Trial Outcomes & Findings for You and Me COVID Free (NCT NCT05212883)

NCT ID: NCT05212883

Last Updated: 2023-06-06

Results Overview

Those that used a test from a kit were asked to provide the reason why they were doing a test. The possible answers are: "I wanted to be sure I/my child did not have COVID-19 before being around others", "I/my child had COVID-19 like symptoms", "I/my child was in close contact with someone who might have COVID-19", "I/my child was in close contact with someone who tested positive for COVID-19", "Someone in my household might have COVID-19", "Someone in my household tested positive for COVID-19", "Other"

• Recruitment status: COMPLETED
• Target enrollment: 2778 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2023-06-06

Participant Flow

The project team utilized a robust communications campaign and mobilized community partners to assist with outreach and to organize COVID-19 (SARs-CoV-2) antigen testing kit distribution events. Community members received tests via in person at local distribution centers and events.

Participant milestones

Measure	Behavioral Questionnaires Questionnaires will collect data on demographic characteristics, medical history and health status, COVID testing and symptoms, social interactions, knowledge of prevention strategies, infection risk, and attitudes towards vaccines.
Overall Study STARTED	2778
Overall Study COMPLETED	2653
Overall Study NOT COMPLETED	125

Reasons for withdrawal

Measure	Behavioral Questionnaires Questionnaires will collect data on demographic characteristics, medical history and health status, COVID testing and symptoms, social interactions, knowledge of prevention strategies, infection risk, and attitudes towards vaccines.
Overall Study Invalid test result	125

Baseline Characteristics

You and Me COVID Free

Baseline characteristics by cohort

Measure	Behavioral Questionnaires n=1001 Participants Questionnaires will collect data on demographic characteristics, medical history and health status, COVID testing and symptoms, social interactions, knowledge of prevention strategies, infection risk, and attitudes towards vaccines.
Age, Continuous	39 years n=5 Participants
Sex/Gender, Customized Female	687 Participants n=5 Participants
Sex/Gender, Customized Male	280 Participants n=5 Participants
Sex/Gender, Customized Unknown or Not Reported	34 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	529 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	434 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	38 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	35 Participants n=5 Participants
Race (NIH/OMB) Asian	74 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	5 Participants n=5 Participants
Race (NIH/OMB) Black or African American	39 Participants n=5 Participants
Race (NIH/OMB) White	546 Participants n=5 Participants
Race (NIH/OMB) More than one race	36 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	266 Participants n=5 Participants
Region of Enrollment United States	1001 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Those that used a test from a kit were asked to provide the reason why they were doing a test. The possible answers are: "I wanted to be sure I/my child did not have COVID-19 before being around others", "I/my child had COVID-19 like symptoms", "I/my child was in close contact with someone who might have COVID-19", "I/my child was in close contact with someone who tested positive for COVID-19", "Someone in my household might have COVID-19", "Someone in my household tested positive for COVID-19", "Other"

Outcome measures

Measure	Behavioral Questionnaires n=2778 Participants Questionnaires will collect data on demographic characteristics, medical history and health status, COVID testing and symptoms, social interactions, knowledge of prevention strategies, infection risk, and attitudes towards vaccines.
Main Reason for Testing for COVID-19 I wanted to be sure I/my child did not have COVID-19 before being around others	1632 Participants
Main Reason for Testing for COVID-19 I/my child was in close contact with someone who might have COVID-19	238 Participants
Main Reason for Testing for COVID-19 I/my child was in close contact with someone who tested positive for COVID-19	343 Participants
Main Reason for Testing for COVID-19 I/my child had COVID-19 like symptoms	493 Participants
Main Reason for Testing for COVID-19 Someone in my household might have COVID-19	118 Participants
Main Reason for Testing for COVID-19 Someone in my household tested positive for COVID-19	152 Participants
Main Reason for Testing for COVID-19 Other	209 Participants

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Measure	Behavioral Questionnaires n=2778 Participants Questionnaires will collect data on demographic characteristics, medical history and health status, COVID testing and symptoms, social interactions, knowledge of prevention strategies, infection risk, and attitudes towards vaccines.
Number of Positive COVID-19 Test Results	269 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Participants who completed the baseline survey.

Outcome measures

Measure	Behavioral Questionnaires n=1001 Participants Questionnaires will collect data on demographic characteristics, medical history and health status, COVID testing and symptoms, social interactions, knowledge of prevention strategies, infection risk, and attitudes towards vaccines.
Number of Participants Who Responded That They Have Received a COVID Vaccine	850 Participants

SECONDARY outcome

Timeframe: Baseline

Population: Participants who completed the baseline survey.

Outcome measures

Measure	Behavioral Questionnaires n=1001 Participants Questionnaires will collect data on demographic characteristics, medical history and health status, COVID testing and symptoms, social interactions, knowledge of prevention strategies, infection risk, and attitudes towards vaccines.
Number of Participants Who Indicated That They Have Access to Necessary Personal Protective Equipment in Work Place	475 Participants

SECONDARY outcome

Timeframe: Baseline

Population: Participants who completed the baseline survey and indicated having tested for COVID.

Outcome measures

Measure	Behavioral Questionnaires n=821 Participants Questionnaires will collect data on demographic characteristics, medical history and health status, COVID testing and symptoms, social interactions, knowledge of prevention strategies, infection risk, and attitudes towards vaccines.
Number of Participants Who Indicated They Have Tested Positive for COVID in Their Lifetime	237 Participants

SECONDARY outcome

Timeframe: Baseline

Population: Participants who completed the baseline survey.

Outcome measures

Measure	Behavioral Questionnaires n=1001 Participants Questionnaires will collect data on demographic characteristics, medical history and health status, COVID testing and symptoms, social interactions, knowledge of prevention strategies, infection risk, and attitudes towards vaccines.
Number of Participants Who Report Knowing Where to Get COVID-19 Tests in the Community	757 Participants

SECONDARY outcome

Timeframe: Baseline

Population: Participants who completed the baseline survey.

Outcome measures

Measure	Behavioral Questionnaires n=1001 Participants Questionnaires will collect data on demographic characteristics, medical history and health status, COVID testing and symptoms, social interactions, knowledge of prevention strategies, infection risk, and attitudes towards vaccines.
Number of Participants Who Report COVID Symptoms During Previous Week	627 Participants

SECONDARY outcome

Timeframe: Baseline

Population: Participants with front door survey entries that indicated the responder had not received a COVID-19 vaccine.

Number of participants with front door survey entries indicating various levels of the likelihood the responder will get vaccinated in the future. Available options: "Very likely", "Somewhat likely", "Not very likely", "Not at all likely", and "Prefer not to answer".

Outcome measures

Measure	Behavioral Questionnaires n=489 Participants Questionnaires will collect data on demographic characteristics, medical history and health status, COVID testing and symptoms, social interactions, knowledge of prevention strategies, infection risk, and attitudes towards vaccines.
Likelihood of Future COVID-19 Vaccination Very likely	119 Participants
Likelihood of Future COVID-19 Vaccination Somewhat likely	140 Participants
Likelihood of Future COVID-19 Vaccination Not very likely	59 Participants
Likelihood of Future COVID-19 Vaccination Not at all likely	92 Participants
Likelihood of Future COVID-19 Vaccination Prefer not to answer/missing	79 Participants

SECONDARY outcome

Timeframe: Baseline

Population: Participants who indicated they have not received a COVID-19 vaccine on the baseline survey. More than one answer can be selected by an individual participant.

Number of participants indicating various reasons for why they have not received a COVID-19 vaccine on the baseline survey. Available options: "I'm allergic to vaccines", "I don't like needles", "I'm not concerned about getting really sick from COVID-19", "I'm concerned about side effects from the vaccines", "I don't think vaccines work very well", "I don't trust that the vaccines will be safe", "I don't believe the COVID-19 pandemic is as bad as some people say it is", "I don't want to pay for it", and "I don't know enough about how well a COVID-19 vaccine works".

Outcome measures

Measure	Behavioral Questionnaires n=121 Participants Questionnaires will collect data on demographic characteristics, medical history and health status, COVID testing and symptoms, social interactions, knowledge of prevention strategies, infection risk, and attitudes towards vaccines.
Reasons for Not Getting a COVID-19 Vaccine I don't like needles	22 Participants
Reasons for Not Getting a COVID-19 Vaccine I'm not concerned about getting really sick from COVID-19	3 Participants
Reasons for Not Getting a COVID-19 Vaccine I'm concerned about side effects from the vaccines	47 Participants
Reasons for Not Getting a COVID-19 Vaccine I don't trust that the vaccines will be safe	34 Participants
Reasons for Not Getting a COVID-19 Vaccine I don't believe the COVID-19 pandemic is as bad as some people say it is	4 Participants
Reasons for Not Getting a COVID-19 Vaccine I don't want to pay for it	3 Participants
Reasons for Not Getting a COVID-19 Vaccine I don't know enough about how well a COVID-19 vaccine works	16 Participants
Reasons for Not Getting a COVID-19 Vaccine I'm allergic to vaccines	5 Participants
Reasons for Not Getting a COVID-19 Vaccine I don't think vaccines work very well	7 Participants
Reasons for Not Getting a COVID-19 Vaccine Other	15 Participants

SECONDARY outcome

Timeframe: Baseline

Population: Participants who indicated they have received a COVID-19 vaccine on the baseline survey. More than one answer can be selected by an individual participant.

Number of participants indicating various reasons for why they have received a COVID-19 vaccine on the baseline survey. Available options: "I want to keep my family safe", "I want to keep my community safe", "I want to keep myself safe", "I have a chronic health problem, like asthma or diabetes", "My doctor told me to get a COVID-19 vaccine", "I don't want to get really sick from COVID-19", "I want to feel safe around other people", "I believe life won't go back to normal until most people get a COVID-19 vaccine", "Required by my school or workplace", and "Required for travel".

Outcome measures

Measure	Behavioral Questionnaires n=850 Participants Questionnaires will collect data on demographic characteristics, medical history and health status, COVID testing and symptoms, social interactions, knowledge of prevention strategies, infection risk, and attitudes towards vaccines.
Reasons for Getting a COVID-19 Vaccine I want to keep my family safe	712 Participants
Reasons for Getting a COVID-19 Vaccine I want to feel safe around other people	404 Participants
Reasons for Getting a COVID-19 Vaccine I want to keep my community safe	477 Participants
Reasons for Getting a COVID-19 Vaccine I want to keep myself safe	557 Participants
Reasons for Getting a COVID-19 Vaccine I have a chronic health problem, like asthma or diabetes	135 Participants
Reasons for Getting a COVID-19 Vaccine My doctor told me to get a COVID-19 vaccine	86 Participants
Reasons for Getting a COVID-19 Vaccine I don't want to get really sick from COVID-19	378 Participants
Reasons for Getting a COVID-19 Vaccine I believe life won't go back to normal until most people get a COVID-19 vaccine	313 Participants
Reasons for Getting a COVID-19 Vaccine Required by my school or workplace	169 Participants
Reasons for Getting a COVID-19 Vaccine Required for travel	126 Participants
Reasons for Getting a COVID-19 Vaccine Other	24 Participants

SECONDARY outcome

Timeframe: Baseline

Number of front door survey entries indicating various ways in which participants would find it easy to get free COVID-19 oral medications. Available options: "An urgent care center". "A doctor's or other health professional's office", "A mobile health unit", "A drug store / pharmacy", "A grocery store", "A community center", "A place of worship", "A community park", "A neighborhood school", or "other". More than one answer can be selected by an individual participant.

Outcome measures

Measure	Behavioral Questionnaires n=2778 Participants Questionnaires will collect data on demographic characteristics, medical history and health status, COVID testing and symptoms, social interactions, knowledge of prevention strategies, infection risk, and attitudes towards vaccines.
Perspective on Easiest Way to Obtain Free Oral COVID-19 Medications An urgent care center	503 Participants
Perspective on Easiest Way to Obtain Free Oral COVID-19 Medications A doctor's or other health professional's office	526 Participants
Perspective on Easiest Way to Obtain Free Oral COVID-19 Medications A mobile health unit	189 Participants
Perspective on Easiest Way to Obtain Free Oral COVID-19 Medications A drug store / pharmacy	1225 Participants
Perspective on Easiest Way to Obtain Free Oral COVID-19 Medications A grocery store	209 Participants
Perspective on Easiest Way to Obtain Free Oral COVID-19 Medications A community center	87 Participants
Perspective on Easiest Way to Obtain Free Oral COVID-19 Medications A place of worship	38 Participants
Perspective on Easiest Way to Obtain Free Oral COVID-19 Medications A community park	50 Participants
Perspective on Easiest Way to Obtain Free Oral COVID-19 Medications A neighborhood school	116 Participants
Perspective on Easiest Way to Obtain Free Oral COVID-19 Medications Other	25 Participants

SECONDARY outcome

Timeframe: Baseline

Population: Participants who indicated that they have tested for COVID-19.

Number of participants indicating the method used to test for COVID-19 on the baseline survey. Available options: "Nasal swab", "Throat swab", "Blood sample", and "Saliva".

Outcome measures

Measure	Behavioral Questionnaires n=821 Participants Questionnaires will collect data on demographic characteristics, medical history and health status, COVID testing and symptoms, social interactions, knowledge of prevention strategies, infection risk, and attitudes towards vaccines.
Method Used to Test for COVID-19 Saliva	17 Participants
Method Used to Test for COVID-19 Missing	2 Participants
Method Used to Test for COVID-19 Nasal swab	783 Participants
Method Used to Test for COVID-19 Throat swab	15 Participants
Method Used to Test for COVID-19 Blood sample	4 Participants

Adverse Events

Behavioral Questionnaires

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

Saira Siddiqui, M.P.H.

Duke University

Phone: 919-688-8464

Email: saira.siddiqui@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place