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Protecting Our Community: COVID-19 Testing
NA trial testing Home-based SARS-CoV-2 test kit in SARS-CoV-2 in 273 participants. Completed in 9 March 2022.
| Lead sponsor | Montana State University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | diagnostic |
| Enrollment | 273 |
| Start date | 26 April 2021 |
| Primary completion | 25 February 2022 |
| Estimated completion | 9 March 2022 |
| Sites | 2 locations across United States |
Montana State University
18 and older, any sex, with SARS-CoV-2 or Covid19. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Comparing the completed and successfully-completed test kits by study arm (randomization to either the active or passive arm)
| Group | Value | 95% CI |
|---|---|---|
| Passive Delivery | 75 | |
| Active Delivery | 94 | |
| Passive Delivery | 57 | |
| Active Delivery | 42 |
SARS-CoV-2 Home-testing Kit successfully-completed by study arm (randomization to either the active or passive arm)
| Group | Value | 95% CI |
|---|---|---|
| Passive Delivery | 61 | |
| Active Delivery | 74 | |
| Passive Delivery | 71 | |
| Active Delivery | 62 |
SARS-CoV-2 Home-testing Kit Completed vs. Successful completed rates, stratified by community.
| Group | Value | 95% CI |
|---|---|---|
| Passive Delivery | 39 | |
| Active Delivery | 31 | |
| Passive Delivery | 13 | |
| Active Delivery | 14 | |
| Passive Delivery | 47 | |
| Active Delivery | 56 | |
| Passive Delivery | 18 | |
| Active Delivery | 11 |
Time frame: Adverse experiences (adverse events and social impacts) were collected from day 0 through the last study assessment or day 21, whichever occurred first.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Passive Delivery | Active Delivery |
|---|---|---|---|
| Social Impacts | Social circumstances | — | — |
Data from ClinicalTrials.gov NCT04866303 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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