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Background: The World Health Organization (WHO) encourages all member states to adopt and implement a package of essential evidence-based interventions called the Best Buys to reduce the burden of non-communicable diseases (NCDs). To date, little is known about the implementation of national policies and interventions for NCD control in the WHO member states in sub-Saharan Africa. Our study aimed to evaluate the implementation of national policies and interventions (WHO Best Buys) for non-communicable disease prevention and control in Ghana. Methods: This was explanatory mixed methods research which started with a document review of Ghana's WHO Best Buys scores from the 2015, 2017, 2018, 2020 and 2022 WHO NCD Progress Monitor Reports. Thereafter, we conducted 25 key informant interviews and one focus group discussion (11 participants) with key policymakers and stakeholders in the NCD landscape in Ghana to understand the implementation of the NCD policies and interventions, and the policy implementation gaps and challenges faced. Data from the NCD Progress reports were presented using mean scores whilst the qualitative data was analysed thematically. Results: Ghana has shown some advancements in the implementation of the WHO Best Buys measures. Ghana's implementation scores for 2015, 2017, 2020 and 2022 were 5.0, 9.0, 5.0 and 5.5 respectively, against the mean implementation scores of 7.6/19 for lower-middle-income countries and 9.5/19 for upper-middle-income countries. Efforts to decrease major risk factors such as excessive alcohol consumption and unhealthy diet have been progressing slowly. The most common challenges were related to a) the role of socio-cultural factors, b) stakeholder engagement, c) enforcement and implementation of public health policies, d) implementation guidelines, e) public awareness and education on NCDs, f) financing of NCD prevention and control, g) curative-centered health systems, and h) over-centralization of NCD care. Conclusion: Ghana has made progress in adopting the WHO Best Buys targeting risk factors of NCDs. However, the country faces contextual barriers to effective implementation. With the retrogression of some measures over time despite making progress in some earlier years, further investigation is needed to identify facilitators for sustained implementation of the WHO Best Buys interventions. [ABSTRACT FROM AUTHOR]

Primary schools are key settings for social–emotional and mental health promotion. Reviews have assessed the effectiveness of primary school interventions delivered universally to all pupils for improving child social–emotional and mental health outcomes. This is the first study to review economic evaluations of such interventions and their value for money, which is key for informing policy. Peer-reviewed English language publications were systematically searched from database inception dates until 17 October 2022. We included economic evaluations of universal primary school interventions, or interventions with a universal component, to improve social–emotional and mental health outcomes in primary school children—regardless of evaluation methods or location. Key data and results were extracted from included studies for descriptive and narrative synthesis. Extracted costs were converted to International Dollars (Int$) and inflated to the year 2021. The reporting quality of included studies was appraised using the 2022 CHEERS checklist. Our review was prospectively registered on PROSPERO (CRD42020190148) and funded by the UK Economic and Social Research Council (ES/T005149/1). A total of 25 economic evaluations were included for analysis in our review. Full economic evaluations combining both costs and outcomes comprised 20 of the 25 evaluations, of which 16 used comparable outcomes. The remaining five economic evaluations were cost analyses (partial). Study quality varied substantially and was higher amongst full economic evaluations. Evaluated interventions consisted primarily of programmes and curricula (n = 9) and universal interventions combining a targeted component (n = 5), amongst other intervention types such as teacher practices (n = 3). Average annual costs per child varied substantially (Int$18.7-Int$83,656) across intervention types. Universal interventions combining a targeted component were the least costly (Int$26.9-Int$66.8), along with an intervention designed to improve school operational culture (Int$46.0), and most of the programmes and curricula evaluated (Int$21.4-Int$396). All except for one of the 16 full economic evaluations using comparable outcomes found interventions were cost-effective (cost-saving–Int$25,463/QALY) relative to country cost-effectiveness thresholds or yielded positive returns on investment (Int$1.31–11.55 for each Int$1 invested) compared with usual practice. We identified several low-cost interventions that likely provide good value for money and should be considered by policymakers in high-income countries. However, there is a need for more economic evaluations in low- and middle-income countries, and a need to improve study reporting quality and better value outcomes more generally. [ABSTRACT FROM AUTHOR]

Background: Despite improvements, the prevalence of HIV, syphilis, and hepatitis B remains high in Asia. These sexually transmitted infections (STIs) can be transmitted from infected mothers to their children. Antenatal screening and treatment are effective interventions to prevent mother-to-child transmission (MTCT), but coverage of antenatal screening remains low. Understanding factors influencing antenatal screening is essential to increase its uptake and design effective interventions. This systematic literature review aims to investigate barriers and facilitators to antenatal screening for HIV, syphilis, and hepatitis B in Asia. Methods: We conducted a systematic review by searching Ovid (MEDLINE, Embase, PsycINFO), Scopus, Global Index Medicus and Web of Science for published articles between January 2000 and June 2023, and screening abstracts and full articles. Eligible studies include peer-reviewed journal articles of quantitative, qualitative and mixed-method studies that explored factors influencing the use of antenatal screening for HIV, syphilis or hepatitis B in Asia. We extracted key information including study characteristics, sample, aim, identified barriers and facilitators to screening. We conducted a narrative synthesis to summarise the findings and presented barriers and facilitators following Andersen's conceptual model. Results: The literature search revealed 23 articles suitable for inclusion, 19 used quantitative methods, 3 qualitative and one mixed method. We found only three studies on syphilis screening and one on hepatitis B. The analysis demonstrates that antenatal screening for HIV in Asia is influenced by many barriers and facilitators including (1) predisposing characteristics of pregnant women (age, education level, knowledge) (2) enabling factors (wealth, place of residence, husband support, health facilities characteristics, health workers support and training) (3) need factors of pregnant women (risk perception, perceived benefits of screening). Conclusion: Knowledge of identified barriers to antenatal screening may support implementation of appropriate interventions to prevent MTCT and help countries achieve Sustainable Development Goals' targets for HIV and STIs. [ABSTRACT FROM AUTHOR]

Background: Anemia is estimated to cause 115,000 maternal deaths each year. In Nepal, 46% of pregnant women have anemia. As part of an integrated anemia-prevention strategy, family engagement and counseling of pregnant women can increase compliance to iron folic acid tablets, but marginalized women often have lower access to these interventions. We implemented the VALID (Virtual antenatal intervention for improved diet and iron intake) randomized controlled trial to test a family-focused virtual counseling mHealth intervention designed to inclusively increase iron folic acid compliance in rural Nepal; here we report findings from our process evaluation research. Methods: We conducted semi structured interviews with 20 pregnant women who had received the intervention, eight husbands, seven mothers-in-laws and four health workers. We did four focus groups discussions with intervention implementers, 39 observations of counseling, and used routine monitoring data in our evaluation. We used inductive and deductive analysis of qualitative data, and descriptive statistics of monitoring data. Results: We were able to implement the intervention largely as planned and all participants liked the dialogical counseling approach and use of story-telling to trigger conversation. However, an unreliable and inaccessible mobile network impeded training families about how to use the mobile device, arrange the counseling time, and conduct the counseling. Women were not equally confident using mobile devices, and the need to frequently visit households to troubleshoot negated the virtual nature of the intervention for some. Women's lack of agency restricted both their ability to speak freely and their mobility, which meant that some women were unable to move to areas with better mobile reception. It was difficult for some women to schedule the counseling, as there were competing demands on their time. Family members were difficult to engage because they were often working outside the home; the small screen made it difficult to interact, and some women were uncomfortable speaking in front of family members. Conclusions: It is important to understand gender norms, mobile access, and mobile literacy before implementing an mHealth intervention. The contextual barriers to implementation meant that we were not able to engage family members as much as we had hoped, and we were not able to minimize in-person contact with families. We recommend a flexible approach to mHealth interventions which can be responsive to local context and the situation of participants. Home visits may be more effective for those women who are most marginalized, lack confidence in using a mobile device, and where internet access is poor. [ABSTRACT FROM AUTHOR]

Background: Engaging communities is an important component of multisectoral action to address the growing burden of non-communicable diseases (NCDs) in low- and middle-income countries. We conducted research with non-communicable disease stakeholders in Bangladesh to understand how a community-led intervention which was shown to reduce the incidence of type 2 diabetes in rural Bangladesh could be scaled-up. Methods: We purposively sampled any actor who could have an interest in the intervention, or that could affect or be affected by the intervention. We interviewed central level stakeholders from donor agencies, national health policy levels, public, non-governmental, and research sectors to identify scale-up mechanisms. We interviewed community health workers, policy makers, and non-governmental stakeholders, to explore the feasibility and acceptability of implementing the suggested mechanisms. We discussed scale-up options in focus groups with community members who had attended a community-led intervention. We iteratively developed our data collection tools based on our analysis and re-interviewed some participants. We analysed the data deductively using a stakeholder analysis framework, and inductively from codes identified in the data. Results: Despite interest in addressing NCDs, there was a lack of a clear community engagement strategy at the government level, and most interventions have been implemented by non-governmental organisations. Many felt the Ministry of Health and Family Welfare should lead on community engagement, and NCD screening and referral has been added to the responsibilities of community health workers and health volunteers. Yet there remains a focus on reproductive health and NCD diagnosis and referral instead of prevention at the community level. There is potential to engage health volunteers in community-led interventions, but their present focus on engaging women for reproductive health does not fit with community needs for NCD prevention. Conclusions: Research highlighted the need for a preventative community engagement strategy to address NCDs, and the potential to utilise existing cadres to scale-up community-led interventions. It will be important to work with key stakeholders to address gender issues and ensure flexibility and responsiveness to community concerns. We indicate areas for further implementation research to develop scaled-up models of community-led interventions to address NCDs. [ABSTRACT FROM AUTHOR]

The “Diabetes: Community-led Awareness, Response and Evaluation” (D:Clare) trial aims to scale up and replicate an evidence-based participatory learning and action cycle intervention in Bangladesh, to inform policy on population-level T2DM prevention and control. The trial was originally designed as a stepped-wedge cluster randomised controlled trial, with the interventions running from March 2020 to September 2022. Twelve clusters were randomly allocated (1:1) to implement the intervention at months 1 or 12 in two steps, and evaluated through three cross-sectional surveys at months 1, 12 and 24. However, due to the COVID-19 pandemic, we suspended project activities on the 20th of March 2020. As a result of the changed risk landscape and the delays introduced by the COVID-19 pandemic, we changed from the stepped-wedge design to a wait-list parallel arm cluster RCT (cRCT) with baseline data. We had four key reasons for eventually agreeing to change designs: equipoise, temporal bias in exposure and outcomes, loss of power and time and funding considerations. Trial registration. Registered on 31 October 2019. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

There is an urgent need for population-based interventions to slow the growth of the diabetes epidemic in low-and middle-income countries. We tested the effectiveness of a population-based mHealth voice messaging intervention for T2DM prevention and control in rural Bangladesh through a cluster randomised controlled trial. mHealth improved knowledge and awareness about T2DM but there was no detectable effect on T2DM occurrence. We conducted mixed-methods research to understand this result. Exposure to messages was limited by technological faults, high frequency of mobile phone number changes, message fatigue and (mis)perceptions that messages were only for those who had T2DM. Persistent social norms, habits and desires made behaviour change challenging, and participants felt they would be more motivated by group discussions than mHealth messaging alone. Engagement with mHealth messages for T2DM prevention and control can be increased by (1) sending identifiable messages from a trusted source (2) using participatory design of mHealth messages to inform modelling of behaviours and increase relevance to the general population (3) enabling interactive messaging. mHealth messaging is likely to be most successful if implemented as part of a multi-sectoral, multi-component approach to address T2DM and non-communicable disease risk factors. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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 . [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Adolescents with depression need access to culturally relevant psychological treatment. In many low- and middle-income countries treatments are only accessible to a minority. We adapted group interpersonal therapy (IPT) for adolescents to be delivered through schools in Nepal. Here we report IPT's feasibility, acceptability, and cost. Methods: We recruited 32 boys and 30 girls (aged 13–19) who screened positive for depression. IPT comprised of two individual and 12 group sessions facilitated by nurses or lay workers. Using a pre-post design we assessed adolescents at baseline, post-treatment (0–2 weeks after IPT), and follow-up (8–10 weeks after IPT). We measured depressive symptoms with the Depression Self-Rating Scale (DSRS), and functional impairment with a local tool. To assess intervention fidelity supervisors rated facilitators' IPT skills across 27/90 sessions using a standardised checklist. We conducted qualitative interviews with 16 adolescents and six facilitators post-intervention, and an activity-based cost analysis from the provider perspective. Results: Adolescents attended 82.3% (standard deviation 18.9) of group sessions. All were followed up. Depression and functional impairment improved between baseline and follow-up: DSRS score decreased by 81% (95% confidence interval 70–95); functional impairment decreased by 288% (249–351). In total, 95.3% of facilitator IPT skills were rated superior/satisfactory. Adolescents found the intervention useful and acceptable, although some had concerns about privacy in schools. The estimate of intervention unit cost was US $96.9 with facilitators operating at capacity. Conclusions: School-based group IPT is feasible and acceptable in Nepal. Findings support progression to a randomised controlled trial to assess effectiveness and cost-effectiveness. [ABSTRACT FROM AUTHOR]

Background: In many high-income countries, life expectancy (LE) has increased, with women outliving men. This gender gap in LE (GGLE) has been explained with biological factors, healthy behaviours, health status, and sociodemographic characteristics, but little attention has been paid to the role of public health policies that include/affect these factors. This study aimed to assess the contributions of avoidable causes of death, as a measure of public health policies and healthcare quality impacts, to the GGLE and its temporal changes in the UK. We also estimated the contributions of avoidable causes of death into the gap in LE between countries in the UK. Methods: We obtained annual data on underlying causes of death by age and sex from the World Health Organization mortality database for the periods 2001–2003 and 2014–2016. We calculated LE at birth using abridged life tables. We applied Arriaga's decomposition method to compute the age- and cause-specific contributions into the GGLE in each period and its changes between two periods as well as the cross-country gap in LE in the 2014–2016 period. Results: Avoidable causes had greater contributions than non-avoidable causes to the GGLE in both periods (62% in 2001–2003 and 54% in 2014–2016) in the UK. Among avoidable causes, ischaemic heart disease (IHD) followed by injuries had the greatest contributions to the GGLE in both periods. On average, the GGLE across the UK narrowed by about 1.0 year between 2001–2003 and 2014–2016 and three avoidable causes of IHD, lung cancer, and injuries accounted for about 0.8 years of this reduction. England & Wales had the greatest LE for both sexes in 2014–2016. Among avoidable causes, injuries in men and lung cancer in women had the largest contributions to the LE advantage in England & Wales compared to Northern Ireland, while drug-related deaths compared to Scotland in both sexes. Conclusion: With avoidable causes, particularly preventable deaths, substantially contributing to the gender and cross-country gaps in LE, our results suggest the need for behavioural changes by implementing targeted public health programmes, particularly targeting younger men from Scotland and Northern Ireland. [ABSTRACT FROM AUTHOR]

Background: Type 2 diabetes mellitus poses a major health challenge worldwide and in low-income countries such as Bangladesh, however little is known about the care-seeking of people with diabetes. We sought to understand the factors that affect care-seeking and diabetes management in rural Bangladesh in order to make recommendations as to how care could be better delivered.Methods: Survey data from a community-based random sample of 12,047 adults aged 30 years and above identified 292 individuals with a self-reported prior diagnosis of diabetes. Data on health seeking practices regarding testing, medical advice, medication and use of non-allopathic medicine were gathered from these 292 individuals. Qualitative semi-structured interviews and focus group discussions with people with diabetes and semi-structured interviews with health workers explored care-seeking behaviour, management of diabetes and perceptions on quality of care. We explore quality of care using the WHO model with the following domains: safe, effective, patient-centred, timely, equitable and efficient.Results: People with diabetes who are aware of their diabetic status do seek care but access, particularly to specialist diabetes services, is hindered by costs, time, crowded conditions and distance. Locally available services, while more accessible, lack infrastructure and expertise. Women are less likely to be diagnosed with diabetes and attend specialist services. Furthermore costs of care and dissatisfaction with health care providers affect medication adherence.Conclusion: People with diabetes often make a trade-off between seeking locally available accessible care and specialised care which is more difficult to access. It is vital that health services respond to the needs of patients by building the capacity of local health providers and consider practical ways of supporting diabetes care.Trial Registration: ISRCTN41083256 . Registered on 30/03/2016. [ABSTRACT FROM AUTHOR]

Background: An estimated 463 million people globally have diabetes, with the prevalence growing in low-and middle-income settings, such as Bangladesh. Given the need for context-appropriate interventions to prevent type 2 diabetes mellitus (T2DM), the 'Diabetes: Community-led Awareness, Response and Evaluation' (D:Clare) trial will rigorously evaluate the replication and scale-up of a participatory learning and action (PLA) cycle intervention in Bangladesh, to inform policy on population-level T2DM prevention and control.Methods: This is a stepped-wedge cluster randomised controlled trial, with integrated process and economic evaluations, conducted from March 2020 to September 2022. The trial will evaluate a community-based four-phase PLA cycle intervention focused on prevention and control of T2DM implemented over 18 months, against a control of usual care. Twelve clusters will be randomly allocated (1:1) to implement the intervention at project month 1 or 12. The intervention will be evaluated through three cross-sectional surveys at months 1, 12 and 24. The trial will be conducted in Alfadanga Upazila, Faridpur district, with an estimated population of 120,000. Clusters are defined as administrative geographical areas, with approximately equal populations. Each of the six unions in Alfadanga will be divided into two clusters, forming 12 clusters in total. Given the risk of inter-cluster contamination, evaluation surveys will exclude villages in border areas. Participants will be randomly sampled, independently for each survey, from a population census conducted in January 2020. The primary outcome is the combined prevalence of intermediate hyperglycaemia and T2DM, measured through fasting and 2-h post-glucose load blood tests. A total of 4680 participants provide 84% power to detect a 30% reduction in the primary outcome, assuming a baseline of 30% and an ICC of 0.07. The analysis will be by intention-to-treat, comparing intervention and control periods across all clusters, adjusting for geographical clustering.Discussion: This study will provide further evidence of effectiveness for community-based PLA to prevent T2DM at scale in a rural Bangladesh setting. However, we encountered several challenges in applying the stepped-wedge design to our research context, with particular consideration given to balancing seasonality, timing and number of steps and estimation of partial versus full effect.Trial Registration: ISRCTN: ISRCTN42219712 . Registered on 31 October 2019. [ABSTRACT FROM AUTHOR]

WHO recommends participatory learning and action cycles with women's groups as a cost-effective strategy to reduce neonatal deaths. Coverage is a determinant of intervention effectiveness, but little is known about why cost-effectiveness estimates vary significantly. This article reanalyses primary cost data from six trials in India, Nepal, Bangladesh and Malawi to describe resource use, explore reasons for differences in costs and cost-effectiveness ratios, and model the cost of scale-up. Primary cost data were collated, and costing methods harmonized. Effectiveness was extracted from a meta-analysis and converted to neonatal life-years saved. Cost-effectiveness ratios were calculated from the provider perspective compared with current practice. Associations between unit costs and cost-effectiveness ratios with coverage, scale and intensity were explored. Scale-up costs and outcomes were modelled using local unit costs and the meta-analysis effect estimate for neonatal mortality. Results were expressed in 2016 international dollars. The average cost was $203 (range: $61-$537) per live birth. Start-up costs were large, and spending on staff was the main cost component. The cost per neonatal life-year saved ranged from $135 to $1627. The intervention was highly cost-effective when using income-based thresholds. Variation in cost-effectiveness across trials was strongly correlated with costs. Removing discounting of costs and life-years substantially reduced all cost-effectiveness ratios. The cost of rolling out the intervention to rural populations ranges from 1.2% to 6.3% of government health expenditure in the four countries. Our analyses demonstrate the challenges faced by economic evaluations of community-based interventions evaluated using a cluster randomized controlled trial design. Our results confirm that women's groups are a cost-effective and potentially affordable strategy for improving birth outcomes among rural populations. [ABSTRACT FROM AUTHOR]

Background: Catastrophic health expenditures (CHE) are of concern to policy makers and can prevent individuals accessing effective health care services. The exposure of households to CHE is one of the indices used to evaluate and address the level of financial risk protection in health systems, which is a key priority in the global health policy agenda and an indicator of progress toward the UN Sustainable Development Goal for Universal Health Coverage. This study aims to assess the CHE at population and disease levels and its influencing factors in Iran. Methods: This study is a systematic review and meta-analysis. The following keywords and their Persian equivalents were used for the review: Catastrophic Health Expenditures; Health Equity; Health System Equity; Financial Contribution; Health Expenditures; Financial Protection; Financial Catastrophe; and Health Financing Equity. These keywords were searched with no time limit until October 2019 in PubMed, Web of Science, Scopus, ProQuest, ScienceDirect, Embase, and the national databases of Iran. Studies that met a set of inclusion criteria formed part of the meta-analysis and results were analyzed using a random-effects model. Results: The review identified 53 relevant studies, of which 40 are conducted at the population level and 13 are disease specific. At the population level, the rate of CHE is 4.7% (95% CI 4.1% to 5.3%, n = 52). Across diseases, the percentage of CHE is 25.3% (95% CI 11.7% to 46.5%, n = 13), among cancer patients, while people undergoing dialysis face the highest percentage of CHE (54.5%). The most important factors influencing the rate of CHE in these studies are health insurance status, having a household member aged 60–65 years or older, gender of the head of household, and the use of inpatient and outpatient services. Conclusion: The results suggest that catastrophic health spending in Iran has increased from 2001 to 2015 and has reached its highest levels in the last 5 years. It is therefore imperative to review and develop fair health financing policies to protect people against financial hardship. This review and meta-analysis provides evidence to help inform effective health financing strategies and policies to prioritise high-burden disease groups and address the determinants of CHE. [ABSTRACT FROM AUTHOR]

Objectives The current study aimed to assess the factors associated with health-related quality of life (HRQoL) and health utility (HU) among patients with diabetes in Zabol, Southeast Iran. Methods Among patients referred to Zabol city diabetes clinic, a total of 213 consecutive patients 18 years and older consent to participate in the study in 2015. The Persian version of EuroQol-5D-3L (EQ-5D-3L) using the UK preference weights was applied to derive HU. Logistic regression and ordinary least squares were used for data analysis. The STATA version 13 (StataCorp LP, College Station, TX, USA) was used for statistical analysis. Results The highest and lowest proportions of "some or extreme problems" were seen in pain/discomfort (86.6%) and self-care (27.8%) dimensions of the EQ-5D-3L, respectively. About 33% of women and 14% of men rated their health worse than death (p=0.002). The mean EQ-5D-3L index score and visual analogue scale were 0.37 (95% CI: 0.31-0.42) and 51.6 (95% CI: 48.7-54.5), respectively. Older age at diagnosis, longer duration of diabetes, lower education, and history of macrovascular complications were associated with lower HRQoL and HU. Conclusion This study highlights the importance of education and diabetes-related complications in HRQoL/HU of diabetes people. The findings suggest that urgent interventions are required to improve HRQoL/HU of diabetes patients in Zabol. Moreover, our results provide inputs for future economic evaluation studies among diabetes patients with similar socioeconomic status in Iran. [ABSTRACT FROM AUTHOR]

Background: Although spatial effects contribute to inequalities in health care service utilisation and other health outcomes in low and middle income countries, there have been no attempts to incorporate the impact of neighbourhood effects into equity analyses based on concentration indices. This study aimed to decompose and estimate the contribution of spatial effects on inequalities in uptake of HIV tests in Malawi. Methods: We developed a new method of reflecting spatial effects within the concentration index using a spatial weight matrix. Spatial autocorrelation is presented using a spatial lag model. We use data from the Malawi Demographic Health Survey (n = 24,562) to illustrate the new methodology. Need variables such as 'Any STI last 12 month', 'Genital sore/ulcer', 'Genital discharge' and non need variables such as Education, Literacy, Wealth, Marriage, and education were used in the concentration index. Using our modified concentration index that incorporates spatial effects, we estimate inequalities in uptake of HIV testing amongst both women and men living in Malawi in 2015–2016, controlling for need and non-need variables. Results: For women, inequalities due to need variables were estimated at − 0.001 and − 0.0009 (pro-poor) using the probit and new spatial probit estimators, respectively, whereas inequalities due to non-need variables were estimated at 0.01 and 0.0068 (pro-rich) using the probit and new spatial probit estimators. The results suggest that spatial effects increase estimated inequalities in HIV uptake amongst women. Horizontal inequity was almost identical (0.0103 vs 0.0102) after applying the spatial lag model. For men, inequalities due to need variables were estimated at − 0.0002 using both the probit and new spatial probit estimators; however, inequalities due to non-need variables were estimated at − 0.006 and − 0.0074 for the probit and new spatial probit models. Horizontal inequity was the same for both models (− 0.0057). Conclusion: Our findings suggest that men from lower socioeconomic groups are more likely to receive an HIV test after adjustment for spatial effects. This study develops a novel methodological approach that incorporates estimation of spatial effects into a common approach to equity analysis. We find that a significant component of inequalities in HIV uptake in Malawi driven by non-need factors can be explained by spatial effects. When the spatial model was applied, the inequality due to non need in Lilongwe for men and horizontal inequity in Salima for women changed the sign. This approach can be used to explore inequalities in other contexts and settings to better understand the impact of spatial effects on health service use or other health outcomes, impacting on recommendations for service delivery. [ABSTRACT FROM AUTHOR]

Introduction A wealth of evidence from a range of country settings indicates that antenatal care, facility delivery and postnatal care can reduce maternal and child mortality and morbidity in high-burden settings. However, the utilisation of these services by pregnant women, particularly in low/middle-income country settings, is well below that recommended by the WHO. The Afya trial aims to assess the impact, cost-effectiveness and scalability of conditional cash transfers to promote increased utilisation of these services in rural Kenya and thus retain women in the continuum of care during pregnancy, birth and the postnatal period. This protocol describes the planned economic evaluation of the Afya trial. Methods and analysis The economic evaluation will be conducted from the provider perspective as a within-trial analysis to evaluate the incremental costs and health outcomes of the cash transfer programme compared with the status quo. Incremental cost-effectiveness ratios will be presented along with a cost-consequence analysis where the incremental costs and all statistically significant outcomes will be listed separately. Sensitivity analyses will be undertaken to explore uncertainty and to ensure that results are robust. A fiscal space assessment will explore the affordability of the intervention. In addition, an analysis of equity impact of the intervention will be conducted. Ethics and dissemination The study has received ethics approval from the Maseno University Ethics Review Committee, REF MSU/DRPI/MUERC/00294/16. The results of the economic evaluation will be disseminated in a peer-reviewed journal and presented at a relevant international conference. [ABSTRACT FROM AUTHOR]

Introduction To progress towards Universal Health Coverage (UHC), countries will need to define a health benefits package of services free at the point of use. Financial risk protection is a core component of UHC and should therefore be considered a key dimension of health benefits packages. Allocative efficiency modelling tools can support national analytical capacity to inform an evidencebased selection of services, but none are currently able to estimate financial risk protection. A review of existing methods used to measure financial risk protection can facilitate their inclusion in modelling tools so that the latter can become more relevant to national decision making in light of UHC. Methods and analysis This protocol proposes to conduct a scoping review of existing methods used to measure financial risk protection and assess their potential to inform the selection of services in a health benefits package. The proposed review will follow the methodological framework developed by Arksey and O'Malley and the subsequent recommendations made by Levac et al. Several databases will be systematically searched including: (1) PubMed; (2) Scopus; (3) Web of Science and (4) Google Scholar. Grey literature will also be scanned, and the bibliography of all selected studies will be hand searched. Following the selection of studies according to defined inclusion and exclusion criteria, key characteristics will be collected from the studies using a data extraction tool. Key characteristics will include the type of method used, geographical region of focus and application to specific services or packages. The extracted data will then be charted, collated, reported and summarised using descriptive statistics, a thematic analysis and graphical presentations. Ethics and dissemination The scoping review proposed in this protocol does not require ethical approval. The final results will be disseminated via publication in a peerreviewed journal, conference presentations and shared with key stakeholders. [ABSTRACT FROM AUTHOR]

Introduction Type 2 diabetes mellitus (T2DM) remains one of the most common chronic diseases of adulthood which creates high degrees of morbidity and mortality worldwide. The incidence of T2DM continues to rise and recently, mHealth interventions have been increasingly used in the prevention, monitoring and management of T2DM. The aim of this study is to systematically review the published evidence on cost and cost-effectiveness of mHealth interventions for T2DM, as well as assess the quality of reporting of the evidence. Methods and analysis A comprehensive review of PubMed, EMBASE, Science Direct and Web of Science of articles published until January 2019 will be conducted. Included studies will be partial or full economic evaluations which provide cost or cost-effectiveness results for mHealth interventions targeting individuals diagnosed with, or at risk of, T2DM. The quality of reporting evidence will be assessed using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist. Results will be presented using a flowchart following the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) guidelines. Graphical and tabulated representations of the results will be created for both descriptive and numerical results. The cost and cost-effectiveness values will be presented as reported by the original studies as well as converted into international dollars to allow comparability. As we are predicting heterogenous results, we will conduct a narrative and interpretive analysis of the data. Ethics and dissemination No formal approval or review of ethics is required for this systematic review as it will involve the collection and analysis of secondary data. This protocol follows the current PRISMA-P guidelines. The review will provide information on the cost and cost-effectiveness of mHealth interventions targeting T2DM. These results will be disseminated through publication and submission to conferences for presentations and posters. PROSPERO registration number CRD42019123476 [ABSTRACT FROM AUTHOR]

Background: The Base of the Pyramid (BoP) project is a public–private partnership initiated by Novo Nordisk that aims to facilitate access to diabetes care for people at the base of the economic pyramid in low- and middle-income countries (LMICs). In Kenya, the BoP, through a partnership model, aims to strengthen five pillars of diabetes care: increased awareness of diabetes; early diagnosis of diabetes; access to quality care by trained professionals; stable and affordable insulin supply; and improved self-management through patient education. Objectives: This study evaluates the extent to which BoP Kenya is scalable and sustainable, whether stakeholders share in its value, and whether BoP Kenya has improved access to diabetes care. Method: The Rapid Assessment Protocol for Insulin Access (RAPIA), an approach developed to provide a broad situational analysis of diabetes care, was used to examine health infrastructure and diabetes care pathways in Kenya. At the national level, the RAPIA was applied in a SWOT analysis of the BoP through in-depth interviews with key stakeholders. At individual and county health system levels, RAPIA was adapted to explore the impact of the BoP on access to diabetes care through a comparison of an intervention and control county. Results: The BoP was implemented in 28 of 47 counties in Kenya. Meru, a county where BoP was implemented, had 35 of 62 facilities (56%) participating in the BoP. Of the five pillars of the BoP, most notable progress was made in achieving the fourth (stable and affordable insulin supply). A price ceiling of 500KSh (US$5) per vial of insulin was established in the intervention county, with greater fluctuation and stock-outs in the non-intervention county. Despite reduced insulin costs, many patients with diabetes could not afford the additive expenses of monitoring, medicines, and travel. Less progress was made over the other pillars, which also faced challenges to sustainability and scalability. Conclusion: In the context of the rising prevalence of non-communicable diseases in LMICs, cross-sector approaches to improving access to care are increasingly needed. Public–private partnerships such as the BoP are necessary but not sufficient to ensure access to health care for people with diabetes at the base of the economic pyramid in Kenya. [ABSTRACT FROM AUTHOR]

Background: mHealth interventions have huge potential to reach large numbers of people in resource poor settings but have been criticised for lacking theory-driven design and rigorous evaluation. This paper shares the process we developed when developing an awareness raising and behaviour change focused mHealth intervention, through applying behavioural theory to in-depth qualitative research. It addresses an important gap in research regarding the use of theory and formative research to develop an mHealth intervention. Objectives: To develop a theory-driven contextually relevant mHealth intervention aimed at preventing and managing diabetes among the general population in rural Bangladesh. Methods: In-depth formative qualitative research (interviews and focus group discussions) were conducted in rural Faridpur. The data were analysed thematically and enablers and barriers to behaviour change related to lifestyle and the prevention of and management of diabetes were identified. In addition to the COM-B (Capability, Opportunity, Motivation-Behaviour) model of behaviour change we selected the Transtheoretical Domains Framework (TDF) to be applied to the formative research in order to guide the development of the intervention. Results: A six step-process was developed to outline the content of voice messages drawing on in-depth qualitative research and COM-B and TDF models. A table to inform voice messages was developed and acted as a guide to scriptwriters in the production of the messages. Conclusions: In order to respond to the local needs of a community in Bangladesh, a process of formative research, drawing on behavioural theory helped in the development of awareness-raising and behaviour change mHealth messages through helping us to conceptualise and understand behaviour (for example by categorising behaviour into specific domains) and subsequently identify specific behavioural strategies to target the behaviour. [ABSTRACT FROM AUTHOR]

Background: Somalia has been affected by conflict since 1991, with children aged <5 years presenting a high acute malnutrition prevalence. Cash-based interventions (CBIs) have been used in this context since 2011, despite sparse evidence of their nutritional impact. We aimed to understand whether a CBI would reduce acute malnutrition and its risk factors.Methods and Findings: We implemented a non-randomised cluster trial in internally displaced person (IDP) camps, located in peri-urban Mogadishu, Somalia. Within 10 IDP camps (henceforth clusters) selected using a humanitarian vulnerability assessment, all households were targeted for the CBI. Ten additional clusters located adjacent to the intervention clusters were selected as controls. The CBI comprised a monthly unconditional cash transfer of US$84.00 for 5 months, a once-only distribution of a non-food-items kit, and the provision of piped water free of charge. The cash transfers started in May 2016. Cash recipients were female household representatives. In March and September 2016, from a cohort of randomly selected households in the intervention (n = 111) and control (n = 117) arms (household cohort), we collected household and individual level data from children aged 6-59 months (155 in the intervention and 177 in the control arms) and their mothers/primary carers, to measure known malnutrition risk factors. In addition, between June and November 2016, data to assess acute malnutrition incidence were collected monthly from a cohort of children aged 6-59 months, exhaustively sampled from the intervention (n = 759) and control (n = 1,379) arms (child cohort). Primary outcomes were the mean Child Dietary Diversity Score in the household cohort and the incidence of first episode of acute malnutrition in the child cohort, defined by a mid-upper arm circumference < 12.5 cm and/or oedema. Analyses were by intention-to-treat. For the household cohort we assessed differences-in-differences, for the child cohort we used Cox proportional hazards ratios. In the household cohort, the CBI appeared to increase the Child Dietary Diversity Score by 0.53 (95% CI 0.01; 1.05). In the child cohort, the acute malnutrition incidence rate (cases/100 child-months) was 0.77 (95% CI 0.70; 1.21) and 0.92 (95% CI 0.53; 1.14) in intervention and control arms, respectively. The CBI did not appear to reduce the risk of acute malnutrition: unadjusted hazard ratio 0.83 (95% CI 0.48; 1.42) and hazard ratio adjusted for age and sex 0.94 (95% CI 0.51; 1.74). The CBI appeared to increase the monthly household expenditure by US$29.60 (95% CI 3.51; 55.68), increase the household Food Consumption Score by 14.8 (95% CI 4.83; 24.8), and decrease the Reduced Coping Strategies Index by 11.6 (95% CI 17.5; 5.96). The study limitations were as follows: the study was not randomised, insecurity in the field limited the household cohort sample size and collection of other anthropometric measurements in the child cohort, the humanitarian vulnerability assessment data used to allocate the intervention were not available for analysis, food market data were not available to aid results interpretation, and the malnutrition incidence observed was lower than expected.Conclusions: The CBI appeared to improve beneficiaries' wealth and food security but did not appear to reduce acute malnutrition risk in IDP camp children. Further studies are needed to assess whether changing this intervention, e.g., including specific nutritious foods or social and behaviour change communication, would improve its nutritional impact.Trial Registration: ISRCTN Registy ISRCTN29521514. [ABSTRACT FROM AUTHOR]

Abstract: Unconditional cash transfers (UCTs) are used as a humanitarian intervention to prevent acute malnutrition, despite a lack of evidence about their effectiveness. In Niger, UCT and supplementary feeding are given during the June–September “lean season,” although admissions of malnourished children to feeding programmes may rise from March/April. We hypothesised that earlier initiation of the UCT would reduce the prevalence of global acute malnutrition (GAM) in children 6–59 months old in beneficiary households and at population level. We conducted a 2‐armed cluster‐randomised controlled trial in which the poorest households received either the standard UCT (4 transfers between June and September) or a modified UCT (6 transfers from April); both providing 130,000 FCFA/£144 in total. Eligible individuals (pregnant and lactating women and children 6–<24 months old) in beneficiary households in both arms also received supplementary food between June and September. We collected data in March/April and October/November 2015. The modified UCT plus 4 months supplementary feeding did not reduce the prevalence of GAM compared with the standard UCT plus 4 months supplementary feeding (adjusted odds ratios 1.09 (95% CI [0.77, 1.55], p = 0.630) and 0.93 (95% CI [0.58, 1.49], p = 0.759) among beneficiaries and the population, respectively). More beneficiaries receiving the modified UCT plus supplementary feeding reported adequate food access in April and May (p < 0.001) but there was no difference in endline food security between arms. In both arms and samples, the baseline prevalence of GAM remained elevated at endline (p > 0.05), despite improved food security (p < 0.05), possibly driven by increased fever/malaria in children (p < 0.001). Nonfood related drivers of malnutrition, such as disease, may limit the effectiveness of UCTs plus supplementary feeding to prevent malnutrition in this context. Caution is required in applying the findings of this study to periods of severe food insecurity. [ABSTRACT FROM AUTHOR]

Introduction Type 2 diabetes mellitus (T2DM) is one of the leading causes of death and disability worldwide, generating substantial economic burden for people with diabetes and their families, and to health systems and national economies. Bangladesh has one of the largest numbers of adults with diabetes in the South Asian region. This paper describes the planned economic evaluation of a three-arm cluster randomised control trial of mHealth and community mobilisation interventions to prevent and control T2DM and non-communicable diseases' risk factors in rural Bangladesh (D-Magic trial). Methods and analysis The economic evaluation will be conducted as a within-trial analysis to evaluate the incremental costs and health outcomes of mHealth and community mobilisation interventions compared with the status quo. The analyses will be conducted from a societal perspective, assessing the economic impact for all parties affected by the interventions, including implementing agencies (programme costs), healthcare providers, and participants and their households. Incremental costeffectiveness ratios (ICERs) will be calculated in terms of cost per case of intermediate hyperglycaemia and T2DM prevented and cost per case of diabetes prevented among individuals with intermediate hyperglycaemia at baseline and cost per mm Hg reduction in systolic blood pressure. In addition to ICERs, the economic evaluation will be presented as a cost-consequence analysis where the incremental costs and all statistically significant outcomes will be listed separately. Robustness of the results will be assessed through sensitivity analyses. In addition, an analysis of equity impact of the interventions will be conducted. Ethics and dissemination The approval to conduct the study was obtained by the University College London Research Ethics Committee (4766/002) and by the Ethical Review Committee of the Diabetic Association of Bangladesh (BADAS-ERC/EC/t5100246). The findings of this study will be disseminated through different means within academia and the wider policy sphere. [ABSTRACT FROM AUTHOR]

Abstract: Introduction: With limited funds available, meeting global health targets requires countries to both mobilize and prioritize their health spending. Within this context, countries have recognized the importance of allocating funds for HIV as efficiently as possible to maximize impact. Over the past six years, the governments of 23 countries in Africa, Asia, Eastern Europe and Latin America have used the Optima HIV tool to estimate the optimal allocation of HIV resources. Methods: Each study commenced with a request by the national government for technical assistance in conducting an HIV allocative efficiency study using Optima HIV. Each study team validated the required data, calibrated the Optima HIV epidemic model to produce HIV epidemic projections, agreed on cost functions for interventions, and used the model to calculate the optimal allocation of available funds to best address national strategic plan targets. From a review and analysis of these 23 country studies, we extract common themes around the optimal allocation of HIV funding in different epidemiological contexts. Results and discussion: The optimal distribution of HIV resources depends on the amount of funding available and the characteristics of each country's epidemic, response and targets. Universally, the modelling results indicated that scaling up treatment coverage is an efficient use of resources. There is scope for efficiency gains by targeting the HIV response towards the populations and geographical regions where HIV incidence is highest. Across a range of countries, the model results indicate that a more efficient allocation of HIV resources could reduce cumulative new HIV infections by an average of 18% over the years to 2020 and 25% over the years to 2030, along with an approximately 25% reduction in deaths for both timelines. However, in most countries this would still not be sufficient to meet the targets of the national strategic plan, with modelling results indicating that budget increases of up to 185% would be required. Conclusions: Greater epidemiological impact would be possible through better targeting of existing resources, but additional resources would still be required to meet targets. Allocative efficiency models have proven valuable in improving the HIV planning and budgeting process. [ABSTRACT FROM AUTHOR]

Background: Prioritizing investments across health interventions is complicated by the nonlinear relationship between intervention coverage and epidemiological outcomes. It can be difficult for countries to know which interventions to prioritize for greatest epidemiological impact, particularly when budgets are uncertain. Methods: We examined four case studies of HIV epidemics in diverse settings, each with different characteristics. These case studies were based on public data available for Belarus, Peru, Togo, and Myanmar. The Optima HIV model and software package was used to estimate the optimal distribution of resources across interventions associated with a range of budget envelopes. We constructed “investment staircases”, a useful tool for understanding investment priorities. These were used to estimate the best attainable cost-effectiveness of the response at each investment level. Findings: We find that when budgets are very limited, the optimal HIV response consists of a smaller number of ‘core’ interventions. As budgets increase, those core interventions should first be scaled up, and then new interventions introduced. We estimate that the cost-effectiveness of HIV programming decreases as investment levels increase, but that the overall cost-effectiveness remains below GDP per capita. Significance: It is important for HIV programming to respond effectively to the overall level of funding availability. The analytic tools presented here can help to guide program planners understand the most cost-effective HIV responses and plan for an uncertain future. [ABSTRACT FROM AUTHOR]

Background: The prevalence of acute malnutrition is often high in emergency-affected populations and is associated with elevated mortality risk and long-term health consequences. Increasingly, cash transfer programmes (CTP) are used instead of direct food aid as a nutritional intervention, but there is sparse evidence on their nutritional impact. We aim to understand whether CTP reduces acute malnutrition and its known risk factors.Methods/design: A non-randomised, cluster-controlled trial will assess the impact of an unconditional cash transfer of US$84 per month for 5 months, a single non-food items kit, and free piped water on the risk of acute malnutrition in children, aged 6-59 months. The study will take place in camps for internally displaced persons (IDP) in peri-urban Mogadishu, Somalia. A cluster will consist of one IDP camp and 10 camps will be allocated to receive the intervention based on vulnerability targeting criteria. The control camps will then be selected from the same geographical area. Needs assessment data indicates small differences in vulnerability between camps. In each trial arm, 120 households will be randomly sampled and two detailed household surveys will be implemented at baseline and 3 months after the initiation of the cash transfer. The survey questionnaire will cover risk factors for malnutrition including household expenditure, assets, food security, diet diversity, coping strategies, morbidity, WASH, and access to health care. A community surveillance system will collect monthly mid-upper arm circumference measurements from all children aged 6-59 months in the study clusters to assess the incidence of acute malnutrition over the duration of the intervention. Process evaluation data will be compiled from routine quantitative programme data and primary qualitative data collected using key informant interviews and focus group discussions. The UK Department for International Development will provide funding for this study. The European Civil Protection and Humanitarian Aid Operations will fund the intervention. Concern Worldwide will implement the intervention as part of their humanitarian programming.Discussion: This non-randomised cluster controlled trial will provide needed evidence on the role of unconditional CTP in reducing the risk of acute malnutrition among IDP in this context.Trial Registration: ISRCTN29521514 . Registered 19 January 2016. [ABSTRACT FROM AUTHOR]

Background: Neonatal mortality remains unacceptably high in many low and middle-income countries, including India. A community mobilisation intervention using participatory learning and action with women's groups facilitated by Accredited Social Health Activists (ASHAs) was conducted to improve maternal and newborn health. The intervention was evaluated through a cluster-randomised controlled trial conducted in Jharkhand and Odisha, eastern India. This aims to assess the cost-effectiveness this intervention. Methods: Costs were estimated from the provider's perspective and calculated separately for the women's group intervention and for activities to strengthen Village Health Sanitation and Nutrition Committees (VHNSC) conducted in all trial areas. Costs were estimated at 2017 prices and converted to US dollar (USD). The incremental cost-effectiveness ratio (ICER) was calculated with respect to a do-nothing alternative and compared with the WHO thresholds for cost-effective interventions. ICERs were calculated for cases of neonatal mortality and disability-adjusted life years (DALYs) averted. Results: The incremental cost of the intervention was USD 83 per averted DALY (USD 99 inclusive of VHSNC strengthening costs), and the incremental cost per newborn death averted was USD 2545 (USD 3046 inclusive of VHSNC strengthening costs). The intervention was highly cost-effective according to WHO threshold, as the cost per life year saved or DALY averted was less than India's Gross Domestic Product (GDP) per capita. The robustness of the findings to assumptions was tested using a series of one-way sensitivity analyses. The sensitivity analysis does not change the conclusion that the intervention is highly cost-effective. Conclusion: Participatory learning and action with women's groups facilitated by ASHAs was highly cost-effective to reduce neonatal mortality in rural settings with low literacy levels and high neonatal mortality rates. This approach could effectively complement facility-based care in India and can be scaled up in comparable high mortality settings. [ABSTRACT FROM AUTHOR]

Background: Increasing rates of type 2 diabetes mellitus place a substantial burden on health care services, communities, families and individuals living with the disease or at risk of developing it. Estimates of the combined prevalence of intermediate hyperglycaemia and diabetes in Bangladesh vary, and can be as high as 30% of the adult population. Despite such high prevalence, awareness and control of diabetes and its risk factors are limited. Prevention and control of diabetes and its complications demand increased awareness and action of individuals and communities, with positive influences on behaviours and lifestyle choices. In this study, we will test the effect of two different interventions on diabetes occurrence and its risk factors in rural Bangladesh. Methods/design: A three-arm cluster randomised controlled trial of mobile health (mHealth) and participatory community group interventions will be conducted in four rural upazillas in Faridpur District, Bangladesh. Ninety-six clusters (villages) will be randomised to receive either the mHealth intervention or the participatory community group intervention, or be assigned to the control arm. In the mHealth arm, enrolled individuals will receive twiceweekly voice messages sent to their mobile phone about prevention and control of diabetes. In the participatory community group arm, facilitators will initiate a series of monthly group meetings for men and women, progressing through a Participatory Learning and Action cycle whereby group members and communities identify, prioritise and tackle problems associated with diabetes and the risk of developing diabetes. Both interventions will run for 18 months. The primary outcomes of the combined prevalence of intermediate hyperglycaemia and diabetes and the cumulative 2-year incidence of diabetes among individuals identified as having intermediate hyperglycaemia at baseline will be evaluated through baseline and endline sample surveys of permanent residents aged 30 years or older in each of the study clusters. Data on blood glucose level, blood pressure, body mass index and hip-to-waist ratio will be gathered through physical measurements by trained fieldworkers. Demographic and socioeconomic data, as well as data on knowledge of diabetes, chronic disease risk factor prevalence and quality of life, will be gathered through interviews with sampled respondents. Discussion: This study will increase our understanding of diabetes and other non-communicable disease burdens and risk factors in rural Bangladesh. By documenting and evaluating the delivery, impact and cost-effectiveness of participatory community groups and mobile phone voice messaging, study findings will provide evidence on how population-level strategies of community mobilisation and mHealth can be implemented to prevent and control noncommunicable diseases and risk factors in this population. Trial registration: ISRCTN41083256. Registered on 30 Mar 2016 (Retrospectively Registered). Trial acronym: D-Magic: Diabetes Mellitus - Action through Groups or mobile Information for better Control. [ABSTRACT FROM AUTHOR]

Introduction: Undernutrition affects ~165 million children globally and contributes up to 45% of all child deaths. India has the highest proportion of global undernutrition-related morbidity and mortality. This protocol describes the planned economic evaluation of a community-based intervention to improve growth in children under 2 years of age in two rural districts of eastern India. The intervention is being evaluated through a cluster-randomised controlled trial (cRCT, the CARING trial). Methods and analysis: A cost-effectiveness and cost-utility analysis nested within a cRCT will be conducted from a societal perspective, measuring programme, provider, household and societal costs. Programme costs will be collected prospectively from project accounts using a standardised tool. These will be supplemented with time sheets and key informant interviews to inform the allocation of joint costs. Direct and indirect costs incurred by providers will be collected using key informant interviews and time use surveys. Direct and indirect household costs will be collected prospectively, using time use and consumption surveys. Incremental cost-effectiveness ratios (ICERs) will be calculated for the primary outcome measure, that is, cases of stunting prevented, and other outcomes such as cases of wasting prevented, cases of infant mortality averted, life years saved and disabilityadjusted life years (DALYs) averted. Sensitivity analyses will be conducted to assess the robustness of results. Ethics and dissemination: There is a shortage of robust evidence regarding the cost-effectiveness of strategies to improve early child growth. As this economic evaluation is nested within a large scale, cRCT, it will contribute to understanding the fiscal space for investment in early child growth, and the relative (in)efficiency of prioritising resources to this intervention over others to prevent stunting in this and other comparable contexts. The protocol has all necessary ethical approvals and the findings will be disseminated within academia and the wider policy sphere. [ABSTRACT FROM AUTHOR]

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Background: A baseline cross-sectional survey among female sex workers (FSWs) was conducted in four cities within the context of an implementation research project aiming to improve FSWs’ access to HIV, and sexual and reproductive health (SRH) services. The survey measured where FSWs seek HIV/SRH care and what motivates their choice. Methods: Using respondent-driven sampling (RDS), FWSs were recruited in Durban, South Africa (n = 400), Tete, Mozambique (n = 308), Mombasa, Kenya (n = 400) and Mysore, India (n = 458) and interviewed. RDS-adjusted proportions were estimated by non-parametric bootstrapping, and compared across cities using post-hoc pairwise comparison tests. Results: Across cities, FSWs most commonly sought care for the majority of HIV/SRH services at public health facilities, most especially in Durban (ranging from 65% for condoms to 97% for HIV care). Services specifically targeting FSWs only had a high coverage in Mysore for STI care (89%) and HIV testing (79%). Private-for-profit clinics were important providers in Mombasa (ranging from 17% for STI care and HIV testing to 43% for HIV care), but not in the other cities. The most important reason for the choice of care provider in Durban and Mombasa was proximity, in Tete ‘where they always go’, and in Mysore cost of care. Where available, clinics specifically targeting FSWs were more often chosen because of shorter waiting times, perceived higher quality of care, more privacy and friendlier personnel. Conclusion: The place where care is sought for HIV/SRH services differs substantially between cities. Targeted services have limited coverage in the African cities compared to Mysore. Convenience appears more important for choosing the place of care than aspects of quality of care. The best model to improve access, linking targeted interventions with general health services, will need to be tailored to the specific context of each city. [ABSTRACT FROM AUTHOR]

Background: The increasing number of patients co-affected with Diabetes and TB may place individuals with low socio-economic status at particular risk of persistent poverty. Kyrgyz health sector reforms aim at reducing this burden, with the provision of essential health services free at the point of use through a State-Guaranteed Benefit Package (SGBP). However, despite a declining trend in out-of-pocket expenditure, there is still a considerable funding gap in the SGBP. Using data from Bishkek, Kyrgyzstan, this study aims to explore how households cope with the economic burden of Diabetes, TB and co-prevalence.Methods: This study uses cross-sectional data collected in 2010 from Diabetes and TB patients in Bishkek, Kyrgyzstan. Quantitative questionnaires were administered to 309 individuals capturing information on patients' socioeconomic status and a range of coping strategies. Coarsened exact matching (CEM) is used to generate socio-economically balanced patient groups. Descriptive statistics and logistic regression are used for data analysis.Results: TB patients are much younger than Diabetes and co-affected patients. Old age affects not only the health of the patients, but also the patient's socio-economic context. TB patients are more likely to be employed and to have higher incomes while Diabetes patients are more likely to be retired. Co-affected patients, despite being in the same age group as Diabetes patients, are less likely to receive pensions but often earn income in informal arrangements. Out-of-pocket (OOP) payments are higher for Diabetes care than for TB care. Diabetes patients cope with the economic burden by using social welfare support. TB patients are most often in a position to draw on income or savings. Co-affected patients are less likely to receive social welfare support than Diabetes patients. Catastrophic health spending is more likely in Diabetes and co-affected patients than in TB patients.Conclusions: This study shows that while OOP are moderate for TB affected patients, there are severe consequences for Diabetes affected patients. As a result of the underfunding of the SGBP, Diabetes and co-affected patients are challenged by OOP. Especially those who belong to lower socio-economic groups are challenged in coping with the economic burden. [ABSTRACT FROM AUTHOR]

Background: In India, Village Health Sanitation and Nutrition Committees (VHSNCs) are participatory community health forums, but there is little information about their composition, functioning and effectiveness. Our study examined VHSNCs as enablers of participatory action for community health in two rural districts in two states of eastern India - West Singhbhum in Jharkhand and Kendujhar, in Odisha.Methods: We conducted a cross-sectional survey of 169 VHSNCs and ten qualitative focus group discussions with purposively selected better and poorer performing committees, across the two states. We analysed the quantitative data using descriptive statistics and the qualitative data using a Framework approach.Results: We found that VHSNCs comprised equitable representation from vulnerable groups when they were formed. More than 75 % members were women. Almost all members belonged to socially disadvantaged classes. Less than 1 % members had received any training. Supervision of committees by district or block officials was rare. Their work focused largely on strengthening village sanitation, conducting health awareness activities, and supporting medical treatment for ill or malnourished children and pregnant mothers. In reality, 62 % committees monitored community health workers, 6.5 % checked sub-centres and 2.4 % monitored drug availability with community health workers. Virtually none monitored data on malnutrition. Community health and nutrition workers acted as conveners and record keepers. Links with the community involved awareness generation and community monitoring of VHSNC activities. Key challenges included irregular meetings, members' limited understanding of their roles and responsibilities, restrictions on planning and fund utilisation, and weak linkages with the broader health system.Conclusions: Our study suggests that VHSNCs perform few of their specified functions for decentralized planning and action. If VHSNCs are to be instrumental in improving community health, sanitation and nutrition, they need education, mobilisation and monitoring for formal links with the wider health system. [ABSTRACT FROM AUTHOR]

Background Human immunodeficiency virus (HIV) is a significant contributor to Malawi's burden of disease. Despite a number of studies describing socio-economic differences in HIV prevalence, there is a paucity of evidence on socio-economic inequity in HIV testing in Malawi. Objective To assess horizontal inequity (HI) in HIV testing in Malawi. Design Data from the Demographic and Health Surveys (DHSs) 2004 and 2010 in Malawi are used for the analysis. The sample size for DHS 2004 was 14,571 (women =11,362 and men=3,209), and for DHS 2010 it was 29,830 (women=22,716 and men=7,114). The concentration index is used to quantify the amount of socio-economic-related inequality in HIV testing. The inequality is a primary method in this study. Corrected need, a further adjustment of the standard decomposition index, was calculated. Standard HI was compared with corrected need-adjusted inequity. Variables used to measure health need include symptoms of sexually transmitted infections. Non-need variables include wealth, education, literacy and marital status. Results Between 2004 and 2010, the proportion of the population ever tested for HIV increased from 15 to 75% among women and from 16 to 54% among men. The need for HIV testing among men was concentrated among the relatively wealthy in 2004, but the need was more equitably distributed in 2010. Standard HI was 0.152 in 2004 and 0.008 in 2010 among women, and 0.186 in 2004 and 0.04 in 2010 among men. Rural–urban inequity also fell in this period, but HIV testing remained pro-rich among rural men (HI 0.041). The main social contributors to inequity in HIV testing were wealth in 2004 and education in 2010. Conclusions Inequity in HIV testing in Malawi decreased between 2004 and 2010. This may be due to the increased support to HIV testing by global donors over this period. [ABSTRACT FROM AUTHOR]

Background: The global burden of acute malnutrition among children remains high, and prevalence rates are highest in humanitarian contexts such as Niger. Unconditional cash transfers are increasingly used to prevent acute malnutrition in emergencies but lack a strong evidence base. In Niger, non-governmental organisations give unconditional cash transfers to the poorest households from June to September; the 'hunger gap'. However, rising admissions to feeding programmes from March/April suggest the intervention may be late.Methods/design: This cluster-randomised controlled trial will compare two types of unconditional cash transfer for 'very poor' households in 'vulnerable' villages defined and identified by the implementing organisation. 3,500 children (6-59 months) and 2,500 women (15-49 years) will be recruited exhaustively from households targeted for cash and from a random sample of non-recipient households in 40 villages in Tahoua district. Clusters of villages with a common cash distribution point will be assigned to either a control group which will receive the standard intervention (n = 10), or a modified intervention group (n = 10). The standard intervention is 32,500 FCFA/month for 4 months, June to September, given cash-in-hand to female representatives of 'very poor' households. The modified intervention is 21,500 FCFA/month for 5 months, April, May, July, August, September, and 22,500 FCFA in June, providing the same total amount. In both arms the recipient women attend an education session, women and children are screened and referred for acute malnutrition treatment, and the households receive nutrition supplements for children 6-23 months and pregnant and lactating women. The trial will evaluate whether the modified unconditional cash transfer leads to a reduction in acute malnutrition among children 6-59 months old compared to the standard intervention. The sample size provides power to detect a 5 percentage point difference in prevalence of acute malnutrition between trial arms. Quantitative and qualitative process evaluation data will be prospectively collected and programme costs will be collected and cost-effectiveness ratios calculated.Discussion: This randomised study design with a concurrent process evaluation will provide evidence on the effectiveness and cost-effectiveness of earlier initiation of seasonal unconditional cash transfer for the prevention of acute malnutrition, which will be generalisable to similar humanitarian situations.Trial Registration: ISRCTN25360839, registered March 19, 2015. [ABSTRACT FROM AUTHOR]

Objective: This study aims to assess inequity in expenditure on sexual and reproductive health (SRH) services in India and Kenya. In addition, this analysis aims to measure the extent to which payments are catastrophic and to explore coping mechanisms used to finance health spending. Methods: Data for this study were collected as a part of the situational analysis for the “Diagonal Interventions to Fast Forward Enhanced Reproductive Health” (DIFFER) project, a multi-country project with fieldwork sites in three African sites; Mombasa (Kenya), Durban (South Africa) and Tete (Mozambique), and Mysore in India. Information on access to SRH services, the direct costs of seeking care and a range of socio-economic variables were obtained through structured exit interviews with female SRH service users in Mysore (India) and Mombasa (Kenya) (n = 250). The costs of seeking care were analysed by household income quintile (as a measure of socio-economic status). The Kakwani index and quintile ratios are used as measures of inequitable spending. Catastrophic spending on SRH services was calculated using the threshold of 10 % of total household income. Results: The results showed that spending on SRH services was highly regressive in both sites, with lower income households spending a higher percentage of their income on seeking care, compared to households with a higher income. Spending on SRH as a percentage of household income ranged from 0.02 to 6.2 % and 0.03-7.5 % in India and Kenya, respectively. There was a statistically significant difference in the proportion of spending on SRH services across income quintiles in both settings. In India, the poorest households spent two times, and in Kenya ten times, more on seeking care than the least poor households. The most common coping mechanisms in India and Kenya were “receiving [money] from partner or household members” (69 %) and “using own savings or regular income” (44 %), respectively. Conclusion: Highly regressive spending on SRH services highlights the heavier burden borne by the poorest when seeking care in resource-constrained settings such as India and Kenya. The large proportion of service users, particularly in India, relying on money received from family members to finance care seeking suggests that access would be more difficult for those with weak social ties, small social networks or weak bargaining positions within the family - although this requires further study. [ABSTRACT FROM AUTHOR]

Objective: This study aims to assess inequity in expenditure on sexual and reproductive health (SRH) services in India and Kenya. In addition, this analysis aims to measure the extent to which payments are catastrophic and to explore coping mechanisms used to finance health spending. Methods: Data for this study were collected as a part of the situational analysis for the “Diagonal Interventions to Fast Forward Enhanced Reproductive Health” (DIFFER) project, a multi-country project with fieldwork sites in three African sites; Mombasa (Kenya), Durban (South Africa) and Tete (Mozambique), and Mysore in India. Information on access to SRH services, the direct costs of seeking care and a range of socio-economic variables were obtained through structured exit interviews with female SRH service users in Mysore (India) and Mombasa (Kenya) (n = 250). The costs of seeking care were analysed by household income quintile (as a measure of socio-economic status). The Kakwani index and quintile ratios are used as measures of inequitable spending. Catastrophic spending on SRH services was calculated using the threshold of 10 % of total household income. Results: The results showed that spending on SRH services was highly regressive in both sites, with lower income households spending a higher percentage of their income on seeking care, compared to households with a higher income. Spending on SRH as a percentage of household income ranged from 0.02 to 6.2 % and 0.03-7.5 % in India and Kenya, respectively. There was a statistically significant difference in the proportion of spending on SRH services across income quintiles in both settings. In India, the poorest households spent two times, and in Kenya ten times, more on seeking care than the least poor households. The most common coping mechanisms in India and Kenya were “receiving [money] from partner or household members” (69 %) and “using own savings or regular income” (44 %), respectively. Conclusion: Highly regressive spending on SRH services highlights the heavier burden borne by the poorest when seeking care in resource-constrained settings such as India and Kenya. The large proportion of service users, particularly in India, relying on money received from family members to finance care seeking suggests that access would be more difficult for those with weak social ties, small social networks or weak bargaining positions within the family - although this requires further study. [ABSTRACT FROM AUTHOR]

Background: Understanding the cost-effectiveness and affordability of interventions to reduce maternal and newborn deaths is critical to persuading policymakers and donors to implement at scale. The effectiveness of community mobilisation through women's groups and health facility quality improvement, both aiming to reduce maternal and neonatal mortality, was assessed by a cluster randomised controlled trial conducted in rural Malawi in 2008-2010. In this paper, we calculate intervention cost-effectiveness and model the affordability of the interventions at scale. Methods: Bayesian methods are used to estimate the incremental cost-effectiveness of the community and facility interventions on their own (CI, FI), and together (FICI), compared to current practice in rural Malawi. Effects are estimated with Monte Carlo simulation using the combined full probability distributions of intervention effects on stillbirths, neonatal deaths and maternal deaths. Cost data was collected prospectively from a provider perspective using an ingredients approach and disaggregated at the intervention (not cluster or individual) level. Expected Incremental Benefit, Cost-effectiveness Acceptability Curves and Expected Value of Information (EVI) were calculated using a threshold of $780 per disability-adjusted life-year (DALY) averted, the per capita gross domestic product of Malawi in 2013 international $. Results: The incremental cost-effectiveness of CI, FI, and combined FICI was $79, $281, and $146 per DALY averted respectively, compared to current practice. FI is dominated by CI and FICI. Taking into account uncertainty, both CI and combined FICI are highly likely to be cost effective (probability 98% and 93%, EVI $210,423 and $598,177 respectively). Combined FICI is incrementally cost effective compared to either intervention individually (probability 60%, ICER $292, EIB $9,334,580 compared to CI). Future scenarios also found FICI to be the optimal decision. Scaling-up to the whole of Malawi, CI is of greatest value for money, potentially averting 13.0% of remaining annual DALYs from stillbirths, neonatal and maternal deaths for the equivalent of 6.8% of current annual expenditure on maternal and neonatal health in Malawi. Conclusions: Community mobilisation through women's groups is a highly cost-effective and affordable strategy to reduce maternal and neonatal mortality in Malawi. Combining community mobilisation with health facility quality improvement is more effective, more costly, but also highly cost-effective and potentially affordable in this context. [ABSTRACT FROM AUTHOR]

There is growing evidence of the effectiveness of early childhood interventions to improve the growth and development of children. Although, historically, nutrition and stimulation interventions may have been delivered separately, they are increasingly being tested as a package of early childhood interventions that synergistically improve outcomes over the life course. However, implementation at scale is seldom possible without first considering the relative cost and cost-effectiveness of these interventions. An evidence gap in this area may deter large-scale implementation, particularly in low-and middle-income countries. We conduct a literature review to establish what is known about the cost-effectiveness of early childhood nutrition and development interventions. A set of predefined search terms and exclusion criteria standardized the search across five databases. The search identified 15 relevant articles. Of these, nine were from studies set in high-income countries and six in low-and middle-income countries. The articles either calculated the cost-effectiveness of nutrition-specific interventions (n =8) aimed at improving child growth, or parenting interventions (stimulation) to improve early childhood development (n =7). No articles estimated the cost-effectiveness of combined interventions. Comparing results within nutrition or stimulation interventions, or between nutrition and stimulation interventions was largely prevented by the variety of outcome measures used in these analyses. This article highlights the need for further evidence relevant to low-and middle-income countries. To facilitate comparison of cost-effectiveness between studies, and between contexts where appropriate, a move towards a common outcome measure such as the cost per disability-adjusted life years averted is advocated. Finally, given the increasing number of combined nutrition and stimulation interventions being tested, there is a significant need for evidence of cost-effectiveness for combined programmes. This too would be facilitated by the use of a common outcome measure able to pool the impact of both nutrition and stimulation activities. [ABSTRACT FROM AUTHOR]

Background: Child stunting (low height-for-age) is a marker of chronic undernutrition and predicts children's subsequent physical and cognitive development. Around one third of the world's stunted children live in India. Our study aims to assess the impact, cost-effectiveness, and scalability of a community intervention with a government-proposed community-based worker to improve growth in children under two in rural India. Methods: The study is a cluster randomised controlled trial in two rural districts of Jharkhand and Odisha (eastern India). The intervention tested involves a community-based worker carrying out two activities: (a) one home visit to all pregnant women in the third trimester, followed by subsequent monthly home visits to all infants aged 0-24 months to support appropriate feeding, infection control, and care-giving; (b) a monthly women's group meeting using participatory learning and action to catalyse individual and community action for maternal and child health and nutrition. Both intervention and control clusters also receive an intervention to strengthen Village Health Sanitation and Nutrition Committees. The unit of randomisation is a purposively selected cluster of approximately 1000 population. A total of 120 geographical clusters covering an estimated population of 121,531 were randomised to two trial arms: 60 clusters in the intervention arm receive home visits, group meetings, and support to Village Health Sanitation and Nutrition Committees; 60 clusters in the control arm receive support to Committees only. The study participants are pregnant women identified in the third trimester of pregnancy and their children (n = 2520). Mothers and their children are followed up at seven time points: during pregnancy, within 72 hours of delivery, and at 3, 6, 9, 12 and 18 months after birth. The trial's primary outcome is children's mean length-for-age Z scores at 18 months. Secondary outcomes include wasting and underweight at all time points, birth weight, growth velocity, feeding, infection control, and care-giving practices. Additional qualitative and quantitative data are collected for process and economic evaluations. Discussion: This trial will contribute to evidence on effective strategies to improve children's growth in India. Trial registration: ISRCTN register 51505201; Clinical Trials Registry of India number 2014/06/004664. [ABSTRACT FROM AUTHOR]

Background Understanding the cost-effectiveness and affordability of interventions to reduce maternal and newborn deaths is critical to persuading policymakers and donors to implement at scale. The effectiveness of community mobilisation through women's groups and health facility quality improvement, both aiming to reduce maternal and neonatal mortality, was assessed by a cluster randomised controlled trial conducted in rural Malawi in 2008-2010. In this paper, we calculate intervention cost-effectiveness and model the affordability of the interventions at scale. Methods Bayesian methods are used to estimate the incremental cost-effectiveness of the community and facility interventions on their own (CI, FI), and together (FICI), compared to current practice in rural Malawi. Effects are estimated with Monte Carlo simulation using the combined full probability distributions of intervention effects on stillbirths, neonatal deaths and maternal deaths. Cost data was collected prospectively from a provider perspective using an ingredients approach and disaggregated at the intervention (not cluster or individual) level. Expected Incremental Benefit, Cost-effectiveness Acceptability Curves and Expected Value of Information (EVI) were calculated using a threshold of $780 per disability-adjusted life-year (DALY) averted, the per capita gross domestic product of Malawi in 2013 international $. Results The incremental cost-effectiveness of CI, FI, and combined FICI was $79, $281, and $146 per DALY averted respectively, compared to current practice. FI is dominated by CI and FICI. Taking into account uncertainty, both CI and combined FICI are highly likely to be cost effective (probability 98% and 93%, EVI $210,423 and $598,177 respectively). Combined FICI is incrementally cost effective compared to either intervention individually (probability 60%, ICER $292, EIB $9,334,580 compared to CI). Future scenarios also found FICI to be the optimal decision. Scaling-up to the whole of Malawi, CI is of greatest value for money, potentially averting 13.0% of remaining annual DALYs from stillbirths, neonatal and maternal deaths for the equivalent of 6.8% of current annual expenditure on maternal and neonatal health in Malawi. Conclusions Community mobilisation through women's groups is a highly cost-effective and affordable strategy to reduce maternal and neonatal mortality in Malawi. Combining community mobilisation with health facility quality improvement is more effective, more costly, but also highly cost-effective and potentially affordable in this context. [ABSTRACT FROM AUTHOR]