Trial Outcomes & Findings for COVID-19 Self-Testing Through Rapid Network Distribution (NCT NCT04797858)
NCT ID: NCT04797858
Last Updated: 2025-05-11
Results Overview
The primary outcome is the proportion of study participants who distributed tests/referrals to least two network contacts who completed testing. This outcome will be measured by number of participants with at least 2 unique network contacts who completed a test linked to a study participant by week 8. The investigators will test for differences in the primary outcome between the two study arms.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
792 participants
Primary outcome timeframe
8 weeks
Results posted on
2025-05-11
Participant Flow
Participant milestones
| Measure |
Self-Test Kit Distribution
Participants in the self-test arm receive multiple COVID-19 self-test kits to distribute to others in their social networks.
COVID-19 self-test: 5 COVID-19 self-test kits will be given to participants after they have been tested for COVID-19. Participants will be instructed to give test kits to others in their social networks who are symptomatic, exposed to COVID-19, or otherwise at high risk of COVID-19.
|
Test Referral Distribution
Participants in the test referral arm receive multiple COVID-19 test referral cards and text messages to distribute to others in their social networks.
COVID-19 test referral: 5 test referral cards and text messages on how to obtain COVID-19 testing will be given to participants after they have been tested for COVID-19. These cards and text messages will have information on how to obtain free COVID-19 tests at local testing sites. Participants will be instructed to give out referral cards and text messages to others in their social networks to obtain testing.
|
|---|---|---|
|
Overall Study
STARTED
|
395
|
397
|
|
Overall Study
COMPLETED
|
388
|
388
|
|
Overall Study
NOT COMPLETED
|
7
|
9
|
Reasons for withdrawal
| Measure |
Self-Test Kit Distribution
Participants in the self-test arm receive multiple COVID-19 self-test kits to distribute to others in their social networks.
COVID-19 self-test: 5 COVID-19 self-test kits will be given to participants after they have been tested for COVID-19. Participants will be instructed to give test kits to others in their social networks who are symptomatic, exposed to COVID-19, or otherwise at high risk of COVID-19.
|
Test Referral Distribution
Participants in the test referral arm receive multiple COVID-19 test referral cards and text messages to distribute to others in their social networks.
COVID-19 test referral: 5 test referral cards and text messages on how to obtain COVID-19 testing will be given to participants after they have been tested for COVID-19. These cards and text messages will have information on how to obtain free COVID-19 tests at local testing sites. Participants will be instructed to give out referral cards and text messages to others in their social networks to obtain testing.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Excluded due to administrative error
|
7
|
8
|
Baseline Characteristics
2 individuals declined to answer.
Baseline characteristics by cohort
| Measure |
Self-Test Kit Distribution
n=388 Participants
Participants in the self-test arm receive multiple COVID-19 self-test kits to distribute to others in their social networks.
COVID-19 self-test: 5 COVID-19 self-test kits will be given to participants after they have been tested for COVID-19. Participants will be instructed to give test kits to others in their social networks who are symptomatic, exposed to COVID-19, or otherwise at high risk of COVID-19.
|
Test Referral Distribution
n=388 Participants
Participants in the test referral arm receive multiple COVID-19 test referral cards and text messages to distribute to others in their social networks.
COVID-19 test referral: 5 test referral cards and text messages on how to obtain COVID-19 testing will be given to participants after they have been tested for COVID-19. These cards and text messages will have information on how to obtain free COVID-19 tests at local testing sites. Participants will be instructed to give out referral cards and text messages to others in their social networks to obtain testing.
|
Total
n=776 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=388 Participants
|
0 Participants
n=388 Participants
|
0 Participants
n=776 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
352 Participants
n=388 Participants
|
352 Participants
n=388 Participants
|
704 Participants
n=776 Participants
|
|
Age, Categorical
>=65 years
|
36 Participants
n=388 Participants
|
36 Participants
n=388 Participants
|
72 Participants
n=776 Participants
|
|
Age, Continuous
|
44 years
n=388 Participants
|
44 years
n=388 Participants
|
44 years
n=776 Participants
|
|
Sex: Female, Male
Female
|
219 Participants
n=387 Participants • 2 individuals declined to answer.
|
221 Participants
n=387 Participants • 2 individuals declined to answer.
|
440 Participants
n=774 Participants • 2 individuals declined to answer.
|
|
Sex: Female, Male
Male
|
168 Participants
n=387 Participants • 2 individuals declined to answer.
|
166 Participants
n=387 Participants • 2 individuals declined to answer.
|
334 Participants
n=774 Participants • 2 individuals declined to answer.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
53 Participants
n=388 Participants • Not all participants provided data or agreed to answer this question.
|
59 Participants
n=388 Participants • Not all participants provided data or agreed to answer this question.
|
112 Participants
n=776 Participants • Not all participants provided data or agreed to answer this question.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
322 Participants
n=388 Participants • Not all participants provided data or agreed to answer this question.
|
318 Participants
n=388 Participants • Not all participants provided data or agreed to answer this question.
|
640 Participants
n=776 Participants • Not all participants provided data or agreed to answer this question.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=388 Participants • Not all participants provided data or agreed to answer this question.
|
11 Participants
n=388 Participants • Not all participants provided data or agreed to answer this question.
|
24 Participants
n=776 Participants • Not all participants provided data or agreed to answer this question.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=388 Participants
|
5 Participants
n=388 Participants
|
8 Participants
n=776 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=388 Participants
|
12 Participants
n=388 Participants
|
24 Participants
n=776 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=388 Participants
|
1 Participants
n=388 Participants
|
1 Participants
n=776 Participants
|
|
Race (NIH/OMB)
Black or African American
|
230 Participants
n=388 Participants
|
249 Participants
n=388 Participants
|
479 Participants
n=776 Participants
|
|
Race (NIH/OMB)
White
|
88 Participants
n=388 Participants
|
69 Participants
n=388 Participants
|
157 Participants
n=776 Participants
|
|
Race (NIH/OMB)
More than one race
|
18 Participants
n=388 Participants
|
12 Participants
n=388 Participants
|
30 Participants
n=776 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
37 Participants
n=388 Participants
|
40 Participants
n=388 Participants
|
77 Participants
n=776 Participants
|
|
Region of Enrollment
United States
|
388 participants
n=388 Participants
|
388 participants
n=388 Participants
|
776 participants
n=776 Participants
|
PRIMARY outcome
Timeframe: 8 weeksThe primary outcome is the proportion of study participants who distributed tests/referrals to least two network contacts who completed testing. This outcome will be measured by number of participants with at least 2 unique network contacts who completed a test linked to a study participant by week 8. The investigators will test for differences in the primary outcome between the two study arms.
Outcome measures
| Measure |
Self-Test Kit Distribution
n=388 Participants
Participants in the self-test arm receive multiple COVID-19 self-test kits to distribute to others in their social networks.
COVID-19 self-test: 5 COVID-19 self-test kits will be given to participants after they have been tested for COVID-19. Participants will be instructed to give test kits to others in their social networks who are symptomatic, exposed to COVID-19, or otherwise at high risk of COVID-19.
|
Test Referral Distribution
n=388 Participants
Participants in the test referral arm receive multiple COVID-19 test referral cards and text messages to distribute to others in their social networks.
COVID-19 test referral: 5 test referral cards and text messages on how to obtain COVID-19 testing will be given to participants after they have been tested for COVID-19. These cards and text messages will have information on how to obtain free COVID-19 tests at local testing sites. Participants will be instructed to give out referral cards and text messages to others in their social networks to obtain testing.
|
|---|---|---|
|
Network Contact Test Uptake
|
5 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Through study completion, up to 30 months.Test uptake among at least two network contacts. This outcome will be measured by the number of participants with at least two unique network contacts who completed a test linked to an index participant by end of study.
Outcome measures
| Measure |
Self-Test Kit Distribution
n=388 Participants
Participants in the self-test arm receive multiple COVID-19 self-test kits to distribute to others in their social networks.
COVID-19 self-test: 5 COVID-19 self-test kits will be given to participants after they have been tested for COVID-19. Participants will be instructed to give test kits to others in their social networks who are symptomatic, exposed to COVID-19, or otherwise at high risk of COVID-19.
|
Test Referral Distribution
n=388 Participants
Participants in the test referral arm receive multiple COVID-19 test referral cards and text messages to distribute to others in their social networks.
COVID-19 test referral: 5 test referral cards and text messages on how to obtain COVID-19 testing will be given to participants after they have been tested for COVID-19. These cards and text messages will have information on how to obtain free COVID-19 tests at local testing sites. Participants will be instructed to give out referral cards and text messages to others in their social networks to obtain testing.
|
|---|---|---|
|
Network Contact Test Uptake, End of Study
|
8 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Note that each participant could have up to 5 network contacts, so the denominator = 5 times the number of index participants.
Number of unique network contacts who completed a test linked to an index participant by week 8. Participants analyzed reflects the number of network contacts only who completed a test.
Outcome measures
| Measure |
Self-Test Kit Distribution
n=1940 Network contacts
Participants in the self-test arm receive multiple COVID-19 self-test kits to distribute to others in their social networks.
COVID-19 self-test: 5 COVID-19 self-test kits will be given to participants after they have been tested for COVID-19. Participants will be instructed to give test kits to others in their social networks who are symptomatic, exposed to COVID-19, or otherwise at high risk of COVID-19.
|
Test Referral Distribution
n=1940 Network contacts
Participants in the test referral arm receive multiple COVID-19 test referral cards and text messages to distribute to others in their social networks.
COVID-19 test referral: 5 test referral cards and text messages on how to obtain COVID-19 testing will be given to participants after they have been tested for COVID-19. These cards and text messages will have information on how to obtain free COVID-19 tests at local testing sites. Participants will be instructed to give out referral cards and text messages to others in their social networks to obtain testing.
|
|---|---|---|
|
Number of Contacts Tested at 8 Weeks
|
23 Network contacts
|
13 Network contacts
|
SECONDARY outcome
Timeframe: Through study completion, up to 30 monthsPopulation: Note that each participant could have up to 5 network contacts, so the denominator = 5 times the number of index participants.
Number of unique network contacts who completed a test linked to an index participant by end of study.
Outcome measures
| Measure |
Self-Test Kit Distribution
n=1940 Network contacts
Participants in the self-test arm receive multiple COVID-19 self-test kits to distribute to others in their social networks.
COVID-19 self-test: 5 COVID-19 self-test kits will be given to participants after they have been tested for COVID-19. Participants will be instructed to give test kits to others in their social networks who are symptomatic, exposed to COVID-19, or otherwise at high risk of COVID-19.
|
Test Referral Distribution
n=1940 Network contacts
Participants in the test referral arm receive multiple COVID-19 test referral cards and text messages to distribute to others in their social networks.
COVID-19 test referral: 5 test referral cards and text messages on how to obtain COVID-19 testing will be given to participants after they have been tested for COVID-19. These cards and text messages will have information on how to obtain free COVID-19 tests at local testing sites. Participants will be instructed to give out referral cards and text messages to others in their social networks to obtain testing.
|
|---|---|---|
|
Number of Contacts Tested
|
31 Network contacts
|
16 Network contacts
|
SECONDARY outcome
Timeframe: 8 weeksNumber of participants with at least one network contact who tested positive for COVID-19 within 8 weeks of enrollment.
Outcome measures
| Measure |
Self-Test Kit Distribution
n=388 Participants
Participants in the self-test arm receive multiple COVID-19 self-test kits to distribute to others in their social networks.
COVID-19 self-test: 5 COVID-19 self-test kits will be given to participants after they have been tested for COVID-19. Participants will be instructed to give test kits to others in their social networks who are symptomatic, exposed to COVID-19, or otherwise at high risk of COVID-19.
|
Test Referral Distribution
n=388 Participants
Participants in the test referral arm receive multiple COVID-19 test referral cards and text messages to distribute to others in their social networks.
COVID-19 test referral: 5 test referral cards and text messages on how to obtain COVID-19 testing will be given to participants after they have been tested for COVID-19. These cards and text messages will have information on how to obtain free COVID-19 tests at local testing sites. Participants will be instructed to give out referral cards and text messages to others in their social networks to obtain testing.
|
|---|---|---|
|
Number of Participants With at Least One Network Contact Who Tested Positive for COVID-19 at 8 Weeks
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Through study completion, up to 30 monthsNumber of participants with at least one network contact who tested positive for COVID-19 by the end of study
Outcome measures
| Measure |
Self-Test Kit Distribution
n=388 Participants
Participants in the self-test arm receive multiple COVID-19 self-test kits to distribute to others in their social networks.
COVID-19 self-test: 5 COVID-19 self-test kits will be given to participants after they have been tested for COVID-19. Participants will be instructed to give test kits to others in their social networks who are symptomatic, exposed to COVID-19, or otherwise at high risk of COVID-19.
|
Test Referral Distribution
n=388 Participants
Participants in the test referral arm receive multiple COVID-19 test referral cards and text messages to distribute to others in their social networks.
COVID-19 test referral: 5 test referral cards and text messages on how to obtain COVID-19 testing will be given to participants after they have been tested for COVID-19. These cards and text messages will have information on how to obtain free COVID-19 tests at local testing sites. Participants will be instructed to give out referral cards and text messages to others in their social networks to obtain testing.
|
|---|---|---|
|
Number of Participants With at Least One Network Contact Who Tested Positive for COVID-19, End of Study
|
3 Participants
|
0 Participants
|
Adverse Events
Self-Test Kit Distribution
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Test Referral Distribution
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place