PATH launches clinical trial on the use of artificial intelligence in primary health care
The Nairobi-based trial aims to build evidence for whether AI can improve quality of care, by reducing instances of incorrect or missed diagnoses, spare patients unnecessary repeat visits, and ensure guideline-based treatment plans.
Penda Health clinicians Oscar Murebu and Naomi Ndwiga review information in the clinic's electronic medical record, which includes an integrated AI consult tool for clinical decision support.
Nairobi, Kenya, March 11, 2025–A landmark Phase 3 randomized controlled trial (RCT), the largest of its kind to take place in Africa, will assess the impact of a Large Language Model-based (LLM) tool on improving quality of care in a clinical setting in low- and middle-income countries. LLMs are applications of AI that synthesize vast sums of data and generate a response like a human. The LLM tool in this trial acts as an assistant to primary health care clinicians, providing guidance throughout the clinical encounter (from supporting diagnosis to providing treatment recommendations) based on the patient's health history, clinical visit notes, and any laboratory results.
Many low and middle-income countries face significant challenges in clinical diagnosis and guideline-based care. Limited resources, overstretched health care systems, and a shortage of health care professionals mean clinicians see a high volume of patients with a wide range of health complaints on a daily basis and make rapid diagnosis and treatment decisions, often with limited information.
The trial in Nairobi aims to build the evidence base for whether AI can improve quality of care by reducing instances of incorrect or missed diagnosis, spare patients unnecessary repeat visits, and ensure guideline-based treatment plans.
The trial, launched by PATH, a non-profit global health organization, in collaboration with a consortium of research [the Kenya Paediatric Research Consortium (Keprecon), and the University of Birmingham] and clinical partners (Penda Health), will test AI's real-world effectiveness at scale. 9,000 participants will be recruited, with results anticipated by the end of 2025.
Prof. Bilal Mateen, Chief AI Officer at PATH, said:
“This is a massive step forward for evaluating the potential of GenAI tools to improve clinical decision-making. Potential applications must be backed by rigorous research that demonstrates benefits for both patients and healthcare systems, and we’re excited to demonstrate that it is possible to deliver a best-in-class study, at record pace, to dispel the myth that good quality science can’t match the pace of innovation in tech.”
The trial builds on Kenya’s growing reputation as a leader in digital health innovation. Dr. Deborah Mlongo Barasa, Kenya’s Cabinet Secretary of Health, welcomed the initiative, stating:
“This trial marks an important milestone for our health sector. AI has the potential to bridge health care gaps, particularly in underserved regions. We look forward to the insights it will generate to guide responsible and effective AI adoption.”
“This trial marks an important milestone for our health sector. AI has the potential to bridge health care gaps, particularly in underserved regions.”— Dr. Deborah Mlongo Barasa, Cabinet Secretary of Health, Kenya
The trial aims to close the evidence gap between the potential for AI to improve clinical decision-making and the quality of patient care in low and middle-income countries and its performance in clinical settings. To date, trials assessing LLM-based clinical decision support systems have largely been based on simulated cases and historical clinical interactions, not real patients in real time. Only three RCTs have rigorously evaluated AI-based clinical decision tools in Africa, and greater investment from donors and governments is required to build the evidence base at scale.
Sir Jeremy Farrar, Chief Scientist at the World Health Organization, said:
“With South Africa and Canada prioritizing AI in their G20 and G7 agendas this year, this is a critical moment to scale investments in AI evidence generation. This trial is a crucial step in informing global policies and approaches to AI-driven healthcare solutions.”
About PATH
PATH is a global nonprofit dedicated to achieving health equity. With more than 40 years of experience forging multisector partnerships, and with expertise in science, economics, technology, advocacy, and dozens of other specialties, PATH develops and scales up innovative solutions to the world’s most pressing health challenges.
For media inquiries, please contact: Lauren Grella, Senior Director of Marketing & Communications - media@path.org
About Penda Health
Founded in 2012, Penda Health has a mission to deliver high-quality health care to underserved communities in Kenya, ensuring accessible, affordable care for middle- to low-income families. Penda’s services include comprehensive outpatient services, preventive care, maternal health, chronic disease management, and digital health services. Penda operates 16 branches in Kenya.
About Keprecon
The Kenya Paediatric Research Consortium (Keprecon) is a Non-Governmental Organization registered in Kenya. Keprecon focuses on health systems strengthening, implementation research, advocacy, social and behavior change, and clinical trials to improve reproductive, maternal, newborn, child, and adolescent health (RMNCAH), nutrition, immunization, and Primary Health Care (PHC) service delivery in Kenya. Keprecon membership comprises paediatricians, researchers, health workers, social scientists, and other professionals who have experience and interest in health research and those who have project grants being administered at the organization.