Communities Fighting COVID-19!

Sponsor
San Diego State University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05148936
Collaborator
National Cancer Institute (NCI) (NIH)
42,000
1
4
19.2
2189

Study Details

Study Description

Brief 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 populations and reduce Covid-19 related disparities.

Condition or Disease Intervention/Treatment Phase
  • Other: COVID-19 Testing Home-based (Aim 1)
  • Other: COVID-19 Testing Mobile (Aim 1)
  • Other: COVID-19 Testing Mobile Approach 1 (Aim 2)
  • Other: COVID-19 Testing Mobile Approach 2 (Aim 2)
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
42000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Cluster Randomized TrialCluster Randomized Trial
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Communities Fighting COVID!
Actual Study Start Date :
Oct 25, 2020
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: At home testing (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.

Other: COVID-19 Testing Home-based (Aim 1)
Implementation of Antigen and PCR testing at participant homes

Active Comparator: Mobile testing (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.

Other: COVID-19 Testing Mobile (Aim 1)
Implementation of Antigen and PCR testing at mobile test sites

Other: Mobile testing approach 1 (Aim 2)

Mobile testing utilizing active outreach

Other: COVID-19 Testing Mobile Approach 1 (Aim 2)
Implementation of Antigen and PCR testing at mobile test sites - active outreach

Other: Mobile testing approach 2 (Aim 2)

Mobile testing utilizing baseline outreach approaches

Other: COVID-19 Testing Mobile Approach 2 (Aim 2)
Implementation of Antigen and PCR testing at mobile test sites - baseline outreach

Outcome Measures

Primary Outcome Measures

  1. Test uptake [Through study completion, expected to be 20 months]

    Testing volume by study arm as cumulative count per hours testing site operated

Secondary Outcome Measures

  1. Test access [Through study completion, expected to be 20 months]

    Proportion of individuals by study arm who note that this strategy has facilitated ability to test.

  2. Test Impact (COVID-19 diagnoses) [Through study completion, expected to be 20 months]

    Proportion of COVID-19 diagnoses of those tested by study arm

  3. Test Impact (number needed to screen) [Through study completion, expected to be 20 months]

    Number needed to screen (number tested in order to detect one new infection).

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 120 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • African American, Arabic speaking, Filipino, and Latino/a populations
Exclusion Criteria:
  • Younger than 6, not in focus populations

Contacts and Locations

Locations

Site City State Country Postal Code
1 Contact Households San Diego California United States 92182

Sponsors and Collaborators

  • San Diego State University
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Susan M Kiene, PhD, San Diego State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Susan M Kiene, Professor, San Diego State University
ClinicalTrials.gov Identifier:
NCT05148936
Other Study ID Numbers:
  • HS-2020-0186
  • 3U54CA132384-10S1
First Posted:
Dec 8, 2021
Last Update Posted:
Dec 8, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 8, 2021