m-Africa: Building mobile phone-connected diagnostics and online care pathways to support HIV prevention and management in decentralised settings.

m-Africa's long term vision is to build user-friendly, mobile phone-connected HIV tests which link to online pathways for prevention and medical care. These systems will be used by people within their own homes and communities and they can be set up quickly in South African communities hardest hit by HIV. This will enable people to take full advantage of recent breakthroughs in HIV care and ultimately empower those at greatest risk to manage their own health.

The United Nations aims to end the HIV/AIDS epidemic by 2030. Yet despite huge advances in HIV treatment, prevention and care, many countries lack the set up to roll them out on a large scale and many people remain afraid of testing and seeking care.

South Africa is the country most affected by HIV; almost seven million people are living with HIV and 300,000 people acquire HIV each year. The province of KwaZulu-Natal, home to The Africa Health Research Institute (AHRI), is particularly hard hit. Forty five percent of women attending antenatal clinics have HIV and only half of all people diagnosed with HIV go for medical care within the following year. AHRI research showed that regular home-based HIV testing and immediate treatment could reduce HIV and prolong lives, but getting young people into clinic once they had been diagnosed was hugely challenging. This was because young people felt judged and looked down on once others knew they had HIV. Also they simply couldn't afford to miss work in order to come for an appointment.

The aim of m-Africa is to build a new generation of mobile phone-connected HIV diagnostic tests together with an online app that allows a person, from within their home or local community, to get their test results and medical care online. This could even include getting HIV drugs for prevention or treatment. This would allow people to test with more privacy, avoiding the clinic visits they find so difficult. South Africans have more smartphones than people in almost any other African country. We want to take advantage of this to enable more people to get tested, especially those who have never tested before.

But in order for these exciting new ideas to succeed we have to develop solutions which people at risk of HIV, health care professionals and government find appealing. So our research will start by asking people from these groups for their opinions on our ideas. We will use focus groups, individual interviews and questions in a regular AHRI household survey of 100,000 people.

In parallel we will develop and ask people to test out diagnostic test prototypes, which will include looking at how new ultra-sensitive "nanomaterial" tests could best work. These can detect HIV at the very early stages of infection, when transmission is most likely and prevention most important. We will also design apps to interpret already available HIV tests, which could link results to a doctor for online care.

We will engage with key stakeholders from the outset, including the Community Advisory Board, Directorate of Health KwaZulu Natal, industry, policy makers and regulators, to ensure we develop solutions that will be quickly put into practice. This is important because the technologies we develop could be applied across a wide range of infections and medical conditions. This plan is very much in line with the South African mobile health strategy.

Our team brings together outstanding clinicians, scientists, engineers and public health researchers from South Africa and the UK, with the primary goal of improving HIV prevention and care to deliver major health and economic benefits at the global epicentre of HIV.

Undiagnosed and untreated HIV can have devastating consequences for the individual and populations, leading to increased morbidity, mortality, and transmission. South Africa has a forward looking mHealth strategy to deliver improved HIV health services but this emerging field is still in its infancy, with currently no safe and acceptable online care pathways and very limited knowledge of the usability and performance of devices in care pathways in low and middle income countries.
With this Foundation Award we will assess facilitators and barriers to implementation of new mobile phone-connected diagnostics and online care pathways into the KwaZulu Natal health system for HIV prevention, diagnosis and clinical management. We will use mixed-method studies using qualitative (key informant interviews, focus groups) and quantitative methods (AHRI household survey of 100,000 residents) to: (i) map current HIV diagnostic capability and needs; (ii) explore smartphone/mobile phone and digital capability among service providers and users; (iii) explore ways mobile technologies are used and viewed; (iv) explore the acceptability and feasibility of integrating new diagnostics into a range of models, including health worker-led testing and self-tests. In parallel we will develop a range of innovative smartphone connected diagnostic tests, benchmark their performance to gold-standard tests (e.g. sensitivity, specificity, speed, cost compared ot laboratory ELISAs and PCR) and run small scale pilots of their usability in primary care and home settings. Technologies at our disposal span from apps to interpret commercial HIV tests to early stage assays utilizing advanced nanomaterials to detect p24 in acute infections and viral load. We will engage with a broad range of stakeholders to ensure we develop solutions allied to their needs. This work is pivotal to building a fit-for-purpose integrated mHealth diagnostic, prevention and clinical platform for HIV prevention in LMICs.

Our long term vision is to build a fit for purpose integrated digital diagnostic, prevention and clinical platform for HIV to ultimately empower patients to self-diagnose and self-manage remote from traditional health services, using HIV as an example, with broad applicability across infections and non-communicable diseases. This will bring major impact in the following areas:

1. Population benefits - The major beneficiaries will of course be the populations in the HIV endemic region of KwaZulu-Natal who will benefit from a more person -centered approach to HIV testing, prevention and care. The convenience of self-testing within their home, providing more rapid and reliable diagnoses of their illness, and supporting community and home-based provision of HIV prevention and care, will lead to reduced morbidity and mortality, and improvements in quality of life. Wider public benefits include reduced risk of onwards transmission, particularly by those who are unaware of their status.

2. South African and global healthcare systems - will benefit from improved clinical practice and health service delivery by:
i. Widening access to testing for HIV in community settings and the home will enable more patients be tested and linked to care.
ii. A highly innovative opportunity to engage young people with HIV testing, prevention and care by shifting delivery from problematic facility-based care into a self-directed model of online, and supported community based services.
iii. Potential to support HIV self-testing, task shifting to the community care givers and to support virtual adherence-support groups, would allow this project to digitally support current innovations in health care delivery in South Africa i.e. the community care givers program and the use of MSF inspired adherence clubs to support on-going care in stable HIV patients.
iv. Reducing pressure on health facilities and workers - Online patient pathways will allow results, to be rapidly and securely transmitted into KwaZulu-Natal health electronic systems, potentially supporting virtual appointments and treatment to be dispensed in the community, reducing the enormous pressure on facility centres and the administrative burden on staff.
v. More timely public health interventions and new capabilities to monitor the impact of these interventions.
vi. Health-economic benefits - South Africa spends in excess of $1 billion on HIV/AIDS programmes and every case of HIV that is prevented would save a lifetime of antiretroviral costs.
3. Commercial opportunities - Beyond trained man/women power, the potential commercial benefits to South Africa accrue through better population testing, prevention and care, and new employment opportunities in the emerging mHealth sector. We will reach out to local industries, including diagnostic test manufacturers, mobile network providers, handset manufacturers, app developers, policy makers and regulators through our second Workshop, planned at the end of year 1, to communicate developments in our understanding of the needs, technology developments and seed new collaborations. South Africa is well placed to grow commercial opportunities in this space, given its high smartphone penetration (among the highest in Africa), a flourishing mobile industry ($51M investment in tech start ups 'GSMA The Mobile Economy - Africa 2016') and forward looking national mHealth strategy.