Insufficient reductions in maternal and neonatal deaths and stillbirths in the past decade are a threat to achieving the Sustainable Development Goal 3. Overcoming the knowledge-do gap to ensure implementation of known evidence-based intervention during the intrapartum period – the period from onset of labour to immediately after childbirth – has the potential to avert at least 2.5 million deaths in mothers and their offspring annually. Our ALERT approach targets this period and will develop and evaluate a multifaceted health system intervention to strengthen the implementation of evidence-based interventions and responsive care in Sub-Saharan African hospitals, where 40-50% of all births in the region take place. 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; iv) empowerment and leadership mentoring of maternity unit leaders complemented by district based bi-annual coordination and accountability meetings. We will apply a gender lens to explore constraints in intrapartum care in the context of the multidisciplinary teams providing maternity care. Repositioning midwifery with its preventive, promotive and curative aspects is a cross-cutting theme. We will evaluate the intervention through a stepped-wedge design, the primary outcome being in-facility perinatal (stillbirths and early neonatal) mortality. Our nested realist process evaluation will help to understand what works, for whom and under which condition. An economic evaluation will report on scalability and costs. Our research aims to inform programming for the Sustainable Development Goals and Every Women Every Child Agendas of the United Nations to support Universal Health Coverage and patient-centred care which will be relevant beyond the project focus

An effective and strong regulatory system for health technologies is critical, especially during epidemics and pandemic situations. The demand for rapid approval and application of a variety of health technologies including diagnostics and medicines during COVID-19 has reawakened the world to the urgent need to have resilient regulatory capacities that can respond in a timely manner with corresponding efficiency. National Medicines Regulatory Authorities and Research Ethics Committees are duty bound to prepare and be ready to respond in any health emergency. Through EDCTP-2-funded projects namely SMERT, PROFORMA, PAVIA and ASCEND, substantial progress has been made on strengthening some procedures for clinical trial control and pharmacovigilance. These projects have enabled Tanzania to attain WHO Maturity level 3, making it a role model in East Africa. Despite of this, health technologies regulation in Tanzania has struggled to cope with emergencies as witnessed in the COVID-19 pandemics due to limited capacity in the area of Research Ethics, therapeutics, vaccines, medical devices and other health technologies. We now propose BREEDIME to further build our capacity in the context of epidemic and pandemic preparedness. BREEDIME will enable Tanzania to achieve rapid response clinical trial regulatory capacity for therapeutics, vaccines, and diagnostics; capacity for post-market evaluation and appraisal of health technologies; establish research ethics framework for electronic health data and materials storage, access and sharing within and outside the country; and establish a south-south learning centre in clinical trials regulatory and ethical review capacities. These objectives will be achieved through engagement of stakeholders in academia, civil society, public and government to generate evidence to inform new regulatory guidelines. This will strengthen health technologies regulation and will enable rapid access to health care and technology during emergency. Rwanda, which recently established her Food and Drugs Agency will become the first mentee under the BREEDIME south-south networking in ethics and medicines regulatory capacity building. The impact of the outputs of this study will be ensuring safety of pre- and post- registration health technologies in Tanzania and East Africa at large.

The project ultimately aims at improving patient care and wellbeing in Tanzania. Central notions in this are: Respectful and Compassiante patient centered Care (RCC), communication skills and Health Literacy (HL).RCC and HL have entered strategic plans in education, but are not truly embedded in educational and professional practice in Tanzania yet. Universities have insufficient tools to develop and implement this within the study programmes. This is also identified by the Ministry of Health (involved in this proposal itself). The project aims at enabling Tanzanian universities (and hospitals) to do so.In concrete terms, the project consists of:- Curriculum development in the fields of RCC, HL, student communication skills, adapted to the situation in Tanzania.- Capacity building at university and hospital level: a train the trainer programme will be developed for Tanzania to start to build a pool of lecturers and clinical instructors, competent in teaching and assessing a curriculum based training for Nursing students in Respectful and Compassionate patient centered Care using Health Literacy communication skills. On the Tanzanian side, the partnership consists of three Tanzanian universities in Health, three referral hospitals and the Ministry of Health, Community Development, Gender, Elderly and Children. On the European side, three universities (schools in Nursing/Health) from Ireland, Norway and the Netherlands are involved, as well as a University Medical Centre in the Netherlands.The project will take place in three regions of Tanzania. It is foreseen that the curriculum and training will be introduced in the other regions as well (after the project period), with the Ministry as leading institution (Tanzania has a national curriculum in Nursing).