Community-Engaged Research on COVID-19 Testing in the US Territories

Abstract: COVID-19 has created an unparalleled health crisis across the globe that has ravaged underserved and vulnerablepopulations in the US, including in the territories of Puerto Rico (PR) and the U.S. Virgin Islands (USVI). Whiletesting for COVID-19 has increased in the Caribbean territories, it is still deeply inadequate. The USVI and PR haveexperienced barriers to wide-spread testing, including an overall shortage of testing equipment and supplies, whichhas led to a sharp increase in cases since early July. Data from our Eastern Caribbean Health Outcomes ResearchNetwork Cohort Study (ECS) indicate nearly 61% of our population-based random sample (n=3000) has at leastone chronic condition, making them high risk for severe complications from COVID-19. We propose to enhance andamplify the COVID-19 diagnostic testing cascade in the USVI and PR by utilizing community-based assets-Federally Qualified Health Centers (FQHCs) and their community organization (CBO) partners-to address barriersto full participation in the testing continuum from diagnosis through to self-isolation and quarantine. We will partnerwith 3 FQHCs-one in PR and two in USVI-and CBO partners for each. We will provide FQHCs with protocols fordiagnosis and follow-up and will procure new testing technologies to make testing more efficient. CBOs connectedto the FQHCs will help reach underserved community members not currently being tested, such as those withelevated medical risk, those living without homes, or those living in congregate settings such as nursing homes.After notification of a positive result, we will support FQHCs to provide ambulatory care for active clinical monitoringat home and will deploy a screener for social determinants of health. CBO partners will connect patients with socialneeds to resources to support quarantine and self-isolation recommendations. We will additionally assess thediffusion and uptake of FDA authorized and approved testing technologies across existing and emerging testingmodels. We will utilize a rigorous quasi-experimental approach to focus on assessing our implementationoutcomes. Specifically, we will employ a hybrid III implementation-effectiveness study design. The primaryimplementation outcome will be reach-a measure of the amount of testing that is being done in the community-using an interrupted time series design (ITS). Other outcomes of interest include adoption of new testingtechnologies, fidelity to the intervention, its acceptability, and its effectiveness. We will deploy the RE-AIMframework to guide the evaluation of the intervention. Throughout the project period, we will collaborate with theRADx-Up Coordination and Data Collection Center (CDCC) across all activities, including harmonizing datacollection and procuring new COVID-19 testing technologies. We will also work closely with the CommunityEngagement domain to enhance the experience of our participating stakeholder partners. Finally, the enhanceddiagnostic testing cascade will improve reach, access, uptake, and effectiveness for underserved and vulnerablecommunities in the USVI and PR. This will strengthen the capacity of each stakeholder organization to contribute tovaccine distribution networks for influenza now and a SARS-CoV-2 vaccine in the future.