Kulinda is designed to prevent transmission of HIV through breastfeeding in sub-Saharan Africa. It is a simple, clear, binary indicator which works in conjunction with a process called Flash Heating to show when HIV has been deactivated in breast milk. This enables HIV positive mothers with limited resources in sub-Saharan Africa to accurately treat their breast milk before feeding to their babies, providing them with food and nutrients in a safe, economical way. Each device costs 20p and can be provided with a pictorial instruction booklet, bag and container.

I was shocked and upset to see first hand the effect of HIV and AIDS when volunteering in South Africa and Nepal. It was here that I learnt about the transmission of HIV through breastfeeding and wanted to try and do something to reduce this.

22.5 million people are living with HIV/AIDS in sub-Saharan Africa and 90% of the 370,000 annual infections in children are avoidable and caused by mother-to child transmission with 40% of these being through breastfeeding.

I set out to create something to reduce the risk of HIV transmission in breastfeeding for use in sub-Saharan Africa. This could be used by mothers themselves or in milk banks or disaster situations where there are a large number of babies needing milk and a quick way of treating it is required.

The initial solutions developed while working on the project were complicated and costly. However it quickly became apparent that a more low cost and simple solution would be the most effective as it would not be appropriate if the desired users could not understand or afford the product.

I investigated a number of different ways of reducing HIV transmission through breastfeeding but decided to focus the solution around Flash Heating. This involves heating breast milk to a temperature of 72C and maintaining this for 15 seconds to deactivate HIV. This process does not require any additional drugs, does not effect the nutritional properties of breast milk and is more effective for eliminating HIV activity than other heating methods.

It was decided that the main criteria the project needed to meet were:

Education - the user needs to be able to understand how the device and the process of Flash Heating worked without needing to be literate (only 62% of the target population are literate)

Trust - the users needed to trust that HIV had been deactivated in the breast milk.

Simplicity - the solution needed to be simple in operation and understanding.

Affordability - something needed to be developed that was low enough cost for the users to be able to afford it themselves or for a charity or government be able to fund a wide distribution of them. 51% of the population in sub Saharan Africa are living on under $1.25 a day.

A large number of iterations occurred during the development of this project to make it as accurate and as culturally appropriate as possible.

Initial ideas included using a dynamo or solar power to heat the milk however it became clear that these were too expensive and a large amount of research and testing were carried out to develop the simplest and most appropriate solution possible.

Unfortunately I could not obtain ethics approval to speak to HIV mothers directly however I read a number of scientific studies on different heating and treatment methods and watched videos by HIV positive mothers about Flash Heating. Feedback was gained throughout the design process on the indicator, container and instructions from a number of experts in the Flash Heating field to develop the most appropriate solution. The designs were also shown to mothers and fathers around the world to get their ideas for improvements.

Once it had been decided that an accurate indicator to work alongside Flash Heating was the best solution a number of different indicators were looked into including liquid thermometers, bimetallic strips and turkey timers! These were then tested with milk using the Flash Heating process to ensure that the indicator worked accurately and was easy to understand. It was then decided that a Two way Shape Memory Alloy was the best option as it can be reused and triggered to set off at the correct temperature. When the breast milk has reached a temperature of 72°C the two way Shape Memory Alloy in Kulinda expands causing the blue indicator to rise and show in the clear slot, showing that the milk is safe. The Shape Memory Alloy then compresses again on cooling ready for the next use. The Shape Memory Alloy can be manufactured so that it takes the 15 seconds required to expand.

I have liaised with manufacturers and suppliers worldwide and although I would like to support manufacturing in sub-Saharan Africa the product would initially be manufactured in China and shipped to South Africa as this is the cheapest way and ensures the correct ISO standards are met. Manufacturers have been sourced to make and assemble the indicator, container, leaflet and bag. Shipping has also been quoted on to transport the products from China to South Africa.

According to Nolen "Of the 26 million children worldwide with HIV/Aids 90% are Africans and half die before they are two, most of the rest before age 5." The impact of this project is potentially large Kulinda is an easy to understand, affordable device that could help to reduce the risk of HIV transmission from mother to child. The pictorial instruction booklet helps to educate people around the world on how to safely carry out the Flash Heating Process.

Flash Heating deactivates HIV in 99.7% of cases and this project helps to improve the understanding and accuracy of the process as well as enabling more trust in it.

Cultural considerations were taken into account throughout the project from initial design to details such as colouring. The colours blue and white were used as these are seen as a positive and clean colour in comparison with green which is associated with the drug trade and corruption in some areas of Africa. Kulinda is designed to not look like a medical device or be immediately associated with HIV, therefore if someone saw the user using the device it would hopefully not cause them to be stigmatised.

The ideal distribution is that a number of devices would be distributed to one woman in each community, she would also be trained in how to carry out Flash Heating accurately. In turn she would then distribute the product throughout the community and train others on how to use it.

In the time that I was carrying out the project I did not receive ethics approval to speak to mothers with HIV in sub-Saharan Africa. However I have spent time in sub-Saharan Africa before the project so was aware of some of the cultural considerations that needed to be taken into account while developing Kulinda. I was also lucky enough to speak to experts on Flash heating who could advise on the process and how the is implemented in South Africa. These included Kiersten Israel-Ballard, a worldwide expert on Flash Heating and Anna Coutsoudis who works on Flash Heating in South Africa. They were able to advise me throughout the design, ensuring that my design was appropriate for the community in sub-Saharan Africa.

Dame Claire Bertschinger gave invaluable advise on the project and making it effective and desirable having worked within the healthcare setting around the world in areas including sub Saharan Africa and during disaster relief situations.

I also interviewed and gained feedback on the project from a number of mothers worldwide, midwives, breast feeding experts and a number of people who have volunteered in the healthcare sector in different Africa countries. I met with others working on a project for treating breast milk using Antiretroviral therapy to share ideas and discuss implementation and community values.

If 20,000 units of Kulinda were produced annually each device would cost 53p for the first year of production and 20p thereafter. The quotation obtained for the product is based on an initial production of 20,000 units in China and includes assembly and distribution to South Africa. The products would then be distributed through out the rest of sub Saharan Africa.

Although there is still a cost, each device would last for the entire duration of breastfeeding of one child and it is much more cost efficient and beneficial to prevent the transmission of HIV than to then pay for Antiretroviral Therapy if the baby was to contract it.

Antiretroviral Therapy costs approximately $61-412 per woman for 12 months during pregnancy, due to the cost and availability of the drugs many women do not take all of the medication and Kulinda provides a safe alternative.

Kulinda could help to prevent the spread of HIV transmission to children while still allowing them to gain the nutritional benefits from breast milk.