NCT05212883: YMCF

You and Me COVID Free

Completed Results posted Last updated 6 June 2023

What this trial tests

trial testing Behavioral questionaires in COVID-19 in 2,778 participants. Completed in 19 April 2022.

Timeline

15 November 2021

Primary endpoint
8 March 2022

19 April 2022

Quick facts

Lead sponsor	Duke University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	2,778
Start date	15 November 2021
Primary completion	8 March 2022
Estimated completion	19 April 2022
Sites	1 location across United States

Drugs / interventions tested

• Behavioral questionaires

Conditions studied

• COVID-19 — all drugs for COVID-19 →

Sponsor

Duke University

Who can join

12 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Main Reason for Testing for COVID-19 Primary · 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"

I wanted to be sure I/my child did not have COVID-19 before being around others

Group	Value	95% CI
Behavioral Questionnaires	1632

I/my child had COVID-19 like symptoms

Group	Value	95% CI
Behavioral Questionnaires	493

I/my child was in close contact with someone who might have COVID-19

Group	Value	95% CI
Behavioral Questionnaires	238

I/my child was in close contact with someone who tested positive for COVID-19

Group	Value	95% CI
Behavioral Questionnaires	343

Someone in my household might have COVID-19

Group	Value	95% CI
Behavioral Questionnaires	118

Someone in my household tested positive for COVID-19

Group	Value	95% CI
Behavioral Questionnaires	152

Other

Group	Value	95% CI
Behavioral Questionnaires	209

Number of Positive COVID-19 Test Results Primary · Baseline

Group	Value	95% CI
Behavioral Questionnaires	269

Number of Participants Who Responded That They Have Received a COVID Vaccine Primary · Baseline

Group	Value	95% CI
Behavioral Questionnaires	850

Number of Participants Who Indicated That They Have Access to Necessary Personal Protective Equipment in Work Place Secondary · Baseline

Group	Value	95% CI
Behavioral Questionnaires	475

Number of Participants Who Indicated They Have Tested Positive for COVID in Their Lifetime Secondary · Baseline

Group	Value	95% CI
Behavioral Questionnaires	237

Number of Participants Who Report Knowing Where to Get COVID-19 Tests in the Community Secondary · Baseline

Group	Value	95% CI
Behavioral Questionnaires	757

Number of Participants Who Report COVID Symptoms During Previous Week Secondary · Baseline

Group	Value	95% CI
Behavioral Questionnaires	627

Likelihood of Future COVID-19 Vaccination Secondary · Baseline

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".

Group	Value	95% CI
Behavioral Questionnaires	119
Behavioral Questionnaires	140
Behavioral Questionnaires	59
Behavioral Questionnaires	92

Reasons for Not Getting a COVID-19 Vaccine Secondary · Baseline

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".

I'm allergic to vaccines

Group	Value	95% CI
Behavioral Questionnaires	5

I don't like needles

Group	Value	95% CI
Behavioral Questionnaires	22

I'm not concerned about getting really sick from COVID-19

Group	Value	95% CI
Behavioral Questionnaires	3

I'm concerned about side effects from the vaccines

Group	Value	95% CI
Behavioral Questionnaires	47

I don't think vaccines work very well

Group	Value	95% CI
Behavioral Questionnaires	7

I don't trust that the vaccines will be safe

Group	Value	95% CI
Behavioral Questionnaires	34

I don't believe the COVID-19 pandemic is as bad as some people say it is

Group	Value	95% CI
Behavioral Questionnaires	4

I don't want to pay for it

Group	Value	95% CI
Behavioral Questionnaires	3

Reasons for Getting a COVID-19 Vaccine Secondary · Baseline

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".

I want to keep my family safe

Group	Value	95% CI
Behavioral Questionnaires	712

I want to keep my community safe

Group	Value	95% CI
Behavioral Questionnaires	477

I want to keep myself safe

Group	Value	95% CI
Behavioral Questionnaires	557

I have a chronic health problem, like asthma or diabetes

Group	Value	95% CI
Behavioral Questionnaires	135

My doctor told me to get a COVID-19 vaccine

Group	Value	95% CI
Behavioral Questionnaires	86

I don't want to get really sick from COVID-19

Group	Value	95% CI
Behavioral Questionnaires	378

I want to feel safe around other people

Group	Value	95% CI
Behavioral Questionnaires	404

I believe life won't go back to normal until most people get a COVID-19 vaccine

Group	Value	95% CI
Behavioral Questionnaires	313

Perspective on Easiest Way to Obtain Free Oral COVID-19 Medications Secondary · 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.

An urgent care center

Group	Value	95% CI
Behavioral Questionnaires	503

A doctor's or other health professional's office

Group	Value	95% CI
Behavioral Questionnaires	526

A mobile health unit

Group	Value	95% CI
Behavioral Questionnaires	189

A drug store / pharmacy

Group	Value	95% CI
Behavioral Questionnaires	1225

A grocery store

Group	Value	95% CI
Behavioral Questionnaires	209

A community center

Group	Value	95% CI
Behavioral Questionnaires	87

A place of worship

Group	Value	95% CI
Behavioral Questionnaires	38

A community park

Group	Value	95% CI
Behavioral Questionnaires	50

Method Used to Test for COVID-19 Secondary · Baseline

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".

Group	Value	95% CI
Behavioral Questionnaires	783
Behavioral Questionnaires	15
Behavioral Questionnaires	4
Behavioral Questionnaires	17

Sponsor's own description

Observational, study that distributes rapid at-home, self-administered, SARS-CoV-2 antigen testing kits to households within pre-selected communities.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Increasing access and uptake of SARS-CoV-2 at-home tests using a community-engaged approach.
   D'Agostino EM, Corbie G, Kibbe WA, Hornik CP, et al · · 2022 · cited 6× · PMID 36061814 · DOI 10.1016/j.pmedr.2022.101967