CRADLE-5: a stepped-wedge type 2 hybrid implementation-effectiveness cluster randomised controlled trial to evaluate the real-world scale-up of the CRADLE Vital Signs Alert intervention into routine maternity care in Sierra Leone-study protocol.

BACKGROUND: The CRADLE Vital Signs Alert intervention (an accurate easy-to-use device that measures blood pressure and pulse with inbuilt traffic-light early warning system, and focused training package) was associated with reduced rates of eclampsia and maternal death when trialled in urban areas in Sierra Leone. Subsequently, implementation was successfully piloted as evidenced by measures of fidelity, feasibility and adoption. The CRADLE-5 trial will examine whether national scale-up, including in the most rural areas, will reduce a composite outcome of maternal and fetal mortality and maternal morbidity and will evaluate how the CRADLE package can be embedded sustainably into routine clinical pathways. METHODS: CRADLE-5 is a stepped-wedge cluster-randomised controlled trial of the CRADLE intervention compared to routine maternity care across eight rural districts in Sierra Leone (Bonthe, Falaba, Karene, Kailahun, Koinadugu, Kono, Moyamba, Tonkolili). Each district will cross from control to intervention at six-weekly intervals over the course of 1 year (May 2022 to June 2023). All women identified as pregnant or within six-weeks postpartum presenting for maternity care in the district are included. Primary outcome data (composite rate of maternal death, stillbirth, eclampsia and emergency hysterectomy) will be collected. A mixed-methods process and scale-up evaluation (informed by Medical Research Council guidance for complex interventions and the World Health Organization ExpandNet tools) will explore implementation outcomes of fidelity, adoption, adaptation and scale-up outcomes of reach, maintenance, sustainability and integration. Mechanisms of change and contextual factors (barriers and facilitators) will be assessed. A concurrent cost-effectiveness analysis will be undertaken. DISCUSSION: International guidance recommends that all pregnant and postpartum women have regular blood pressure assessment, and healthcare staff are adequately trained to respond to abnormalities. Clinical effectiveness to improve maternal and perinatal health in more rural areas, and ease of integration and sustainability of the CRADLE intervention at scale has yet to be investigated. This trial will explore whether national scale-up of the CRADLE intervention reduces maternal and fetal mortality and severe maternal adverse outcomes and understand the strategies for adoption, integration and sustainability in low-resource settings. If successful, the aim is to develop an adaptable, evidence-based scale-up roadmap to improve maternal and infant outcomes. TRIAL REGISTRATION: ISRCTN 94429427. Registered on 20 April 2022.

Scale-up of a novel vital signs alert device to improve maternity care in Sierra Leone: a mixed methods evaluation of adoption.

BACKGROUND: The CRADLE (Community blood pressure monitoring in Rural Africa: Detection of underLying pre-Eclampsia) Vital Signs Alert device-designed specifically to improve maternity care in low resource settings-had varying impact when trialled in different countries. To better understand the contextual factors that may contribute to this variation, this study retrospectively evaluated the adoption of CRADLE, during scale-up in Sierra Leone. METHODS: This was a mixed methods study. A quantitative indicator of adoption (the proportion of facilities trained per district) was calculated from existing training records, then focus groups were held with 'CRADLE Champions' in each district (n = 32), to explore adoption qualitatively. Template Analysis was used to deductively interpret qualitative data, guided by the NASSS (non-adoption, abandonment, scale-up, spread, sustainability) Framework. FINDINGS: Substantial but non-significant variation was found in the proportion of facilities trained in each district (range 59-90%) [X2 (7, N = 8) = 10.419, p = 0.166]. Qualitative data identified complexity in two NASSS domains that may have contributed to this variation: 'the technology' (for example, charging issues, difficulty interpreting device output and concerns about ongoing procurement) and 'the organisation' (for example, logistical barriers to implementing training, infighting and high staff turnover). Key strategies mentioned to mitigate against these issues included: transparent communication at all levels; encouraging localised adaptations during implementation (including the involvement of community leaders); and selecting Champions with strong soft skills (particularly conflict resolution and problem solving). CONCLUSIONS: Complexity related to the technology and the organisational context were found to influence the adoption of CRADLE in Sierra Leone, with substantial inter-district variation. These findings emphasise the importance of gaining an in-depth understanding of the specific system and context in which a new healthcare technology is being implemented. This study has implications for the ongoing scale-up of CRADLE, and for those implementing or evaluating other health technologies in similar contexts.

Many women die during pregnancy and childbirth from causes that could be prevented, and the vast majority of these deaths occur in low-resource settings. The 'CRADLE Vital Signs Alert' is a medical device that helps identify problems during pregnancy­designed specifically for healthcare professionals in low-resource settings. However, for unknown reasons, the device appears to have varying impact according to the country or setting in which it is used. This study aimed to explore in depth whether, and why, healthcare professionals in Sierra Leone adopted the device and engaged in training (or not). Between March 2020 and January 2021, the CRADLE device and training package was disseminated across 8 districts in Sierra Leone. This relied on a few healthcare workers (nominated 'CRADLE Champions') to voluntarily distribute the devices and training in their local areas. Group discussions were held with CRADLE Champions in each district after the rollout to gather their feedback. In addition, the proportion of facilities trained in each district was recorded. The study found differences in how well the device and training was adopted in each district. Common challenges reported across districts related to technological difficulties (such as issues charging the devices) and organisational barriers (such as high levels of staff turnover at facilities). These findings will help to inform future rollout of the CRADLE device and training in Sierra Leone and highlight factors that may need to be considered by those implementing other health technologies in similar settings.

What it takes to get it right: A qualitative study exploring optimal handover of health programmes in Tonkolili District, Sierra Leone.

Since 2015 Médecins Sans Frontières (MSF) has been supporting the Ministry of Health (MoH) in Tonkolili district, Sierra Leone, with an integrated health care approach at the community, primary health centre (PHC), and hospital level. This programme is planned to be handed over to MoH. To prepare for this handover, a qualitative study exploring elements of a successful handover was undertaken in 2019. Focus group discussions (FGD) with the community members (n-48) and in-depth interviews (IDI) with MSF staff, community leaders, and MoH staff in Sierra Leone (n-15) were conducted. Data were audio-recorded, transcribed verbatim from English, Creole, and Themne, coded, and thematically analysed. Participants expressed that an optimal project handover and exit strategy should be a continuous, long-term, the staggered process included from the inception of the programme design. It requires clear communication and relationship building by all relevant stakeholders and demands efficient resources and management capacity. Associated policy implications are applicable across humanitarian settings on the handover of programmes where the government is functional and willing to accept responsibilities.

Healthcare utilization and maternal and child mortality during the COVID-19 pandemic in 18 low- and middle-income countries: An interrupted time-series analysis with mathematical modeling of administrative data.

BACKGROUND: The Coronavirus Disease 2019 (COVID-19) pandemic has had wide-reaching direct and indirect impacts on population health. In low- and middle-income countries, these impacts can halt progress toward reducing maternal and child mortality. This study estimates changes in health services utilization during the pandemic and the associated consequences for maternal, neonatal, and child mortality. METHODS AND FINDINGS: Data on service utilization from January 2018 to June 2021 were extracted from health management information systems of 18 low- and lower-middle-income countries (Afghanistan, Bangladesh, Cameroon, Democratic Republic of the Congo (DRC), Ethiopia, Ghana, Guinea, Haiti, Kenya, Liberia, Madagascar, Malawi, Mali, Nigeria, Senegal, Sierra Leone, Somalia, and Uganda). An interrupted time-series design was used to estimate the percent change in the volumes of outpatient consultations and maternal and child health services delivered during the pandemic compared to projected volumes based on prepandemic trends. The Lives Saved Tool mathematical model was used to project the impact of the service utilization disruptions on child and maternal mortality. In addition, the estimated monthly disruptions were also correlated to the monthly number of COVID-19 deaths officially reported, time since the start of the pandemic, and relative severity of mobility restrictions. Across the 18 countries, we estimate an average decline in OPD volume of 13.1% and average declines of 2.6% to 4.6% for maternal and child services. We projected that decreases in essential health service utilization between March 2020 and June 2021 were associated with 113,962 excess deaths (110,686 children under 5, and 3,276 mothers), representing 3.6% and 1.5% increases in child and maternal mortality, respectively. This excess mortality is associated with the decline in utilization of the essential health services included in the analysis, but the utilization shortfalls vary substantially between countries, health services, and over time. The largest disruptions, associated with 27.5% of the excess deaths, occurred during the second quarter of 2020, regardless of whether countries reported the highest rate of COVID-19-related mortality during the same months. There is a significant relationship between the magnitude of service disruptions and the stringency of mobility restrictions. The study is limited by the extent to which administrative data, which varies in quality across countries, can accurately capture the changes in service coverage in the population. CONCLUSIONS: Declines in healthcare utilization during the COVID-19 pandemic amplified the pandemic's harmful impacts on health outcomes and threaten to reverse gains in reducing maternal and child mortality. As efforts and resource allocation toward prevention and treatment of COVID-19 continue, essential health services must be maintained, particularly in low- and middle-income countries.

Digital Health Solutions and State of Interoperability: Landscape Analysis of Sierra Leone.

BACKGROUND: The government and partners have invested heavily in the health information system (HIS) for service delivery, surveillance, reporting, and monitoring. Sierra Leone's government launched its first digital health strategy in 2018. In 2019, a broader national innovation and digital strategy was launched. The health pillar direction will use big data and artificial intelligence (AI) to improve health care in general and maternal and child health in particular. Understanding the number, distribution, and interoperability of digital health solutions is crucial for successful implementation strategies. OBJECTIVE: This paper presents the state of digital health solutions in Sierra Leone and how these solutions currently interoperate. This study further presents opportunities for big data and AI applications. METHODS: All the district health management teams, all digital health implementing organizations, and a stratified sample of 72 (out of 1284) health facilities were purposefully selected from all health districts and surveyed. RESULTS: The National Health Management Information System's (NHMIS's) aggregate reporting solution populated by health facility forms HF1 to HF9 was, by far, the most used tool. A health facility-based weekly aggregate electronic integrated disease surveillance and response solution was also widely used. Half of the health facilities had more than 2 digital health solutions in use. The different digital health software solutions do not share data among one another, though aggregate reporting data were sent as necessary. None of the respondents use any of the health care registries for patient, provider, health facility, or terminology identification. CONCLUSIONS: Many digital health solutions are currently used at health facilities in Sierra Leone. The government can leverage current investment in HIS from surveillance and reporting for using big data and AI for care. The vision of using big data for health care is achievable if stakeholders prioritize individualized and longitudinal patient data exchange using agreed use cases from national strategies. This study has shown evidence of distribution, types, and scale of digital health solutions in health facilities and opportunities for leveraging big data to fill critical gaps necessary to achieve the national digital health vision.

What are the trends in seeking health care for fever in children under-five in Sierra Leone? evidence from four population-based studies before and after the free health care initiative.

BACKGROUND: In 2010, the government of Sierra Leone implemented the Free Health Care Initiative (FHCI) in the country with the objective of reducing the high maternal, infant, and child mortality rates and improving general health indicators. The objective of this study was to assess the trends in the prevalence of health care-seeking and to identify the determinants of healthcare service utilization by caregivers of children younger than five years. METHODS: The analysis of health-care-seeking behavior was done using data from four population-based surveys in Sierra Leone before (2008) and after (2013, 2016, 2019) the FHCI was implemented. Care-seeking behavior was assessed with regard to caregivers seeking care for children under-five in the two weeks prior to each survey. We compared the percentages of healthcare-seeking behavior change and identify factors associated with healthcare-seeking using a modified Poisson regression model with generalized estimating equations. RESULTS: In 2008, a total of 1208 children with fever were recorded, compared with 2823 children in 2013, 1633 in 2016, and 1464 in 2019. Care-seeking for children with fever was lowest in 2008 (51%; 95% CI (46.4-55.5)) than in 2013 (71.5%; 95% CI (68.4-74.5)), 2016 (70.3%; 95% CI (66.6-73.8)), and 2019 (74.6%; 95% CI (71.6-77.3)) (p < 0.001). Care-seeking in 2013, 2016 and 2019 was at least 1.4 time higher than in 2008 (p < 0.001) after adjusting for mother's age, wealth, religion, education level, household head and the child's age. Care-seeking was lowest for children older than 12 months, mothers older than 35 years, children living in the poorest households, and in the northern region. A trend was observed for the sex of the household head. The level of care-seeking was lowest when the household head was a man. CONCLUSIONS: The increase in healthcare-seeking for children under-five with fever followed the introduction of the FHCI in Sierra Leone. Care-seeking for fever varied by the child's age, caregiver's age, household wealth, the sex of the household head and region. Maintaining the FHCI with adequate strategies to address other barriers beyond financial ones is essential to reduce disparities between age groups, regions and, households.

Electricity, Computing Hardware, and Internet Infrastructures in Health Facilities in Sierra Leone: Field Mapping Study.

BACKGROUND: Years of health information system investment in many countries have facilitated service delivery, surveillance, reporting, and monitoring. Electricity, computing hardware, and internet networks are vital for health facility-based information systems. Availability of these infrastructures at health facilities is crucial for achieving national digital health visions. OBJECTIVE: The aim of this study was to gain insight into the state of computing hardware, electricity, and connectivity infrastructure at health facilities in Sierra Leone using a representative sample. METHODS: Stratified sampling of 72 (out of 1284) health facilities distributed in all districts of Sierra Leone was performed, factoring in the rural-urban divide, digital health activity, health facility type, and health facility ownership. Enumerators visited each health facility over a 2-week period. RESULTS: Among the 72 surveyed health facilities, 59 (82%) do not have institutionally provided internet. Among the 15 Maternal and Child Health Posts, as a type of primary health care unit (PHU), 9 (60%) use solar energy as their only electricity source and the other 6 (40%) have no electricity source. Similarly, among the 13 hospitals, 5 (38%) use a generator as a primary electricity source. All hospitals have at least one functional computer, although only 7 of the 13 hospitals have four or more functional computers. Similarly, only 2 of the 59 (3%) PHUs have one computer each, and 37 (63%) of the PHUs have one tablet device each. We consider this health care computing infrastructure mapping to be representative with a 95% confidence level within an 11% margin of error. Two-thirds of the PHUs have only alternate solar electricity, only 10 of the 72 surveyed health facilities have functional official internet, and most use suboptimal computing hardware. Overall, 43% of the surveyed health facilities believe that inadequate electricity is the biggest threat to digitization. Similarly, 16 (22%) of the 72 respondents stated that device theft is a primary hindrance to digitization. CONCLUSIONS: Electricity provision for off-electricity-grid health facilities using alternative and renewable energy sources is emerging. The current trend where GSM (Global System for Mobile Communication) service providers provide the internet to all health facilities may change to other promising alternatives. This study provides evidence of the critical infrastructure gaps in health facilities in Sierra Leone.

Child, maternal, and adult mortality in Sierra Leone: nationally representative mortality survey 2018-20.

BACKGROUND: Sierra Leone's child and maternal mortality rates are among the highest in the world. However, little is known about the causes of premature mortality in the country. To rectify this, the Ministry of Health and Sanitation of Sierra Leone launched the Sierra Leone Sample Registration System (SL-SRS) of births and deaths. Here, we report cause-specific mortality from the first SL-SRS round, representing deaths from 2018 to 2020. METHODS: The Countrywide Mortality Surveillance for Action platform established the SL-SRS, which involved conducting electronic verbal autopsies in 678 randomly selected villages and urban blocks throughout the country. 61 surveyors, in teams of four or five, enrolled people and ascertained deaths of individuals younger than 70 years in 2019-20, capturing verbal autopsies on deaths from 2018 to 2020. Centrally, two trained physicians independently assigned causes of death according to the International Classification of Diseases (tenth edition). SL-SRS death proportions were applied to 5-year mortality averages from the UN World Population Prospects (2019) to derive cause-specific death totals and risks of death nationally and in four Sierra Leone regions, with comparisons made with the Western region where Freetown, the capital, is located. We compared SL-SRS results with the cause-specific mortality estimates for Sierra Leone in the 2019 WHO Global Health Estimates. FINDINGS: Between Sept 1, 2019, and Dec 15, 2020, we enrolled 343 000 people and ascertained 8374 deaths of individuals younger than 70 years. Malaria was the leading cause of death in children and adults, nationally and in each region, representing 22% of deaths under age 70 years in 2020. Other infectious diseases accounted for an additional 16% of deaths. Overall maternal mortality ratio was 510 deaths per 100 000 livebirths (95% CI 483-538), and neonatal mortality rate was 31·1 deaths per 1000 livebirths (95% CI 30·4-31·8), both among the highest rates in the world. Haemorrhage was the major cause of maternal mortality and birth asphyxia or trauma was the major cause of neonatal mortality. Excess deaths were not detected in the months of 2020 corresponding to the peak of the COVID-19 pandemic. Half of the deaths occurred in rural areas and at home. If the Northern, Eastern, and Southern regions of Sierra Leone had the lower death rates observed in the Western region, about 20 000 deaths (just over a quarter of national total deaths in people younger than 70 years) would have been avoided. WHO model-based data vastly underestimated malaria deaths and some specific causes of injury deaths, and substantially overestimated maternal mortality. INTERPRETATION: Over 60% of individuals in Sierra Leone die prematurely, before age 70 years, most from preventable or treatable causes. Nationally representative mortality surveys such as the SL-SRS are of high value in providing reliable cause-of-death information to set public health priorities and target interventions in low-income countries. FUNDING: Bill & Melinda Gates Foundation, Canadian Institutes of Health Research, Queen Elizabeth Scholarship Program.

Disruptions in maternal and child health service utilization during COVID-19: analysis from eight sub-Saharan African countries.

The coronavirus-19 pandemic and its secondary effects threaten the continuity of essential health services delivery, which may lead to worsened population health and a protracted public health crisis. We quantify such disruptions, focusing on maternal and child health, in eight sub-Saharan countries. Service volumes are extracted from administrative systems for 63 954 facilities in eight countries: Cameroon, Democratic Republic of Congo, Liberia, Malawi, Mali, Nigeria, Sierra Leone and Somalia. Using an interrupted time series design and an ordinary least squares regression model with facility-level fixed effects, we analyze data from January 2018 to February 2020 to predict what service utilization levels would have been in March-July 2020 in the absence of the pandemic, accounting for both secular trends and seasonality. Estimates of disruption are derived by comparing the predicted and observed service utilization levels during the pandemic period. All countries experienced service disruptions for at least 1 month, but the magnitude and duration of the disruptions vary. Outpatient consultations and child vaccinations were the most commonly affected services and fell by the largest margins. We estimate a cumulative shortfall of 5 149 491 outpatient consultations and 328 961 third-dose pentavalent vaccinations during the 5 months in these eight countries. Decreases in maternal health service utilization are less generalized, although significant declines in institutional deliveries, antenatal care and postnatal care were detected in some countries. There is a need to better understand the factors determining the magnitude and duration of such disruptions in order to design interventions that would respond to the shortfall in care. Service delivery modifications need to be both highly contextualized and integrated as a core component of future epidemic response and planning.

Diet Quality and Urbanization in Mozambique.

Robust income growth combined with the highest urban population growth in the world is driving rapid changes in the food system of sub-Saharan Africa. Demand is increasing for higher quality as well as more processed foods. Countries are increasingly experiencing a double burden of over and under nutrition as the overweight and obesity epidemic spreads. In this context, we seek to understand the key drivers and likely evolution of diet quality in Mozambique, in both its positive and negative dimensions, while specifically examining the role of farm ownership among increasingly urban populations. We use national household expenditure survey data and a set of ordinary least square and analysis of variance regressions to observe patterns of current diet quality across city size categories, household income, household education, and other demographic variables. We then anticipate the likely directions of change in diet quality over these same dimensions based on expected income growth and expenditure elasticities developed for several alternative nutrients. We find that growing incomes and the consumption of processed foods are associated with a worsening of negative factors in the diet. Furthermore, urbanization, controlling for income, is associated more strongly with a worsening of negative factors than with an improvement in positive factors in the diet. The effect on diet quality of farm ownership, however, is positive and significant, primarily driven by these households purchasing fewer unhealthy foods. African cities need to consider what mix of policies will counteract the negative effects of continued urbanization and rising incomes on diets.

Non-communicable diseases in the Western Area District, Sierra Leone, following the Ebola outbreak.

Background: Non-communicable diseases (NCDs) are the leading causes of morbidity and mortality in the world. During infectious disease outbreaks, such as the Ebola virus disease outbreak in West Africa from 2014-2015, the health system is often strained, and diagnosis, management and care of NCDs may be compromised. This study assessed numbers and distribution of NCDs in all health facilities in the Western-Area District, Sierra Leone, in the post-Ebola period (June-December 2015) comparing findings with the pre-Ebola (June-December 2013) and Ebola outbreak (June-December 2014) periods. Methods: This was a cross-sectional study using secondary data from routine records of aggregate monthly NCD reports. Data were analysed using Open EPI and comparisons were made between the post-Ebola and pre-Ebola/Ebola periods using the chi-square test. Results: There were 10,011 people reported with NCDs during the three six-month periods, with 6194 (62%) presenting at peripheral health units (PHU). Reported NCDs decreased during Ebola and increased post-Ebola, but did not recover to pre-Ebola levels. Hypertension cases remained fairly constant throughout being mainly managed at PHU. Numbers with diabetes mellitus generally stayed the same except for a significant post-Ebola increase in tertiary hospitals. Small numbers were reported with mental health disorders across all facilities in all time periods. Conclusion: NCD reporting is recovering in the immediate post-Ebola period. Decentralization of NCD care is welcome and is an effective strategy for management as evidenced by hypertension. To be successful, this must be supported by strengthening other elements of the health system such as training of health workers, robust information and referral systems and reliable medicine supply chains.