Award Title: NIHR Global Health Research Group: Implementation of simple solutions to reduce maternal and neonatal mortality and build research capacity in Sierra Leone
Funder: Department of Health and Social Care

Abstract: We propose to create an NIHR Global Health Research Group, focussed on reducing maternal and neonatal mortality in Sierra Leone._x000D_
Background to the planned research:_x000D_
In Sierra Leone (SL) 1 in every 17 women will die during pregnancy or childbirth; it is one of the most dangerous places to give birth in the world, with 40% of all maternal deaths occurring amongst teenagers related to poor access to care. It is widely recognised that many women die in pregnancy because the problem is recognised too late, related to late care-seeking behaviour, and treatment delay once admitted. In all of these instances, triage following simply monitoring could be lifesaving. Early recognition is required to allow timely management and treatment to be instigated before serious, irreversible complications or death. Unfortunately in SL, access and availability of monitoring equipment is challenging; Our aims are to:_x000D_
•	To evaluate the impact of the CRADLE VSA, a novel monitor that detects blood pressure and pulse and calculates shock, with a traffic light alert, in a rural setting and to validate the use of other point of care (POC) technologies in the management of haemorrhage and sepsis; specifically the Shock Index (SI) readily available on the CRADLE VSA, and a POC creatinine device to detect acute kidney injury._x000D_
•	Evaluate the impact of the 2 young lives intervention of mentorship scheme to teenagers, and the contribution hypertensive disorders make on teenage maternal and neonatal mortality._x000D_
•	Determine the health economic benefit of implementation of the CRADLE VSA intervention through evaluating the costs of context specific process and impact on clinical outcome measures and define the necessary policy framework for the ultimate roll out of the optimal interventions determined in our current research. _x000D_
•	Build junior research capacity through 3 local  PhD students (in implementation science, health policy and economics), and incorporate research training into the National School of Midwifery’s curricula and mentoring a cadre of medical/midwifery academics through KCL Master’s modules in Public Health and Research Methodology. This will include working with the MoHS’ Quality Management Directorate to build the country's first PPI programme. UK Academics will mentor senior clinicians and build fellowship opportunities for health professionals, including through the NIHR Leadership Programme._x000D_
Methods_x000D_
1)	An evaluation of the CRADLE VSA in 8 districts (50% of the country) i.e. a rural setting, using pragmatic, stepped-wedge, type 2 hybrid implementation-effectiveness trial, implementing the adapted CRADLE intervention into the remaining 8 districts in Sierra Leone._x000D_
•	A feasibility cluster randomised trial to evaluate the mentorship intervention on teenage mortality and other morbidities._x000D_
•	Validation of the shock index and Cr POC technologies in high risk pregnancies to predict adverse outcomes.  _x000D_
•	A cost benefit analysis and subsequent adoption and policy pathway of all these interventions_x000D_
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The trials will recruit, and complete data collection and report within the 36 month programme. The observational data in all validation studies will complete within these trials. The outputs will be published in high impact journals, and shared with relevant policy and other stakeholders nationally. We will disseminate at international conferences.

Lay Abstract: In Sierra Leone 1 in 17 women die in pregnancy.  It is one of the most dangerous places in the world to give birth, with nearly half of the deaths occurring in adolescents, due to poor access to care.  When a mother dies, her child is 10 times more likely to die within the first two years.  We have shown that three quarters of women die from bleeding, infection or blood pressure problems, all of which can be identified by measuring blood pressure and heart rate, and are preventable with simple, cheap interventions.  But Sierra Leone lacks monitoring equipment and training which means that women lack timely, lifesaving care._x000D_
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In the UK, research underpins health policy and improves care, but in Sierra Leone there are no formal training opportunities to develop research leaders.  Over 5 years, King’s College London, Ministry of Health & Sanitation and Welbodi Partnership have carried out discovery science in Sierra Leone.  The CRADLE 3 study for example, showed that providing a portable blood pressure and heart rate monitor (CRADLE VSA), with early warning traffic lights, and training resulted in improved care and 60% less women dying around the main City, Freetown.  The CRADLE device has been identified as a key strategy to reduce maternal and neonatal deaths but its implementation needs to be optimised, along with evaluation of other related novel interventions including:_x000D_
_x000D_
1)	Evaluation of the CRADLE VSA throughout the country, (where outcomes are worse and treatment most challenging), leading to earlier detection of women who are deteriorating secondary to common pregnancy related problems (Shock Index – also measured by the CRADLE VSA, and a test to identify kidney failure);_x000D_
2)	Introduction and evaluation of a mentorship intervention targeted to pregnant teenagers, to improve access to care and education, and to better understand how blood pressure problems affect the health of this group of pregnant women;_x000D_
3)	An evaluation of how cost effective it would be to introduce the CRADLE VSA and related interventions at scale in Sierra Leone, and the pathways to dissemination by government_x000D_
4)	Development of research capacity through supervision of 3 PhD students (in the area of implementation science, health policy and health economics), inclusion of research training into National School of Midwifery Curriculum and mentoring for medic/midwife academics, and creation of Sierra Leone’s first Patient and Public Involvement Initiative to give women and community members in Sierra Leone a new voice._x000D_
The primary aim of this NIHR Global Health Research Group is to reduce deaths of mothers and their babies in Sierra Leone.  To do this we have created a programme of work in collaboration with our research colleagues and implementing partners in Sierra Leone in order to build new research capacity, which is currently underdeveloped, and to develop existing research projects related to the evaluation and implementation of novel life-saving interventions.  We will publish in open access, high impact journals, and present our work at international conferences to disseminate our findings widely.  Through equitable partnerships, with ongoing stakeholder engagement we hope to drive delivery of sustainable, evidence-based, effective maternity and newborn care.

Research Activity Codes: 4.2 EVALUATION OF MARKERS AND TECHNOLOGIES;6.3 MEDICAL DEVICES;6.8 COMPLEMENTARY;8.2 HEALTH AND WELFARE ECONOMICS
Health Categories: REPRODUCTIVE HEALTH AND CHILDBIRTH