Molecular point of care testing among disadvantaged and vulnerable populations in Australia to contain COVID-19 outbreaks and prevent morbidity and mortality

Project Description: Equity matters when tackling COVID-19. Around the world, COVID-19 has affected vulnerable populations disproportionately. In Australia, the most disadvantaged and vulnerable people include Aboriginal and Torres Strait Islander peoples (hereafter respectfully referred to as Aboriginal), people who are incarcerated, people who inject drugs, and homeless people. These vulnerable people experience higher rates of chronic disease and mental health illness, lower levels of education, employment, income, poorer quality housing and less access to care, compared with other Australians. These social determinants and comorbidities place them at high risk of COVID-19 related morbidity and mortality as was shown in the 2009 H1N1 influenza pandemic, where Aboriginal people comprised 2.5% of the Australian population but accounted for 16% of hospitalisations and 9.7% of intensive care unit (ICU) admissions. Inequitable public health responses for vulnerable populations. Physical (social) distancing and self-isolation, which are key parts of the COVID-19 public health response in mainstream Australia are impractical or difficult to implement for disadvantaged and vulnerable populations because of overcrowding, housing shortage or no housing. Thus, the public health response is strongly reliant on rapid case detection and contact tracing, to minimise unnecessary isolation (or evacuation from remote settings) for people without infection, and rapidly identify options for people with infection. Yet for most disadvantaged and vulnerable populations these responses are hindered by delays in access to testing and laboratory test results. We have the tools available to provide a more equitable response. The Cepheid Xpress Xpert SARS-CoV-2 assay is the only TGA approved molecular point of care (POC) test for diagnosis of COVID-19 outside the laboratory in Australia. This user-friendly POC test uses real time polymerase chain reaction (PCR), has 100% concordance with laboratory assays and provides results in 45 minutes. Building on substantial emergency programmatic activity we will use UNSW funding to bring together a team of 27 researchers to conduct implementation research which aims to evaluate the clinical and public health impact, and cost-effectiveness of the rapid scale-up of molecular POC testing for COVID-19 among disadvantaged and vulnerable populations in Australia. The specific objectives are to evaluate the impact of the POC program on: (1) The number and proportion of contacts tested within 2 days of an index case; (2) days of self-isolation and evacuations avoided; and (3) community transmissions, hospitalisations, ICU admissions and mortality avoided. We will also; (4) evaluate the cost-effectiveness and budget impact of delivering POC testing across diverse primary health care services; and (5) describe the acceptability and health system requirements of integrating POC testing into clinical and public health responses. Study design and methods: An observational cohort design, based on routine records, will be established via health services which have joined the COVID-19 POC Programs and agree to provide data for the cohort. We will compile routine programmatic data (collected by the health services and health departments) on the number of people who had a POC test, the time to result, the clinical status of those tested, the reason for testing (symptoms, contact), the referral pathway for those tested and clinical outcomes. Mathematical modelling will estimate days of self-isolation and evacuations, transmissions, hospitalisations, ICU admissions and deaths avoided. We will also evaluate the cost-effectiveness of the POC program compared to standard care and use qualitative research to determine the acceptability and health system infrastructure requirements of POC testing from a community, provider and public health perspective. The evaluation will be overseen by a reference group with representation from peak bodies representing the populations targeted in the program. Expected Outcomes: Our evaluation will assess across a diverse range of populations and services, the extent of improvement in COVID-19 clinical and public heath responses that occurred due to a programmatic shift from centralised laboratory testing to molecular POC testing and the resources required to achieve specific levels of improvement. The evaluation will also provide key information to inform future pandemic preparedness and the role of molecular POC testing technology.