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UNICEF Innovation

ARIDA (Acute Respiratory Infection Diagnostic Aid)

Advanced diagnostic tools, such as chest x-rays and laboratory tests, are not readily available in low-resource health settings. Instead, health workers are trained to diagnose pneumonia by observing and counting how quickly a child’s chest rises and fall

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OVERVIEW

Pneumonia Community Case Management (CCM)The WHO Integrated Management of Childhood Illnesses (IMCI) guidelines prescribe how children under 5 should be managed at primary health care facilities. For the diagnosis of pneumonia, health facility staff workers should assess whether a child has fast breathing by measuring their respiratory rate. For children between 2-12 months, a diagnosis of pneumonia is determined when they present with 50 or more breaths per minute. For children from 12 months to 5 years the threshold is 40 breaths per minute.

Studies show that community health workers (CHWs) can also be trained to manage pneumonia cases according to the IMCI guidelines.  They are highly motivated individuals who live in the community where they work.  After receiving specialized training, usually by the Ministry of Health, they provide care and treatment for children beyond health facilities. Often in these settings there is no electricity, running water or motorized transportation.

There is accumulating evidence that with appropriate supervision, CHWs can make a significant impact in reducing child mortality. Large scale community case management (CCM) pneumonia programmes are currently running in several countries, including Pakistan, Ghana, Uganda, Ethiopia and Rwanda.

In addition, CHWs providing home-based newborn care are now also being trained to identify fast breathing during their home visits after birth.

Acute Respiratory Infection Timer
To help health workers determine how long they need to count a child’s breaths, UNICEF and WHO developed a one-minute Acute Respiratory Infection (ARI) Timer in the 1990s. In the last five years nearly half a million timers have been supplied to over 70 countries. In line with the increasing adoption by Ministries of Health of pneumonia CCM policies, UNICEF procurement for it increased from 25000 in 2005 to 122000 in 2010.

However, anecdotal feedback from pneumonia CCM experts indicated the need to re-design the ARI Timer. Subsequent user research (see Resources) in Ghana and Uganda has given CHWs an opportunity to co-create an improved diagnostic tool. The research confirmed that the ticking sound it makes, to indicate to CHWs that the timer is functioning, distracts them during the count.  The alarm at 30 seconds is startling to the parents, and can also confuse the CHW as to whether the end of the minute has been reached or not. Improvements are currently being implemented through a new product specification to ensure that future ARI Timers will be more fit for purpose.

Determining Breath Rates
In addition to monitoring the one-minute time requirement, the CHW also needs to assess the breath counts. This can create difficulties, as focusing on a child for a full minute, whilst visually identifying breaths and counting silently is more difficult than it first appears.

  • This count can go up to as high as 60-70 breaths per minute
  • The child may become restless, the CHW may not be able to concentrate and simply lose track
  • CHWs also worry that they do not see all the breaths
  • CHWs who are not  always numerically literate may have difficulties with counting breaths and applying prescribed age-specific IMCI thresholds

This potentially leads to recounts, time lost and reduced accuracy.

Simplifying Countings
Solutions are being explored to help CHWs keep accurate count. In Ghana, Uganda and South Sudan, Save the Children, International Rescue Committee and UNICEF have piloted and implemented the use of counting beads. Similar to prayer beads, counting beads is a concept that already exists in many communities.

Pilot tests show that a combination of color-coded and age-specific strands of beads can greatly improve the accuracy of pneumonia diagnosis.  The impact is most significant in remote areas where CHWs may have had less schooling and fewer opportunities to learn about numbers and counting. The age-specific colour-coded strands remove the need to interpret the breath count against the cut-off rates. The color-coding is also a tool to communicate the diagnosis.  A parent, who can “see” the diagnosis expressed in beads, is less likely to insist on antibiotics if that type of treatment is not necessary – and potentially harmful.

Based on these initial findings and potential diagnosis improvements UNICEF Supply Division is currently considering the development of an “ARI counting beads” design guide.  It would instruct how to assemble ARI counting beads so that count accuracy will be improved, while using locally-procured materials.

High Trust in Technology
The user research also showed that patients do have some experience with ‘low-tech’ health products, such as thermometers, stethoscopes, blood pressure meters and pregnancy tests, and they have a high degree of trust in them.  Patients generally believe that health technology reduces human error. When one of these tools is used on them, people feel that they have been properly examined; raising confidence in the health worker and potentially reducing their desire to self-medicate, use traditional healing methods or seek advice from unlicensed ‘chemists’.

Creating the Dream Solution: ‘the Judge’
While there are developments on the horizon, appropriate rapid diagnostic tests for point of care application are not currently available on the market. Based on existing technologies, UNICEF is advocating for the development of a tool that could automatically and precisely determine respiratory rates, and hence detect pneumonia, in children under 5.

Such an automated tool would be relevant for both (primary) clinics, where there is a higher patient load, and to improve the quality of care given by CHWs. 

As a CHW in Uganda put it: “…We need a Judge to decide if the child should receive treatment or not and to also tell this to the mother…”.  For many CHWs participating in user research on pneumonia diagnostics, an ideal device is something that can be put on the child, somehow does the counting and diagnosis on its own and then shows the result in a way that the child’s mother would understand. This would also help to reduce “wasting drugs” on children that just have a common cough or cold.

The device should be durable enough to withstand extreme environmental conditions. It should also not be reliant on electricity or other power sources, which are unavailable in many settings. For patients and families, its credibility would be boosted through a clean but sophisticated look.

Target Product Profile 
In November 2014, UNICEF launched a Target Product Profile. The purpose of the TPP is to contribute to increasing the availability of improved tools to support diagnosing pneumonia, which UNICEF, Government’s and implementing partners can procure and supply to health workers around the world and thereby prevent some of the deaths of children that occur due to pneumonia not being diagnosed and treated.  This TPP conveys information regarding the intended use, context of use, user needs and stakeholder needs to potential suppliers for tools that can be used to support the assessment of fast breathing as an aid to pneumonia diagnosis.  

Since the launch of the TPP, UNICEF has been in discussions with different developers of ARIDA devices, from academia to commercial companies. To ensure transparency all clarifications are shared here 

This list is updated as the discussions are had and therefore please check back here for any other updates. 

The next phase of the ARIDA Project 
The goal of the project is to make devices available that can enable accurate and easy-to-use respiratory rate counting for diagnosing pneumonia in children. Concretely, we are looking for products that do automated breath counting. 

During this phase of the ARIDA project will procure limited quantities of ARIDA devices for implementation pilots. These commercially available products must be clinically-trialled and regulatory-approved (CE, FDA or equivalent medical device stringent regulatory approval). During the implementation pilots the ARIDA devices will be put in the hands of health workers including, community health workers, health centre workers, etc. to get first-hand experience of the use in UNICEF’s context. The results will inform on product performance, acceptability and potential for scale-up and routine national implementation. UNICEF is working with national governments to design the implementation pilots, which will likely have the following features: 

  • Duration of approximately 3 months per implementation pilot;
  • Take place throughout 2016, and possibly beyond;
  • Include up to 17 countries that have expressed interest (it is expected, though, that pilots will take place in a reduced number of countries);
  • Include approximately 300 devices per implementation pilot;
  • Include use by Community Health Workers and Primary Health Facility workers;
  • Include thorough training in the use of ARIDA products;
  • Include several feedback loops where users and mothers can report on their perspectives;
  • Managed by UNICEF, but implemented using a third-party research consultancy/institution with full collaboration and approvals with the local UNICEF country offices and ministries. 

The implementation pilots aim to commence in Q1 2016 and assuming positive results, the ARIDA project will subsequently move into facilitating scale-up and routine national implementation of ARIDA devices in different countries, starting with the countries where the implementation pilots took place. 

UNICEF Supply Division has launched an Request for Expression of Interest (REOI) targeted to potential suppliers of ARIDA medical devices, with the expectancy of issuing a competitive tender towards the end 2015. Through the links you can find both the REOI and the Expression of Interest (EOI) form.

Deadline for the submission of the EOI form is 13 October 2015. In addition, we would be grateful if you would share this with professional networks from which you are or have been involved. 

LATEST UPDATE

December, 2016

The ARIDA team went on a mission to Ethiopia to design the field trial protocols jointly with the Ethiopia Federal Ministry of Health (FMOH), UNICEF's Country Office and UNICEF's implementing partner, Malaria Consortium (MC). Read more about their experience in the blog post here

November, 2016 

UNICEF gave a presentation on the ARIDA project at the American Society of Tropical Medicine and Hygiene (ASTMH) 2016 Symposium, explaining the benefits of the introduction of improved pneumonia diagnostics and some of the challenges that have been faced and solutions for mitigating these.  

November, 2016
There was a mission to Addis Ababa with a single, simple, outcome goal: to ensure all stakeholders and partners are on board with upcoming field trial activities in Ethiopia and proposed next steps of the ARIDA project. Read more here on the objectives of the mission, the stakeholders involved in Ethiopia, and the status of the project.  

July, 2016
UNICEF has just launched a request for proposals for ARIDA devices to be included in the field trials. See https://www.unicef.org/supply/index_91808.html for more information.

June, 2016
On 10 June, an update on ARIDA was shared with the Pneumonia and Diarrhea Working Group in New York. Here is a copy of the presentation.

April, 2016
Bolivia is one location where the ARIDA devices will be Field Trialed (FT). UNICEF team members visited potential sites for the field trial which were deemed to have the biggest impact on the project and investigated the existing health system in Bolivia whilst meeting relevant stakeholders in the country. Read about the visit in the blog post here.

February, 2016 
Planning Field Trials in Ethiopia plus hypothesis of where ARIDA will add value. The project team have been working closely with the UNICEF Ethiopia Country office to plan the first Field Trials of ARIDA devices. Read the blog from the recent mission here: http://www.unicefstories.org/2016/02/19/planning-field-trials-of-innovative-diagnostics-for-pneumonia-with-unicef-ethiopia/Additionally, the team have been working to hypothesis where ARIDA will add value. The Field Trials will aim to answer some of these hypothesis.

January, 2016 

Request for Expression of Interest
UNICEF launched a Request for Expression of Interest (REOI) in September 2015, targeted at industry and academia engaged in the development of ARIDA medical devices. The REOI invited relevant stakeholders to express their interest in becoming a future UNICEF supplier of ARIDA products, and to provide commercial and regulatory information about their existing and future products.

As a result of the REOI, UNICEF plans to launch of a competitive tender before the end of Q1 2016, with the expectancy to commence field trials early Q3 2016 of the available ARIDA products that meet the commercial, technical and quality tender criteria. Suppliers can check UNICEF’s tender plans at

https://www.unicef.org/supply/index_25983.html; please note calendars are updated regularly to  reflect the most recent tender plans.

Field Trials:
The first field trial is expected to take place in Ethiopia where, at community level the ARIDA devices will be assessed for efficiency and effectiveness by community health workers at health posts in assessing fast breathing in under 5s. Details have not yet been finalised and more information will be shared in due course. 

The field trials are likely to have the following set up:

  • 300 ARIDA units across health posts.
  • Duration of 3 months.

    Funding:
    "la Caixa" Foundation has supported the ARIDA project with a 5 million euro contribution. The funds will be used to identify innovative ways to improve the diagnosis of pneumonia among children. For more information please see the below:

    https://www.unicef.org/corporate_partners/index_86144.html

    Learn more about pneumonia and UNIEF's work in this area here: https://www.unicef.org/health/index_91917.html 

     


     

     

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