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Protecting Our Community: COVID-19 Testing

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ClinicalTrials.gov Identifier: NCT04866303
Recruitment Status : Recruiting
First Posted : April 29, 2021
Last Update Posted : May 5, 2021
Sponsor:
Collaborators:
National Institute of General Medical Sciences (NIGMS)
University of Washington
Fred Hutchinson Cancer Research Center
Salish Kootenai College
Information provided by (Responsible Party):
Montana State University

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.

Condition or disease Intervention/treatment Phase
SARS-CoV-2 Covid19 Diagnostic Test: Home-based SARS-CoV-2 test kit Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A two-arm pragmatic randomized trial of SARS-CoV-2 home-based testing kit completion using active kit delivery by community health educators vs. passive kit delivery via mail.
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Protecting Our Community: A Pragmatic Randomized Trial of Home-Based COVID-19 Testing With Native American and Latino Communities
Actual Study Start Date : April 26, 2021
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : October 2021

Arm Intervention/treatment
Experimental: Active delivery
For 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.
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.

Experimental: Passive delivery
Participants 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.
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.




Primary Outcome Measures :
  1. SARS-CoV-2 home-testing kit completion in active vs. passive arm [ Time Frame: 4-month trial ]
    Participants will complete the Everlywell home COVID testing kit by doing anterior-nasal swabs, placing swabs in the supplied test tubes and biosafety envelope, and returning kits via prepaid padded mailer to Everlywell's assigned lab for testing. Simple and multivariate logistic regression will be used to model the association between the primary predictor variable, testing distribution mechanism (active vs passive), and the primary outcome variable, completion of self-test (yes/no). Multivariate models will include age, community.


Secondary Outcome Measures :
  1. Active vs. passive self-test completion rates across the communities [ Time Frame: 4-month trial ]
    Using logistic regression to model the association between active vs. passive outreach and self-test completion status, stratified by community.

  2. Satisfaction/dissatisfaction with delivery mechanism [ Time Frame: Up to 2 months post-trial ]
    Examine differences by post-trial survey by community, trial arm, and participant characteristics. Descriptive statistics will be stratified by active vs. passive distribution mechanism, and between-group differences will be tested using Pearson Chi-Square for categorical variables and ANOVA for linear variables.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 years old or older
  • Member of study community
  • No current significant symptoms consistent with COVID-19

Exclusion Criteria:

  • < 18 years old
  • Not a member of the study community
  • Current significant symptoms consistent with COVID-19

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04866303


Contacts
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Contact: Alexandra K Adams, MD, PhD 406-994-6077 alexandra.adams2@montana.edu
Contact: James Burroughs 406-994-4407 jburroughs@montana.edu

Locations
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United States, Montana
Salish Kootenai College Not yet recruiting
Pablo, Montana, United States, 59855
Contact: Virgil DuPuis    406-275-4899    virgil_dupuis@skc.edu   
United States, Washington
Fred Hutchinson Cancer Research Center Recruiting
Seattle, Washington, United States, 98109
Contact: Sonia Bishop    206-667-5952    sbishop@fredhutch.org   
Sponsors and Collaborators
Montana State University
National Institute of General Medical Sciences (NIGMS)
University of Washington
Fred Hutchinson Cancer Research Center
Salish Kootenai College
Investigators
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Principal Investigator: Alexandra K Adams, MD, PhD Montana State University
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Responsible Party: Montana State University
ClinicalTrials.gov Identifier: NCT04866303    
Other Study ID Numbers: 3P20GM104417-07S1 ( U.S. NIH Grant/Contract )
3P20GM104417-07S1 ( U.S. NIH Grant/Contract )
First Posted: April 29, 2021    Key Record Dates
Last Update Posted: May 5, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Montana State University:
SARS-CoV-2
COVID-19
home-based testing
at home testing