Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04866303 |
| Other study ID # |
5P20GM104417 |
| Secondary ID |
5P20GM104417 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 26, 2021 |
| Est. completion date |
March 9, 2022 |
Study information
| Verified date |
December 2023 |
| Source |
Montana State University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
This clinical trial utilizes community-based participatory research partnerships to test the
hypothesis that home-based testing for COVID-19 will be feasible, impactful, and better
accepted using active assistance with the testing kits by trusted community members vs.
passive delivery 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 Hispanic community. The
investigators will implement a two-arm pragmatic randomized trial during February to June
2021. Two hundred (200) adults per community will be randomized and stratified by age (18-25,
26-59, and 60+) to active vs. passive delivery. Our primary outcome will be the proportion of
subjects who return testing collection kits in the active vs. passive arm. The trial will
enable us to determine best practices and issues with home-based testing delivery in American
Indian and Latino communities.
Participants randomized to both the active and passive arms will receive home testing kits
augmented with materials developed by the study in both English and Spanish. In order to
control for potential barriers to home testing kit delivery in this population (including
internet access, digital literacy, English language proficiency) and limited access to mail
delivery services (UPS, FedEx, etc.), participants in both study arms will be provided kit
delivery and home collected sample return support coordinated by study staff. Coordination
support options include (1) pick up / drop off at the research site, (2) shipping the home
testing kit to the participant's mailing address by USPS or (3) home delivery/pick up to
accommodate those with mobility concerns. The home testing kit selected in this study is the
Everlywell COVID home-sampling kit.
Participants randomized to the passive arm will receive a home test kit with instructions on
how to self-register their kit online, and will be directed to contact Everywell for
assistance, if needed.
Participants randomized to the active arm will have their home collection kit registered on
their behalf by community health workers while the participant remains on the phone. Study
developed materials will direct participants to contact the study team for assistance.
Participants in both arms will receive study developed instructions to access their test
results from the Everlywell online portal. Positive test results will be verbally provided by
Everlywell contracted physicians. Study staff will confirm all participants have retrieved
their test results from the online portal and referred to appropriate public health or
clinical support as needed.
An initial survey of participant demographics and any current symptoms and medical conditions
(including the RADx-UP Coordination and Data Collection Center common data & evaluation
metrics) will be done via phone with participants prior to kit delivery.
Home testing kits returned and tested within 14 days of randomization will be considered
"complete", while testing kits not returned or returned later than 14 days will be considered
"not-complete". Within 14 days of randomization, will will conduct a phone delivered
post-testing feedback survey with participants who completed their home testing kit to ask
opinions on testing barriers and supports, interest in and barriers to self-testing before
and after the study and usefulness of training materials. Participants who did not complete
the home testing kit will be asked to provide reasons and barriers to completion.
Post-testing feedback surveys will be brief and participants will receive a $35 gift card
incentive for survey completion.
The investigators will also conduct in-depth, semi-structured, phone interview with 40
participants, 20 at each site, to collect perceptions of and experience with the home testing
kit, vaccinations and other issues related to the pandemic. To facilitate collection of data
at multiple timepoints in the study, interviews will be staggered. Interviews will occur
roughly every two weeks over a 10-week period. The investigators will attempt to match
interviews by active and passive arm assignment, completer and non-completer status, and
timeframe. Twenty interviews with participants randomized to the active arm (10 participants
who completed their home testing kits and 10 who did not) will be conducted as well as 20
interviews with participants randomized to the passive arm, also split evenly between
participants who completed and not-completed their home testing kit. Participants who
complete the in-depth, semi-structured phone interview will receive an incentive equal to
$25.
Study consent, enrollment and study assessments will be conducted in the participant's
preference of Spanish or English.
Harms
The investigators expect an extremely low occurrence of unfavorable events in this study and
will be classifying negative study related harms to human subjects as either "social
impacts", which for the purposes of this study are defined as an inadvertent and negative
impact on an individual's standing in the community, within their family, their job, with the
government, or with their finances as a result of participating in the study. Social impacts
may also include worry (warranted or unwarranted), feeling upset or depressed, embarrassed,
shameful, or guilty as a result of study participation or alternatively adverse events (AE)
which are defined as any untoward medical occurrence in a subject during study participation.
Identification of both social impacts and AE will primarily be through passive surveillance,
such as survey responses and conversations with site staff, and will be documented following
informed consent until the final study assessment is complete. All social impacts and adverse
events will be reported to the Data Safety Monitoring Board. Adverse events will be reported
to the Montana State University IRB within 24 hours of site awareness. Study staff at each
site will be trained in techniques to help resolve distress and connect participants to
appropriate resources
Data Analysis and Sample Size Considerations
Our prior work with passive strategies has produced a return rate of approximately 70%.The
investigators view a relative increase of 20% (absolute increase of 14%) to be a meaningful
impact associated with the effort involved in active outreach, and therefore the
investigators selected a sample with adequate power to detect such a difference.
Specifically, with 400 total subjects (stratified by community) the study will have 90% power
to detect an effect size associated with a rate ratio of 1.20, or an absolute difference of
14% (70% in passive, 84% in active). The investigators evaluated the design for robustness to
assumptions regarding the passive return rate, and they have > 80% power to detect an
absolute difference of 14% (relative rate of 1.23) if the passive return rate is 60%. No
correction will be made for missing outcomes since the outcome is negative if no kit is
returned. In addition, exploring the impact of using regression adjustment (logistic
regression with an identity link) to account for community stratification, and the primary
analysis maintains > 80% power for a range of passive rate differences across communities
(ranging from 5% to 10%). All power calculations used the R statistical package and the PWR
library and simulation methods.
The investigators will evaluate the net improvement in the rate of returning kits (primary
outcome), comparing active vs. passive community outreach for uptake of home-based testing.
Within each community, individuals will be randomized to active or passive delivery, and our
primary analysis will compare the difference in the proportion of subjects who return
collection kits while adjusting for community. Secondary analysis will compare active and
passive rates across the communities to evaluate consistency of the intervention effect.
Quantitative analysis of survey responses will focus on the creation of summary statistics
that characterize the response to key survey items. An important statistical consideration is
survey non-response and the potential for non-representative samples. The investigators will
evaluate baseline factors that are potentially associated with non-response and then use
inverse probability weighting (IPW) to correct for any potential bias associated with
measured factors.
All statistical tests will be carried out at the 0.05 significance level, and estimates, 95%
confidence intervals, and associated p-values will be reported for all tests. Analyses will
be conducted using SAS 9.4 statistical software.
