Protecting Our Community: COVID-19 Testing
Protecting Our Community: A Pragmatic Randomized Trial of Home-Based COVID-19 Testing With Native American and Latino Communities
1 other identifier
interventional
273
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2021
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 26, 2021
CompletedFirst Submitted
Initial submission to the registry
April 27, 2021
CompletedFirst Posted
Study publicly available on registry
April 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 25, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 9, 2022
CompletedResults Posted
Study results publicly available
August 30, 2023
CompletedDecember 7, 2023
December 1, 2023
10 months
April 27, 2021
February 23, 2023
December 5, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
SARS-CoV-2 Home-testing Kit Completion Active vs. Passive Arms
Comparing the completed and successfully-completed test kits by study arm (randomization to either the active or passive arm)
14 days from randomization for both completed and successfully-completed measurements
SARS-CoV-2 Home-testing Kit Successfully-Completed Active vs. Passive Arms
SARS-CoV-2 Home-testing Kit successfully-completed by study arm (randomization to either the active or passive arm)
14 days from randomization for both completed and successfully-completed measurements
Study Arms (2)
Active delivery
EXPERIMENTALFor the participants randomized to the active arm will have their home collection kit registered on their behalf by bilingual (Spanish and English) community health workers, who are trusted community members. Home testing kits augmented with study developed materials will direct participants to contact the study team for assistance.
Passive delivery
EXPERIMENTALParticipants randomized to the passive arm will receive a home test kit augmented with instructions on how to self-register their kit online, and will be directed to contact Everlywell for assistance, if needed.
Interventions
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.
Eligibility Criteria
You may qualify if:
- years old or older
- Member of study community
- No current significant symptoms consistent with COVID-19
You may not qualify if:
- \< 18 years old
- Not a member of the study community
- Current significant symptoms consistent with COVID-19
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Montana State Universitylead
- National Institute of General Medical Sciences (NIGMS)collaborator
- University of Washingtoncollaborator
- Fred Hutchinson Cancer Centercollaborator
- Salish Kootenai Collegecollaborator
Study Sites (2)
Salish Kootenai College
Pablo, Montana, 59855, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Manager
- Organization
- University of Washington
Study Officials
- PRINCIPAL INVESTIGATOR
Alexandra K Adams, MD, PhD
Montana State University
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2021
First Posted
April 29, 2021
Study Start
April 26, 2021
Primary Completion
February 25, 2022
Study Completion
March 9, 2022
Last Updated
December 7, 2023
Results First Posted
August 30, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share
In conjunction with tribal partners on the Flathead Reservation and at Salish Kootenai College in Montana, and with community partners in the Yakima Valley in Washington, we have developed a Data Sharing Plan. We will work closely with the Coordination and Data Collection Center (CDCC); the Social, Ethical, and Behavioral Implications program (SEBI); and the RADx-Up Consortium throughout the study to implement the Plan. All data will be deidentified and assigned an anonymous code by a member of the study team in each community before sharing with the broader study team for analysis. In addition, data collection instruments (including surveys, focus group and key informant interview questions, informed consent forms, community data collection tools, and educational material), deidentified coded data, and analyzed study trial results will be shared with the CDCC, SEBI, and RADx-UP Consortium.