Protecting Our Community: A Pragmatic Randomized Trial of Home-Based COVID-19 Testing With Native American and Latino Communities

This clinical trial utilizes community-based participatory research partnerships to test the hypothesis that home-based testing for COVID-19 will be feasible, impactful, and better accepted using active assistance with the testing kits by trusted community members vs. passive delivery in two vulnerable high-risk rural communities. Our two long-term partner communities are the Flathead Indian Reservation of the Confederated Salish and Kootenai Tribes in Montana and the Yakima Valley of Washington, a large Hispanic community. The investigators will implement a two-arm pragmatic randomized trial during February to June 2021. Two hundred (200) adults per community will be randomized and stratified by age (18-25, 26-59, and 60+) to active vs. passive delivery. Our primary outcome will be the proportion of subjects who return testing collection kits in the active vs. passive arm. The trial will enable us to determine best practices and issues with home-based testing delivery in American Indian and Latino communities.

Participants randomized to both the active and passive arms will receive home testing kits augmented with materials developed by the study in both English and Spanish. In order to control for potential barriers to home testing kit delivery in this population (including internet access, digital literacy, English language proficiency) and limited access to mail delivery services (UPS, FedEx, etc.), participants in both study arms will be provided kit delivery and home collected sample return support coordinated by study staff. Coordination support options include (1) pick up / drop off at the research site, (2) shipping the home testing kit to the participant's mailing address by USPS or (3) home delivery/pick up to accommodate those with mobility concerns. The home testing kit selected in this study is the Everlywell COVID home-sampling kit.

Participants randomized to the passive arm will receive a home test kit with instructions on how to self-register their kit online, and will be directed to contact Everywell for assistance, if needed.

Participants randomized to the active arm will have their home collection kit registered on their behalf by community health workers while the participant remains on the phone. Study developed materials will direct participants to contact the study team for assistance.

Participants in both arms will receive study developed instructions to access their test results from the Everlywell online portal. Positive test results will be verbally provided by Everlywell contracted physicians. Study staff will confirm all participants have retrieved their test results from the online portal and referred to appropriate public health or clinical support as needed.