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.

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.

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.

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.

Effect of early neonatal vitamin A supplementation on mortality during infancy in Ghana (Neovita): a randomised, double-blind, placebo-controlled trial.

BACKGROUND: Results of randomised controlled trials of newborn (age 1-3 days) vitamin A supplementation have been inconclusive. The WHO is coordinating three large randomised trials in Ghana, India, and Tanzania (Neovita trials). We present the findings of the Neovita trial in Ghana. METHODS: This study was a population-based, individually randomised, double-blind, placebo-controlled trial in the Brong Ahafo region of Ghana. The trial participants were infants aged at least 2 h, identified at home or facilities on the day of birth or in the next 2 days, able to feed orally, and likely to stay in the study area for at least 6 months. They were randomly assigned (ratio 1:1) to receive either one oral dose of vitamin A (50,000 IU) or placebo immediately after recruitment. The research team and parents of the infants were masked to treatment assignment. Follow-up home visits were undertaken every 4 weeks, when data were recorded for deaths, facility use, and care seeking. The primary outcome was post-supplementation mortality to 6 months of age. Analysis was by intention to treat. Potential adverse events were recorded at 1 and 3 days after supplementation. This trial is registered with the Australian New Zealand Clinical Trials Registry (ANZCTR)CTRN12610000582055. FINDINGS: We assessed 26,414 livebirths for eligibility between Aug 16, 2010, and Nov 7, 2011. We recruited 22,955 newborn infants, with 11,474 randomly assigned to receive vitamin A and 11,481 to receive placebo. Loss to follow-up was low with vital status at 6 months of age reported for 22,698 (98·9%) infants. We recorded 278 post-supplementation deaths to 6 months of age in the vitamin A group (mortality risk 24·5 in 1000 supplemented infants) and 248 deaths in the placebo group (mortality risk 21·8 per 1000 supplemented infants), relative risk (RR) 1·12 (95% CI 0·95-1·33; p=0·183) and risk difference (RD) 2·66 (95% CI -1·25 to 6·57; p=0·18). Adverse events within 3 days of supplementation did not differ by trial group. 122 infants died in the first 3 days after supplementation; 70 (0·6%) in the vitamin A and 52 (0·5%) in the placebo group (risk ratio [RR] 1·35, 95% CI 0·94-1·93, p=0·102). 53 infants were reported to have a bulging fontanelle; 32 (0·3%) in the vitamin A group and 21 (0·2%) in the placebo group (RR 1·53, 0·88-2·62, p=0·130). INTERPRETATION: The results of this trial do not support inclusion of newborn vitamin A supplementation as a child survival strategy in Ghana. FUNDING: Bill & Melinda Gates Foundation grant to the WHO.

Determinants of postnatal depression in rural ghana: findings from the don population based cohort study.

BACKGROUND: Risk factors for postnatal depression (PND), one of the most pervasive complications of child bearing, are poorly understood in Africa. A recent systematic review of 31 studies found that the strongest predictors are social and economic disadvantage and gender-based factors; only six of these studies were community based, and almost all were in South Asia. METHODS: Cohort study nested within 4 weekly surveillance of all women of reproductive age to identify pregnancies and collect data on births and deaths in the Kintampo Health Research Centre study area of Ghana. Women were screened for depression during pregnancy and after birth using the Patient Health Questionnaire to ascertain DSM-IV major or minor depression. Information was collected on determinants relating to the mother, birth, and baby, which were examined using logistic regression; effect sizes reported as relative risks with 95% confidence intervals. RESULTS: Thirteen thousand nine hundred and twenty nine women were screened both during pregnancy and after birth, of whom 13,360 (95.9%) had complete data on potential determinants. Two hundred and fifty five (3.8%, 95% CI: 3.5%, 4.1%) had PND. Antenatal depression (AND) was the strongest determinant accounting for 34.4% of PND cases. Other determinants were season of delivery, peripartum/postpartum complications, newborn ill health, still birth, or neonatal death. Common determinants were observed for onset and persistent depression. CONCLUSIONS: Although most AND resolves in this setting, more than a third of women with PND also had AND. Adverse birth- and baby-related outcomes are the other main determinants. We recommend that programs detect and treat depression during pregnancy and provide support to women with adverse birth outcomes.

Effect of the Newhints home-visits intervention on neonatal mortality rate and care practices in Ghana: a cluster randomised controlled trial.

BACKGROUND: In 2009, on the basis of promising evidence from trials in south Asia, WHO and UNICEF issued a joint statement about home visits as a strategy to improve newborn survival. In the Newhints trial, we aimed to test this home-visits strategy in sub-Saharan Africa by assessing the effect on all-cause neonatal mortality rate (NMR) and essential newborn-care practices. METHODS: The Newhints cluster randomised trial was undertaken in 98 zones in seven districts in the Brong Ahafo Region, Ghana. 49 zones were randomly assigned to the Newhints intervention and 49 to the control intervention by use of restricted randomisation with stratification to ensure comparability between interventions. Community-based surveillance volunteers (CBSVs) in Newhints zones were trained to identify pregnant women in their community and to make two home visits during pregnancy and three in the first week of life to promote essential newborn-care practices, weigh and assess babies for danger signs, and refer as necessary. Primary outcomes were NMR and coverage of key essential newborn-care practices. Analyses were by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00623337. FINDINGS: 16,168 (99%) of 16,329 deliveries between November, 2008, and December, 2009, were livebirths; the status at 1 month was known for 15,619 (97%) livebirths. 482 neonatal deaths were recorded. Coverage data were available from 6029 women in Newhints zones; of these 4358 (72%) reported having CBSV visits during pregnancy and 3815 (63%) reported having postnatal visits. This coverage increased substantially from June, 2009, after the introduction of new implementation strategies and reached almost 90% for pregnancy visits by the end of the trial and 75% for postnatal visits. The Newhints intervention significantly increased coverage of key essential newborn-care behaviours, except for four or more antenatal-care visits (5975 [76%] of 7859 vs 5988 [74%] of 8121, respectively; relative risk 1·02, 95% CI 0·96-1·09; p=0·52) and baby delivered in a facility (5373 [68%] vs 5539 [68%], respectively; 0·97, 0·81-1·14; p=0·69). The largest increase was for care-seeking, with 102 (77%) of 132 sick babies in Newhints zones taken to a hospital or clinic compared with 77 (55%) of 139 in control zones (1·43, 1·17-1·76; p=0·001). Increases were also noted in bednet use during pregnancy (5398 [69%] of 7859 vs 5135 [63%] of 8121, respectively; 1·12, 1·03-1·21; p=0·005), money saved for delivery or emergency (5730 [86%] of 6681 vs 5525 [80%] of 6941, respectively; 1·09, 1·05-1·12; p<0·0001), transport arranged in advance for facility (2496 [37%] vs 2061 [30%], respectively; 1·30, 1·12-1·49; p=0·0004), birth assistant for home delivery washed hands with soap (1853 [93%] of 1992 vs 1817 [87%] of 2091, respectively; 1·05, 1·02-1·09; p=0·001), initiation of breastfeeding in less than 1 h of birth (3743 [49%] of 7673 vs 3280 [41%] of 7921, respectively; 1·22, 1·07-1·40; p=0·004), skin to skin contact (3355 [44%] vs 1931 [24%], respectively; 2·30, 1·85-2·87; p=0·0002), first bath delayed for longer than 6 h (3131 [41%] vs 2269 [29%], respectively; 1·65, 1·27-2·13; p<0·0001), exclusive breastfeeding for 26-32 days (1217 [86%] of 1414 vs 1091 [80%] of 1371; 1·10, 1·04-1·16; p=0·001), and baby sleeping under bednet for 8-56 days (4548 [79%] of 5756 vs 4291 [73%] of 5846; 1·09, 1·03-1·15; p=0·002). There were 230 neonatal deaths in the Newhints zones compared with 252 in the control zones. The overall NMRs per 1000 livebirths were 29·8 and 31·9, respectively (0·92, 0·75-1·12; p=0·405). INTERPRETATION: The reduction in NMR with Newhints is consistent with the reductions achieved in three trials undertaken in programme settings in south Asia. Because there is no suggestion of any heterogeneity (p=0·850) between these trials and Newhints, the meta-analysis summary estimate of a reduction of 12% (95% CI 5-18) provides the best evidence for the likely effect of the home-visits strategy delivered within programmes in sub-Saharan Africa and in south Asia. Improvements in the quality of delivery and neonatal care in health facilities and development of innovative, effective strategies to increase coverage of home visits on the day of birth could lead to the achievement of more substantial reductions. FUNDING: WHO, Bill & Melinda Gates Foundation, and UK Department for International Development.

Socio-economic determinants and inequities in coverage and timeliness of early childhood immunisation in rural Ghana.

OBJECTIVES: To assess the extent of socio-economic inequity in coverage and timeliness of key childhood immunisations in Ghana. METHODS: Secondary analysis of vaccination card data collected from babies born between January 2008 and January 2010 who were registered in the surveillance system supporting the ObaapaVita and Newhints Trials was carried out. 20 251 babies had 6 weeks' follow-up, 16 652 had 26 weeks' follow-up, and 5568 had 1 year's follow-up. We performed a descriptive analysis of coverage and timeliness of vaccinations by indicators for urban/rural status, wealth and educational attainment. The association of coverage with socio-economic indicators was tested using a chi-square-test and the association with timeliness using Cox regression. RESULTS: Overall coverage at 1 year of age was high (>95%) for Bacillus Calmette-Guérin (BCG), all three pentavalent diphtheria-pertussis-tetanus-haemophilus influenzae B-hepatitis B (DPTHH) doses and all polio doses except polio at birth (63%). Coverage against measles and yellow fever was 85%. Median delay for BCG was 1.7 weeks. For polio at birth, the median delay was 5 days; all other vaccine doses had median delays of 2-4 weeks. We found substantial health inequity across all socio-economic indicators for all vaccines in terms of timeliness, but not coverage at 1 year. For example, for the last DPTHH dose, the proportion of children delayed more than 8 weeks were 27% for urban children and 31% for rural children (P < 0.001), 21% in the wealthiest quintile and 41% in the poorest quintile (P < 0.001), and 9% in the most educated group and 39% in the least educated group (P < 0.001). However, 1-year coverage of the same dose remained above 90% for all levels of all socio-economic indicators. CONCLUSIONS: Ghana has substantial health inequity across urban/rural, socio-economic and educational divides. While overall coverage was high, most vaccines suffered from poor timeliness. We suggest that countries achieving high coverage should include timeliness indicators in their surveillance systems.

Methods to measure potential spatial access to delivery care in low- and middle-income countries: a case study in rural Ghana.

BACKGROUND: Access to skilled attendance at childbirth is crucial to reduce maternal and newborn mortality. Several different measures of geographic access are used concurrently in public health research, with the assumption that sophisticated methods are generally better. Most of the evidence for this assumption comes from methodological comparisons in high-income countries. We compare different measures of travel impedance in a case study in Ghana's Brong Ahafo region to determine if straight-line distance can be an adequate proxy for access to delivery care in certain low- and middle-income country (LMIC) settings. METHODS: We created a geospatial database, mapping population location in both compounds and village centroids, service locations for all health facilities offering delivery care, land-cover and a detailed road network. Six different measures were used to calculate travel impedance to health facilities (straight-line distance, network distance, network travel time and raster travel time, the latter two both mechanized and non-mechanized). The measures were compared using Spearman rank correlation coefficients, absolute differences, and the percentage of the same facilities identified as closest. We used logistic regression with robust standard errors to model the association of the different measures with health facility use for delivery in 9,306 births. RESULTS: Non-mechanized measures were highly correlated with each other, and identified the same facilities as closest for approximately 80% of villages. Measures calculated from compounds identified the same closest facility as measures from village centroids for over 85% of births. For 90% of births, the aggregation error from using village centroids instead of compound locations was less than 35 minutes and less than 1.12 km. All non-mechanized measures showed an inverse association with facility use of similar magnitude, an approximately 67% reduction in odds of facility delivery per standard deviation increase in each measure (OR = 0.33). CONCLUSION: Different data models and population locations produced comparable results in our case study, thus demonstrating that straight-line distance can be reasonably used as a proxy for potential spatial access in certain LMIC settings. The cost of obtaining individually geocoded population location and sophisticated measures of travel impedance should be weighed against the gain in accuracy.

How changes in coverage affect equity in maternal and child health interventions in 35 Countdown to 2015 countries: an analysis of national surveys.

BACKGROUND: Achievement of global health goals will require assessment of progress not only nationally but also for population subgroups. We aimed to assess how the magnitude of socioeconomic inequalities in health changes in relation to different rates of national progress in coverage of interventions for the health of mothers and children. METHODS: We assessed coverage in low-income and middle-income countries for which two Demographic Health Surveys or Multiple Indicator Cluster Surveys were available. We calculated changes in overall coverage of skilled birth attendants, measles vaccination, and a composite coverage index, and examined coverage of a newly introduced intervention, use of insecticide-treated bednets by children. We stratified coverage data according to asset-based wealth quintiles, and calculated relative and absolute indices of inequality. We adjusted correlation analyses for time between surveys and baseline coverage levels. FINDINGS: We included 35 countries with surveys done an average of 9·1 years apart. Pro-rich inequalities were very prevalent. We noted increased coverage of skilled birth attendants, measles vaccination, and the composite index in most countries from the first to the second survey, while inequalities were reduced. Rapid changes in overall coverage were associated with improved equity. These findings were not due to a capping effect associated with limited scope for improvement in rich households. For use of insecticide-treated bednets, coverage was high for the richest households, but countries making rapid progress did almost as well in reaching the poorest groups. National increases in coverage were primarily driven by how rapidly coverage increased in the poorest quintiles. INTERPRETATION: Equity should be accounted for when planning the scaling up of interventions and assessing national progress. FUNDING: Bill & Melinda Gates Foundation; World Bank; Governments of Australia, Brazil, Canada, Norway, Sweden, and UK.

Effect of vitamin A supplementation on cause-specific mortality in women of reproductive age in Ghana: a secondary analysis from the ObaapaVitA trial.

OBJECTIVE: To determine the effect of weekly low-dose vitamin A supplementation on cause-specific mortality in women of reproductive age in Ghana. METHODS: A cluster-randomized, triple-blind, placebo-controlled trial was conducted in seven districts of the Brong Ahafo region of Ghana. Women aged 15-45 years who were capable of giving informed consent and intended to live in the trial area for at least 3 months were enrolled and randomly assigned, according to their cluster of residence, to receive oral vitamin A (7500 µg) or placebo once a week. Randomization was blocked, with two clusters in each fieldwork area allocated to vitamin A and two to placebo. Every 4 weeks, fieldworkers distributed capsules and collected data during home visits. Verbal autopsies were conducted by field supervisors and reviewed by physicians, who assigned a cause of death. Cause-specific mortality rates in both arms were compared by means of random-effects Poisson regression models to allow for the cluster randomization. Analysis was by intention-to-treat, based on cluster of residence, with women eligible for inclusion once they had consistently received the supplement or placebo capsules for 6 months. FINDINGS: The analysis was based on 581 870 woman-years and 2624 deaths. Cause-specific mortality rates were found to be similar in the two study arms. CONCLUSION: Low-dose vitamin A supplements administered weekly are of no benefit in programmes to reduce mortality in women of childbearing age.

Résumé OBJECTIF: Déterminer l'effet de la supplémentation hebdomadaire en vitamine A à faible dose sur la mortalité spécifique des femmes en âge de procréer au Ghana. MÉTHODES: Une étude randomisée, en triple aveugle, contrôlée contre placebo, a été menée dans sept districts de la région de Brong Ahafo au Ghana. Les femmes âgées de 15 à 45 ans, capables de donner un consentement éclairé et amenées à vivre dans la région de l'étude pendant au moins 3 mois, ont été incluses et il a été déterminé qu'elles recevraient une fois par semaine, au hasard selon leur groupe de résidence, de la vitamine A par voie orale (7 500 µg) ou un placebo. La randomisation a été fixée par deux groupes dans chaque zone recevant la vitamine A et deux groupes recevant le placebo. Toutes les 4 semaines, les agents de terrain distribuaient les capsules et recueillaient les données lors de visites à domicile. Des autopsies orales ont été effectuées par les superviseurs sur le terrain et analysées par des médecins, qui déterminaient la cause du décès. Les taux de mortalité spécifique dans les deux groupes ont été comparés à l'aide d'une régression de Poisson pour valider la randomisation des groupes. L'analyse, basée sur l'intention de traiter, était basée sur le groupe de résidence, pour des femmes éligibles à l'étude ayant reçu les capsules de supplément ou de placebo de manière constante pendant 6 mois. RÉSULTATS: L'analyse s'est basée sur 581 870 années-femmes et 2624 décès. Les taux de mortalité spécifique ont été jugés similaires dans les deux groupes de l'étude. CONCLUSION: Les suppléments en vitamine A à faible dose administrés hebdomadairement ne sont d'aucune utilité dans les programmes visant à réduire la mortalité chez les femmes en âge de procréer.

Resumen OBJETIVO: Determinar el efecto de la administración semanal de dosis bajas de vitamina A en la mortalidad por causas específicas de mujeres en edad reproductiva en Ghana. MÉTODOS: Se realizó un ensayo aleatorio de grupos, triple ciego y controlado por placebo en siete distritos de la región de Brong Ahafo, en Ghana. Se inscribieron mujeres de entre 15 y 45 años de edad capaces de dar su consentimiento informado y que tuvieran previsto vivir en el área de ensayo durante al menos tres meses. De acuerdo con el grupo de residencia al que habían sido asignadas de forma aleatoria, recibieron semanalmente vitamina A por vía oral (7500 µg) o placebo. La distribución aleatoria se limitó en cada área de trabajo a dos grupos a los que se les administró vitamina A y dos grupos que recibieron placebo. Cada cuatro semanas, los investigadores de campo distribuyeron cápsulas y recogieron datos durante las visitas a los hogares. Las autopsias verbales realizadas por los supervisores de campo fueron revisadas por médicos, quienes determinaron la causa de la muerte. Se compararon las tasas de mortalidad por causas específicas de ambos brazos mediante los modelos de regresión de Poisson con efectos aleatorios para facilitar la distribución aleatoria de los grupos. El análisis fue por intención de tratar, según el grupo de residencia y con mujeres que cumplieron las condiciones de inclusión una vez habían recibido de forma constante las cápsulas de suplemento o placebo durante seis meses. RESULTADOS: El análisis se basó en 581 870 años-mujer y 2624 muertes. Se descubrió que las tasas de mortalidad por causas específicas fueron similares en ambos brazos del estudio. CONCLUSIÓN: Los suplementos de dosis bajas de vitamina A administrados semanalmente no presentan ninguna ventaja en los programas para reducir la mortalidad de las mujeres en edad reproductiva.

Promoting skin-to-skin care for low birthweight babies: findings from the Ghana Newhints cluster-randomised trial.

OBJECTIVE: To evaluate whether the Newhints home visits intervention increased the adoption of skin-to-skin care (SSC), in particular, among low birthweight (LBW) (<2.5 kg) babies. METHODS: A cluster-randomised trial, with 49 Newhints zones and 49 control zones, was conducted in seven districts in the Brong Ahafo Region, Ghana. It included all live births between November 2008 and December 2009. In Newhints zones, existing community-based surveillance volunteers were trained to conduct home visits during which they weighed babies and counselled mothers of LBW babies on SSC. Performance of any SSC and SSC for more than 2 h was evaluated. RESULTS: Of 15,615 live births, 68.5% had recorded birthweights; 10.1% were LBW. Any SSC was 19.4% higher among babies in Newhints vs. control zones (risk ratio, RR: 1.81; 95% confidence interval, CI: 1.40-2.35). Performance of SSC for more than 2 h was, however, low, at only 7.5%, although more than double compared with control zones (RR: 2.72; 95% CI: 1.80-4.10). LBW babies visited and weighed by a volunteer were more likely to receive SSC (PA ny  = 0.005; P >  2 h  = 0.021), greater for LBW babies, particularly for more than 2 h of SSC (Pinteraction  = 0.050). CONCLUSION: Newhints successfully promoted the uptake of SSC in rural Ghana. Although findings are encouraging, promotion in rural community settings in sub-Saharan Africa is challenging. Lessons learned can help shape SSC promotion in efforts to increase adoption and save newborn lives.

Mobile health (mHealth) approaches and lessons for increased performance and retention of community health workers in low- and middle-income countries: a review.

BACKGROUND: Mobile health (mHealth) describes the use of portable electronic devices with software applications to provide health services and manage patient information. With approximately 5 billion mobile phone users globally, opportunities for mobile technologies to play a formal role in health services, particularly in low- and middle-income countries, are increasingly being recognized. mHealth can also support the performance of health care workers by the dissemination of clinical updates, learning materials, and reminders, particularly in underserved rural locations in low- and middle-income countries where community health workers deliver integrated community case management to children sick with diarrhea, pneumonia, and malaria. OBJECTIVE: Our aim was to conduct a thematic review of how mHealth projects have approached the intersection of cellular technology and public health in low- and middle-income countries and identify the promising practices and experiences learned, as well as novel and innovative approaches of how mHealth can support community health workers. METHODS: In this review, 6 themes of mHealth initiatives were examined using information from peer-reviewed journals, websites, and key reports. Primary mHealth technologies reviewed included mobile phones, personal digital assistants (PDAs) and smartphones, patient monitoring devices, and mobile telemedicine devices. We examined how these tools could be used for education and awareness, data access, and for strengthening health information systems. We also considered how mHealth may support patient monitoring, clinical decision making, and tracking of drugs and supplies. Lessons from mHealth trials and studies were summarized, focusing on low- and middle-income countries and community health workers. RESULTS: The review revealed that there are very few formal outcome evaluations of mHealth in low-income countries. Although there is vast documentation of project process evaluations, there are few studies demonstrating an impact on clinical outcomes. There is also a lack of mHealth applications and services operating at scale in low- and middle-income countries. The most commonly documented use of mHealth was 1-way text-message and phone reminders to encourage follow-up appointments, healthy behaviors, and data gathering. Innovative mHealth applications for community health workers include the use of mobile phones as job aides, clinical decision support tools, and for data submission and instant feedback on performance. CONCLUSIONS: With partnerships forming between governments, technologists, non-governmental organizations, academia, and industry, there is great potential to improve health services delivery by using mHealth in low- and middle-income countries. As with many other health improvement projects, a key challenge is moving mHealth approaches from pilot projects to national scalable programs while properly engaging health workers and communities in the process. By harnessing the increasing presence of mobile phones among diverse populations, there is promising evidence to suggest that mHealth can be used to deliver increased and enhanced health care services to individuals and communities, while helping to strengthen health systems.

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.

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.

Economic evaluation of a task-shifting intervention for common mental disorders in India.

OBJECTIVE: To carry out an economic evaluation of a task-shifting intervention for the treatment of depressive and anxiety disorders in primary-care settings in Goa, India. METHODS: Cost-utility and cost-effectiveness analyses based on generalized linear models were performed within a trial set in 24 public and private primary-care facilities. Subjects were randomly assigned to an intervention or a control arm. Eligible subjects in the intervention arm were given psycho-education, case management, interpersonal psychotherapy and/or antidepressants by lay health workers. Subjects in the control arm were treated by physicians. The use of health-care resources, the disability of each subject and degree of psychiatric morbidity, as measured by the Revised Clinical Interview Schedule, were determined at 2, 6 and 12 months. FINDINGS: Complete data, from all three follow-ups, were collected from 1243 (75.4%) and 938 (81.7%) of the subjects enrolled in the study facilities from the public and private sectors, respectively. Within the public facilities, subjects in the intervention arm showed greater improvement in all the health outcomes investigated than those in the control arm. Time costs were also significantly lower in the intervention arm than in the control arm, whereas health system costs in the two arms were similar. Within the private facilities, however, the effectiveness and costs recorded in the two arms were similar. CONCLUSION: Within public primary-care facilities in Goa, the use of lay health workers in the care of subjects with common mental disorders was not only cost-effective but also cost-saving.

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).

Effectiveness of an intervention led by lay health counsellors for depressive and anxiety disorders in primary care in Goa, India (MANAS): a cluster randomised controlled trial.

BACKGROUND: Depression and anxiety disorders are common mental disorders worldwide. The MANAS trial aimed to test the effectiveness of an intervention led by lay health counsellors in primary care settings to improve outcomes of people with these disorders. METHODS: In this cluster randomised trial, primary care facilities in Goa, India, were assigned (1:1) by computer-generated randomised sequence to intervention or control (enhanced usual care) groups. All adults who screened positive for common mental disorders were eligible. The collaborative stepped-care intervention offered case management and psychosocial interventions, provided by a trained lay health counsellor, supplemented by antidepressant drugs by the primary care physician and supervision by a mental health specialist. The research assessor was masked. The primary outcome was recovery from common mental disorders as defined by the International Statistical Classification of Diseases and Related Health Problems-10th revision (ICD-10) at 6 months. This study is registered with ClinicalTrials.gov, number NCT00446407. FINDINGS: 24 study clusters, with an equal proportion of public and private facilities, were randomised equally between groups. 1160 of 1360 (85%) patients in the intervention group and 1269 of 1436 (88%) in the control group completed the outcome assessment. Patients with ICD-10-confirmed common mental disorders in the intervention group were more likely to have recovered at 6 months than were those in the control group (n=620 [65·0%] vs 553 [52·9%]; risk ratio 1·22, 95% CI 1·00-1·47; risk difference=12·1%, 95% CI 1·6%-22·5%). The intervention had strong evidence of an effect in public facility attenders (369 [65·9%] vs 267 [42·5%], risk ratio 1·55, 95% CI 1·02-2·35) but no evidence for an effect in private facility attenders (251 [64·1%] vs 286 [65·9%], risk ratio 0·95, 0·74-1·22). There were three deaths and four suicide attempts in the collaborative stepped-care group and six deaths and six suicide attempts in the enhanced usual care group. None of the deaths were from suicide. INTERPRETATION: A trained lay counsellor-led collaborative care intervention can lead to an improvement in recovery from CMD among patients attending public primary care facilities. FUNDING: The Wellcome Trust.

Effect of vitamin A supplementation in women of reproductive age on maternal survival in Ghana (ObaapaVitA): a cluster-randomised, placebo-controlled trial.

BACKGROUND: A previous trial in Nepal showed that supplementation with vitamin A or its precursor (betacarotene) in women of reproductive age reduced pregnancy-related mortality by 44% (95% CI 16-63). We assessed the effect of vitamin A supplementation in women in Ghana. METHODS: ObaapaVitA was a cluster-randomised, double-blind, placebo-controlled trial undertaken in seven districts in Brong Ahafo Region in Ghana. The trial area was divided into 1086 small geographical clusters of compounds with fieldwork areas consisting of four contiguous clusters. All women of reproductive age (15-45 years) who gave informed consent and who planned to remain in the area for at least 3 months were recruited. Participants were randomly assigned by cluster of residence to receive a vitamin A supplement (25 000 IU retinol equivalents) or placebo capsule orally once every week. Randomisation was blocked and based on an independent, computer-generated list of numbers, with two clusters in each fieldwork area allocated to vitamin A supplementation and two to placebo. Capsules were distributed during home visits undertaken every 4 weeks, when data were gathered on pregnancies, births, and deaths. Primary outcomes were pregnancy-related mortality and all-cause female mortality. Cause of death was established by verbal post mortems. Analysis was by intention to treat (ITT) with random-effects regression to account for the cluster-randomised design. Adverse events were synonymous with the trial outcomes. This trial is registered with ClinicalTrials.gov, number NCT00211341. FINDINGS: 544 clusters (104 484 women) were randomly assigned to vitamin A supplementation and 542 clusters (103 297 women) were assigned to placebo. The main reason for participant drop out was migration out of the study area. In the ITT analysis, there were 39 601 pregnancies and 138 pregnancy-related deaths in the vitamin A supplementation group (348 deaths per 100 000 pregnancies) compared with 39 234 pregnancies and 148 pregnancy-related deaths in the placebo group (377 per 100 000 pregnancies); adjusted odds ratio 0.92, 95% CI 0.73-1.17; p=0.51. 1326 women died in 292 560 woman-years in the vitamin A supplementation group (453 deaths per 100 000 years) compared with 1298 deaths in 289 310 woman-years in the placebo group (449 per 100 000 years); adjusted rate ratio 1.01, 0.93-1.09; p=0.85. INTERPRETATION: The body of evidence, although limited, does not support inclusion of vitamin A supplementation for women in either safe motherhood or child survival strategies. FUNDING: UK Department for International Development, and USAID.