Trial Outcomes & Findings for Protecting Our Community: COVID-19 Testing (NCT NCT04866303)
NCT ID: NCT04866303
Last Updated: 2023-12-07
Results Overview
Comparing the completed and successfully-completed test kits by study arm (randomization to either the active or passive arm)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
273 participants
Primary outcome timeframe
14 days from randomization for both completed and successfully-completed measurements
Results posted on
2023-12-07
Participant Flow
While 273 participants were randomized, 268 were included in the analysis due to early withdraw or lost to follow-up
Participant milestones
| Measure |
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.
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.
|
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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
136
|
137
|
|
Overall Study
Withdrawal or Lost to Follow Up
|
4
|
1
|
|
Overall Study
COMPLETED
|
132
|
136
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Baseline data not collected for 4 participants in the Passive Delivery Arm, Baseline data not collected for 1 participants in the Active Delivery Arm
Baseline characteristics by cohort
| Measure |
Passive Delivery
n=136 Participants
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.
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.
|
Active Delivery
n=137 Participants
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.
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.
|
Total
n=273 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18-25 years old
|
17 Participants
n=132 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm, Baseline data not collected for 1 participants in the Active Delivery Arm
|
16 Participants
n=136 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm, Baseline data not collected for 1 participants in the Active Delivery Arm
|
33 Participants
n=268 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm, Baseline data not collected for 1 participants in the Active Delivery Arm
|
|
Age, Customized
26-59 years old
|
96 Participants
n=132 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm, Baseline data not collected for 1 participants in the Active Delivery Arm
|
101 Participants
n=136 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm, Baseline data not collected for 1 participants in the Active Delivery Arm
|
197 Participants
n=268 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm, Baseline data not collected for 1 participants in the Active Delivery Arm
|
|
Age, Customized
60+ years old
|
19 Participants
n=132 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm, Baseline data not collected for 1 participants in the Active Delivery Arm
|
19 Participants
n=136 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm, Baseline data not collected for 1 participants in the Active Delivery Arm
|
38 Participants
n=268 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm, Baseline data not collected for 1 participants in the Active Delivery Arm
|
|
Sex/Gender, Customized
Male
|
22 Participants
n=132 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
27 Participants
n=136 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
49 Participants
n=268 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
|
Sex/Gender, Customized
Female
|
110 Participants
n=132 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
106 Participants
n=136 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
216 Participants
n=268 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
|
Sex/Gender, Customized
Missing
|
0 Participants
n=132 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
3 Participants
n=136 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
3 Participants
n=268 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
|
Race/Ethnicity, Customized
Native American or Alaska Native
|
28 Participants
n=132 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
32 Participants
n=136 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
60 Participants
n=268 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
104 Participants
n=132 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
103 Participants
n=136 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
207 Participants
n=268 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
9 Participants
n=132 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
9 Participants
n=136 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
18 Participants
n=268 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
|
Region of Enrollment
United States
|
132 participants
n=132 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
136 participants
n=136 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
268 participants
n=268 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
|
Rural-Urban Commuting Area (RUCA)
Metropolitan
|
17 Participants
n=132 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
10 Participants
n=136 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
27 Participants
n=268 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
|
Rural-Urban Commuting Area (RUCA)
Micropolitan
|
77 Participants
n=132 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
88 Participants
n=136 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
165 Participants
n=268 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
|
Rural-Urban Commuting Area (RUCA)
Small town
|
21 Participants
n=132 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
15 Participants
n=136 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
36 Participants
n=268 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
|
Rural-Urban Commuting Area (RUCA)
Rural
|
17 Participants
n=132 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
23 Participants
n=136 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
40 Participants
n=268 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
|
Education
No formal education
|
2 Participants
n=132 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
2 Participants
n=136 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
4 Participants
n=268 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
|
Education
Elementary school
|
14 Participants
n=132 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
14 Participants
n=136 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
28 Participants
n=268 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
|
Education
Some high school
|
19 Participants
n=132 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
24 Participants
n=136 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
43 Participants
n=268 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
|
Education
High school degree or GED
|
28 Participants
n=132 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
21 Participants
n=136 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
49 Participants
n=268 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
|
Education
Tech school
|
4 Participants
n=132 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
5 Participants
n=136 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
9 Participants
n=268 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
|
Education
Some college
|
28 Participants
n=132 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
26 Participants
n=136 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
54 Participants
n=268 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
|
Education
College degree
|
13 Participants
n=132 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
19 Participants
n=136 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
32 Participants
n=268 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
|
Education
Graduate school degree
|
2 Participants
n=132 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
3 Participants
n=136 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
5 Participants
n=268 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
|
Education
Missing
|
22 Participants
n=132 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
22 Participants
n=136 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
44 Participants
n=268 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
|
Location
Flathead Reservation
|
33 Participants
n=132 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
35 Participants
n=136 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
68 Participants
n=268 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
|
Location
Yakima Valley
|
99 Participants
n=132 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
101 Participants
n=136 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
200 Participants
n=268 Participants • Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm
|
PRIMARY outcome
Timeframe: 14 days from randomization for both completed and successfully-completed measurementsPopulation: 273 participants were both consented and randomized. 5 participants were lost to follow-up and excluded from analysis. An additional measure was added to make this more clear
Comparing the completed and successfully-completed test kits by study arm (randomization to either the active or passive arm)
Outcome measures
| Measure |
Passive Delivery
n=132 Participants
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.
|
Active Delivery
n=136 Participants
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.
|
|---|---|---|
|
SARS-CoV-2 Home-testing Kit Completion Active vs. Passive Arms
Completed (kit arrived at processing lab)
|
75 Participants
|
94 Participants
|
|
SARS-CoV-2 Home-testing Kit Completion Active vs. Passive Arms
Not-Completed (kit did not arrive at processing lab)
|
57 Participants
|
42 Participants
|
PRIMARY outcome
Timeframe: 14 days from randomization for both completed and successfully-completed measurementsPopulation: 273 participants were both consented and randomized. 5 participants were lost to follow-up and excluded from analysis. An additional measure was added to make this more clear
SARS-CoV-2 Home-testing Kit successfully-completed by study arm (randomization to either the active or passive arm)
Outcome measures
| Measure |
Passive Delivery
n=132 Participants
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.
|
Active Delivery
n=136 Participants
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.
|
|---|---|---|
|
SARS-CoV-2 Home-testing Kit Successfully-Completed Active vs. Passive Arms
Successfully-Completed (kit was processed at lab, yielding a positive or negative result)
|
61 Participants
|
74 Participants
|
|
SARS-CoV-2 Home-testing Kit Successfully-Completed Active vs. Passive Arms
Unsuccessful-Completed (kit was not processed at lab due to sample effort)
|
71 Participants
|
62 Participants
|
POST_HOC outcome
Timeframe: 14 days from randomization for both completed and successfully-completed measurementsPopulation: Participants who provided consent and were randomized (both events happening on day 0). Baseline data not collected for 4 participants in the Passive Delivery Arm. Baseline data not collected for 1 participants in the Active Delivery Arm.
SARS-CoV-2 Home-testing Kit Completed vs. Successful completed rates, stratified by community.
Outcome measures
| Measure |
Passive Delivery
n=132 Participants
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.
|
Active Delivery
n=136 Participants
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.
|
|---|---|---|
|
SARS-CoV-2 Home-testing Kit Completion vs. Successful Rates Across the Communities
Yakima Valley, Not-Completed
|
39 Participants
|
31 Participants
|
|
SARS-CoV-2 Home-testing Kit Completion vs. Successful Rates Across the Communities
Yakima Valley, Completed-Not Successful
|
13 Participants
|
14 Participants
|
|
SARS-CoV-2 Home-testing Kit Completion vs. Successful Rates Across the Communities
Yakima Valley, Completed-Successful
|
47 Participants
|
56 Participants
|
|
SARS-CoV-2 Home-testing Kit Completion vs. Successful Rates Across the Communities
Flathead, Not-Completed
|
18 Participants
|
11 Participants
|
|
SARS-CoV-2 Home-testing Kit Completion vs. Successful Rates Across the Communities
Flathead, Completed-Not Successful
|
1 Participants
|
6 Participants
|
|
SARS-CoV-2 Home-testing Kit Completion vs. Successful Rates Across the Communities
Flathead, Completed-Successful
|
14 Participants
|
18 Participants
|
Adverse Events
Passive Delivery
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active Delivery
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Passive Delivery
n=132 participants at risk；n=136 participants at risk
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.
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.
|
Active Delivery
n=136 participants at risk；n=137 participants at risk
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.
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.
|
|---|---|---|
|
Social circumstances
Social Impacts
|
0.00%
0/132 • Adverse experiences (adverse events and social impacts) were collected from day 0 through the last study assessment or day 21, whichever occurred first.
In addition to the clinicaltrials.gov definition of adverse event, we also included a breakdown of safety procedures in our adverse event definition. Social impacts were defined as (1) 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. Adverse experiences were identified through surveys, and per protocol conversations \& study assessments.
|
0.74%
1/136 • Number of events 1 • Adverse experiences (adverse events and social impacts) were collected from day 0 through the last study assessment or day 21, whichever occurred first.
In addition to the clinicaltrials.gov definition of adverse event, we also included a breakdown of safety procedures in our adverse event definition. Social impacts were defined as (1) 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. Adverse experiences were identified through surveys, and per protocol conversations \& study assessments.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Flathead Tribal Council expects prior approval for any secondary usage of Tribal data uploaded to RADx-UP central repository and coordinating center and maintains the authority to review all publications, conference presentations and other scholarly works prior to dissemination.
- Publication restrictions are in place
Restriction type: OTHER