In 2016 an estimated 5.6 million children died before their fifth birthday. Pneumonia (24%), diarrhoea (15%), and malaria (9%) remain the leading causes of death in children ages 1 – 59 months, and malnutrition is an underlying factor associated with nearly half of under-five deaths. Both pneumonia and malaria are febrile illnesses, and common causes of diarrhoea in children (e.g. rotavirus, Escherichia coli) can also include fever. While all are treatable, the effectiveness of key medicines is currently at risk: resistance to artemisinin-based combination therapies (ACTs) is spreading in South-East Asia and antibiotic resistance is a growing global concern. Efforts to improve child survival and preserve essential medicines currently threatened by resistance require a more effective, integrated response to childhood fever.
Over three-quarters of children seeking care at facilities and in the community in low- and middle-income countries (LMICs) present with fever. The recent scale-up of malaria rapid diagnostic tests, together with decreasing malaria incidence, have resulted in an increasing number of fevers being diagnosed as malaria-negative. Evidence suggests that many non-malarial fevers are not appropriately managed due in part to a lack of diagnostic tools, leading to: inappropriate treatment including overuse and wastage of both malaria medicines and antibiotics; increased spread of antibiotic resistance; and high costs related to the management of drug-resistant patients. Moreover, missed opportunities to effectively treat sick children can result in severe disease (including severe malaria), which is often overlooked and contributes directly to increased child mortality.
Hypoxaemia, or low oxygen saturation in the blood, is a key indicator of severe disease that requires onwards referral and treatment, including oxygen therapy. While screening for hypoxaemia with pulse oximetry is currently recommended at primary health care and is included in the Integrated Management of Childhood Illness (IMCI) guidelines, this is rarely implemented due in large part to a lack of tools adapted for use in these settings in LMICs.
Promising, new pulse oximeters have recently entered the market that are better adapted for primary care use in children in LMIC. Pilot implementation of these devices is now needed in early-adopter countries to lay the foundation for standard use in primary healthcare facilities and to prepare for their widespread scale-up. In addition, multimodal handheld devices which can detect hypoxaemia as well as other vital signs including respiratory rate, non-invasive haemoglobin and temperature are currently being developed and have the potential to improve integrated care at the frontline. If a sustainable market for these tools is established, they also have the ability to support wider connectivity with other health services.
Under this Call, Unitaid is soliciting proposals for the following interventions aimed at accelerating the availability, adoption and scale-up of improved tools to identify severe disease including:
Pilots should demonstrate proof of concept in early adopter countries and focus on scale-up preparatory activities including evaluation of the impact, cost-effectiveness and operational feasibility of implementing adapted pulse oximeters at the primary healthcare level, in uncontrolled settings. Pilots should aim to catalyse demand, adoption and scale-up of adapted pulse oximeters for primary healthcare use in children in LMIC. This includes the generation of evidence to support operational guidance, including practical guidance to support primary healthcare workers in integrating pulse oximeters into their daily work. Additionally, innovative procurement and supply chain approaches for pulse oximeters in highly-fragmented LMIC markets such as: improving distribution methods to ensure the availability of replacement probes, batteries and devices; coordinated ordering; and price sharing forums etc. could be considered as relevant activities. Activities should also include Identifying and collaborating with key partners to ensure that widespread scale-up of pulse oximeters is supported.
Market entry/access preparatory activities include the development of a business plan and should consider market sizing, market sustainability, device prices, and potential use cases, as well as an analysis of demand- and supply- side barriers to introduction (e.g. health worked acceptability assessments), regulatory and distribution pathways, cost effectiveness/willingness-to-pay studies, etc. Evidence generated through large-scale field evaluations should support a broader set of policy-making activities such as work to establish priorities of new tools for severe disease and the development of a Target Product Profile for multimodal devices.
To ensure that tools to improve the identification of severe disease are adopted and used, promising digital technologies such as electronic decision-support applications that could both improve adherence to clinical algorithms and collect real-time data on fever, could be incorporated as part of proposed projects to introduce new tools for severe disease.
In order to have impact, activities to accelerate access to tools for severe disease must be closely coordinated with efforts to increase access to dispersible amoxicillin and other key medicines for childhood fever, particularly where large access barriers exist, as well as efforts to improve referral systems and access to oxygen therapy.
For this Call for Proposals, multimodal handheld devices are tools that can detect hypoxaemia as well as at least one other vital sign including respiratory rate, non-invasive haemoglobin and temperature.
Data generated through all activities should be suitable for assessment through World Health Organization product registration and policy pathways and should demonstrate the public health impact of the new product. Given that grants awarded under this Call are likely to begin in early-2019, proponents should demonstrate the potential for field evaluations and pilot implementation of the product to begin in this timeframe.
Topics which are out of scope for this Call include: basic and early-stage research, including small-scale field evaluations and product adaptions/modifications i.e. products that are yet to be design-locked.
Proposals submitted should clearly demonstrate the fit with the objectives set out above, the expected impact and value for money as well as the complementarity and added value to similar projects.
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