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NCT04866303 · ClinicalTrials.gov registry record · NA
Protecting Our Community: COVID-19 Testing
A NA study, sponsored by Montana State University.
- Completed
- Registry status
- NA
- Development phase
- 273
- Enrollment target
NCT04866303: Completed NA study, sponsored by Montana State University.
NCT04866303 is a NA study that has completed, run by Montana State University. The registered enrollment target is 273 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04866303, a NA study, has completed, sponsored by Montana State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 273 participants
- Enrollment target
Study 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.
Primary Outcome
Comparing the completed and successfully-completed test kits by study arm (randomization to either the active or passive arm)
Interventions
- DIAGNOSTIC_TEST Home-based SARS-CoV-2 test kit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 273 participants |
| Start Date | 2021-04-26 |
| Est. Completion | 2022-03-09 |
| Phase | NA |
What the finished NCT04866303 record still lists
NCT04866303 is an interventional study that assigns participants to a tested intervention. The registered 273 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 1 intervention - of which Home-based SARS-CoV-2 test kit is the first listed.
NCT04866303 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04866303 about?
NCT04866303 is a clinical study titled "Protecting Our Community: COVID-19 Testing". 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 c...
What is the current status of trial NCT04866303?
This trial is currently completed. It is a NA study. The enrollment target is 273 participants. The study started on 2021-04-26. Estimated completion is 2022-03-09.
What interventions are being tested in trial NCT04866303?
The interventions under investigation include: Home-based SARS-CoV-2 test kit (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04866303?
This trial is sponsored by Montana State University, which has 36 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04866303's enrollment target sits among peer trials
273 386th of 2000 higher than 1,614 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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