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Communities Fighting COVID-19!

Primary Purpose

Covid19

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
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)
Sponsored by
San Diego State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Covid19

Eligibility Criteria

6 Years - 120 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • African American, Arabic speaking, Filipino, and Latino/a populations

Exclusion Criteria:

  • Younger than 6, not in focus populations

Sites / Locations

  • Contact HouseholdsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Other

Other

Arm Label

At home testing (Aim 1)

Mobile testing (Aim 1)

Mobile testing approach 1 (Aim 2)

Mobile testing approach 2 (Aim 2)

Arm Description

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.

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 utilizing active outreach

Mobile testing utilizing baseline outreach approaches

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Test access
Proportion of individuals by study arm who note that this strategy has facilitated ability to test.
Test Impact (COVID-19 diagnoses)
Proportion of COVID-19 diagnoses of those tested by study arm
Test Impact (number needed to screen)
Number needed to screen (number tested in order to detect one new infection).

Full Information

First Posted
March 31, 2021
Last Updated
December 3, 2021
Sponsor
San Diego State University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05148936
Brief Title
Communities Fighting COVID-19!
Official Title
Communities Fighting COVID!
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 25, 2020 (Actual)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Diego State University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cluster Randomized Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
At home testing (Aim 1)
Arm Type
Experimental
Arm Description
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.
Arm Title
Mobile testing (Aim 1)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Mobile testing approach 1 (Aim 2)
Arm Type
Other
Arm Description
Mobile testing utilizing active outreach
Arm Title
Mobile testing approach 2 (Aim 2)
Arm Type
Other
Arm Description
Mobile testing utilizing baseline outreach approaches
Intervention Type
Other
Intervention Name(s)
COVID-19 Testing Home-based (Aim 1)
Intervention Description
Implementation of Antigen and PCR testing at participant homes
Intervention Type
Other
Intervention Name(s)
COVID-19 Testing Mobile (Aim 1)
Intervention Description
Implementation of Antigen and PCR testing at mobile test sites
Intervention Type
Other
Intervention Name(s)
COVID-19 Testing Mobile Approach 1 (Aim 2)
Intervention Description
Implementation of Antigen and PCR testing at mobile test sites - active outreach
Intervention Type
Other
Intervention Name(s)
COVID-19 Testing Mobile Approach 2 (Aim 2)
Intervention Description
Implementation of Antigen and PCR testing at mobile test sites - baseline outreach
Primary Outcome Measure Information:
Title
Test uptake
Description
Testing volume by study arm as cumulative count per hours testing site operated
Time Frame
Through study completion, expected to be 20 months
Secondary Outcome Measure Information:
Title
Test access
Description
Proportion of individuals by study arm who note that this strategy has facilitated ability to test.
Time Frame
Through study completion, expected to be 20 months
Title
Test Impact (COVID-19 diagnoses)
Description
Proportion of COVID-19 diagnoses of those tested by study arm
Time Frame
Through study completion, expected to be 20 months
Title
Test Impact (number needed to screen)
Description
Number needed to screen (number tested in order to detect one new infection).
Time Frame
Through study completion, expected to be 20 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: African American, Arabic speaking, Filipino, and Latino/a populations Exclusion Criteria: Younger than 6, not in focus populations
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tasi Rodriguez, MPH
Phone
619.594.1707
Email
trodriguez@sdsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan M Kiene, PhD
Organizational Affiliation
San Diego State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Contact Households
City
San Diego
State/Province
California
ZIP/Postal Code
92182
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tasi Rodriguez
Phone
619-594-1707
First Name & Middle Initial & Last Name & Degree
Eyal Oren, PhD
First Name & Middle Initial & Last Name & Degree
Hala Madanat, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Plan to share with Rad-X UP Coordinating Center
IPD Sharing Time Frame
Shared on a periodic basis. RPPR shared with NIH on a 6-month basis
IPD Sharing Access Criteria
Anonymized data access

Learn more about this trial

Communities Fighting COVID-19!

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