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N/A Completed N=273 Randomized Double-blind Diagnostic

Protecting Our Community: COVID-19 Testing

Source: ClinicalTrials.gov NCT04866303 ↗
Enrolled (actual)
273
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcomePrimary: SARS-CoV-2 Home-testing Kit Completion Active vs. Passive Arms — 75; 94; 57; 42 Participants — p=0.04

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
SARS-CoV-2 Home-testing Kit Completion Active vs. Passive Arms
75; 94; 57; 42 0.04 sig
PRIMARY
SARS-CoV-2 Home-testing Kit Successfully-Completed Active vs. Passive Arms
61; 74; 71; 62 0.18

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04866303). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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