ImmunoCARE: rapid, Accurate COVID Testing to Reduce Hospitalization of Immunocompromised Individuals

This study is a randomized control trial with 10,000 participants. Participation willlast for a minimum of 3 months and maximum of 8 months, depending upon COVID‐19 caserates. Half of participants will be randomized to the control group and continue theirexisting testing and healthcare practices. The remaining participants will be randomizedinto the intervention arm. Participants in the intervention will receive one CueCartridge Reader for the duration of the study and up to 10 Cue COVID Molecular tests permonth for their own use and to share with others in their household. In the case that aCue Flu+COVID Molecular Test is available through FDA EUA or other authorization,participants may be provided this multiplex test in lieu of the Cue COVID Molecular Test.All intervention participants will be asked to test themselves if they are exposed orwhen symptoms arise and share tests with members of their household who are exposed toCOVID or symptoms arise. The primary outcome will be the number of hospitalizations. Thisstudy will also compare infection rates, ICU admissions, deaths, and cost of care betweenthe control and intervention group. The hypothesis is that access to high sensitivityportable molecular testing and subsequent telemedicine and prescription delivery cansignificantly decrease hospitalization and thereby the cost of care.Interested individuals will access the study via the MyDataHelps platform by web or appto complete the eligibility and informed consent process. Within the MyDataHelpsexperience, participants will complete study activities such as surveys and sharing ofclaims data. Participants who are randomized to the intervention group will have theoption to use Cue Care should they test positive for COVID‐19. Cue Care contractslicensed Healthcare providers to deliver telemedicine and treatment for COVID‐19. In thecase that the COVID Flu+COVID test is available, the intervention group will also havethe option to use Cue Care should they test positive for Influenza.To learn more and take the eligibility survey, visit https://ImmunoCARE.scripps.edu/