Cost-effectiveness of a complex continuum of care intervention targeting women and children: protocol for an economic evaluation of the Bukhali trial in South Africa.

INTRODUCTION: As nearly two-thirds of women presenting at their first antenatal visit are either overweight or obese in urban South Africa, the preconception period is an opportunity to optimise health and offset transgenerational risk of both obesity and non-communicable diseases. This protocol describes the planned economic evaluation of an individually randomised controlled trial of a complex continuum of care intervention targeting women and children in Soweto, South Africa (Bukhali trial). METHODS AND ANALYSIS: The economic evaluation of the Bukhali trial will be conducted as a within-trial analysis from both provider and societal perspectives. Incremental costs and health outcomes of the continuum of care intervention will be compared with standard care. The economic impact on implementing agencies (programme costs), healthcare providers, participants and their households will be estimated. Incremental cost-effectiveness ratios (ICERs) will be calculated in terms of cost per case of child adiposity at age years averted. Additionally, ICERs will also be reported in terms of cost per quality-adjusted life year gained. If Bukhali demonstrates effectiveness, we will employ a decision analytical model to examine the cost-effectiveness of the intervention over a child's lifetime. A Markov model will be used to estimate long-term health benefits, healthcare costs and cost-effectiveness. Probabilistic sensitivity analyses will be conducted to explore uncertainty and ensure robust results. An analysis will be conducted to assess the equity impact of the intervention, by comparing intervention impact within quintiles of socioeconomic status. ETHICS AND DISSEMINATION: The Bukhali trial economic evaluation has ethical approval from the Human Ethics Research Committee of the University of the Witwatersrand, Johannesburg, South Africa (M240162). The results of the economic evaluation will be disseminated in a peer-reviewed journal and presented at a relevant international conference. TRIAL REGISTRATION NUMBER: Pan African Clinical Trials Registry (PACTR201903750173871; https://pactr.samrc.ac.za).

Young women's social support networks during pregnancy in Soweto, South Africa.

BACKGROUND: Although studies from high-income countries have examined social support during pregnancy, it remains unclear what type of support is received by expectant mothers from low- and middle-income country settings. AIM: To explore young women's social support networks during pregnancy in Soweto, South Africa. SETTING: This study was undertaken in an academic hospital based in the Southwestern Townships (Soweto), Johannesburg, in Gauteng province, South Africa. METHODS: An exploratory descriptive qualitative approach was employed. Eighteen (18) young pregnant women were recruited using a purposive sampling approach. In-depth interviews were conducted, and data were analysed using inductive thematic analysis. RESULTS: Analysis of the data resulted in the development of two superordinate themes namely; (1) relationships during pregnancy and (2) network involvement. Involvement of the various social networks contributed greatly to the young women having a greater sense of potential parental efficacy and increased acceptance of their pregnancies. Pregnant women who receive sufficient social support from immediate networks have increased potential to embrace and give attention to pregnancy-related changes. CONCLUSION: Focusing on less-examined characteristics that could enhance pregnant women's health could help in the reduction of deaths that arise because of pregnancy complications and contribute in globally accelerating increased accessibility to adequate reproductive health.Contribution: This study's findings emphasise the necessity for policymakers and healthcare providers to educate the broader community about the importance of partner, family and peer support to minimise risks that may affect pregnancy care and wellbeing of mothers.

Mobile Technology Use in Clinical Research Examining Challenges and Implications for Health Promotion in South Africa: Mixed Methods Study.

BACKGROUND: The use of mobile technologies in fostering health promotion and healthy behaviors is becoming an increasingly common phenomenon in global health programs. Although mobile technologies have been effective in health promotion initiatives and follow-up research in higher-income countries and concerns have been raised within clinical practice and research in low- and middle-income settings, there is a lack of literature that has qualitatively explored the challenges that participants experience in terms of being contactable through mobile technologies. OBJECTIVE: This study aims to explore the challenges that participants experience in terms of being contactable through mobile technologies in a trial conducted in Soweto, South Africa. METHODS: A convergent parallel mixed methods research design was used. In the quantitative phase, 363 young women in the age cohorts 18 to 28 years were contacted telephonically between August 2019 and January 2022 to have a session delivered to them or to be booked for a session. Call attempts initiated by the study team were restricted to only 1 call attempt, and participants who were reached at the first call attempt were classified as contactable (189/363, 52.1%), whereas those whom the study team failed to contact were classified as hard to reach (174/363, 47.9%). Two outcomes of interest in the quantitative phase were "contactability of the participants" and "participants' mobile number changes," and these outcomes were analyzed at a univariate and bivariate level using descriptive statistics and a 2-way contingency table. In the qualitative phase, a subsample of young women (20 who were part of the trial for ≥12 months) participated in in-depth interviews and were recruited using a convenience sampling method. A reflexive thematic analysis approach was used to analyze the data using MAXQDA software (version 20; VERBI GmbH). RESULTS: Of the 363 trial participants, 174 (47.9%) were hard to reach telephonically, whereas approximately 189 (52.1%) were easy to reach telephonically. Most participants (133/243, 54.7%) who were contactable did not change their mobile number. The highest percentage of mobile number changes was observed among participants who were hard to reach, with three-quarters of the participants (12/16, 75%) being reported to have changed their mobile number ≥2 times. Eight themes were generated following the analysis of the transcripts, which provided an in-depth account of the reasons why some participants were hard to reach. These included mobile technical issues, coverage issues, lack of ownership of personal cell phones, and unregistered number. CONCLUSIONS: Remote data collection remains an important tool in public health research. It could, thus, serve as a hugely beneficial mechanism in connecting with participants while actively leveraging the established relationships with participants or community-based organizations to deliver health promotion and practice.

Principles for Adapting Assessments of Executive Function across Cultural Contexts.

Direct assessments of executive functions (EFs) are increasingly used in research and clinical settings, with a central assumption that they assess "universal" underlying skills. Their use is spreading globally, raising questions about the cultural appropriateness of assessments devised in Western industrialized countries. We selectively reviewed multidisciplinary evidence and theory to identify sets of cultural preferences that may be at odds with the implicit assumptions of EF assessments. These preferences relate to motivation and compliance; cultural expectations for interpersonal engagement; contextualized vs. academic thinking; cultural notions of speed and time; the willingness to be silly, be incorrect, or do the opposite; and subject-matter familiarity. In each case, we discuss how the cultural preference may be incompatible with the assumptions of assessments, and how future research and practice can address the issue. Many of the cultural preferences discussed differ between interdependent and independent cultures and between schooled and unschooled populations. Adapting testing protocols to these cultural preferences in different contexts will be important for expanding our scientific understanding of EF from the narrow slice of the human population that has participated in the research to date.

The role of a community health worker-delivered preconception and pregnancy intervention in achieving a more positive pregnancy experience: the Bukhali trial in Soweto, South Africa.

BACKGROUND: A patient-centered, human-rights based approach to maternal care moves past merely reducing maternal mortality and morbidity, towards achieving a positive pregnancy experience. When evaluating an intervention, particularly in the context of the complex challenges facing maternal care in South Africa, it is therefore important to understand how intervention components are experienced by women. We aimed to qualitatively explore (i) factors influencing the pregnancy and postpartum experience amongst young women in Soweto, South Africa, and (ii) the influence of Bukhali, a preconception, pregnancy, and early childhood intervention delivered by community health workers (CHWs), on these experiences. METHODS: Semi-structured, in-depth interviews were conducted with 15 purposively sampled participants. Participants were 18-28-year-old women who (i) were enrolled in the intervention arm of the Bukhali randomized controlled trial; (ii) were pregnant and delivered a child while being enrolled in the trial; and (iii) had at least one previous pregnancy prior to participation in the trial. Thematic analysis, informed by the positive pregnancy experiences framework and drawing on a codebook analysis approach, was used. RESULTS: The themes influencing participants' pregnancy experiences (aim 1) were participants' feelings about being pregnant, the responsibilities of motherhood, physical and mental health challenges, unstable social support and traumatic experiences, and the pressures of socioeconomic circumstances. In terms of how support, information, and care practices influenced these factors (aim 2), four themes were generated: acceptance and mother/child bonding, growing and adapting in their role as mothers, receiving tools for their health, and having ways to cope in difficult circumstances. These processes were found to be complementary and closely linked to participant context and needs. CONCLUSION: Our findings suggest that, among women aged 18-28, a CHW-delivered intervention combining support, information, and care practices has the potential to positively influence women's pregnancy experience in South Africa. In particular, emotional support and relevant information were key to better meeting participant needs. These findings can help define critical elements of CHW roles in maternal care and highlight the importance of patient-centred solutions to challenges within antenatal care. TRIAL REGISTRATION: Pan African Clinical Trials Registry PACTR201903750173871, 27/03/2019.

A qualitative analysis of community health worker perspectives on the implementation of the preconception and pregnancy phases of the Bukhali randomised controlled trial.

Community health workers (CHWs) play an important role in health systems in low- and middle-income countries, including South Africa. Bukhali is a CHW-delivered intervention as part of a randomised controlled trial, to improve the health trajectories of young women in Soweto, South Africa. This study aimed to qualitatively explore factors influencing implementation of the preconception and pregnancy phases of Bukhali, from the perspective of the CHWs (Health Helpers, HHs) delivering the intervention. As part of the Bukhali trial process evaluation, three focus group discussions were conducted with the 13 HHs employed by the trial. A thematic approach was used to analyse the data, drawing on elements of a reflexive thematic and codebook approach. The following six themes were developed, representing factors impacting implementation of the HH roles: interaction with the existing public healthcare sector; participant perceptions of health; health literacy and language barriers; participants' socioeconomic constraints; family, partner, and community views of trial components; and the HH-participant relationship. HHs reported uses of several trial-based tools to overcome implementation challenges, increasing their ability to implement their roles as planned. The relationship of trust between the HH and participants seemed to function as one important mechanism for impact. The findings supported a number of adaptations to the implementation of Bukhali, such as intensified trial-based follow-up of referrals that do not receive management at clinics, continued HH training and community engagement parallel to trial implementation, with an increased emphasis on health-related stigma and education. HH perspectives on intervention implementation highlighted adaptations across three broad strategic areas: navigating and bridging healthcare systems, adaptability to individual participant needs, and navigating stigma around disease. These findings provide recommendations for the next phases of Bukhali, for other CHW-delivered preconception and pregnancy trials, and for the strengthening of CHW roles in clinical settings with similar implementation challenges. Trial registration: Pan African Clinical Trials Registry; PACTR201903750173871, Registered March 27, 2019.

Youth-centred participatory action approach towards co-created implementation of socially and physically activating environmental interventions in Africa and Europe: the YoPA project study protocol.

INTRODUCTION: The majority of adolescents do not meet guidelines for healthy behaviours, posing major risks for developing multiple non-communicable diseases. Unhealthy lifestyles seem more prevalent in urban than rural areas, with the neighbourhood environment as a mediating pathway. How to develop and implement sustainable and effective interventions focused on adolescent health and well-being in urban vulnerable life situations is a key challenge. This paper describes the protocol of a Youth-centred Participatory Action (YoPA) project aiming to tailor, implement, and evaluate social and physical environmental interventions. METHODS AND ANALYSIS: In diverse urban environments in Denmark, the Netherlands, Nigeria and South Africa, we will engage a dynamic group of 15-20 adolescents (12-19 years) growing up in vulnerable life situations and other key stakeholders (eg, policy makers, urban planners, community leaders) in local co-creation communities. Together with academic researchers and local stakeholders, adolescents will take a leading role in mapping the local system; tailoring; implementing and evaluating interventions during participatory meetings over the course of 3 years. YoPA applies a participatory mixed methods design guided by a novel Systems, User perspectives, Participatory co-creation process, Effects, Reach, Adoption, Implementation and Maintenance framework assessing: (i) the local systems, (ii) user perspectives, (iii) the participatory co-creation process, (iv) effects, (v) reach, (vi) adoption, (vii) implementation and (viii) maintenance of interventions. Through a realist evaluation, YoPA will explore why and how specific outcomes were reached (or not) in each setting (n=800-1000 adolescents in total). ETHICS AND DISSEMINATION: This study received approval from the ethics committees in Denmark, the Netherlands, Nigeria and South Africa and will be disseminated via various collaborative dissemination activities targeting multiple audiences. We will obtain informed consent from all participants. We envision that our YoPA co-creation approach will serve as a guide for participation of adolescents in vulnerable life situations in implementation of health promotion and urban planning in Europe, Africa and globally. TRIAL REGISTRATION NUMBER: NCT06181162.

Enhanced or hindered research benefits? A realist review of community engagement and participatory research practices for non-communicable disease prevention in low- and middle-income countries.

INTRODUCTION: Community engagement and participatory research are widely used and considered important for ethical health research and interventions. Based on calls to unpack their complexity and observed biases in their favour, we conducted a realist review with a focus on non-communicable disease prevention. The aim was to generate an understanding of how and why engagement or participatory practices enhance or hinder the benefits of non-communicable disease research and interventions in low- and middle-income countries. METHODS: We retroductively formulated theories based on existing literature and realist interviews. After initial searches, preliminary theories and a search strategy were developed. We searched three databases and screened records with a focus on theoretical and empirical relevance. Insights about contexts, strategies, mechanisms and outcomes were extracted and synthesised into six theories. Five realist interviews were conducted to complement literature-based theorising. The final synthesis included 17 quality-appraised articles describing 15 studies. RESULTS: We developed six theories explaining how community engagement or participatory research practices either enhance or hinder the benefits of non-communicable disease research or interventions. Benefit-enhancing mechanisms include community members' agency being realised, a shared understanding of the benefits of health promotion, communities feeling empowered, and community members feeling solidarity and unity. Benefit-hindering mechanisms include community members' agency remaining unrealised and participation being driven by financial motives or reputational expectations. CONCLUSION: Our review challenges assumptions about community engagement and participatory research being solely beneficial in the context of non-communicable disease prevention in low- and middle-income countries. We present both helpful and harmful pathways through which health and research outcomes are affected. Our practical recommendations relate to maximising benefits and minimising harm by addressing institutional inflexibility and researcher capabilities, managing expectations on research, promoting solidarity in solving public health challenges and sharing decision-making power.

Associations Between Changes in 24-Hour Movement Behaviors in Children and Adolescents During the COVID-19 Pandemic: A Systematic Review and Mediation-Based Meta-Analysis.

BACKGROUND: Although 24-hour movement behaviors are known to be interconnected, limited knowledge exists about whether change in one behavior during the COVID-19 pandemic (eg, increased screen time) was associated with change in another (eg, reduced physical activity or sleep). This review estimates mediational associations between changes in children's physical activity, screen time, and sleep during the COVID-19 pandemic. METHODS: We included studies published between January 1, 2020 and June 27, 2022, in the PubMed/MEDLINE, Embase, PsycINFO, SPORTDiscus, and Web of Science databases. Summary data were extracted from included studies and analyzed with random-effects meta-regression. RESULTS: This review included 26 studies representing 18,959 children across 18 mid-high-income countries (53% male; mean age, 11.5 [2.9] y). There was very good evidence of decreased total daily physical activity (factor change, 0.62; 90% CI, 0.47-0.81) and strong evidence of increased screen time (1.56; 90% CI, 1.38-1.77). There was very good evidence of decreased moderate to vigorous physical activity (0.75; 90% CI, 0.62-0.90) and weak evidence of increased sleep (1.02; 90% CI, 1.00-1.04). Mediational analysis revealed strong evidence that most of the reduction in total daily physical activity from before, to during, the pandemic was associated with increased screen time (0.53; 90% CI, 0.42-0.67). We observed no further mediational associations. CONCLUSION: Increased reliance on and use of screen-based devices during the COVID-19 pandemic can be linked with reduced child and adolescent physical activity. This finding links COVID-related restrictions to potential displacement effects within child and adolescent 24-hour movement behavior.

Navigating relationship dynamics, pregnancy and fatherhood in the Bukhali trial: a qualitative study with men in Soweto, South Africa.

BACKGROUND: South Africa has a complex range of historical, social, political, and economic factors that have shaped fatherhood. In the context of the Bukhali randomised controlled trial with young women in Soweto, South Africa, a qualitative study was conducted with the male partners of young women who had become pregnant during the trial. This exploratory study aimed to explore individual perceptions around relationship dynamics, their partner's pregnancy, and fatherhood of partners of young women in Soweto, South Africa. METHODS: Individual, in-depth interviews were conducted with male partners (fathers, n = 19, 25-46 years old) of Bukhali participants. A thematic approach was taken to the descriptive and exploratory process of analysis, and three final themes and subthemes were identified: (1) relationship dynamics (nature of relationship, relationship challenges); (2) pregnancy (feelings about the pregnancy, effect of the pregnancy on their relationship, providing support during pregnancy; and 3) fatherhood (view of fatherhood, roles of fathers, influences on views and motivation, challenges of fatherhood). RESULTS: While most male participants were in a committed ("serious") relationship with their female partner, less than half of them were cohabiting. Most reported that their partner's pregnancy was not planned, and shared mixed feelings about the pregnancy (e.g., happy, excited, shocked, nervous), although their views about fatherhood were overwhelmingly positive. Many were concerned about how they would economically provide for their child and partner, particularly those who were unemployed. Participants identified both general and specific ways in which they provided support for their partner, e.g., being present, co-attending antenatal check-ups, providing material resources. For many, the most challenging aspect of fatherhood was having to provide financially. They seemed to understand the level of responsibility expected of them as a father, and that their involvement and presence related to love for and connection with their child. Participants' responses indicated that there were some changes in the norms around fatherhood, suggesting that there is a possibility for a shift in the fatherhood narrative in their context. CONCLUSIONS: These findings suggest that the complex array of factors influencing fatherhood in South Africa continue to play out in this generation, although promising changes are evident.

Inadequate Access to Potable Water Impacts Early Childhood Development in Low-Income Areas in Cape Town, South Africa.

Background: Water and sanitation are vital to human health and well-being. While these factors have been studied in relation to health, very little has been done to consider such environmental risk factors with child development. Here, we investigated possible relations between household water access/storage and early childhood development in four low-income settlements in the City of Cape Town, Western Cape province of South Africa. Our objectives were 1) to determine water access/storage practices in dwellings of children; 2) to assess early childhood development; and 3) and to understand the relationship between water access/storage practices in relation to early childhood development. Methods: We used a questionnaire to assess household water risk factors and the International Development and Early Learning Assessment (IDELA) tool to assess child early learning / cognitive, socio-emotional and motor development. Results: Mean age of the children (N = 192) was 4 years and 55% were female. The mean IDELA score was 48% (range: 36-54%) where the higher the score, the better the child's development. Around 70% of households had a tap inside their dwelling and half said that they stored water with the largest percentage of storage containers (21%) being plastic/no lid. Child IDELA scores were lower for children living in households that did not have an indoor tap and for households who stored water. Conclusions: Given the risks associated with climate change and the already poor conditions many children face regarding water and sanitation, research is needed to further investigate these relations to provide evidence to support appropriate interventions and ensure healthy child development.

Climate change is a threat multiplier for violence against children.

BACKGROUND: The climate crisis is the biggest threat to the health, development, and wellbeing of the current and future generations. While there is extensive evidence on the direct impacts of climate change on human livelihood, there is little evidence on how children and young people are affected, and even less discussion and evidence on how the climate crisis could affect violence against children. PARTICIPANTS AND SETTING: In this commentary, we review selected research to assess the links between the climate crisis and violence against children. METHODS: We employ a social-ecological perspective as an overarching framework to organize findings from the literature and call attention to increased violence against children as a specific, yet under-examined, direct and indirect consequence of the climate crisis. RESULTS: Using such a perspective, we examine how the climate crisis exacerbates the risk of violence against children at the continually intersecting and interacting levels of society, community, family, and the individual levels. We propose increased risk of armed conflict, forced displacement, poverty, income inequality, disruptions in critical health and social services, and mental health problems as key mechanisms linking the climate crisis and heightened risk of violence against children. Furthermore, we posit that the climate crisis serves as a threat multiplier, compounding existing vulnerabilities and inequities within populations and having harsher consequences in settings, communities, households, and for children already experiencing adversities. CONCLUSIONS: We conclude with a call for urgent efforts from researchers, practitioners, and policymakers to further investigate the specific empirical links between the climate crisis and violence against children and to design, test, implement, fund, and scale evidence-based, rights-based, and child friendly prevention, support, and response strategies to address violence against children.

Executive functioning skills and their environmental predictors among pre-school aged children in South Africa and The Gambia.

Executive functions (EFs) in early childhood are predictors of later developmental outcomes and school readiness. Much of the research on EFs and their psychosocial correlates has been conducted in high-income, minority world countries, which represent a small and biased portion of children globally. The aim of this study is to examine EFs among children aged 3-5 years in two African countries, South Africa (SA) and The Gambia (GM), and to explore shared and distinct predictors of EFs in these settings. The SA sample (N = 243, 51.9% female) was recruited from low-income communities within the Cape Town Metropolitan area. In GM, participants (N = 171, 49.7% female) were recruited from the rural West Kiang region. EFs, working memory (WM), inhibitory control (IC) and cognitive flexibility (CF), were measured using tablet-based tasks. Associations between EF task performance and indicators of socioeconomic status (household assets, caregiver education) and family enrichment factors (enrichment activities, diversity of caregivers) were assessed. Participants in SA scored higher on all EF tasks, but children in both sites predominantly scored within the expected range for their age. There were no associations between EFs and household or familial variables in SA, except for a trend-level association between caregiver education and CF. Patterns were similar in GM, where there was a trend-level association between WM and enrichment activities but no other relationships. We challenge the postulation that children in low-income settings have poorer EFs, simply due to lower socioeconomic status, but highlight the need to identify predictors of EFs in diverse, global settings. RESEARCH HIGHLIGHTS: Assessed Executive Functioning (EF) skills and their psychosocial predictors among pre-school aged children (aged 3-5 years) in two African settings (The Gambia and South Africa). On average, children within each setting performed within the expected range for their age, although children in South Africa had higher scores across tasks. There was little evidence of any association between socioeconomic variables and EFs in either site. Enrichment activities were marginally associated with better working memory in The Gambia, and caregiver education with cognitive flexibility in South Africa, both associations were trend-level significance.

A Cross-Sectional Study of the Associations between Biomarkers of Vitamin D, Iron Status, and Hemoglobin in South African Women of Reproductive Age: the Healthy Life Trajectories Initiative, South Africa.

Background: Vitamin D deficiency and anemia impact the health of women of reproductive age. Evidence suggests an inverse relationship between serum vitamin D (25-hydroxyvitamin D [25(OH)D]) and anemia/iron deficiency, but less is known about these associations in women of reproductive age, in particular in a setting with a combined burden of micronutrient deficiency, food insecurity, and obesity. Objective: We aimed to assess the associations between 25(OH)D and biomarkers of iron and anemia in a cohort of women of reproductive age from Soweto, South Africa. The prevalence of vitamin D deficiency was also assessed. Methods: In this cross-sectional substudy of the Healthy Life Trajectories Initiative (HeLTI) South Africa pilot trial, 25(OH)D, iron markers (ferritin and soluble transferrin receptor [sTFR]), and altitude-adjusted hemoglobin (Hb) were measured in 493 women aged 18 to 25 years. Associations between iron deficiency/anemia and vitamin D status were evaluated using multivariable logistic regression, adjusting for confounders including fat mass index (FMI). Structural equation modeling (SEM) was performed to evaluate direct and indirect pathways between 25(OH)D, iron and anemia markers, and covariates. Results: Of 493 participants, 136 (27.6%) had vitamin D insufficiency (25(OH)D ≥12-20 ng/mL), whereas 28 (5.6%) had vitamin D deficiency (<12 ng/mL). Anemia and iron deficiency were not significantly associated with vitamin D category (25(OH)D<20 ng/mL compared with ≥20 ng/mL) in multivariable logistic regression analyses. In SEM, log-transformed 25(OH)D was not significantly associated with Hb, ferritin, or sTFR, but it was significantly associated with season of data collection, hormonal contraceptive use, and FMI (total effects: B = 0.17, 95% CI: 0.104, 0.236, P < 0.001; B: 0.10, 95% CI: 0.041, 0.154, P < 0.001; B: -0.01, 95%CI: -0.016, -0.003, P = 0.003, respectively). Conclusion: No significant association between vitamin D (25(OH)D), anemia (Hb), and iron markers was found. The inverse relationship between FMI and vitamin D status emphasizes the overlap between adiposity and micronutrient deficiencies in young South African women, exacerbating their risk of disease development.