Stillbirth mortality by Robson ten-group classification system: A cross-sectional registry of 80 663 births from 16 hospital in sub-Saharan Africa.

OBJECTIVE: To assess stillbirth mortality by Robson ten-group classification and the usefulness of this approach for understanding trends. DESIGN: Cross-sectional study. SETTING: Prospectively collected perinatal e-registry data from 16 hospitals in Benin, Malawi, Tanzania and Uganda. POPULATION: All women aged 13-49 years who gave birth to a live or stillborn baby weighting >1000 g between July 2021 and December 2022. METHODS: We compared stillbirth risk by Robson ten-group classification, and across countries, and calculated proportional contributions to mortality. MAIN OUTCOME MEASURES: Stillbirth mortality, defined as antepartum and intrapartum stillbirths. RESULTS: We included 80 663 babies born to 78 085 women; 3107 were stillborn. Stillbirth mortality by country were: 7.3% (Benin), 1.9% (Malawi), 1.6% (Tanzania) and 4.9% (Uganda). The largest contributor to stillbirths was Robson group 10 (preterm birth, 28.2%) followed by Robson group 3 (multipara with cephalic term singleton in spontaneous labour, 25.0%). The risk of dying was highest in births complicated by malpresentations, such as nullipara breech (11.0%), multipara breech (16.7%) and transverse/oblique lie (17.9%). CONCLUSIONS: Our findings indicate that group 10 (preterm birth) and group 3 (multipara with cephalic term singleton in spontaneous labour) each contribute to a quarter of stillbirth mortality. High mortality risk was observed in births complicated by malpresentation, such as transverse lie or breech. The high mortality share of group 3 is unexpected, demanding case-by-case investigation. The high mortality rate observed for Robson groups 6-10 hints for a need to intensify actions to improve labour management, and the categorisation may support the regular review of labour progress.

Is convenience really king? Comparative evaluation of catastrophic costs due to tuberculosis in the public and private healthcare sectors of Viet Nam: a longitudinal patient cost study.

BACKGROUND: In Viet Nam, tuberculosis (TB) represents a devastating life-event with an exorbitant price tag, partly due to lost income from daily directly observed therapy in public sector care. Thus, persons with TB may seek care in the private sector for its flexibility, convenience, and privacy. Our study aimed to measure income changes, costs and catastrophic cost incurrence among TB-affected households in the public and private sector. METHODS: Between October 2020 and March 2022, we conducted 110 longitudinal patient cost interviews, among 50 patients privately treated for TB and 60 TB patients treated by the National TB Program (NTP) in Ha Noi, Hai Phong and Ho Chi Minh City, Viet Nam. Using a local adaptation of the WHO TB patient cost survey tool, participants were interviewed during the intensive phase, continuation phase and post-treatment. We compared income levels, direct and indirect treatment costs, catastrophic costs using Wilcoxon rank-sum and chi-squared tests and associated risk factors between the two cohorts using multivariate regression. RESULTS: The pre-treatment median monthly household income was significantly higher in the private sector versus NTP cohort (USD 868 vs USD 578; P = 0.010). However, private sector treatment was also significantly costlier (USD 2075 vs USD 1313; P = 0.005), driven by direct medical costs which were 4.6 times higher than costs reported by NTP participants (USD 754 vs USD 164; P < 0.001). This resulted in no significant difference in catastrophic costs between the two cohorts (Private: 55% vs NTP: 52%; P = 0.675). Factors associated with catastrophic cost included being a single-person household [adjusted odds ratio (aOR = 13.71; 95% confidence interval (CI): 1.36-138.14; P = 0.026], unemployment during treatment (aOR = 10.86; 95% CI: 2.64-44.60; P < 0.001) and experiencing TB-related stigma (aOR = 37.90; 95% CI: 1.72-831.73; P = 0.021). CONCLUSIONS: Persons with TB in Viet Nam face similarly high risk of catastrophic costs whether treated in the public or private sector. Patient costs could be reduced through expanded insurance reimbursement to minimize direct medical costs in the private sector, use of remote monitoring and multi-week/month dosing strategies to avert economic costs in the public sector and greater access to social protection mechanism in general.

Acceptability of IV iron treatment for iron deficiency anaemia in pregnancy in Nigeria: a qualitative study with pregnant women, domestic decision-makers, and health care providers.

BACKGROUND: Anaemia in pregnancy causes a significant burden of maternal morbidity and mortality in sub-Saharan Africa, with prevalence ranging from 25 to 45% in Nigeria. The main treatment, daily oral iron, is associated with suboptimal adherence and effectiveness. Among pregnant women with iron deficiency, which is a leading cause of anaemia (IDA), intravenous (IV) iron is an alternative treatment in moderate or severe cases. This qualitative study explored the acceptability of IV iron in the states of Kano and Lagos in Nigeria. METHODS: We purposively sampled various stakeholders, including pregnant women, domestic decision-makers, and healthcare providers (HCPs) during the pre-intervention phase of a hybrid clinical trial (IVON trial) in 10 healthcare facilities across three levels of the health system. Semi-structured topic guides guided 12 focus group discussions (140 participants) and 29 key informant interviews. We used the theoretical framework of acceptability to conduct qualitative content analysis. RESULTS: We identified three main themes and eight sub-themes that reflected the prospective acceptability of IV iron therapy. Generally, all stakeholders had a positive affective attitude towards IV iron based on its comparative advantages to oral iron. The HCPs noted the effectiveness of IV iron in its ability to evoke an immediate response and capacity to reduce anaemia-related complications. It was perceived as a suitable alternative to blood transfusion for specific individuals based on ethicality. However, to pregnant women and the HCPs, IV iron could present a higher opportunity cost than oral iron for the users and providers as it necessitates additional time to receive and administer it. To all stakeholder groups, leveraging the existing infrastructure to facilitate IV iron treatment will stimulate coherence and self-efficacy while strengthening the existing trust between pregnant women and HCPs can avert misconceptions. Finally, even though high out-of-pocket costs might make IV iron out of reach for poor women, the HCPs felt it can potentially prevent higher treatment fees from complications of IDA. CONCLUSIONS: IV iron has a potential to become the preferred treatment for iron-deficiency anaemia in pregnancy in Nigeria if proven effective. HCP training, optimisation of information and clinical care delivery during antenatal visits, uninterrupted supply of IV iron, and subsidies to offset higher costs need to be considered to improve its acceptability. Trial registration ISRCTN registry ISRCT N6348 4804. Registered on 10 December 2020 Clinicaltrials.gov NCT04976179. Registered on 26 July 2021.

Low blood level in pregnancy is of public health importance and with common occurrence worldwide, but with a higher rate in low resource settings where its burden greatly affects both the mother and her baby. This low blood level is usually caused by poor intake of an iron-rich diet. It could lead to fatigue, decreased work capacity, and dizziness if not detected. Without treatment, this condition could affect the baby, possibly leading to its sudden demise in the womb, immediately after birth, or even the woman's death.The use of oral iron has been the primary treatment; however, it is associated with significant side effects, which have led to poor compliance. Fortunately, an alternative therapy in the form of a drip has been shown to overcome these challenges. However, it is not routinely used in countries like Nigeria. Moreover, being effective is different from being utilised. Therefore, this study was conducted to understand the factors that will make this treatment widely accepted.We interviewed pregnant women, family support and health care providers in 10 health facilities in Lagos and Kano States, Nigeria. Our findings revealed good attitudes to iron drip. However, its inclusion into routine antenatal health talk, training of health care providers, availability of space, drugs and health workers who will provide this care, and ensuring this drug is of low cost are some of the efforts needed for this treatment to be accepted.

Determinants of catastrophic costs among households affected by multi-drug resistant tuberculosis in Ho Chi Minh City, Viet Nam: a prospective cohort study.

BACKGROUND: Globally, most people with multidrug-resistant tuberculosis (MDR-TB) and their households experience catastrophic costs of illness, diagnosis, and care. However, the factors associated with experiencing catastrophic costs are poorly understood. This study aimed to identify risk factors associated with catastrophic costs incurrence among MDR-TB-affected households in Ho Chi Minh City (HCMC), Viet Nam. METHODS: Between October 2020 and April 2022, data were collected using a locally-adapted, longitudinal WHO TB Patient Cost Survey in ten districts of HCMC. Ninety-four people with MDR-TB being treated with a nine-month TB regimen were surveyed at three time points: after two weeks of treatment initiation, completion of the intensive phase and the end of the treatment (approximately five and 10 months post-treatment initiation respectively). The catastrophic costs threshold was defined as total TB-related costs exceeding 20% of annual pre-TB household income. Logistic regression was used to identify variables associated with experiencing catastrophic costs. A sensitivity analysis examined the prevalence of catastrophic costs using alternative thresholds and cost estimation approaches. RESULTS: Most participants (81/93 [87%]) experienced catastrophic costs despite the majority 86/93 (93%) receiving economic support through existing social protection schemes. Among participant households experiencing and not experiencing catastrophic costs, median household income was similar before MDR-TB treatment. However, by the end of MDR-TB treatment, median household income was lower (258 [IQR: 0-516] USD vs. 656 [IQR: 462-989] USD; p = 0.003), and median income loss was higher (2838 [IQR: 1548-5418] USD vs. 301 [IQR: 0-824] USD; p < 0.001) amongst the participant households who experienced catastrophic costs. Being the household's primary income earner before MDR-TB treatment (aOR = 11.2 [95% CI: 1.6-80.5]), having a lower educational level (aOR = 22.3 [95% CI: 1.5-344.1]) and becoming unemployed at the beginning of MDR-TB treatment (aOR = 35.6 [95% CI: 2.7-470.3]) were associated with experiencing catastrophic costs. CONCLUSION: Despite good social protection coverage, most people with MDR-TB in HCMC experienced catastrophic costs. Incurrence of catastrophic costs was independently associated with being the household's primary income earner or being unemployed. Revision and expansion of strategies to mitigate TB-related catastrophic costs, in particular avoiding unemployment and income loss, are urgently required.

A qualitative assessment on the acceptability of providing cash transfers and social health insurance for tuberculosis-affected families in Ho Chi Minh City, Vietnam.

To achieve the Sustainable Development Goal's targets of universal health coverage (UHC) and poverty reduction, interventions are required that strengthen and harmonize both UHC and social protection. Vietnam is committed to achieving financial protection and over 90% of the general population has enrolled in its social health insurance (SHI) scheme. However, an estimated 63% of tuberculosis (TB)-affected households in Vietnam still face catastrophic costs and little is known about the optimal strategies to mitigate the costs of TB care for vulnerable families. This study assessed the acceptability of a social protection package containing cash transfers and SHI using individual interviews (n = 19) and focus group discussions (n = 3 groups). Interviews were analyzed through framework analysis. The study's main finding indicated that both conditional and unconditional cash transfers paired with SHI were acceptable, across six dimensions of acceptability. Cash transfers were considered beneficial for mitigating out-of-pocket expenditure, increasing TB treatment adherence, and improving mental health and general well-being, but the value provided was inadequate to fully alleviate the economic burden of the illness. The conditionality of the cash transfers was not viewed by participants as inappropriate, but it increased the workload of the TB program, which brought into question the feasibility of scale-up. SHI was viewed as a necessity by almost all participants, but people with TB questioned the quality of care received when utilizing it for auxiliary TB services. Access to multiple sources of social protection was deemed necessary to fully offset the costs of TB care. Additional research is needed to assess the impact of cash transfer interventions on health and economic outcomes in order to create an enabling policy environment for scale-up.

Implementing the QUALI-DEC project in Argentina, Burkina Faso, Thailand and Viet Nam: a process delineation and theory-driven process evaluation protocol.

The project 'Quality Decision-making by women and providers' (QUALI-DEC) combines four non-clinical interventions to promote informed decision-making surrounding mode of birth, improve women's birth experiences, and reduce caesarean sections among low-risk women. QUALI-DEC is currently being implemented in 32 healthcare facilities across Argentina, Burkina Faso, Thailand, and Viet Nam. In this paper, we detail implementation processes and the planned process evaluation, which aims to assess how and for whom QUALI-DEC worked, the mechanisms of change and their interactions with context and setting; adaptations to intervention and implementation strategies, feasibility of scaling-up, and cost-effectiveness of the intervention. We developed a project theory of change illustrating how QUALI-DEC might lead to impact. The theory of change, together with on the ground observations of implementation processes, guided the process evaluation strategy including what research questions and perspectives to prioritise. Main data sources will include: 1) regular monitoring visits in healthcare facilities, 2) quantitative process and output indicators, 3) a before and after cross-sectional survey among post-partum women, 4) qualitative interviews with all opinion leaders, and 5) qualitative interviews with postpartum women and health workers in two healthcare facilities per country, as part of a case study approach. We foresee that the QUALI-DEC process evaluation will generate valuable information that will improve interpretation of the effectiveness evaluation. At the policy level, we anticipate that important lessons and methodological insights will be drawn, with application to other settings and stakeholders looking to implement complex interventions aiming to improve maternal and newborn health and wellbeing.Trial registration: ISRCTN67214403.

Provision and utilization of maternal health services during the COVID-19 pandemic in 16 hospitals in sub-Saharan Africa.

Objective: Maintaining provision and utilization of maternal healthcare services is susceptible to external influences. This study describes how maternity care was provided during the COVID-19 pandemic and assesses patterns of service utilization and perinatal health outcomes in 16 referral hospitals (four each) in Benin, Malawi, Tanzania and Uganda. Methods: We used an embedded case-study design and two data sources. Responses to open-ended questions in a health-facility assessment survey were analyzed with content analysis. We described categories of adaptations and care provision modalities during the pandemic at the hospital and maternity ward levels. Aggregate monthly service statistics on antenatal care, delivery, caesarean section, maternal deaths, and stillbirths covering 24 months (2019 and 2020; pre-COVID-19 and COVID-19) were examined. Results: Declines in the number of antenatal care consultations were documented in Tanzania, Malawi, and Uganda in 2020 compared to 2019. Deliveries declined in 2020 compared to 2019 in Tanzania and Uganda. Caesarean section rates decreased in Benin and increased in Tanzania in 2020 compared to 2019. Increases in maternal mortality ratio and stillbirth rate were noted in some months of 2020 in Benin and Uganda, with variability noted between hospitals. At the hospital level, teams were assigned to respond to the COVID-19 pandemic, routine meetings were cancelled, and maternal death reviews and quality improvement initiatives were interrupted. In maternity wards, staff shortages were reported during lockdowns in Uganda. Clinical guidelines and protocols were not updated formally; the number of allowed companions and visitors was reduced. Conclusion: Varying approaches within and between countries demonstrate the importance of a contextualized response to the COVID-19 pandemic. Maternal care utilization and the ability to provide quality care fluctuated with lockdowns and travel bans. Women's and maternal health workers' needs should be prioritized to avoid interruptions in the continuum of care and prevent the deterioration of perinatal health outcomes.

Comparing Catastrophic Costs: Active vs. Passive Tuberculosis Case Finding in Urban Vietnam.

Active case finding (ACF) is a strategy that aims to identify people with tuberculosis (TB) earlier in their disease. This outreach approach may lead to a reduction in catastrophic cost incurrence (costs exceeding 20% of annual household income), a main target of WHO's End TB Strategy. Our study assessed the socio-economic impact of ACF by comparing patient costs in actively and passively detected people with TB. Longitudinal patient cost surveys were prospectively fielded for people with drug-sensitive pulmonary TB, with 105 detected through ACF and 107 passively detected. Data were collected in four Vietnamese cities between October 2020 and March 2022. ACF reduced pre-treatment (USD 10 vs. 101, p < 0.001) and treatment costs (USD 888 vs. 1213, p < 0.001) in TB-affected individuals. Furthermore, it reduced the occurrence of job loss (15.2% vs. 35.5%, p = 0.001) and use of coping strategies (28.6% vs. 45.7%, p = 0.004). However, catastrophic cost incurrence was high at 52.8% and did not differ between cohorts. ACF did not significantly decrease indirect costs, the largest contributor to catastrophic costs. ACF reduces costs but cannot sufficiently reduce the risk of catastrophic costs. As income loss is the largest driver of costs during TB treatment, social protection schemes need to be expanded.

The social determinants of national tuberculosis incidence rates in 116 countries: a longitudinal ecological study between 2005-2015.

BACKGROUND: Accelerating declines in tuberculosis (TB) incidence is paramount for achieving global goals set for 2030 by the Sustainable Development Goals and the End TB Strategy. The aim of this study was to identify key country-level social determinants of national TB incidence trends. METHODS: This longitudinal ecological study used country-level data extracted from online databases from the period 2005-2015. We used multivariable Poisson regression models allowing for distinct within- and between-country effects to estimate associations between national TB incidence rates and 13 social determinants of health. The analysis was stratified by country income status. RESULTS: The study sample included 48 low- and lower-middle-income countries (LLMICs) and 68 high- and upper-middle income countries (HUMICs), with a total of 528 and 748 observations between 2005-2015, respectively. National TB incidence rates declined in 108/116 countries between 2005-2015, with an average drop of 12.95% in LLMICs and 14.09% in HUMICs. Between LLMICs, higher Human Development Index (HDI), social protection spending, TB case detection, and TB treatment success were associated with lower TB incidence. Higher prevalence of HIV/AIDS was associated with higher TB incidence. Within LLMICs, increases in HDI over time were associated with lower TB incidence rates. Between HUMICs, higher HDI, health spending, and diabetes prevalence were associated with lower TB incidence, whereas higher prevalence of HIV/AIDS and alcohol-use were associated with higher TB incidence. Within HUMICs, increases in HIV/AIDS and diabetes prevalence over time were associated with higher TB incidence. CONCLUSIONS: In LLMICs, TB incidence rates remain highest in countries with low human development, social protection spending and TB programme performance, and high rates of HIV/AIDS. Strengthening human development is likely to accelerate declines in TB incidence. In HUMICs, TB incidence rates remain highest in countries with low human development, health spending and diabetes prevalence, and high rates of HIV/AIDS and alcohol use. Here, slowing rising rates of HIV/AIDS and diabetes is likely to accelerate declines in TB incidence.

Application of the Theoretical Framework of Acceptability to assess a telephone-facilitated health coaching intervention for the prevention and management of type 2 diabetes.

BACKGROUND: Lifestyle interventions focusing on diet and physical activity for the prevention and management of type 2 diabetes have been found effective. Acceptance of the intervention is crucial. The Theoretical Framework of Acceptability (TFA) developed by Sekhon et al. (2017) describes the multiple facets of acceptance: Affective attitude, burden, perceived effectiveness, ethicality, intervention coherence, opportunity costs and self-efficacy. The aims of this study were to develop and assess the psychometric properties of a measurement scale for acceptance of a telephone-facilitated health coaching intervention, based on the TFA; and to determine the acceptability of the intervention among participants living with diabetes or having a high risk of diabetes in socioeconomically disadvantaged areas in Stockholm. METHODS: This study was nested in the implementation trial SMART2D (Self-management approach and reciprocal learning for type 2 diabetes). The intervention consisted of nine telephone-facilitated health coaching sessions delivered individually over a 6-month period. The acceptability of the intervention was assessed using a questionnaire consisting of 19 Likert scale questions developed using Sekhon's TFA. Exploratory factor analysis (EFA) was performed. RESULTS: Ratings from 49 participants (19 with type 2 diabetes and 30 at high risk of developing diabetes) in ages 38-65 were analyzed. The EFA on the acceptability scale revealed three factors with acceptable reliabilities: affective attitude (alpha 0.90), coherence and understanding (alpha 0.77), perceived burden (alpha 0.85), explaining 82% of the variance. Positive affect and coherence had high median scores and small variance. Median score for perceived burden was low, but with significant variance due to younger individuals and those at high risk reporting higher burden. CONCLUSIONS: The telephone-facilitated health coaching intervention was perceived as acceptable by the study population using a questionnaire based on Sekhon's TFA, with a wider variation in perceived burden seen among high risk and younger participants.

Methodological reflections on health system-oriented assessment of maternity care in 16 hospitals in sub-Saharan Africa: an embedded case study.

Health facility assessments (HFAs) assessing facilities' readiness to provide services are well-established. However, HFA questionnaires are typically quantitative and lack depth to understand systems in which health facilities operate-crucial to designing context-oriented interventions. We report lessons from a multiple embedded case study exploring the experiences of HFA data collectors in implementing a novel HFA tool developed using systems thinking approach. We assessed 16 hospitals in four countries (Benin, Malawi, Tanzania and Uganda) as part of a quality improvement implementation research. Our tool was organized in 17 sections and included dimensions of hospital governance, leadership and financing; maternity care standards and procedures; ongoing quality improvement practices; interactions with communities and mapping of the areas related to maternal care. Data for this study were collected using in-depth interviews with senior experts who conducted the HFA in the countries 1-3 months after completion of the HFAs. Data were analysed using the inductive thematic analysis approach. Our HFA faced challenges in logistics (accessing key hospital-based respondents, high turnover of managerial staff and difficulty accessing information considered sensitive in the context) and methodology (response bias, lack of data quality and data entry into an electronic platform). Data elements of governance, leadership and financing were the most affected. Opportunities and strategies adopted aimed at enhancing data collection (building on prior partnerships and understanding local and institutional bureaucracies) and enhancing data richness (identifying respondents with institutional memory, learning from experience and conducting observations at various times). Moreover, HFA data collectors conducted abstraction of records and interviews in a flexible and adaptive way to enhance data quality. Lessons and new skills learned from our HFA could be used as inputs to respond to the growing need of integrating the systems thinking approach in HFA to improve the contextual understanding of operations and structure.

Motivational determinants of physical activity in disadvantaged populations with (pre)diabetes: a cross-cultural comparison.

BACKGROUND: Understanding motivational determinants of physical activity (PA) is essential to guide the implementation of PA at individual and population level. Knowledge about the cross-cultural generalizability of these determinants is lacking and they have mostly been studied as separate factors. This study compares a motivational process model across samples from diverse populations with, or at risk of diabetes. METHODS: Measurement invariance of barrier identified regulation, barrier self-efficacy and social support was assessed in a rural Ugandan sample (n = 712) and disadvantaged samples with high proportions of immigrants in urban South Africa (n = 566) and Sweden (n = 147). These motivational determinants were then compared through multigroup structural equation modeling. RESULTS: The studied motivational constructs showed scalar invariance. Latent mean levels of perceived social support and barrier self-efficacy were lower in South Africa and Sweden. Structural models (for different PA outcomes) were not consistent across settings except for the association between perceived social support and identified regulation. Identified regulation was only associated with vigorous PA in Uganda and with moderate PA in South Africa. The association between social support and PA outcomes ranged from weak to not significant and the association between self-efficacy and PA was not significant. Self-reported PA was highest in Uganda and lowest in Sweden. Self-reported vigorous PA was significantly related to lower hemoglobin A1c levels, while moderate PA was not. CONCLUSIONS: Findings suggest that: 1) it is feasible to compare a motivational process model across diverse settings; 2) there is lower perceived social support and self-efficacy in the urban, migrant samples; 3) identified regulation is a more promising determinant of PA than self-efficacy or social support in these populations; 4) associations between motivational determinants and PA depend on the perceived type and/or intensity of PA; 5) perceived relatedness functions as a basic psychological need across diverse settings; and 6) people's perception of the PA they perform depends on their perceived level of intensity of PA which would have major implications for health promotion.

Action leveraging evidence to reduce perinatal mortality and morbidity (ALERT): study protocol for a stepped-wedge cluster-randomised trial in Benin, Malawi, Tanzania and Uganda.

BACKGROUND: Insufficient reductions in maternal and neonatal deaths and stillbirths in the past decade are a deterrence to achieving the Sustainable Development Goal 3. The majority of deaths occur during the intrapartum and immediate postnatal period. Overcoming the knowledge-do-gap to ensure implementation of known evidence-based interventions during this period has the potential to avert at least 2.5 million deaths in mothers and their offspring annually. This paper describes a study protocol for implementing and evaluating a multi-faceted health care system intervention to strengthen the implementation of evidence-based interventions and responsive care during this crucial period. METHODS: This is a cluster randomised stepped-wedge trial with a nested realist process evaluation across 16 hospitals in Benin, Malawi, Tanzania and Uganda. The ALERT intervention will include four main components: i) end-user participation through narratives of women, families and midwifery providers to ensure co-design of the intervention; ii) competency-based training; iii) quality improvement supported by data from a clinical perinatal e-registry and iv) empowerment and leadership mentoring of maternity unit leaders complemented by district based bi-annual coordination and accountability meetings. The trial's primary outcome is in-facility perinatal (stillbirths and early neonatal) mortality, in which we expect a 25% reduction. A perinatal e-registry will be implemented to monitor the trial. Our nested realist process evaluation will help to understand what works, for whom, and under which conditions. We will apply a gender lens to explore constraints to the provision of evidence-based care by health workers providing maternity services. An economic evaluation will assess the scalability and cost-effectiveness of ALERT intervention. DISCUSSION: There is evidence that each of the ALERT intervention components improves health providers' practices and has modest to moderate effects. We aim to test if the innovative packaging, including addressing specific health systems constraints in these settings, will have a synergistic effect and produce more considerable perinatal mortality reductions. TRIAL REGISTRATION: Pan African Clinical Trial Registry ( www.pactr.org ): PACTR202006793783148. Registered on 17th June 2020.

Social and health factors associated with unfavourable treatment outcome in adolescents and young adults with tuberculosis in Brazil: a national retrospective cohort study.

BACKGROUND: Tuberculosis elimination strategies in Brazil might neglect adolescents and young adults aged 10-24 years, hampering tuberculosis control. However, little is known about factors associated with tuberculosis treatment outcomes in this underserved group. In this study, we aimed to investigate social and health factors associated with unfavourable treatment outcomes in young people with tuberculosis in Brazil. METHODS: A national retrospective cohort study was done using data from Sistema de Informação de Agravos de Notificação (SINAN), the national tuberculosis registry in Brazil. People aged 10-24 years (young people) with tuberculosis registered in SINAN between Jan 1, 2015, and Dec 31, 2018, were included. Unfavourable outcomes were defined as loss to follow-up, treatment failure, and death. Favourable outcome was defined as treatment success. Multiple logistic regression models estimated the association between social and health factors and tuberculosis treatment outcomes. FINDINGS: 67 360 young people with tuberculosis were notified to SINAN, and we included 41 870 young people in our study. 7024 (17%) of the 41 870 included individuals had unfavourable treatment outcomes. Young people who received government cash transfers were less likely to have an unfavourable outcome (adjusted odds ratio 0·83, 95% CI 0·70-0·99). Homelessness (3·03, 2·07-4·42), HIV (2·89, 2·45-3·40), and illicit drug use (2·22, 1·93-2·55) were the main factors associated with unfavourable treatment outcome. INTERPRETATION: In this national cohort of young people with tuberculosis in Brazil, tuberculosis treatment success rates were lower than WHO End TB Strategy targets, with almost a fifth of participants experiencing unfavourable treatment outcomes. Homelessness, HIV, and illicit drug use were the main factors associated with unfavourable outcome. In Brazil, strategies are required to support this underserved group to ensure favourable tuberculosis treatment outcomes. FUNDING: Wellcome Trust, UK Medical Research Council, and UK Foreign Commonwealth and Development Office.

The household financial burden of non-communicable diseases in low- and middle-income countries: a systematic review.

BACKGROUND: The chronic nature of noncommunicable diseases (NCD) and costs associated with long-term care can result in catastrophic health expenditure for the patient and their household pushing them deeper into poverty and entrenching inequality in society. As the full financial burden of NCDs is not known, the objective of this study was to explore existing evidence on the financial burden of NCDs in low- and middle-income countries (LMICs), specifically estimating the cost incurred by patients with NCDs and their households to inform the development of strategies to protect such households from catastrophic expenditure. METHODS: This systematic review followed the PRISMA guidelines, PROSPERO: CRD42019141088. Eligible studies published between 1st January 2000 to 7th May 2020 were systematically searched for in three databases: Medline, Embase and Web of Science. A two-step process, comprising of qualitative synthesis proceeded by quantitative (cost) synthesis, was followed. The mean costs are presented in 2018 USD. FINDINGS: 51 articles were included, out of which 41 were selected for the quantitative cost synthesis. Most of the studies were cross-sectional cost-of-illness studies, of which almost half focused on diabetes and/or conducted in South-East Asia. The average total costs per year to a patient/household in LMICs of COPD, CVD, cancers and diabetes were $7386.71, $6055.99, $3303.81, $1017.05, respectively. CONCLUSION: This review highlighted major data and methodological gaps when collecting data on costs of NCDs to households along the cascade of care in LMICs. More empirical data on cost of specific NCDs are needed to identify the diseases and contexts where social protection interventions are needed most. More rigorous and standardised methods of data collection and costing for NCDs should be developed to enable comprehensive and comparable evidence of the economic and financial burden of NCDs to patients and households in LMICs. The available evidence on costs reveals a large financial burden imposed on patients and households in seeking and receiving NCD care and emphasizes the need for adequate and reliable social protection interventions to be implemented alongside Universal Health Coverage.

Effects of improved information and volunteer support on segregation of solid waste at the household level in urban settings in Madhya Pradesh, India (I-MISS): protocol of a cluster randomized controlled trial.

BACKGROUND: Segregation of household waste at the source is an effective and sustainable strategy for management of municipal waste. However, household segregation levels remain insufficient as waste management approaches are mostly top down and lack local support. The realisation and recognition of effective, improved and adequate waste management may be one of the vital drivers for attaining environmental protection and improved health and well-being. The presence of a local level motivator may promote household waste segregation and ultimately pro-environmental behaviour. The present cluster randomized control trial aims to understand if volunteer based information on waste segregation (I-MISS) can effectively promote increased waste segregation practices at the household level when compared with existing routine waste segregation information in an urban Indian setting. METHODS: This paper describes the protocol of an 18 month two-group parallel,cluster randomised controlled trialin the urban setting of Ujjain, Madhya Pradesh, India. Randomization will be conducted at ward level, which is the last administrative unit of the municipality. The study will recruit 425 households in intervention and control groups. Assessments will be performed at baseline (0 months), midline (6 months), end line (12 months) and post intervention (18 months). The primary outcome will be the comparison of change in proportion of households practicing waste segregation and change in proportion of mis-sorted waste across the study period between the intervention and control groups as assessed by pick analysis. Intention to treat analysis will be conducted. Written informed consent will be obtained from all participants. DISCUSSION: The present study is designed to study whether an external motivator, a volunteer selected from the participating community and empowered with adequate training, could disseminate waste segregation information to their community, thus promoting household waste segregation and ultimately pro-environmental behaviour. The study envisages that the volunteers could link waste management service providers and the community, give a local perspective to waste management, and help to change community habits through information, constant communication and feedback. TRIAL REGISTRATION: The study is registered prospectively with Indian Council of Medical Research- Clinical Trial Registry of India ( CTRI/2020/03/024278 ).

"Like filling a lottery ticket with quite high stakes": a qualitative study exploring mothers' needs and perceptions of state-provided financial support for a child with a long-term illness in Finland.

BACKGROUND: A child's long-term illness or disability is always a serious matter that impacts the whole family. Costs related to an illness can substantially affect a family's financial situation. To date, there is little research on how parents experience available support for financial assistance. Surveys in Finland have found that families of children with long-term illnesses and disabilities could experience financial struggle and perceive the state provided financial support system as too complex. This article aimed to explore how caregivers of children with long-term illnesses perceived their financial situation, need for financial support and experienced its provision by the state in the Helsinki greater region. METHODS: Convenience sampling was used. Participants were contacted through peer-support groups on Facebook. Eleven mothers of children with varying long-term illnesses and disabilities residing in the Helsinki greater region were interviewed using in-depth interviews. Recordings of the interviews were transcribed and analysed using framework analysis. An analytical framework was built to label the dataset, which was then charted. Lastly, themes were formed through descriptive analysis. RESULTS: The main findings showed how the burden of caring for a child with a long-term illness or disability causes fatigue, which affects a family's financial situation holistically. This affected both employment and financial management, but also receiving information about and applying for the state provided allowances. Mental resources were further depleted by seeking information and applying for allowances. This contributed to a vicious cycle between parental fatigue and financial struggle. Participants found the allocation of funds inequitable across the country. Finally, participants thought the allowance was insufficient in compensating for time spent caring for their child's illness and did not consider their mental strain. CONCLUSIONS: Even in a welfare state such as Finland, caregivers of children with long-term illnesses are at risk of poverty and struggle with the organization of state provided financial support. Policies should be designed to ensure equity across the country and consider how the parental fatigue should be addressed. The study has implications for achieving sustainable development goals on wellbeing and reducing poverty.

Implementation and evaluation of nonclinical interventions for appropriate use of cesarean section in low- and middle-income countries: protocol for a multisite hybrid effectiveness-implementation type III trial.

BACKGROUND: While cesarean sections (CSs) are a life-saving intervention, an increasing number are performed without medical reasons in low- and middle-income countries (LMICs). Unnecessary CS diverts scarce resources and thereby reduces access to healthcare for women in need. Argentina, Burkina Faso, Thailand, and Vietnam are committed to reducing unnecessary CS, but many individual and organizational factors in healthcare facilities obstruct this aim. Nonclinical interventions can overcome these barriers by helping providers improve their practices and supporting women's decision-making regarding childbirth. Existing evidence has shown only a modest effect of single interventions on reducing CS rates, arguably because of the failure to design multifaceted interventions effectively tailored to the context. The aim of this study is to design, adapt, and test a multifaceted intervention for the appropriate use of CS in Argentina, Burkina Faso, Thailand, and Vietnam. METHODS: We designed an intervention (QUALIty DECision-making-QUALI-DEC) with four components: (1) opinion leaders at heathcare facilities to improve adherence to best practices among clinicians, (2) CS audits and feedback to help providers identify potentially avoidable CS, (3) a decision analysis tool to help women make an informed decision on the mode of birth, and (4) companionship to support women during labor. QUALI-DEC will be implemented and evaluated in 32 hospitals (8 sites per country) using a pragmatic hybrid effectiveness-implementation design to test our implementation strategy, and information regarding its impact on relevant maternal and perinatal outcomes will be gathered. The implementation strategy will involve the participation of women, healthcare professionals, and organizations and account for the local environment, needs, resources, and social factors in each country. DISCUSSION: There is urgent need for interventions and implementation strategies to optimize the use of CS while improving health outcomes and satisfaction in LMICs. This can only be achieved by engaging all stakeholders involved in the decision-making process surrounding birth and addressing their needs and concerns. The study will generate robust evidence about the effectiveness and the impact of this multifaceted intervention. It will also assess the acceptability and scalability of the intervention and the capacity for empowerment among women and providers alike. TRIAL REGISTRATION: ISRCTN67214403.

SMART2D-development and contextualization of community strategies to support self-management in prevention and control of type 2 diabetes in Uganda, South Africa, and Sweden.

Type 2 diabetes (T2D) and its complications are increasing rapidly in low- and middle-income countries, as well as among socioeconomically disadvantaged populations in high-income countries. Support for healthy lifestyle and self-management is paramount but not well implemented in health systems, and there is need for knowledge on how to design and implement interventions that are contextualized and patient centered and address special needs of disadvantaged population groups. The SMART2D project implements and evaluates a lifestyle and self-management intervention for participants recently diagnosed with or being at increased risk for T2D in rural communities in Uganda, an urban township in South Africa, and socioeconomically disadvantaged urban communities in Sweden. Our aim was to develop an intervention with shared key functions and a good fit with the local context, needs, and resources. The intervention program design was conducted in three steps facilitated by a coordinating team: (a) situational analysis based on the SMART2D Self-Management Framework and definition of intervention objectives and core strategies; (b) designing generic tools for the strategies; and (c) contextual translation of the generic tools and their delivery. This article focuses on community strategies to strengthen support from the social and physical environment and to link health care and community support. Situational analyses showed that objectives and key functions addressing mediators from the SMART2D framework could be shared. Generic tools ensured retaining of functions, while content and delivery were highly contextualized. Phased, collaborative approach and theoretical framework ensured that key functions were not lost in contextualization, also allowing for cross-comparison despite flexibility with other aspects of the intervention between the sites. The trial registration number of this study is ISRCTN11913581.

Effect of previous utilization and out-of-pocket expenditure on subsequent utilization of a state led public-private partnership scheme "Chiranjeevi Yojana" to promote facility births in Gujarat, India.

BACKGROUND: In Gujarat, India, a state led public private partnership scheme to promote facility birth named Chiranjeevi Yojana (CY) was implemented in 2005. Institutional birth is provided free of cost at accredited private health facilities to women from socially disadvantaged groups (eligible women). CY has contributed in increasing facility birth and providing substantially subsidized (but not totally free) birth care; however, the retention of mothers in this scheme in subsequent child birth is unknown. Therefore, we conducted a study aimed to determine the effect of previous utilization of the scheme and previous out of pocket expenditure on subsequent child birth among multiparous eligible women in Gujarat. METHODS: This was a retrospective cohort study of multiparous eligible women (after excluding abortions and births at public facility). A structured questionnaire was administered by trained research assistant to those with recent delivery between Jan and Jul 2013. Outcome of interest was CY utilization in subsequent child birth (Jan-Jul 2013). Explanatory variables included socio-demographic characteristics (including category of eligibility), pregnancy related characteristics in previous child birth, before Jan 2013, (including CY utilization, out of pocket expenditure) and type of child birth in subsequent birth. A poisson regression model was used to assess the association of factors with CY utilization in subsequent child birth. RESULTS: Of 997 multiparous eligible women, 289 (29%) utilized and 708 (71%) did not utilize CY in their previous child birth. Of those who utilized CY (n = 289), 182 (63%) subsequently utilized CY and 33 (11%) gave birth at home; whereas those who did not utilize CY (n = 708) had four times higher risk (40% vs. 11%) of subsequent child birth at home. In multivariable models, previous utilization of the scheme was significantly associated with subsequent utilization (adjusted Relative Risk (aRR): 2.7; 95% CI: 2.2-3.3), however previous out of pocket expenditure was not found to be associated with retention in the CY scheme. CONCLUSION: Women with previous CY utilization were largely retained; therefore, steps to increase uptake of CY are expected to increase retention of mothers within CY in their subsequent child birth. To understand the reasons for subsequent child birth at home despite previous CY utilization and previous zero/minimal out of pocket expenditure, future research in the form of systematic qualitative enquiry is recommended.