A pragmatic randomized trial of home-based testing for COVID-19 in rural Native American and Latino communities: Protocol for the "Protecting our Communities" study

Matthew J Thompson; Paul K Drain; Charlie E Gregor; Laurie A Hassell; Linda K Ko; Victoria Lyon; Selena Ahmed; Sonia Bishop; Virgil Dupuis; Lorenzo Garza; Allison A Lambert; Carly Rowe; Teresa Warne; Eliza Webber; Wendy Westbroek; Alexandra K Adams

doi:10.1016/j.cct.2022.106820

A pragmatic randomized trial of home-based testing for COVID-19 in rural Native American and Latino communities: Protocol for the "Protecting our Communities" study

Contemp Clin Trials. 2022 Aug:119:106820. doi: 10.1016/j.cct.2022.106820. Epub 2022 Jun 9.

Authors

Affiliations

¹ Institute of Translational Health Sciences, University of Washington, 850 Republican Street, Box 358051, Seattle, WA 98109, USA; Department of Family Medicine, University of Washington, Box 354696, Seattle, WA 98195, USA.
² Department of Global Health, University of Washington, Box 351620, Seattle, WA 98195, USA; Department of Medicine, University of Washington, Box 356420, Seattle, WA 98195, USA; Department of Epidemiology, University of Washington, Box 351619, Seattle, WA 98195, USA.
³ Institute of Translational Health Sciences, University of Washington, 850 Republican Street, Box 358051, Seattle, WA 98109, USA.
⁴ Institute of Translational Health Sciences, University of Washington, 850 Republican Street, Box 358051, Seattle, WA 98109, USA; Department of Health Systems and Population Health, University of Washington, Box 351621, Seattle, WA 98195, USA; Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, 1100 Fairview Avenue N, PO Box 19024, Seattle, WA 98109, USA.
⁵ Department of Family Medicine, University of Washington, Box 354696, Seattle, WA 98195, USA.
⁶ Center for American Indian and Rural Health Equity (CAIRHE), Montana State University, PO Box 173485, Bozeman, MT 59717, USA.
⁷ Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, 1100 Fairview Avenue N, PO Box 19024, Seattle, WA 98109, USA.
⁸ Salish Kootenai College, 58138 US-93, Pablo, MT, USA.
⁹ Sunnyside School District, 1110 S 6th St., Sunnyside, WA, USA.
¹⁰ Institute of Translational Health Sciences, University of Washington, 850 Republican Street, Box 358051, Seattle, WA 98109, USA; Department of Medicine, University of Washington, Box 356420, Seattle, WA 98195, USA; Providence Medical Research Center, Providence Health Care, 105 W 8th Ave, Suite 6050W, Spokane, WA, USA.
¹¹ Center for American Indian and Rural Health Equity (CAIRHE), Montana State University, PO Box 173485, Bozeman, MT 59717, USA. Electronic address: alexandra.adams2@montana.edu.

Abstract

Background: Home-based testing for COVID-19 has potential to reduce existing health care disparities among underserved populations in the United States. However, implementation of home-based tests in these communities may face significant barriers. This study evaluates the acceptability, feasibility, and success of home-based testing and the potential added benefit of active support from trusted community health workers for Native Americans and Hispanic/Latino adults living in rural Montana and Washington states.

Methods/design: The academic-community research team designed the trial to be responsive to community needs for understanding barriers and supports to home-based COVID-19 testing. The "Protecting Our Community" study is a two-arm pragmatic randomized controlled trial in which a total of 400 participants are randomized to active or passive arms. Participants of both study arms receive a commercially available home collection COVID-19 test kit, which is completed by mailing a self-collected nasal swab to a central laboratory. The primary study outcome is return of the kit to the central lab within 14 days. The cultural, social, behavioral, and economic barriers to home-based COVID-19 testing are also assessed by qualitative research methods. A survey and semi-structured interviews are conducted after the trial to evaluate perceptions and experience of home-based testing.

Discussion: Implementing home-based testing in underserved populations, including among Native American and Hispanic/Latino communities, may require additional support to be successful. The Protecting Our Community trial examines the effect of trusted community health workers on use of home-based testing, which may be adaptable for community-driven models of home-based testing in other underserved populations.

Keywords: COVID-19; Community health worker; Home-based testing; Latino; Native American; SARS-CoV-2.

Publication types

Clinical Trial Protocol
Research Support, N.I.H., Extramural

MeSH terms

American Indian or Alaska Native
COVID-19 Testing
COVID-19*
Hispanic or Latino
Humans
Pragmatic Clinical Trials as Topic
Randomized Controlled Trials as Topic
SARS-CoV-2
United States

Abstract

Publication types

MeSH terms

Grants and funding