Protecting Our Community: COVID-19 Testing

Summary

The COVID-19 pandemic has disproportionately affected American Indian (AI) and Latino communities, and these groups also have increased risk of poor prognosis due to high rates of chronic disease such as diabetes, cardiovascular disease, and cancer. In the northwestern United States, AI and Latino communities already face significant disparities in health care access, which have been further exacerbated by the COVID-19 pandemic. In the proposed study, Protecting Our Community: A Pragmatic Randomized Trial of Home-Based COVID Testing with Native American and Latino Communities, the investigators will leverage our long-term community-based participatory research partnerships to test the hypothesis that home-based testing will be feasible, impactful, and better-accepted using active delivery of test kits by trusted community health educators 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 Latino community. The investigators will determine the cultural, social, behavioral, and economic barriers to home-based SARS-CoV-2 testing; culturally adapt and enhance home-testing educational materials and create home-testing instructional graphics and YouTube videos; conduct a 2-arm pragmatic randomized trial of active (delivered by community health educator) vs. passive (without community health educator) home-based testing kits (n = 200/community) for testing completion; and create a model for community-driven testing protocols that can have significant impact for increasing home-based testing uptake among AI and Latino communities nationally. This work will enable underserved AI and Latino communities to take full advantage of the coming wave of rapid point-of-care home tests and decrease the significant impact of COVID-19 in their communities.

Conditions

• SARS-CoV-2
• Covid19

Interventions

DIAGNOSTIC_TEST

Home-based SARS-CoV-2 test kit

A two-arm pragmatic randomized trial of SARS-CoV-2 home-based testing kit completion using active kit assistance by community health educators vs. passive kit delivery. Will be done with two partner communities, Yakima Valley Latino community in WA and Flathead Reservation, American Indian community in MT. N = 200 participants in each community.

Sponsors & Collaborators

• National Institute of General Medical Sciences (NIGMS)

  collaborator NIH

• University of Washington

  collaborator OTHER

• Fred Hutchinson Cancer Center

  collaborator OTHER

• Salish Kootenai College

  collaborator OTHER

• Montana State University

  lead OTHER

Principal Investigators

• Alexandra K Adams, MD, PhD · Montana State University

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-04-26

Primary Completion

2022-02-25

Completion

2022-03-09

FDA Device

Yes

Countries

• United States

Study Locations