Study protocol for a pilot prospective, observational study investigating the condition suggestion and urgency advice accuracy of a symptom assessment app in sub-Saharan Africa: the AFYA-‘Health’ Study

INTRODUCTION: Due to a global shortage of healthcare workers, there is a lack of basic healthcare for 4 billion people worldwide, particularly affecting low-income and middle-income countries. The utilisation of AI-based healthcare tools such as symptom assessment applications (SAAs) has the potential to reduce the burden on healthcare systems. The purpose of the AFYA Study (AI-based Assessment oF health sYmptoms in TAnzania) is to evaluate the accuracy of the condition suggestions and urgency advice provided by a user on a Swahili language Ada SAA. METHODS AND ANALYSIS: This study is designed as an observational prospective clinical study. The setting is a waiting room of a Tanzanian district hospital. It will include patients entering the outpatient clinic with various conditions and age groups, including children and adolescents. Patients will be asked to use the SAA before proceeding to usual care. After usual care, they will have a consultation with a study-provided physician. Patients and healthcare practitioners will be blinded to the SAA’s results. An expert panel will compare the Ada SAA’s condition suggestions and urgency advice to usual care and study provided differential diagnoses and triage. The primary outcome measures are the accuracy and comprehensiveness of the Ada SAA evaluated against the gold standard differential diagnoses. ETHICS AND DISSEMINATION: Ethical approval was received by the ethics committee (EC) of Muhimbili University of Health and Allied Sciences with an approval number MUHAS-REC-09-2019-044 and the National Institute for Medical Research, NIMR/HQ/R.8c/Vol. I/922. All amendments to the protocol are reported and adapted on the basis of the requirements of the EC. The results from this study will be submitted to peer-reviewed journals, local and international stakeholders, and will be communicated in editorials/articles by Ada Health. TRIAL REGISTRATION NUMBER: NCT04958577.