prevalence ratio [aPR] = 1.36; 95% CI 1.15, 1.61; p < 0.009). They also fared better on most secondary outcomes, including recovery (aPR = 1.98; 95% CI 1.29, 3.03; p = 0.002), any response over time (aPR = 1.45; 95% CI 1.27, 1.66; p < 0.001), higher likelihood of reporting a minimal clinically important difference (aPR = 1.42; 95% CI 1.17, 1.71; p < 0.001), and lower likelihood of reporting suicidal behaviour (aPR = 0.71; 95% CI 0.51, 1.01; p = 0.06). HAP plus EUC also had a marginal effect on WHO Disability Assessment Schedule score at 12 months (aPR = -1.58; 95% CI -3.33, 0.17; p = 0.08); other outcomes (days unable to work, intimate partner violence toward females) did not statistically significantly differ between the two arms. Economic analyses indicated that HAP plus EUC was dominant over EUC alone, with lower costs and better outcomes; uncertainty analysis showed that from this health system perspective there was a 95% chance of HAP being cost-effective, given a willingness to pay threshold of Intl$16,060-equivalent to GDP per capita in Goa-per quality-adjusted life year gained. Patient-reported behavioural activation level at 3 months mediated the effect of the HAP intervention on the 12-month depression score (ß = -2.62; 95% CI -3.28, -1.97; p < 0.001). Serious adverse events were infrequent, and prevalence was similar by arm. We were unable to assess possible episodes of remission and relapse that may have occurred between our outcome assessment time points of 3 and 12 months after randomisation. We did not account for or evaluate the effect of mediators other than behavioural activation. CONCLUSIONS: HAP's superiority over EUC at the end of treatment was largely stable over time and was mediated by patient activation. HAP provides better outcomes at lower costs from a perspective covering publicly funded healthcare services and productivity impacts on patients and their families. TRIAL REGISTRATION: ISRCTN registry ISRCTN95149997.

Comprehensive review of the evidence regarding the effectiveness of community-based primary health care in improving maternal, neonatal and child health: 8. summary and recommendations of the Expert Panel.

BACKGROUND: The contributions that community-based primary health care (CBPHC) and engaging with communities as valued partners can make to the improvement of maternal, neonatal and child health (MNCH) is not widely appreciated. This unfortunate reality is one of the reasons why so few priority countries failed to achieve the health-related Millennium Development Goals by 2015. This article provides a summary of a series of articles about the effectiveness of CBPHC in improving MNCH and offers recommendations from an Expert Panel for strengthening CBPHC that were formulated in 2008 and have been updated on the basis of more recent evidence. METHODS: An Expert Panel convened to guide the review of the effectiveness of community-based primary health care (CBPHC). The Expert Panel met in 2008 in New York City with senior UNICEF staff. In 2016, following the completion of the review, the Panel considered the review's findings and made recommendations. The review consisted of an analysis of 661 unique reports, including 583 peer-reviewed journal articles, 12 books/monographs, 4 book chapters, and 72 reports from the gray literature. The analysis consisted of 700 assessments since 39 were analyzed twice (once for an assessment of improvements in neonatal and/or child health and once for an assessment in maternal health). RESULTS: The Expert Panel recommends that CBPHC should be a priority for strengthening health systems, accelerating progress in achieving universal health coverage, and ending preventable child and maternal deaths. The Panel also recommends that expenditures for CBPHC be monitored against expenditures for primary health care facilities and hospitals and reflect the importance of CBPHC for averting mortality. Governments, government health programs, and NGOs should develop health systems that respect and value communities as full partners and work collaboratively with them in building and strengthening CBPHC programs - through engagement with planning, implementation (including the full use of community-level workers), and evaluation. CBPHC programs need to reach every community and household in order to achieve universal coverage of key evidence-based interventions that can be implemented in the community outside of health facilities and assure that those most in need are reached. CONCLUSIONS: Stronger CBPHC programs that foster community engagement/empowerment with the implementation of evidence-based interventions will be essential for achieving universal coverage of health services by 2030 (as called for by the Sustainable Development Goals recently adopted by the United Nations), ending preventable child and maternal deaths by 2030 (as called for by the World Health Organization, UNICEF, and many countries around the world), and eventually achieving Health for All as envisioned at the International Conference on Primary Health Care in 1978. Stronger CBPHC programs can also create entry points and synergies for expanding the coverage of family planning services as well as for accelerating progress in the detection and treatment of HIV/AIDS, tuberculosis, malaria, hypertension, and other chronic diseases. Continued strengthening of CBPHC programs based on rigorous ongoing operations research and evaluation will be required, and this evidence will be needed to guide national and international policies and programs.

The Healthy Activity Program (HAP), a lay counsellor-delivered brief psychological treatment for severe depression, in primary care in India: a randomised controlled trial.

BACKGROUND: Although structured psychological treatments are recommended as first-line interventions for depression, only a small fraction of people globally receive these treatments because of poor access in routine primary care. We assessed the effectiveness and cost-effectiveness of a brief psychological treatment (Healthy Activity Program [HAP]) for delivery by lay counsellors to patients with moderately severe to severe depression in primary health-care settings. METHODS: In this randomised controlled trial, we recruited participants aged 18-65 years scoring more than 14 on the Patient Health Questionnaire 9 (PHQ-9) indicating moderately severe to severe depression from ten primary health centres in Goa, India. Pregnant women or patients who needed urgent medical attention or were unable to communicate clearly were not eligible. Participants were randomly allocated (1:1) to enhanced usual care (EUC) alone or EUC combined with HAP in randomly sized blocks (block size four to six [two to four for men]), stratified by primary health centre and sex, and allocation was concealed with use of sequential numbered opaque envelopes. Physicians providing EUC were masked. Primary outcomes were depression symptom severity on the Beck Depression Inventory version II and remission from depression (PHQ-9 score of <10) at 3 months in the intention-to-treat population, assessed by masked field researchers. Secondary outcomes were disability, days unable to work, behavioural activation, suicidal thoughts or attempts, intimate partner violence, and resource use and costs of illness. We assessed serious adverse events in the per-protocol population. This trial is registered with the ISRCTN registry, number ISRCTN95149997. FINDINGS: Between Oct 28, 2013, and July 29, 2015, we enrolled and randomly allocated 495 participants (247 [50%] to the EUC plus HAP group [two of whom were subsequently excluded because of protocol violations] and 248 [50%] to the EUC alone group), of whom 466 (95%) completed the 3 month primary outcome assessment (230 [49%] in the EUC plus HAP group and 236 [51%] in the EUC alone group). Participants in the EUC plus HAP group had significantly lower symptom severity (Beck Depression Inventory version II in EUC plus HAP group 19·99 [SD 15·70] vs 27·52 [13·26] in EUC alone group; adjusted mean difference -7·57 [95% CI -10·27 to -4·86]; p<0·0001) and higher remission (147 [64%] of 230 had a PHQ-9 score of <10 in the HAP plus EUC group vs 91 [39%] of 236 in the EUC alone group; adjusted prevalence ratio 1·61 [1·34-1·93]) than did those in the EUC alone group. EUC plus HAP showed better results than did EUC alone for the secondary outcomes of disability (adjusted mean difference -2·73 [-4·39 to -1·06]; p=0·001), days out of work (-2·29 [-3·84 to -0·73]; p=0·004), intimate partner physical violence in women (0·53 [0·29-0·96]; p=0·04), behavioural activation (2·17 [1·34-3·00]; p<0·0001), and suicidal thoughts or attempts (0·61 [0·45-0·83]; p=0·001). The incremental cost per quality-adjusted life-year gained was $9333 (95% CI 3862-28 169; 2015 international dollars), with an 87% chance of being cost-effective in the study setting. Serious adverse events were infrequent and similar between groups (nine [4%] in the EUC plus HAP group vs ten [4%] in the EUC alone group; p=1·00). INTERPRETATION: HAP delivered by lay counsellors plus EUC was better than EUC alone was for patients with moderately severe to severe depression in routine primary care in Goa, India. HAP was readily accepted by this previously untreated population and was cost-effective in this setting. HAP could be a key strategy to reduce the treatment gap for depressive disorders, the leading mental health disorder worldwide. FUNDING: Wellcome Trust.

The influence of distance and quality of care on place of delivery in rural Ghana.

Facility delivery is an important aspect of the strategy to reduce maternal and newborn mortality. Geographic access to care is a strong determinant of facility delivery, but few studies have simultaneously considered the influence of facility quality, with inconsistent findings. In rural Brong Ahafo region in Ghana, we combined surveillance data on 11,274 deliveries with quality of care data from all 64 delivery facilities in the study area. We used multivariable multilevel logistic regression to assess the influence of distance and several quality dimensions on place of delivery. Women lived a median of 3.3 km from the closest delivery facility, and 58% delivered in a facility. The probability of facility delivery ranged from 68% among women living 1 km from their closest facility to 22% among those living 25 km away, adjusted for confounders. Measured quality of care at the closest facility was not associated with use, except that facility delivery was lower when the closest facility provided substandard care on the EmOC dimension. These results do not imply, however, that we should increase geographic accessibility of care without improving facility quality. While this may be successful in increasing facility deliveries, such care cannot be expected to reduce maternal and neonatal mortality.

Increasing access to care for sick newborns: evidence from the Ghana Newhints cluster-randomised controlled trial.

OBJECTIVES: To evaluate the impact of Newhints community-based surveillance volunteer (CBSV) assessments and referrals on access to care for sick newborns and on existing inequities in access. DESIGN: We evaluated a prospective cohort nested within the Newhints cluster-randomised controlled trial. SETTING: Community-based intervention involving more than 750 000, predominantly rural, population in seven contiguous districts in the Brong-Ahafo Region, Ghana. PARTICIPANTS: Participants were recently delivered women (from more than 120 000 women under surveillance) and their 16 168 liveborn babies. Qualitative in-depth interviews with referral narratives (IDIs) were conducted with 92 mothers, CBSVs and health facility front-desk and maternity/paediatrics ward staff. INTERVENTIONS: Newhints trained and effectively supervised 475 CBSVs (existing within the Ghana Health Service) in 49 of 98 supervisory zones (clusters) to assess and refer newborns with any of the 10-key-danger signs to health facilities within the first week after birth; promote independent care seeking for sick newborns and problem-solve around barriers between November 2008 and December 2009. PRIMARY OUTCOMES: The main evaluation outcomes were rates of compliance with referrals and independent care seeking for newborn illnesses. RESULTS: Of 4006 sampled, 2795 (69.8%) recently delivered women received CBSV assessment visits and 279 (10.0%) newborns were referred with danger signs. Compliance with referrals was unprecedentedly high (86.0%) with women in the poorest quintile (Q1) complying better than the least poor (Q5):87.5%(Q1) vs 69.7%(Q5); p=0.038. Three-quarters went to hospitals; 18% were admitted and 58% received outpatient treatment. Some (24%) mothers were turned away at facilities and follow-on IDIs showed that some of these untreated babies subsequently died. Independent care seeking for severe newborn illness increased from 55.4% in control to 77.3% in Newhints zones, especially among Q1 where care seeking almost doubled (95.0% vs 48.6%; RR=1.94 (1.32, 2.84); p=0.001). Rates were the highest among rural residents but urban residents complied quicker. CONCLUSIONS: Home visits are feasible and a potentially pro-poor approach to link sick newborns to facilities. Its effectiveness in improving survival hinges on matched improvement in facility quality of care. TRIAL REGISTRATION NUMBER: NCT00623337.

Cost and cost-effectiveness of newborn home visits: findings from the Newhints cluster-randomised controlled trial in rural Ghana.

BACKGROUND: Every year, 2·9 million newborn babies die worldwide. A meta-analysis of four cluster-randomised controlled trials estimated that home visits by trained community members in programme settings in Ghana and south Asia reduced neonatal mortality by 12% (95% CI 5-18). We aimed to estimate the costs and cost-effectiveness of newborn home visits in a programme setting. METHODS: We prospectively collected detailed cost data alongside the Newhints trial, which tested the effect of a home-visits intervention in seven districts in rural Ghana and showed a reduction of 8% (95% CI -12 to 25%) in neonatal mortality. The intervention consisted of a package of home visits to pregnant women and their babies in the first week of life by community-based surveillance volunteers. We calculated incremental cost-effectiveness ratios (ICERs) with Monte Carlo simulation and one-way sensitivity analyses and characterised uncertainty with cost-effectiveness planes and cost-effectiveness acceptability curves. We then modelled the potential cost-effectiveness for baseline neonatal mortality rates of 20-60 deaths per 1000 livebirths with use of a meta-analysis of effectiveness estimates. FINDINGS: In the 49 zones randomly allocated to receive the Newhints intervention, a mean of 407 (SD 18) community-based surveillance volunteers undertook home visits for 7848 pregnant women who gave birth to 7786 live babies in 2009. Annual economic cost of implementation was US$203 998, or $0·53 per person. In the base-case analysis, the Newhints intervention cost a mean of $10 343 (95% CI 2963 to -7674) per newborn life saved, or $352 (95% CI 104 to -268) per discounted life-year saved, and had a 72% chance of being highly cost effective with respect to Ghana's 2009 gross domestic product per person. Key determinants of cost-effectiveness were the discount rate, protective effectiveness, baseline neonatal mortality rate, and implementation costs. In the scenarios modelled with the meta-analysis results, the ICER increased from $127 per life-year saved at a neonatal mortality rate of 60 deaths per 1000 livebirths, to $379 per life-year saved at a rate of 20 deaths per 1000 livebirths. The strategy had at least a 99% probability of being highly cost effective for lower-middle-income countries in all neonatal mortality rate scenarios modelled, and at least a 95% probability of being highly cost effective for low-income countries at neonatal mortality rates of 30 or more deaths per 1000 livebirths. INTERPRETATION: Our findings show that the seemingly modest mortality reductions achieved by a newborn home-visit strategy might in fact be cost effective. In Ghana, such strategies are also likely to be affordable. Our findings support recommendations from WHO and UNICEF that low-income and middle-income countries implement newborn home visits. FUNDING: The Bill & Melinda Gates Foundation, UK Department for International Development, WHO.

Association between probable postnatal depression and increased infant mortality and morbidity: findings from the DON population-based cohort study in rural Ghana.

OBJECTIVES: To assess the impact of probable depression in the immediate postnatal period on subsequent infant mortality and morbidity. DESIGN: Cohort study nested within 4 weekly surveillance of all women of reproductive age to identify pregnancies and collect data on births and deaths. SETTING: Rural/periurban communities within the Kintampo Health Research Centre study area of the Brong-Ahafo Region of Ghana. PARTICIPANTS: 16,560 mothers who had a live singleton birth reported between 24 March 2008 and 11 July 2009, who were screened for probable postnatal depression (pPND) between 4 and 12 weeks post partum (some of whom had also had depression assessed at pregnancy), and whose infants survived to this point. PRIMARY/SECONDARY OUTCOME MEASURES: All-cause early infant mortality expressed per 1000 infant-months of follow-up from the time of postnatal assessment to 6 months of age. The secondary outcomes were (1) all-cause infant mortality from the time of postnatal assessment to 12 months of age and (2) reported infant morbidity from the time of the postnatal assessment to 12 months of age. RESULTS: 130 infant deaths were recorded and singletons were followed for 67,457.4 infant-months from the time of their mothers' postnatal depression assessment. pPND was associated with an almost threefold increased risk of mortality up to 6 months (adjusted rate ratio (RR), 2.86 (1.58 to 5.19); p=0.001). The RR up to 12 months was 1.88 (1.09 to 3.24; p=0.023). pPND was also associated with increased risk of infant morbidity. CONCLUSIONS: There is new evidence for the association between maternal pPND and infant mortality in low-income and middle-income countries. Implementation of the WHO's Mental Health Gap Action Programme (mhGAP) to scale up packages of care integrated with maternal health is encouraged as an important adjunct to child survival efforts.

An epidemiological study of urban and rural children in Pakistan: examining the relationship between delayed psychomotor development, low birth weight and postnatal growth failure.

BACKGROUND: Low birth weight is known to be associated with postnatal growth failure. It is not yet established that both conditions are determinants of psychomotor development. The study investigated whether or not low birth weight leads to delayed psychomotor development of a child, and whether it can be mitigated by adequate postnatal growth. METHODS: A cross-sectional study was conducted in 2002 in 15 rural and 11 urban communities of Sindh province, Pakistan. Assessment of 1234 children less than 3 years of age included Bayley's Scale of Infant Development II, socioeconomic questionnaire and anthropometry; WHO standards were used to calculate z-scores of height-for-age, weight-for-height and weight-for-age. The underlying study hypotheses were tested through multiple regression modelling. RESULTS: Out of 1219 children, 283 (23.2%) had delayed psychomotor development and 639 (52.4%) were undernourished according to the composite index of anthropometric failure. Strong negative associations with the psychomotor development index were detected between stunting and being underweight, with a larger magnitude of effect for stunting (p<0.001). The strong relationship persisted even when the analysis was restricted to non-malnourished children. The psychomotor index increased by 2.07 points with every unit increase in height-for-age z-score. CONCLUSIONS: The relationship between low birth weight and psychomotor development appears to be mediated largely by postnatal growth and nutritional status. This association suggests that among undernourished children there is significant likelihood of a group that is developmentally delayed. It is important to emphasize developmental needs in programmes that target underprivileged children.