The effect of supervision on community health workers' effectiveness with households in rural South Africa: A cluster randomized controlled trial.

BACKGROUND: Community health workers (CHWs) can supplement professional medical providers, especially in rural settings where resources are particularly scarce. Yet, outcomes of studies evaluating CHWs effectiveness have been highly variable and lack impact when scaled nationally. This study examines if child and maternal outcomes are better when existing government CHWs, who are perinatal home visitors, receive ongoing enhanced supervision and monitoring, compared to standard care. METHODS AND FINDINGS: A cluster randomized controlled effectiveness trial was conducted comparing outcomes over 2 years when different supervision and support are provided. Primary health clinics were randomized by clinic to receive monitoring and supervision from either (1) existing supervisors (Standard Care (SC); n = 4 clinics, 23 CHWs, 392 mothers); or (2) supervisors from a nongovernmental organization that provided enhanced monitoring and supervision (Accountable Care [AC]; n = 4 clinic areas, 20 CHWs, 423 mothers). Assessments were conducted during pregnancy and at 3, 6, 15, and 24 months post-birth with high retention rates (76% to 86%). The primary outcome was the number of statistically significant intervention effects among 13 outcomes of interest; this approach allowed us to evaluate the intervention holistically while accounting for correlation among the 13 outcomes and considering multiple comparisons. The observed benefits were not statistically significant and did not show the AC's efficacy over the SC. Only the antiretroviral (ARV) adherence effect met the significance threshold established a priori (SC mean 2.3, AC mean 2.9, p < 0.025; 95% CI = [0.157, 1.576]). However, for 11 of the 13 outcomes, we observed an improvement in the AC compared to the SC. While the observed outcomes were not statistically significant, benefits were observed for 4 outcomes: increasing breastfeeding for 6 months, reducing malnutrition, increasing ARV adherence, and improving developmental milestones. The major study limitation was utilizing existing CHWs and being limited to a sample of 8 clinics. There were no major study-related adverse events. CONCLUSIONS: Supervision and monitoring were insufficient to improve CHWs' impact on maternal and child outcomes. Alternative strategies for staff recruitment and narrowing the intervention outcomes to the specific local community problems are needed for consistently high impact. TRIAL REGISTRATION: Clinicaltrials.gov, NCT02957799.

Umbilical cord milking in nonvigorous infants: a cluster-randomized crossover trial.

BACKGROUND: Delayed cord clamping and umbilical cord milking provide placental transfusion to vigorous newborns. Delayed cord clamping in nonvigorous newborns may not be provided owing to a perceived need for immediate resuscitation. Umbilical cord milking is an alternative, as it can be performed more quickly than delayed cord clamping and may confer similar benefits. OBJECTIVE: We hypothesized that umbilical cord milking would reduce admission to the neonatal intensive care unit compared with early cord clamping in nonvigorous newborns born between 35 and 42 weeks' gestation. STUDY DESIGN: This was a pragmatic cluster-randomized crossover trial of infants born at 35 to 42 weeks' gestation in 10 medical centers in 3 countries between January 2019 and May 2021. The centers were randomized to umbilical cord milking or early cord clamping for approximately 1 year and then crossed over for an additional year or until the required number of consented subjects was reached. Waiver of consent as obtained in all centers to implement the intervention. Infants were eligible if nonvigorous at birth (poor tone, pale color, or lack of breathing in the first 15 seconds after birth) and were assigned to umbilical cord milking or early cord clamping according to their birth hospital randomization assignment. The baseline characteristics and outcomes were collected following deferred informed consent. The primary outcome was admission to the neonatal intensive care unit for predefined criteria. The main safety outcome was hypoxic-ischemic encephalopathy. Data were analyzed by the intention-to-treat concept. RESULTS: Among 16,234 screened newborns, 1780 were eligible (905 umbilical cord milking, 875 early cord clamping), and 1730 had primary outcome data for analysis (97% of eligible; 872 umbilical cord milking, 858 early cord clamping) either via informed consent (606 umbilical cord milking, 601 early cord clamping) or waiver of informed consent (266 umbilical cord milking, 257 early cord clamping). The difference in the frequency of neonatal intensive care unit admission using predefined criteria between the umbilical cord milking (23%) and early cord clamping (28%) groups did not reach statistical significance (modeled odds ratio, 0.69; 95% confidence interval, 0.41-1.14). Umbilical cord milking was associated with predefined secondary outcomes, including higher hemoglobin (modeled mean difference between umbilical cord milking and early cord clamping groups 0.68 g/dL, 95% confidence interval, 0.31-1.05), lower odds of abnormal 1-minute Apgar scores (Apgar ≤3, 30% vs 34%, crude odds ratio, 0.72; 95% confidence interval, 0.56-0.92); cardiorespiratory support at delivery (61% vs 71%, modeled odds ratio, 0.57; 95% confidence interval, 0.33-0.99), and therapeutic hypothermia (3% vs 4%, crude odds ratio, 0.57; 95% confidence interval, 0.33-0.99). Moderate-to-severe hypoxic-ischemic encephalopathy was significantly less common with umbilical cord milking (1% vs 3%, crude odds ratio, 0.48; 95% confidence interval, 0.24-0.96). No significant differences were observed for normal saline bolus, phototherapy, abnormal 5-minute Apgar scores (Apgar ≤6, 15.7% vs 18.8%, crude odds ratio, 0.81; 95% confidence interval, 0.62-1.06), or a serious adverse event composite of death before discharge. CONCLUSION: Among nonvigorous infants born at 35 to 42 weeks' gestation, umbilical cord milking did not reduce neonatal intensive care unit admission for predefined criteria. However, infants in the umbilical cord milking arm had higher hemoglobin, received less delivery room cardiorespiratory support, had a lower incidence of moderate-to-severe hypoxic-ischemic encephalopathy, and received less therapeutic hypothermia. These data may provide the first randomized controlled trial evidence that umbilical cord milking in nonvigorous infants is feasible, safe and, superior to early cord clamping.

Termination of pregnancy for fetal anomaly: a systematic review of the healthcare experiences and needs of parents.

BACKGROUND: Improved technology and advances in clinical testing have resulted in increased detection rates of congenital anomalies during pregnancy, resulting in more parents being confronted with the possibility of terminating a pregnancy for this reason. There is a large body of research on the psychological experience and impact of terminating a pregnancy for fetal anomaly. However, there remains a lack of evidence on the holistic healthcare experience of parents in this situation. To develop a comprehensive understanding of the healthcare experiences and needs of parents, this systematic review sought to summarise and appraise the literature on parents' experiences following a termination of pregnancy for fetal anomaly. REVIEW QUESTION: What are the healthcare experiences and needs of parents who undergo a termination of pregnancy following an antenatal diagnosis of a fetal anomaly? METHODS: A systematic review was undertaken with searches completed across six multi-disciplinary electronic databases (Medline, Embase, PsycINFO, CINAHL, Web of Science, and Cochrane). Eligible articles were qualitative, quantitative or mixed methods studies, published between January 2010 and August 2021, reporting the results of primary data on the healthcare experiences or healthcare needs in relation to termination of pregnancy for fetal anomaly for either, or both parents. Findings were synthesised using Thematic Analysis. RESULTS: A total of 30 articles were selected for inclusion in this review of which 24 were qualitative, five quantitative and one mixed-methods. Five overarching themes emerged from the synthesis of findings: (1) Contextual impact on access to and perception of care, (2) Organisation of care, (3) Information to inform decision making, (4) Compassionate care, and (5) Partner experience. CONCLUSION: Compassionate healthcare professionals who provide non-judgemental and sensitive care can impact positively on parents' satisfaction with the care they receive. A well organised and co-ordinated healthcare system is needed to provide an effective and high-quality service. TRIAL REGISTRATION: PROSPERO registration number: CRD42020175970 .

World Health Organization and knowledge translation in maternal, newborn, child and adolescent health and nutrition.

The World Health Organization (WHO) has a mandate to promote maternal and child health and welfare through support to governments in the form of technical assistance, standards, epidemiological and statistical services, promoting teaching and training of healthcare professionals and providing direct aid in emergencies. The Strategic and Technical Advisory Group of Experts (STAGE) for maternal, newborn, child and adolescent health and nutrition (MNCAHN) was established in 2020 to advise the Director-General of WHO on issues relating to MNCAHN. STAGE comprises individuals from multiple low-income and middle-income and high-income countries, has representatives from many professional disciplines and with diverse experience and interests.Progress in MNCAHN requires improvements in quality of services, equity of access and the evolution of services as technical guidance, community needs and epidemiology changes. Knowledge translation of WHO guidance and other guidelines is an important part of this. Countries need effective and responsive structures for adaptation and implementation of evidence-based interventions, strategies to improve guideline uptake, education and training and mechanisms to monitor quality and safety. This paper summarises STAGE's recommendations on how to improve knowledge translation in MNCAHN. They include support for national and regional technical advisory groups and subnational committees that coordinate maternal and child health; support for national plans for MNCAHN and their implementation and monitoring; the production of a small number of consolidated MNCAHN guidelines to promote integrated and holistic care; education and quality improvement strategies to support guidelines uptake; monitoring of gaps in knowledge translation and operational research in MNCAHN.

Improving early childhood care and development, HIV-testing, treatment and support, and nutrition in Mokhotlong, Lesotho: study protocol for a cluster randomized controlled trial.

BACKGROUND: Since 1990, the lives of 48 million children under the age of 5 years have been saved because of increased investments in reducing child mortality. However, despite these unprecedented gains, 250 million children younger than 5 years in low- and middle-income countries (LMIC) cannot meet their developmental potential due to poverty, poor health and nutrition, and lack of necessary stimulation and care. Lesotho has high levels of poverty, HIV, and malnutrition, all of which affect child development outcomes. There is a unique opportunity to address these complex issues through the widespread network of informal preschools in rural villages in the country, which provide a setting for inclusive, integrated Early Childhood Care and Development (ECCD) and HIV and nutrition interventions. METHODS: We are conducting a cluster randomised controlled trial in Mokhotlong district, Lesotho, to evaluate a newly developed community-based intervention program to integrate HIV-testing and treatment services, ECCD, and nutrition education for caregivers with children aged 1-5 years living in rural villages. Caregivers and their children are randomly assigned by village to intervention or control condition. We select, train, and supervise community health workers recruited to implement the intervention, which consists of nine group-based sessions with caregivers and children over 12 weeks (eight weekly sessions, and a ninth top-up session 1 month later), followed by a locally hosted community health outreach day event. Group-based sessions focus on using early dialogic book-sharing to promote cognitive development and caregiver-child interaction, health-related messages, including motivation for HIV-testing and treatment uptake for young children, and locally appropriate nutrition education. All children aged 1-5 years and their primary caregivers living in study villages are eligible for participation. Caregivers and their children will be interviewed and assessed at baseline, after completion of the intervention, and 12 months post intervention. DISCUSSION: This study provides a unique opportunity to assess the potential of an integrated early childhood development intervention to prevent or mitigate developmental delays in children living in a context of extreme poverty and high HIV rates in rural Lesotho. This paper presents the intervention content and research protocol for the study. TRIAL REGISTRATION: The Mphatlalatsane: Early Morning Star trial is registered on the International Standard Randomized Controlled Trial Number database, registration number ISRCTN16654287 ; the trial was registered on 3 July 2015.

District mental healthcare plans for five low- and middle-income countries: commonalities, variations and evidence gaps.

BACKGROUND: Little is known about the service and system interventions required for successful integration of mental healthcare into primary care across diverse low- and middle-income countries (LMIC). AIMS: To examine the commonalities, variations and evidence gaps in district-level mental healthcare plans (MHCPs) developed in Ethiopia, India, Nepal, Uganda and South Africa for the PRogramme for Improving Mental health carE (PRIME). METHOD: A comparative analysis of MHCP components and human resource requirements. RESULTS: A core set of MHCP goals was seen across all countries. The MHCPs components to achieve those goals varied, with most similarity in countries within the same resource bracket (low income v. middle income). Human resources for advanced psychosocial interventions were only available in the existing health service in the best-resourced PRIME country. CONCLUSIONS: Application of a standardised methodological approach to MHCP across five LMIC allowed identification of core and site-specific interventions needed for implementation.

Integration of mental health into primary care in low- and middle-income countries: the PRIME mental healthcare plans.

This supplement outlines the development and piloting of district mental healthcare plans from five low- and middle-income countries, together with the methods for their design, evaluation and costing. In this editorial we consider the challenges that these programmes face, highlight their innovations and draw conclusions.

Leveraging paraprofessionals and family strengths to improve coverage and penetration of nutrition and early child development services.

Children need to be protected in intergenerational networks, with parents who have positive mood, resources to feed their children, and skills to promote early childhood development (ECD). Globally, more than 200 million children are raised annually without these resources. This article reviews the potential contributions of increasing coverage and penetration of services for these children, challenges to achieving penetration of services in high-risk families, opportunities created by bundling multiple services within one provider, potential leveraging of paraprofessionals to deliver care, and mobilizing communities to support children in households at high risk for negative outcomes. We end with a number of suggestions for how to ensure the equitable scale-up of integrated ECD and nutrition services that take into account current global priorities, as well as coverage and penetration of services.

An effectiveness study of an integrated, community-based package for maternal, newborn, child and HIV care in South Africa: study protocol for a randomized controlled trial.

BACKGROUND: Progress towards MDG4 in South Africa will depend largely on scaling up effective prevention against mother to child transmission (PMTCT) of HIV and also addressing neonatal mortality. This imperative drives increasing focus on the neonatal period and particularly on the development and testing of appropriate models of sustainable, community-based care in South Africa in order to reach the poor. A number of key implementation gaps affecting progress have been identified. Implementation gaps for HIV prevention in neonates; implementation gaps for neonatal care especially home postnatal care; and implementation gaps for maternal mental health support. We have developed and are evaluating and costing an integrated and scaleable home visit package delivered by community health workers targeting pregnant and postnatal women and their newborns to provide essential maternal/newborn care as well as interventions for Prevention of Mother to Child Transmission (PMTCT) of HIV. METHODS: The trial is a cluster randomized controlled trial that is being implemented in Umlazi which is a peri-urban settlement with a total population of 1 million close to Durban in KwaZulu Natal, South Africa. The trial consists of 30 randomized clusters (15 in each arm). A baseline survey established the homogeneity of clusters and neither stratification nor matching was performed. Sample size was based on increasing HIV-free survival from 74% to 84%, and calculated to be 120 pregnant women per cluster. Primary outcomes are higher levels of HIV free survival and levels of exclusive and appropriate infant feeding at 12 weeks postnatally. The intervention is home based with community health workers delivering two antenatal visits, a postnatal visit within 48 hours of birth, and a further four visits during the first two months of the infants life. We are undertaking programmatic and cost effectiveness analysis to cost the intervention. DISCUSSION: The question is not merely to develop an efficacious package but also to identify and test delivery strategies that enable scaling up, which requires effectiveness studies in a health systems context, adapting and testing Asian community-based studies in various African contexts.

The contribution of child health days to improving coverage of periodic interventions in six African countries.

BACKGROUND: Child Health Days have been implemented since the early 2000s in a number of sub-Saharan African countries with support from UNICEF and other development partners with the aim to reduce child morbidity and mortality. OBJECTIVE: To estimate the effect of Child Health Days on preventive public health intervention coverage, and possible trade-offs of Child Health Days with facility-based health systems coverage, in sub-Saharan Africa. METHODS: Data were assembled and analyzed from population-based sample surveys and administrative records and from local government sources, from six countries. Field observations (published elsewhere) provided context. RESULTS: Child Health Days contributed to improving measles immunization coverage by about 10 percentage points and, importantly, provided an opportunity for a second dose. Child Health Days achieved high coverage of vitamin A supplementation and deworming, and improved access to insecticide-treated nets. Reported measles cases declined to near zero by 2003-5--a result of the combined efforts of routine immunizations and supplementary immunization activities, often integrated with Child Health Days. Collectively these activities were successful in reaching and sustaining a high enough proportion of the child population to achieve herd immunity and prevent measles transmission. CONCLUSIONS: Additional efforts and resources are needed to continue pushing coverage up, particularly for measles immunization, in rural/hard-to-reach areas, amongst younger children, and less educated/poorer groups. In countries with low routine immunization coverage, Child Health Days are still needed.

Survey of iodine deficiency and intestinal parasitic infections in school-going children: Bie Province, Angola.

OBJECTIVE: To obtain baseline pre-intervention prevalence levels of iodine deficiency and parasitic and helminth infections in school-going children in Bie Province, Angola. DESIGN: A cross-sectional study conducted in randomly selected schools. The target population was children aged 6-10 years. SETTING: Bie Province, Angola. SUBJECTS: A total of 1029 children sampled, with 791 stool samples and 826 urine samples collected from twenty-four schools. RESULTS: Widespread severe and moderate deficiencies in iodine. Children in five schools were severely iodine deficient. All sampled schoolchildren were iodine deficient to a greater or lesser extent. In all, 80 % of all children across the twenty-four schools were infected with one or a combination of intestinal helminths and intestinal protozoa. CONCLUSIONS: These findings have serious implications for the cognitive development of Angolan children, as well as for Angola's development in terms of productivity and economic potential. It is strongly recommended that the provincial and national Ministries of Health, in collaboration with international health agencies, immediately plan and implement a strategy to provide sufficient iodine through iodised oil capsules and iodised salt to the iodine-deficient population. National coalitions need to be strengthened among the government, partners and salt producers. It is also recommended that all the children in schools be de-wormed for multiple helminth species at least twice a year.

Moving from vertical to integrated child health programmes: experiences from a multi-country assessment of the Child Health Days approach in Africa.

OBJECTIVES: To assess the effect of child health days (CHDs) on coverage of child survival interventions, to document country experiences with CHDs and to identify ways in which CHDs have strengthened or depleted primary health care (PHC) services. METHODS: Programme evaluation in six countries in sub-Saharan Africa using both quantitative (review of routine child health indicators) and qualitative (key informant interviews) methods. RESULTS: We found that CHDs have raised the profile of child survival at different levels from central government to the community in all six countries. The approach has increased the coverage of vitamin A supplementation and immunizations, especially in previously poorly performing countries. However, similar improvements have not occurred in non-CHD interventions, most notably exclusive breastfeeding. There were examples of duplication, especially in the capturing and use of health information. There was widespread evidence that PHC staff were being diverted from their usual PHC functions, and managers reported being distracted by the time required for the planning and execution of CHDs. Finally, there were examples of where the routine PHC system is becoming distorted through, for example, the payment of health worker incentives during CHD activities only. CONCLUSION: Interventions such as CHDs can rapidly increase coverage of key child survival interventions; however, they need to do so in a manner that strengthens rather than depletes existing PHC services. Our findings suggest that stand alone child health day interventions may gradually need to be integrated with routine PHC through more general health system strengthening.

Mother-infant interactions and infant development are altered by maternal iron deficiency anemia.

The aim of this study was to determine whether iron deficiency anemia (IDA) in young South African mothers alters mother-infant interactions and the infant's development. The study was a prospective, randomized, controlled intervention trial with 3 groups of mothers: nonanemic controls and anemic mothers administered either placebo (25 mg ascorbic acid and 10 microg folate) or daily iron treatment (125 mg FeSO(4) plus ascorbate and folate). Mothers of full-term, normal birth weight infants (n = 81) were followed from 10 wk to 9 mo postpartum. Maternal iron status, socioeconomic level, mother-infant interaction [Parent/Caregiver Involvement Scale (PCIS scale)], and infant development (Griffiths scale) were assessed. At baseline, anemic mothers tended (P < 0.10) to be less responsive to, and more controlling of, their infants. Infants of anemic mothers were developmentally delayed at 10 wk in hand-eye movement and overall quotient. Despite normalization of maternal iron status with supplementation in some mothers, the developmental delays were not diminished at 9 mo. At 9 mo, anemic mothers were significantly more "negative" towards their babies, engaged less in goal setting, and were less "responsive" than control mothers. In contrast, the behavior of anemic mothers given iron treatment toward their children was similar to that of the control mothers on all 11 scales of the PCIS. In conclusion, IDA altered mother-child interactions at both 10 wk and 9 mo postpartum. Additionally, infants whose mothers were anemic in the early postpartum scored worse on developmental tests at 10 wk and 9 mo of age.

Maternal iron deficiency anemia affects postpartum emotions and cognition.

The aim of this study was to determine whether iron deficiency anemia (IDA) in mothers alters their maternal cognitive and behavioral performance, the mother-infant interaction, and the infant's development. This article focuses on the relation between IDA and cognition as well as behavioral affect in the young mothers. This prospective, randomized, controlled, intervention trial was conducted in South Africa among 3 groups of mothers: nonanemic controls and anemic mothers receiving either placebo (10 microg folate and 25 mg vitamin C) or daily iron (125 mg FeS0(4), 10 microg folate, 25 mg vitamin C). Mothers of full-term normal birth weight babies were followed from 10 wk to 9 mo postpartum (n = 81). Maternal hematologic and iron status, socioeconomic, cognitive, and emotional status, mother-infant interaction, and the development of the infants were assessed at 10 wk and 9 mo postpartum. Behavioral and cognitive variables at baseline did not differ between iron-deficient anemic mothers and nonanemic mothers. However, iron treatment resulted in a 25% improvement (P < 0.05) in previously iron-deficient mothers' depression and stress scales as well as in the Raven's Progressive Matrices test. Anemic mothers administered placebo did not improve in behavioral measures. Multivariate analysis showed a strong association between iron status variables (hemoglobin, mean corpuscular volume, and transferrin saturation) and cognitive variables (Digit Symbol) as well as behavioral variables (anxiety, stress, depression). This study demonstrates that there is a strong relation between iron status and depression, stress, and cognitive functioning in poor African mothers during the postpartum period. There are likely ramifications of this poorer "functioning" on mother-child interactions and infant development, but the constraints around this relation will have to be defined in larger studies.