COVID-19YMCFNCT05212883
You and Me COVID Free
An observational study of COVID-19, run by Duke University at 1 site in United States.
Trial summary
Observational, study that distributes rapid at-home, self-administered, SARS-CoV-2 antigen testing kits to households within pre-selected communities. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Behavioral questionaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,778 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2021to 19 Apr 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Adults and children >12 years of age living within pre-identified communities participating in the public health intervention
Who may be able to join
- Self- reported primary residence within the pre-identified communities
- Age >12 years at enrollment
- Provision of signed and dated informed consent form
Who cannot join
- -None if above are met
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rapid Acceleration for Diagnostics in Underserved Populations: Home Testing
Observational, study that distributes rapid at-home, self-administered, SARS-CoV-2 antigen testing kits to households within pre-selected communities.
Read the detailed description
This observational, cohort sub-study is embedded within a larger public health intervention that distributes at-home, self-administered, SARS-CoV-2 antigen testing kits to households within pre-selected communities through the CCPH. Within this sub-study, the investigators will evaluate the socio-behavioral mechanisms of SARS-CoV-2 community transmission, including social interactions, health behaviors, healthcare utilization, knowledge, disease burden, and feasibility of at-home testing. The central hypothesis is that focused community intervention will reduce COVID-19 transmission. The secondary hypothesis is that this intervention will increase vaccine uptake. Surveys and questionnaires will be completed by participants via a QR code from the test kits that directs participants to a link. 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.
- Conditions
- COVID-19
- Being tested
- Behavioral questionaires
- Keywords
- Rapid test, COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral questionairesBehavioural
Behavioral surveys and questionnaires
What is being measured
The primary outcome is the main question the study is designed to answer.
Main Reason for Testing for COVID-19
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"
Measured: Baseline
Number of Positive COVID-19 Test Results
Measured: Baseline
Number of Participants Who Responded That They Have Received a COVID Vaccine
Measured: Baseline
Secondary outcomes (9)
Number of Participants Who Indicated That They Have Access to Necessary Personal Protective Equipment in Work Place
Measured: Baseline
Number of Participants Who Indicated They Have Tested Positive for COVID in Their Lifetime
Measured: Baseline
Number of Participants Who Report Knowing Where to Get COVID-19 Tests in the Community
Measured: Baseline
Number of Participants Who Report COVID Symptoms During Previous Week
Measured: Baseline
Likelihood of Future COVID-19 Vaccination
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".
Measured: Baseline
Reasons for Not Getting a COVID-19 Vaccine
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".
Measured: Baseline
Reasons for Getting a COVID-19 Vaccine
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".
Measured: Baseline
Perspective on Easiest Way to Obtain Free Oral COVID-19 Medications
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.
Measured: Baseline
Method Used to Test 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".
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start15 Nov 2021
- Primary completion8 Mar 2022
- Study completion19 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,778 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Christoph Hornik, MD, PhD, MPH, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05212883
- Sponsor's protocol ID
- Pro00108149_1
- Other IDs
- 3U24MD016258-02S1
- Acronym
- YMCF
- Status last verified
- May 2023
- First submitted
- 25 Jan 2022
- Last updated
- 6 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Acceleration for Diagnostics in Underserved Populations: Home Testing
- ClinicalTrials.gov ID
- NCT05212883
- Acronym / sponsor ID
- YMCF / Pro00108149_1
- Conditions
- COVID-19
- Keywords
- Rapid test, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,778 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 8 Mar 2022 (actual)
- Study completion
- 19 Apr 2022 (actual)
- First posted
- 28 Jan 2022 (actual)
- Results
- Posted 6 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Observational, study that distributes rapid at-home, self-administered, SARS-CoV-2 antigen testing kits to households within pre-selected communities.
Detailed description
This observational, cohort sub-study is embedded within a larger public health intervention that distributes at-home, self-administered, SARS-CoV-2 antigen testing kits to households within pre-selected communities through the CCPH. Within this sub-study, the investigators will evaluate the socio-behavioral mechanisms of SARS-CoV-2 community transmission, including social interactions, health behaviors, healthcare utilization, knowledge, disease burden, and feasibility of at-home testing. The central hypothesis is that focused community intervention will reduce COVID-19 transmission. The secondary hypothesis is that this intervention will increase vaccine uptake. Surveys and questionnaires will be completed by participants via a QR code from the test kits that directs participants to a link. 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults and children >12 years of age living within pre-identified communities participating in the public health intervention
Key inclusion criteria (3 listed)
- Self- reported primary residence within the pre-identified communities
- Age >12 years at enrollment
- Provision of signed and dated informed consent form
Key exclusion criteria (1 listed)
- -None if above are met
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral questionairesBehavioral surveys and questionnaires | Behavioural | – |
Primary outcome
Main Reason for Testing for COVID-19
Time frame: 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"
Number of Positive COVID-19 Test Results
Time frame: Baseline
Number of Participants Who Responded That They Have Received a COVID Vaccine
Time frame: Baseline
9 secondary outcomes
Number of Participants Who Indicated That They Have Access to Necessary Personal Protective Equipment in Work Place
Time frame: Baseline
Number of Participants Who Indicated They Have Tested Positive for COVID in Their Lifetime
Time frame: Baseline
Number of Participants Who Report Knowing Where to Get COVID-19 Tests in the Community
Time frame: Baseline
Number of Participants Who Report COVID Symptoms During Previous Week
Time frame: Baseline
Likelihood of Future COVID-19 Vaccination
Time frame: Baseline
Reasons for Not Getting a COVID-19 Vaccine
Time frame: Baseline
Reasons for Getting a COVID-19 Vaccine
Time frame: Baseline
Perspective on Easiest Way to Obtain Free Oral COVID-19 Medications
Time frame: Baseline
Method Used to Test for COVID-19
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Hornik, MD, PhD, MPH principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Main Reason for Testing for COVID-19 (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2023.