Background and Aims
The Australian Strep A Vaccine Initiative (ASAVI) is an Australian-led initiative with the goal of reducing the burden of Streptococus pyogenes infections through development of a vaccine. The critical first step for ASAVI is to establish the baseline epidemiology of S. pyogenes pharyngeal infection in children. The Australian Strep A Urban Pharyngitis Study (STAMPS) was developed to determine the incidence of S. pyogenes sore throat among healthy children (aged 3-14 years) living in urban settings. As recruitment began during the SARS-CoV-2 pandemic, the close contact nature of visits in the original protocol severely impacted enrolment. Working around a highly communicable disease, the study team sought to develop remote data and biospecimen collection methods to mitigate the risk.
Methods
The original study design for STAMPS involved four in-clinic visits to collect biospecimens and participant health data. A new parent-led remote data and sample collection method was offered to participants and their families.
Results
The pivot to an adaptable study design minimized COVID exposure risk, offered more flexibility and choice for families by allowing home data collection and sampling.
Conclusion
The adapted protocol removed barriers to participation and boosted recruitment to enable the study to continue during the pandemic. Revised recruitment targets were achieved allowing crucial data of S. pyogenes induced pharyngitis in urban children to be collected to inform future vaccine development.