Communities Fighting COVID-19!

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: 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)

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 Type: Interventional
• Enrollment (Actual): 32750
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92182
      • Contact Households

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 120 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Younger than 6, not in focus populations

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Test uptake	Testing volume by study arm as cumulative count per hours testing site operated	Through study completion, expected to be 20 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Test access	Proportion of individuals by study arm who note that this strategy has facilitated ability to test.	Through study completion, expected to be 20 months
Test Impact (COVID-19 diagnoses)	Proportion of COVID-19 diagnoses of those tested by study arm	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).	Through study completion, expected to be 20 months

Collaborators and Investigators

• Sponsor: San Diego State University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Susan M Kiene, PhD, San Diego State University

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2020
• Primary Completion (Actual): August 25, 2023
• Study Completion (Actual): August 25, 2023

Study Registration Dates

• First Submitted: March 31, 2021
• First Submitted That Met QC Criteria: December 3, 2021
• First Posted (Actual): December 8, 2021

Study Record Updates

• Last Update Posted (Actual): June 14, 2024
• Last Update Submitted That Met QC Criteria: June 13, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: HS-2020-0186; 3U54CA132384-10S1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No