COVID-19SYCTNCT04949243
Rapid Acceleration for Diagnostics in Underserved Populations: Home Testing
An observational study of COVID-19, run by Duke University at 2 sites in United States.
Trial summary
This observational, cohort sub-studyis embedded within a larger public health intervention that distributes at-home, self-administered, SARS-CoV-2 antigen testing kits to households within pre-selected communitiesthrough the CDC.Within this sub-study, we will evaluate the socio-behavioral mechanisms of SARS-CoV-2… Read more about this study
- Who is it for?
- Ages 8 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
- 338 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Apr 2021to 23 Nov 2021
- 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 8 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Adults and children > 8 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> 8 years at enrollment
- Provision of signed and dated informed consent form
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hamilton County
Chattanooga, Tennessee, 37341
Greenville Pitt County
Greenville, North Carolina, 27705
About this study
This observational, cohort sub-studyis embedded within a larger public health intervention that distributes at-home, self-administered, SARS-CoV-2 antigen testing kits to households within pre-selected communitiesthrough the CDC.Within this sub-study, we 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 study hypothesis is that positive at-home test results will be associated withaltered self-reported social interactions and altered health behaviors compared to negative test results. Surveys and questionnaires will be completed by participants through the smartphone app or via call center phone calls according to the schedule of events.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
- 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 questionaires
| Study group | Role | What they receive |
|---|---|---|
| People who use the self administered SARs-CoV-2 antigen testing kits | Not described Receives: Behavioral: Behavioral questionaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Reported Not Following Social Distancing Guidelines
Number of participants who reported at their first follow-up assessment as having close contact (within 6 feet) with people who do not live with them.
Measured: 2 weeks
Secondary outcomes (4)
Number of Participants That Avoided Public Spaces, Gatherings, or Crowds as a Prevention Measure
Number of participants who reported at their first follow-up assessment as having avoided public spaces, gatherings, or crowds as a prevention measure.
Measured: 2 weeks
Number of Participants Who Are Knowledgeable of Precautionary Measures to Prevent Infection
Measured: 4 months
Number of Participants With Positive SARs-CoV-2 Antigen Test Results
Measured: 4 months
Number of Healthcare Utilization Measures
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start4 Apr 2021
- Primary completion23 Nov 2021
- Study completion23 Nov 2021
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
- 338 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- christoph Hornik, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04949243
- Sponsor's protocol ID
- Pro00108149
- Acronym
- SYCT
- Status last verified
- Nov 2022
- First submitted
- 25 Jun 2021
- Last updated
- 22 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- 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 22 Sep 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
- NCT04949243
- Acronym / sponsor ID
- SYCT / Pro00108149
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 338 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 4 Apr 2021 (actual)
- Primary completion
- 23 Nov 2021 (actual)
- Study completion
- 23 Nov 2021 (actual)
- First posted
- 2 Jul 2021 (actual)
- Results
- Posted 22 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observational, cohort sub-studyis embedded within a larger public health intervention that distributes at-home, self-administered, SARS-CoV-2 antigen testing kits to households within pre-selected communitiesthrough the CDC.Within this sub-study, we 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 study hypothesis is that positive at-home test results will be associated withaltered self-reported social interactions and altered health behaviors compared to negative test results. Surveys and questionnaires will be completed by participants through the smartphone app or via call center phone calls according to the schedule of events.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
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People who use the self administered SARs-CoV-2 antigen testing kits | – | Behavioral: Behavioral questionaires |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults and children > 8 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> 8 years at enrollment
- Provision of signed and dated informed consent form
Key exclusion criteria (1 listed)
- -
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 questionaires | Behavioural | People who use the self administered SARs-CoV-2 antigen testing kits |
Primary outcome
Number of Participants Who Reported Not Following Social Distancing Guidelines
Time frame: 2 weeks
Number of participants who reported at their first follow-up assessment as having close contact (within 6 feet) with people who do not live with them.
4 secondary outcomes
Number of Participants That Avoided Public Spaces, Gatherings, or Crowds as a Prevention Measure
Time frame: 2 weeks
Number of Participants Who Are Knowledgeable of Precautionary Measures to Prevent Infection
Time frame: 4 months
Number of Participants With Positive SARs-CoV-2 Antigen Test Results
Time frame: 4 months
Number of Healthcare Utilization Measures
Time frame: 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 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 principal investigator
Duke University
2 sites 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 2 sites 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 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 22 Sep 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?
Number of Participants Who Reported Not Following Social Distancing Guidelines (time frame: 2 weeks). 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 22 Sep 2023.