​A game changer that could revolutionise the ongoing worldwide battle against tuberculosis (TB), is on the cards thanks to a huge research grant that was awarded to Stellenbosch University's Faculty of Medicine and Health Sciences (FMHS) for the development of a smart phone app that can distinguish the sound of a TB cough from other types of coughs.

The European and Developing Countries Clinical Trials Partnership (EDCTP) awarded a grant of €2 891 456 (more than R48 million) to Prof Grant Theron, Head of the Clinical Mycobacteriology and Epidemiology (CLIME) Group in the FMHS' Division of Molecular Biology & Human Genetics, for his automated smartphone-based cough audio classification for rapid tuberculosis triage testing (Cough Audio Triage for TB or CAGE-TB) project.

The EDCTP aims to reduce the social and economic burden of poverty-related diseases in developing countries, especially in sub-Saharan Africa, by accelerating the clinical development of effective, safe, accessible, suitable and affordable medical interventions for HIV/Aids, tuberculosis, malaria and neglected infectious diseases.

According to Dr Byron Reeve, CLIME project manager of CAGE-TB, CLIME is very privileged to be the custodians of European tax payers' money. “The grant will enable us to enrol 1 700 patients (enough to ensure sound testing), obtain the best equipment, hire a large team to do the patient recording, interviewing and testing, while top class data analysts and engineers will analyse the cough audio."

CAGE-TB is a four-way partnership between the SU's FMHS and Department of Electrical and Electronic Engineering, the University of Makerere in Uganda, as well as collaborators in the Amsterdam Institute for Global Health and Development, Netherlands and the University of Gottingen, Germany. Theron is the principal investigator – “the academic brains behind CAGE-TB who will be making sure the four partners do the dance together".

The aim of CAGE-TB is to develop a screening app to discern whether someone might be TB infected and to identify those in need of further laboratory testing. “Preliminary data suggests that TB has a unique signature – a sound that is specific to a TB cough compared to other coughs such as smokers' cough," Reeve explains. “We are going to collect TB cough sounds by asking participants to cough into their phones and this captured audio will eventually be packaged into the app.

“Participants will also be asked to submit a sputum specimen for laboratory testing that will determine whether they have TB. Their cough audio will be analysed by SU engineers and the results of the cough audio and the laboratory tests will be compared.

“We are not trying to definitively diagnose TB. The app is meant for triage – screening a lot of patients – and determining who is most likely to have TB. They will undergo more extensive sputum testing. This is a very powerful first step in the African context, because patients often only seek help once extensive damage has been done. We are hoping a simple cough into their phone will change this," Reeve explains.

“No harsh language will be used," he stresses. “The app will simply ask participants to go to a clinic, or assure them that they are fine and what the next steps are. TB stigmatisation is a big problem and we are hoping the app will address that."   

All the enrolment of patients and sound recording will be done in South Africa and Uganda. The SU engineers will be responsible for the hardware necessary for the recording and analysis of the sound files, while the German collaborators will ensure that the app is user-friendly with clear instructions. “Once the other partners have made sure it works correctly on a scientific level, our collaborators in the Netherlands will collect feedback from participants about their experience of the app – data to illustrate that it works. This is key for international endorsement and to get the attention of the World Health Organisation and governments worldwide, including our own government and the Department of Health.

“There will be a massive international team effort to put the app in the international spotlight and change how we screen TB patients. The whole world has been using the same screening method for decades and this new piece of technology will be a game changer that will revolutionise screening," says Reeve. “Problems such as time-consuming one-on-one interviews to obtain the clinical history and hesitance on the part of patients will be solved with an app that can even be used in the privacy of one's own home."

Reeve says the EDCTP award to the FMHS speaks to a lot of good ongoing work led by the project leader, Theron, on the back of years of research. “Theron noticed that we can screen better. The Faculty has fostered an environment for excellent TB research and already has the necessary infrastructure and a huge international research network comprising various disciplines at its disposal.

“One person doesn't have all the skills necessary for this project. It is a matter of different minds coming together in one little block on your cell phone screen for three steps: 1. Cough into your phone speakers 2. Get the results. 3. Receive specialised care. 

“I believe this is a missing piece of the puzzle – an innovative TB screening approach that will put SU on the map regarding new mobile solutions for African health problems like TB," Reeve concludes.

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