Cost-effectiveness of a radio intervention to stimulate early childhood development: protocol for an economic evaluation of the SUNRISE trial in Burkina Faso.

INTRODUCTION: Approximately 250 million children under 5 years of age are at risk of poor development in low-income and middle-income countries. However, existing early childhood development (ECD) interventions can be expensive, labour intensive and challenging to deliver at scale. Mass media may offer an alternative approach to ECD intervention. This protocol describes the planned economic evaluation of a cluster-randomised controlled trial of a radio campaign promoting responsive caregiving and opportunities for early learning during the first 3 years of life in rural Burkina Faso (SUNRISE trial). METHODS AND ANALYSIS: The economic evaluation of the SUNRISE trial will be conducted as a within-trial analysis from the provider's perspective. Incremental costs and health outcomes of the radio campaign will be compared with standard broadcasting (ie, 'do nothing' comparator). All costs associated with creating and broadcasting the radio campaign during intervention start-up and implementation will be captured. The cost per child under 3 years old reached by the intervention will be calculated. Incremental cost-effectiveness ratios will be calculated for the trial's primary outcome (ie, incremental cost per SD of cognitive gain). A cost-consequence analysis will also be presented, whereby all relevant costs and outcomes are tabulated. Finally, an analysis will be conducted to assess the equity impact of the intervention. ETHICS AND DISSEMINATION: The SUNRISE trial has ethical approval from the ethics committees of the Ministry of Health, Burkina Faso, University College London and the London School of Hygiene and Tropical Medicine. The results of the economic evaluation will be disseminated in a peer-reviewed journal and presented at a relevant international conference. TRIAL REGISTRATION NUMBER: The SUNRISE trial was registered with ClinicalTrials.gov on 19 April 2019 (identifier: NCT05335395).

Implementing and evaluating group interpersonal therapy for postnatal depression in Lebanon and Kenya-individually randomised superiority trial.

BACKGROUND: Depression ranks as the foremost mental health concern among childbearing women. Within low- and middle-income countries (LMICs), between 20 and 25% of women encounter depression during pregnancy or soon after delivery. This condition impacts not only the mothers but also their offspring. Offspring of women suffering from postnatal depression (PND) exhibit suboptimal cognitive development and increased emotional and behavioural issues throughout their growth. This scenario becomes more pronounced in LMICs, where numerous adversities further jeopardise children's developmental progress. Despite antenatal services providing a pivotal platform to address women's mental health needs, PND treatment remains inaccessible in many LMICs. The World Health Organization advocates interpersonal psychotherapy (IPT) for treating depression. While research from high-income countries has established the efficacy of IPT and group-IPT (g-IPT) for PND, its effectiveness within the LMIC context and its potential benefits for child development remain uncharted. This study seeks to gauge the potency of g-IPT for women with PND in two LMICs. METHODS: This multi-site randomised controlled trial is a continuation of two preceding phases-conceptual mapping and a feasibility study executed in Lebanon and Kenya. Insights gleaned from these phases underpin this comprehensive RCT, which contrasts the efficacy and cost-effectiveness of high-quality standard care (HQ-SC) augmented with g-IPT against HQ-SC in isolation. The trial, characterised as an individually randomised superiority assessment, targets women with postnatal depression in Beirut, Lebanon, and Nairobi, Kenya. It aims to determine if culturally tailored g-IPT, administered within community settings in both countries, outperforms HQ-SC in influencing child developmental outcomes, maternal depression, and the quality of the mother-child bond. DISCUSSION: The SUMMIT trial, designed with pragmatism, possesses the magnitude to evaluate g-IPT within two LMIC frameworks. It seeks to enlighten policymakers, service commissioners, professionals, and users about g-IPT's potential to alleviate maternal PND and bolster child developmental outcomes in LMICs. Additionally, the trial will generate valuable data on the clinical and economic merits of high-quality standard care. TRIAL REGISTRATION: ISRCTN, ISRCTN15154316. Registered on 27 September 2023, https://doi.org/10.1186/ISRCTN15154316.

Integrated management of HIV, diabetes, and hypertension in sub-Saharan Africa (INTE-AFRICA): a pragmatic cluster-randomised, controlled trial.

BACKGROUND: In sub-Saharan Africa, health-care provision for chronic conditions is fragmented. The aim of this study was to determine whether integrated management of HIV, diabetes, and hypertension led to improved rates of retention in care for people with diabetes or hypertension without adversely affecting rates of HIV viral suppression among people with HIV when compared to standard vertical care in medium and large health facilities in Uganda and Tanzania. METHODS: In INTE-AFRICA, a pragmatic cluster-randomised, controlled trial, we randomly allocated primary health-care facilities in Uganda and Tanzania to provide either integrated care or standard care for HIV, diabetes, and hypertension. Random allocation (1:1) was stratified by location, infrastructure level, and by country, with a permuted block randomisation method. In the integrated care group, participants with HIV, diabetes, or hypertension were managed by the same health-care workers, used the same pharmacy, had similarly designed medical records, shared the same registration and waiting areas, and had an integrated laboratory service. In the standard care group, these services were delivered vertically for each condition. Patients were eligible to join the trial if they were living with confirmed HIV, diabetes, or hypertension, were aged 18 years or older, were living within the catchment population area of the health facility, and were likely to remain in the catchment population for 6 months. The coprimary outcomes, retention in care (attending a clinic within the last 6 months of study follow-up) for participants with either diabetes or hypertension (tested for superiority) and plasma viral load suppression for those with HIV (>1000 copies per mL; tested for non-inferiority, 10% margin), were analysed using generalised estimating equations in the intention-to-treat population. This trial is registered with ISCRTN 43896688. FINDINGS: Between June 30, 2020, and April 1, 2021 we randomly allocated 32 health facilities (17 in Uganda and 15 in Tanzania) with 7028 eligible participants to the integrated care or the standard care groups. Among participants with diabetes, hypertension, or both, 2298 (75·8%) of 3032 were female and 734 (24·2%) of 3032 were male. Of participants with HIV alone, 2365 (70·3%) of 3365 were female and 1000 (29·7%) of 3365 were male. Follow-up lasted for 12 months. Among participants with diabetes, hypertension, or both, the proportion alive and retained in care at study end was 1254 (89·0%) of 1409 in integrated care and 1457 (89·8%) of 1623 in standard care. The risk differences were -0·65% (95% CI -5·76 to 4·46; p=0·80) unadjusted and -0·60% (-5·46 to 4·26; p=0·81) adjusted. Among participants with HIV, the proportion who had a plasma viral load of less than 1000 copies per mL was 1412 (97·0%) of 1456 in integrated care and 1451 (97·3%) of 1491 in standard care. The differences were -0·37% (one-sided 95% CI -1·99 to 1·26; pnon-inferiority<0·0001 unadjusted) and -0·36% (-1·99 to 1·28; pnon-inferiority<0·0001 adjusted). INTERPRETATION: In sub-Saharan Africa, integrated chronic care services could achieve a high standard of care for people with diabetes or hypertension without adversely affecting outcomes for people with HIV. FUNDING: European Union Horizon 2020 and Global Alliance for Chronic Diseases.

Can home visits for early child development be implemented with sufficient coverage and quality at scale? Evidence from the SPRING program in India and Pakistan.

Introduction: There is limited evidence from low and middle-income settings on the effectiveness of early child development interventions at scale. To bridge this knowledge-gap we implemented the SPRING home visiting program where we tested integrating home visits into an existing government program (Pakistan) and employing a new cadre of intervention workers (India). We report the findings of the process evaluation which aimed to understand implementation. Methods and materials: We collected qualitative data on acceptability and barriers and facilitators for change through 24 in-depth interviews with mothers; eight focus group discussions with mothers, 12 with grandmothers, and 12 with fathers; and 12 focus group discussions and five in-depth interviews with the community-based agents and their supervisors. Results: Implementation was sub-optimal in both settings. In Pakistan issues were low field-supervision coverage and poor visit quality related to issues scheduling supervision, a lack of skill development, high workloads and competing priorities. In India, issues were low visit coverage - in part due to employing new workers and an empowerment approach to visit scheduling. Coaching caregivers to improve their skills was sub-optimal in both sites, and is likely to have contributed to caregiver perceptions that the intervention content was not new and was focused on play activities rather than interaction and responsivity - which was a focus of the coaching. In both sites caregiver time pressures was a key reason for low uptake among families who received visits. Discussion: Programs need feasible strategies to maximize quality, coverage and supervision including identifying and managing problems through monitoring and feedback loops. Where existing community-based agents are overstretched and system strengthening is unlikely, alternative implementation strategies should be considered such as group delivery. Core intervention ingredients such as coaching should be prioritized and supported during training and implementation. Given that time and resource constraints were a key barrier for families a greater focus on communication, responsivity and interaction during daily activities could have improved feasibility.

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.

Maternal time investment in caregiving activities to promote early childhood development: evidence from rural India.

Introduction: Intervention strategies that seek to improve early childhood development outcomes are often targeted at the primary caregivers of children, usually mothers. The interventions require mothers to assimilate new information and then act upon it by allocating sufficient physical resources and time to adopt and perform development promoting behaviours. However, women face many competing demands on their resources and time, returning to familiar habits and behaviours. In this study, we explore mothers' allocation of time for caregiving activities for children under the age of 2, nested within a cluster randomised controlled trial of a nutrition and care for development intervention in rural Haryana, India. Methods: We collected quantitative maternal time use data at two time points in rural Haryana, India, using a bespoke survey instrument. Data were collected from 704 mothers when their child was 12 months old, and 603 mothers when their child was 18 months old. We tested for significant differences in time spent by mothers on different activities when children are 12 months of age vs. 18 months of age between arms as well as over time, using linear regression. As these data were collected within a randomised controlled trial, we adjusted for clusters using random effects when testing for significant differences between the two time points. Results: At both time points, no statistically significant difference in maternal time use was found between arms. On average, mothers spent most of their waking time on household chores (over 6 h and 30 min) at both time points. When children were aged 12 months, approximately three and a half hours were spent on childcare activities for children under the age of 2 years. When children were 18 months old, mothers spent more time on income generating activities (30 min) than when the children were 12 years old, and on leisure (approximately 4 h and 30 min). When children were 18 months old, less time was spent on feeding/breastfeeding children (30 min less) and playing with children (15 min). However, mothers spent more time talking or reading to children at 18 months than at 12 months. Conclusion: We find that within a relatively short period of time in early childhood, maternal (or caregiver) time use can change, with time allocation being diverted away from childcare activities to others. This suggests that changing maternal time allocation in resource poor households may be quite challenging, and not allow the uptake of new and/or optimal behaviours.

Economic evaluation of participatory women's groups scaled up by the public health system to improve birth outcomes in Jharkhand, eastern India.

An estimated 2.4 million newborn infants died in 2020, 80% of them in sub-Saharan Africa and South Asia. To achieve the Sustainable Development Target for neonatal mortality reduction, countries with high mortality need to implement evidence-based, cost-effective interventions at scale. Our study aimed to estimate the cost, cost-effectiveness, and benefit-cost ratio of a participatory women's groups intervention scaled up by the public health system in Jharkhand, eastern India. The intervention was evaluated through a pragmatic cluster non-randomised controlled trial in six districts. We estimated the cost of the intervention at scale from a provider perspective, with a 42-month time horizon for 20 districts. We estimated costs using a combination of top-down and bottom-up approaches. All costs were adjusted for inflation, discounted at 3% per year, and converted to 2020 International Dollars (INT$). Incremental cost-effectiveness ratios (ICERs) were estimated using extrapolated effect sizes for the impact of the intervention in 20 districts, in terms of cost per neonatal deaths averted and cost per life year saved. We assessed the impact of uncertainty on results through one-way and probabilistic sensitivity analyses. We also estimated benefit-cost ratio using a benefit transfer approach. Total intervention costs for 20 districts were INT$ 15,017,396. The intervention covered an estimated 1.6 million livebirths across 20 districts, translating to INT$ 9.4 per livebirth covered. ICERs were estimated at INT$ 1,272 per neonatal death averted or INT$ 41 per life year saved. Net benefit estimates ranged from INT$ 1,046 million to INT$ 3,254 million, and benefit-cost ratios from 71 to 218. Our study suggests that participatory women's groups scaled up by the Indian public health system were highly cost-effective in improving neonatal survival and had a very favourable return on investment. The intervention can be scaled up in similar settings within India and other countries.

Public health benefits of shifting from hospital-focused to ambulatory TB care in Eastern Europe: Optimising TB investments in Belarus, the Republic of Moldova, and Romania.

High rates of drug-resistant tuberculosis (DR-TB) continue to threaten public health, especially in Eastern Europe. Costs for treating DR-TB are substantially higher than treating drug-susceptible TB, and higher yet if DR-TB services are delivered in hospital. The WHO recommends that multidrug-resistant (MDR) TB be treated using mainly ambulatory care, shown to have non-inferior health outcomes, however, there has been a delay to transition away from hospital-focused MDR-TB care in certain Eastern European countries. Allocative efficiency analyses were conducted for three countries in Eastern Europe, Belarus, the Republic of Moldova, and Romania, to minimise a combination of TB incidence, prevalence, and mortality by 2035. A primary focus of these studies was to determine the health benefits and financial savings that could be realised if DR-TB service delivery shifted from hospital-focused to ambulatory care. Here we provide a comprehensive assessment of findings from these studies to demonstrate the collective benefit of transitioning from hospital-focused to ambulatory TB care, and to address common regional considerations. We highlight that transitioning from hospital-focused to ambulatory TB care could reduce treatment costs by 20% in Romania, 24% in Moldova, and by as much as 40% in Belarus or almost 35 million US dollars across these three countries by 2035 without affecting quality of care. Improved TB outcomes could be achieved, however, without additional spending by reinvesting these savings in higher-impact TB diagnosis and more efficacious DR-TB treatment regimens. We found commonalities in the large portion of TB cases treated in hospital across these three regional countries, and similar obstacles to transitioning to ambulatory care. National governments in the Eastern European region should examine barriers delaying adoption of ambulatory DR-TB care and consider lost opportunities caused by delays in switching to more efficient treatment modes.

Using costing to facilitate policy making towards Universal Health Coverage: findings and recommendations from country-level experiences.

As countries progress towards universal health coverage (UHC), they frequently develop explicit packages of health services compatible with UHC goals. As part of the Disease Control Initiative 3 Country Translation project, a systematic survey instrument was developed and used to review the experience of five low-income and lower-middle-income countries-Afghanistan, Ethiopia, Pakistan, Somalia and Sudan-in estimating the cost of their proposed packages. The paper highlights the main results of the survey, providing information about how costing exercises were conducted and used and what country teams perceived to be the main challenges. Key messages are identified to facilitate similar exercises and improve their usefulness. Critical challenges to be addressed include inconsistent application of costing methods, measurement errors and data reliability issues, the lack of adequate capacity building, and the lack of integration between costing and budgeting. The paper formulates four recommendations to address these challenges: (1) developing more systematic guidance and standard ways to implement costing methodologies, particularly regarding the treatment of health systems-related common costs, (2) acknowledging ranges of uncertainty of costing results and integrating sensitivity analysis, (3) building long-term capacity at the local level and institutionalising the costing process in order to improve both reliability and policy relevance, and (4) closely linking costing exercises to public budgeting.

Implementation of the Afya conditional cash transfer intervention to retain women in the continuum of care: a mixed-methods process evaluation.

OBJECTIVES: We report the results of a mixed-methods process evaluation that aimed to provide insight on the Afya conditional cash transfer (CCT) intervention fidelity and acceptability. INTERVENTION, SETTING AND PARTICIPANTS: The Afya CCT intervention aimed to retain women in the continuum of maternal healthcare including antenatal care (ANC), delivery at facility and postnatal care (PNC) in Siaya County, Kenya. The cash transfers were delivered using an electronic card reader system at health facilities. It was evaluated in a trial that randomised 48 health facilities to intervention or control, and which found modest increases in attendance for ANC and immunisation appointments, but little effect on delivery at facility and PNC visits. DESIGN: A mixed-methods process evaluation was conducted. We used the Afya electronic portal with recorded visits and payments, and reports on use of the electronic card reader system from each healthcare facility to assess fidelity. Focus group interviews with participants (N=5) and one-on-one interviews with participants (N=10) and healthcare staff (N=15) were conducted to assess the acceptability of the intervention. Data analyses were conducted using descriptive statistics and qualitative content analysis, as appropriate. RESULTS: Delivery of the Afya CCT intervention was negatively affected by problems with the electronic card reader system and a decrease in adherence to its use over the intervention period by healthcare staff, resulting in low implementation fidelity. Acceptability of cash transfers in the form of mobile transfers was high for participants. Initially, the intervention was acceptable to healthcare staff, especially with respect to improvements in attaining facility targets for ANC visits. However, acceptability was negatively affected by significant delays linked to the card reader system. CONCLUSIONS: The findings highlight operational challenges in delivering the Afya CCT intervention using the Afya electronic card reader system, and the need for greater technology readiness before further scale-up. TRIAL REGISTRATION NUMBER: NCT03021070.

Understanding the effects of nutrition-sensitive agriculture interventions with participatory videos and women's group meetings on maternal and child nutrition in rural Odisha, India: A mixed-methods process evaluation.

A trial of three nutrition-sensitive agriculture interventions with participatory videos and women's group meetings in rural Odisha, India, found improvements in maternal and child dietary diversity, limited effects on agricultural production, and no effects on women and children's nutritional status. Our process evaluation explored fidelity, reach, and mechanisms behind interventions' effects. We also examined how context affected implementation, mechanisms, and outcomes. We used data from intervention monitoring systems, review notes, trial surveys, 32 case studies with families (n = 91 family members), and 20 group discussions with women's group members and intervention workers (n = 181 and 32, respectively). We found that interventions were implemented with high fidelity. Groups reached around half of the mothers of children under 2 years. Videos and meetings increased women's knowledge, motivation and confidence to suggest or make changes to their diets and agricultural production. Families responded in diverse ways. Many adopted or improved rainfed homestead garden cultivation for consumption, which could explain gains in maternal and child dietary diversity seen in the impact evaluation. Cultivation for income was less common. This was often due to small landholdings, poor access to irrigation and decision-making dominated by men. Interventions helped change norms about heavy work during pregnancy, but young women with little family support still did considerable work. Women's ability to shape cultivation, income and workload decisions was strongly influenced by support from male relatives. Future nutrition-sensitive agriculture interventions could include additional flexibility to address families' land, water, labour and time constraints, as well as actively engage with spouses and in-laws.

Economic Evaluation of Nutrition-Sensitive Agricultural Interventions to Increase Maternal and Child Dietary Diversity and Nutritional Status in Rural Odisha, India.

BACKGROUND: Economic evaluations of nutrition-sensitive agriculture (NSA) interventions are scarce, limiting assessment of their potential affordability and scalability. OBJECTIVES: We conducted cost-consequence analyses of 3 participatory video-based interventions of fortnightly women's group meetings using the following platforms: 1) NSA videos; 2) NSA and nutrition-specific videos; or 3) NSA videos with a nutrition-specific participatory learning and action (PLA) cycle. METHODS: Interventions were tested in a 32-mo, 4-arm cluster-randomized controlled trial, Upscaling Participatory Action and Videos for Agriculture and Nutrition (UPAVAN) in the Keonjhar district, Odisha, India. Impacts were evaluated in children aged 0-23 mo and their mothers. We estimated program costs using data collected prospectively from expenditure records of implementing and technical partners and societal costs using expenditure assessment data collected from households with a child aged 0-23 mo and key informant interviews. Costs were adjusted for inflation, discounted, and converted to 2019 US$. RESULTS: Total program costs of each intervention ranged from US$272,121 to US$386,907. Program costs per pregnant woman or mother of a child aged 0-23 mo were US$62 for NSA videos, US$84 for NSA and nutrition-specific videos, and US$78 for NSA videos with PLA (societal costs: US$125, US$143, and US$122, respectively). Substantial shares of total costs were attributable to development and delivery of the videos and PLA (52-69%) and quality assurance (25-41%). Relative to control, minimum dietary diversity was higher in the children who underwent the interventions incorporating nutrition-specific videos and PLA (adjusted RRs: 1.19 and 1.27; 95% CIs: 1.03-1.37 and 1.11, 1.46, respectively). Relative to control, minimum dietary diversity in mothers was higher in those who underwent NSA video (1.21 [1.01, 1.45]) and NSA with PLA (1.30 [1.10, 1.53]) interventions. CONCLUSION: NSA videos with PLA can increase both maternal and child dietary diversity and have the lowest cost per unit increase in diet diversity. Building on investments made in developing UPAVAN, cost-efficiency at scale could be increased with less intensive monitoring, reduced startup costs, and integration within existing government programs. This trial was registered at clinicaltrials.gov as ISRCTN65922679.

National tuberculosis spending efficiency and its associated factors in 121 low-income and middle-income countries, 2010-19: a data envelopment and stochastic frontier analysis.

BACKGROUND: Maximising the efficiency of national tuberculosis programmes is key to improving service coverage, outcomes, and progress towards End TB targets. We aimed to determine the overall efficiency of tuberculosis spending and investigate associated factors in 121 low-income and middle-income countries between 2010 and 2019. METHODS: In this data envelopment and stochastic frontier analysis, we used data from the WHO Global TB report series on tuberculosis spending as the input and treatment coverage as the output to estimate tuberculosis spending efficiency. We investigated associations between 25 independent variables and overall efficiency. FINDINGS: We estimated global tuberculosis spending efficiency to be between 73·8% (95% CI 71·2-76·3) and 87·7% (84·9-90·6) in 2019, depending on the analytical method used. This estimate suggests that existing global tuberculosis treatment coverage could be increased by between 12·3% (95% CI 9·4-15·1) and 26·2% (23·7-28·8) for the same amount of spending. Efficiency has improved over the study period, mainly since 2015, but a substantial difference of 70·7-72·1 percentage points between the most and least efficient countries still exists. We found a consistent significant association between efficiency and current health expenditure as a share of gross domestic product, out-of-pocket spending on health, and some Sustainable Development Goal (SDG) indicators such as universal health coverage. INTERPRETATION: To improve efficiency, treatment coverage will need to be increased, particularly in the least efficient contexts where this might require additional spending. However, progress towards global End TB targets is slow even in the most efficient countries. Variables associated with TB spending efficiency suggest efficiency is complimented by commitments to improving health-care access that is free at the point of use and wider progress towards the SDGs. These findings support calls for additional investment in tuberculosis care. FUNDING: None.

Factors associated with women's healthcare decision-making during and after pregnancy in urban slums in Mumbai, India: a cross-sectional analysis.

BACKGROUND: Understanding factors associated with women's healthcare decision-making during and after pregnancy is important. While there is considerable evidence related to general determinants of women's decision-making abilities or agency, there is little evidence on factors associated with women's decision-making abilities or agency with regards to health care (henceforth, health agency), especially for antenatal and postnatal care. We assessed women's health agency during and after pregnancy in slums in Mumbai, India, and examined factors associated with increased participation in healthcare decisions. METHODS: Cross-sectional data were collected from 2,630 women who gave birth and lived in 48 slums in Mumbai. A health agency module was developed to assess participation in healthcare decision-making during and after pregnancy. Linear regression analysis was used to examine factors associated with increased health agency. RESULTS: Around two-thirds of women made decisions about perinatal care by themselves or jointly with their husband, leaving about one-third outside the decision-making process. Participation increased with age, secondary and higher education, and paid employment, but decreased with age at marriage and household size. The strongest associations were with age and household size, each accounting for about a 0.2 standard deviation difference in health agency score for each one standard deviation change (although in different directions). Similar differences were observed for those in paid employment compared to those who were not, and for those with higher education compared to those with no schooling. CONCLUSION: Exclusion of women from maternal healthcare decision-making threatens the effectiveness of health interventions. Factors such as age, employment, education, and household size need to be considered when designing health interventions targeting new mothers living in challenging conditions, such as urban slums in low- and middle-income countries.

Comprehensive Anaemia Programme and Personalized Therapies (CAPPT): protocol for a cluster-randomised controlled trial testing the effect women's groups, home counselling and iron supplementation on haemoglobin in pregnancy in southern Nepal.

BACKGROUND: Anaemia in pregnancy remains prevalent in Nepal and causes severe adverse health outcomes. METHODS: This non-blinded cluster-randomised controlled trial in the plains of Nepal has two study arms: (1) Control: routine antenatal care (ANC); (2) Home visiting, iron supplementation, Participatory Learning and Action (PLA) groups, plus routine ANC. Participants, including women in 54 non-contiguous clusters (mean 2582; range 1299-4865 population) in Southern Kapilbastu district, are eligible if they consent to menstrual monitoring, are resident, married, aged 13-49 years and able to respond to questions. After 1-2 missed menses and a positive pregnancy test, consenting women < 20 weeks' gestation, who plan to reside locally for most of the pregnancy, enrol into trial follow-up. Interventions comprise two home-counselling visits (at 12-21 and 22-26 weeks' gestation) with iron folic acid (IFA) supplement dosage tailored to women's haemoglobin concentration, plus monthly PLA women's group meetings using a dialogical problem-solving approach to engage pregnant women and their families. Home visits and PLA meetings will be facilitated by auxiliary nurse midwives. The hypothesis is as follows: Haemoglobin of women at 30 ± 2 weeks' gestation is ≥ 0.4 g/dL higher in the intervention arm than in the control. A sample of 842 women (421 per arm, average 15.6 per cluster) will provide 88% power, assuming SD 1.2, ICC 0.09 and CV of cluster size 0.27. Outcomes are captured at 30 ± 2 weeks gestation. Primary outcome is haemoglobin concentration (g/dL). Secondary outcomes are as follows: anaemia prevalence (%), mid-upper arm circumference (cm), mean probability of micronutrient adequacy (MPA) and number of ANC visits at a health facility. Indicators to assess pathways to impact include number of IFA tablets consumed during pregnancy, intake of energy (kcal/day) and dietary iron (mg/day), a score of bioavailability-enhancing behaviours and recall of one nutrition knowledge indicator. Costs and cost-effectiveness of the intervention will be estimated from a provider perspective. Using constrained randomisation, we allocated clusters to study arms, ensuring similarity with respect to cluster size, ethnicity, religion and distance to a health facility. Analysis is by intention-to-treat at the individual level, using mixed-effects regression. DISCUSSION: Findings will inform Nepal government policy on approaches to increase adherence to IFA, improve diets and reduce anaemia in pregnancy. TRIAL REGISTRATION: ISRCTN 12272130 .

Effectiveness of conditional cash transfers (Afya credits incentive) to retain women in the continuum of care during pregnancy, birth and the postnatal period in Kenya: a cluster-randomised trial.

OBJECTIVES: Given high maternal and child mortality rates, we assessed the impact of conditional cash transfers (CCTs) to retain women in the continuum of care (antenatal care (ANC), delivery at facility, postnatal care (PNC) and child immunisation). DESIGN: We conducted an unblinded 1:1 cluster-randomised controlled trial. SETTING: 48 health facilities in Siaya County, Kenya were randomised. The trial ran from May 2017 to December 2019. PARTICIPANTS: 2922 women were recruited to the control and 2522 to the intervention arm. INTERVENTIONS: An electronic system recorded attendance and triggered payments to the participant's mobile for the intervention arm (US$4.5), and phone credit for the control arm (US$0.5). Eligibility criteria were resident in the catchment area and access to a mobile phone. PRIMARY OUTCOMES: Primary outcomes were any ANC, delivery, any PNC between 4 and 12 months after delivery, childhood immunisation and referral attendance to other facilities for ANC or PNC. Given problems with the electronic system, primary outcomes were obtained from maternal clinic books if participants brought them to data extraction meetings (1257 (50%) of intervention and 1053 (36%) control arm participants). Attendance at referrals to other facilities is not reported because of limited data. RESULTS: We found a significantly higher proportion of appointments attended for ANC (67% vs 60%, adjusted OR (aOR) 1.90; 95% CI 1.36 to 2.66) and child immunisation (88% vs 85%; aOR 1.74; 95% CI 1.10 to 2.77) in intervention than control arm. No intervention effect was seen considering delivery at the facility (90% vs 92%; aOR 0.58; 95% CI 0.25 to 1.33) and any PNC attendance (82% vs 81%; aOR 1.25; 95% CI 0.74 to 2.10) separately. The pooled OR across all attendance types was 1.64 (1.28 to 2.10). CONCLUSIONS: Demand-side financing incentives, such as CCTs, can improve attendance for appointments. However, attention needs to be paid to the technology, the barriers that remain for delivery at facility and PNC visits and encouraging women to attend ANC visits within the recommended WHO timeframe. TRIAL REGISTRATION: NCT03021070.

Improving access to diabetes care for children: An evaluation of the changing diabetes in children project in Kenya and Bangladesh.

BACKGROUND: The changing diabetes in children (CDiC) project is a public-private partnership implemented by Novo Nordisk, to improve access to diabetes care for children with type 1 diabetes. This paper outlines the findings from an evaluation of CDiC in Bangladesh and Kenya, assessing whether CDiC has achieved its objectives in each of six core program components. RESEARCH DESIGN AND METHODS: The Rapid Assessment Protocol for Insulin Access (RAPIA) framework was used to analyze the path of insulin provision and the healthcare infrastructure in place for diagnosis and treatment of diabetes. The RAPIA facilitates a mixed-methods approach to multiple levels of data collection and systems analysis. Information is collected through questionnaires, in-depth interviews and focus group discussions, site visits, and document reviews, engaging a wide range of stakeholders (N = 127). All transcripts were analyzed thematically. RESULTS: The CDiC scheme provides a stable supply of free insulin to children in implementing facilities in Kenya and Bangladesh, and offers a comprehensive package of pediatric diabetes care. However, some elements of the CDiC program were not functioning as originally intended. Transitions away from donor funding and toward government ownership are a particular concern, as patients may incur additional treatment costs, while services offered may be reduced. Additionally, despite subsidized treatment costs, indirect costs remain a substantial barrier to care. CONCLUSION: Public-private partnerships such as the CDiC program can improve access to life-saving medicines. However, our analysis found several limitations, including concerns over the sustainability of the project in both countries. Any program reliant on external funding and delivered in a high-turnover staffing environment will be vulnerable to sustainability concerns.