A Global Low- and Middle-Income Country Primary Care (PC) Antimicrobial Stewardship Trial using the WHO AWaRe system – the AWaRe 1 Trial.

The global rise in inappropriate antibiotic use is a threat to population health. Over 90% of human use is in primary care (PC), with rapidly increasing use of broad-spectrum oral Watch antibiotics seen in low- and middle-income countries (LMICs). A core component of antibiotic stewardship is improvement in clinical treatment decision-making by frontline health workers. The overall aim of this proposal is to develop and test a framework for future surveillance, benchmarking and population-based interventional trials of optimal antibiotic use in LMIC PC settings. We will pilot new methods of estimating patterns of antibiotic use (WS1), develop a new AMS intervention (WS2) and evaluate it in a paradigmatic clinical trial (WS3). Novel methods of measuring antibiotic use will be designed to facilitate national surveillance, benchmarking and improved outcome capture in LMIC PC clinical trials. The educational and organisational intervention will be based on the 2022 WHO Essential Medicines List (EML) AWaRe (Access–Watch–Reserve) Book. The pragmatic global cluster randomised trial will be performed in countries across Asia and Africa to determine the effectiveness and safety of an AWaRe system-based intervention on appropriately reducing total and oral Watch antibiotic prescribing and will be designed as a blueprint for future population-based PC trials.