Covid19NCT05148936
Communities Fighting COVID-19!
A study testing COVID-19 Testing Home-based (Aim 1), COVID-19 Testing Mobile (Aim 1) and COVID-19 Testing Mobile Approach 1 (Aim 2) in people with Covid19, run by San Diego State University at 1 site in United States.
Trial summary
To create and evaluate effective COVID-19 testing uptake strategies that focus on underserved individuals who are exposed but have not accessed testing, and underserved individuals who are not routinely tested because they are unaware of their exposure or risk status in order to increase testing among these… Read more about this study
- Who is it for?
- Ages 6 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- COVID-19 Testing Home-based (Aim 1), COVID-19 Testing Mobile (Aim 1) and COVID-19 Testing Mobile Approach 1 (Aim 2)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32,750 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2020to 25 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 120 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- African American, Arabic speaking, Filipino, and Latino/a populations
Who cannot join
- Younger than 6, not in focus populations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Communities Fighting COVID!
To create and evaluate effective COVID-19 testing uptake strategies that focus on underserved individuals who are exposed but have not accessed testing, and underserved individuals who are not routinely tested because they are unaware of their exposure or risk status in order to increase testing among these populations and reduce Covid-19 related disparities.
Read the detailed description
Communities Fighting COVID is a partnership between San Diego State's School of Public Health and numerous communities in San Diego focused on providing community-based testing to specific language-speaking communities and vulnerable populations. This partnership is funded by the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics-Undeserved Populations (Radx-UP), with the aim of ensuring all Americans have access to timely COVID-19 testing and diagnosis. Many communities, particularly immigrant and people of color communities, have a harder time accessing existing COVID-19 resources due to transportation, language barriers, or other barriers.
- Conditions
- Covid19
- Being tested
- COVID-19 Testing Home-based (Aim 1), COVID-19 Testing Mobile (Aim 1), COVID-19 Testing Mobile Approach 1 (Aim 2), COVID-19 Testing Mobile Approach 2 (Aim 2)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 Testing Home-based (Aim 1)Other
Implementation of Antigen and PCR testing at participant homes
COVID-19 Testing Mobile (Aim 1)Other
Implementation of Antigen and PCR testing at mobile test sites
COVID-19 Testing Mobile Approach 1 (Aim 2)Other
Implementation of Antigen and PCR testing at mobile test sites - active outreach
COVID-19 Testing Mobile Approach 2 (Aim 2)Other
Implementation of Antigen and PCR testing at mobile test sites - baseline outreach
| Study group | Role | What they receive |
|---|---|---|
| At home testing (Aim 1) | Experimental | High-risk friends and family of contacts exposed to COVID-19 will be provided with COVID-19 testing provided at home by a healthcare worker. Receives: Other: COVID-19 Testing Home-based (Aim 1) |
| Mobile testing (Aim 1) | Active comparator | High-risk friends and family of contacts exposed to COVID-19 will be referred to study operated mobile testing sites in the community for COVID-19 testing. Receives: Other: COVID-19 Testing Mobile (Aim 1) |
| Mobile testing approach 1 (Aim 2) | Other | Mobile testing utilizing active outreach Receives: Other: COVID-19 Testing Mobile Approach 1 (Aim 2) |
| Mobile testing approach 2 (Aim 2) | Other | Mobile testing utilizing baseline outreach approaches Receives: Other: COVID-19 Testing Mobile Approach 2 (Aim 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test uptake
Testing volume by study arm as cumulative count per hours testing site operated
Measured: Through study completion, expected to be 20 months
Secondary outcomes (3)
Test access
Proportion of individuals by study arm who note that this strategy has facilitated ability to test.
Measured: Through study completion, expected to be 20 months
Test Impact (COVID-19 diagnoses)
Proportion of COVID-19 diagnoses of those tested by study arm
Measured: Through study completion, expected to be 20 months
Test Impact (number needed to screen)
Number needed to screen (number tested in order to detect one new infection).
Measured: Through study completion, expected to be 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start25 Oct 2020
- Primary completion25 Aug 2023
- Study completion25 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by San Diego State 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster Randomized Trial
- Masking
- None (open label)
- Enrolment
- 32,750 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Susan M Kiene, San Diego State University
- Investigators
- Susan M Kiene, PhD, Principal investigator, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05148936
- Sponsor's protocol ID
- HS-2020-0186
- Other IDs
- 3U54CA132384-10S1
- Status last verified
- Jun 2024
- First submitted
- 31 Mar 2021
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan to share with Rad-X UP Coordinating Center
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Communities Fighting COVID!
- ClinicalTrials.gov ID
- NCT05148936
- Acronym / sponsor ID
- HS-2020-0186
- Conditions
- Covid19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32,750 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 25 Oct 2020 (actual)
- Primary completion
- 25 Aug 2023 (actual)
- Study completion
- 25 Aug 2023 (actual)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To create and evaluate effective COVID-19 testing uptake strategies that focus on underserved individuals who are exposed but have not accessed testing, and underserved individuals who are not routinely tested because they are unaware of their exposure or risk status in order to increase testing among these populations and reduce Covid-19 related disparities.
Detailed description
Communities Fighting COVID is a partnership between San Diego State's School of Public Health and numerous communities in San Diego focused on providing community-based testing to specific language-speaking communities and vulnerable populations. This partnership is funded by the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics-Undeserved Populations (Radx-UP), with the aim of ensuring all Americans have access to timely COVID-19 testing and diagnosis. Many communities, particularly immigrant and people of color communities, have a harder time accessing existing COVID-19 resources due to transportation, language barriers, or other barriers.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Cluster Randomized Trial
| Arm | Type | Receives |
|---|---|---|
| At home testing (Aim 1) | Experimental | Other: COVID-19 Testing Home-based (Aim 1)High-risk friends and family of contacts exposed to COVID-19 will be provided with COVID-19 testing provided at home by a healthcare worker. |
| Mobile testing (Aim 1) | Active comparator | Other: COVID-19 Testing Mobile (Aim 1)High-risk friends and family of contacts exposed to COVID-19 will be referred to study operated mobile testing sites in the community for COVID-19 testing. |
| Mobile testing approach 1 (Aim 2) | Other | Other: COVID-19 Testing Mobile Approach 1 (Aim 2)Mobile testing utilizing active outreach |
| Mobile testing approach 2 (Aim 2) | Other | Other: COVID-19 Testing Mobile Approach 2 (Aim 2)Mobile testing utilizing baseline outreach approaches |
Who may qualify
- Ages
- 6 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- African American, Arabic speaking, Filipino, and Latino/a populations
Key exclusion criteria (1 listed)
- Younger than 6, not in focus populations
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 |
|---|---|---|
| COVID-19 Testing Home-based (Aim 1)Implementation of Antigen and PCR testing at participant homes | Other | At home testing (Aim 1) |
| COVID-19 Testing Mobile (Aim 1)Implementation of Antigen and PCR testing at mobile test sites | Other | Mobile testing (Aim 1) |
| COVID-19 Testing Mobile Approach 1 (Aim 2)Implementation of Antigen and PCR testing at mobile test sites - active outreach | Other | Mobile testing approach 1 (Aim 2) |
| COVID-19 Testing Mobile Approach 2 (Aim 2)Implementation of Antigen and PCR testing at mobile test sites - baseline outreach | Other | Mobile testing approach 2 (Aim 2) |
Primary outcome
Test uptake
Time frame: Through study completion, expected to be 20 months
Testing volume by study arm as cumulative count per hours testing site operated
3 secondary outcomes
Test access
Time frame: Through study completion, expected to be 20 months
Test Impact (COVID-19 diagnoses)
Time frame: Through study completion, expected to be 20 months
Test Impact (number needed to screen)
Time frame: Through study completion, expected to be 20 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Individual participant dataSharing planned: Yes. Plan to share with Rad-X UP Coordinating Center
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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.
Susan M Kiene, PhD principal investigator
San Diego State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COVID-19 Testing Home-based (Aim 1), COVID-19 Testing Mobile (Aim 1) and COVID-19 Testing Mobile Approach 1 (Aim 2) in people with Covid19, run by San Diego State 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 1 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 14 Jun 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Test uptake (time frame: Through study completion, expected to be 20 months). 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 14 Jun 2024.