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CO-CREATE-Ex: Community-engaged Optimization of COVID-19 Rapid Evaluation And TEsting Experiences
Throughout the Coronavirus disease (COVID-19) pandemic, rates of COVID-19 have been persistently high in San Diego County's central and southern communities near the United States/Mexico border. These regions predominantly house Latino residents, the ethnic minority community most impacted by COVID-19 in San Diego. In the Phase I project, University of California, San Diego (UCSD) partnered with San Ysidro Health (SYH) and the Global Action Research Center, to co-create and demonstrate the impact of a COVID-19 testing program in San Ysidro, one of the most impacted areas from COVID-19 in San Diego County. To date, the project tested \>10,000 community members (92% Latino) and received requests to scale-out the testing program to additional primary care clinic sites. In this Phase III project, Community-engaged Optimization of COVID-19 Rapid Evaluation And TEsting Experiences (CO-CREATE-Ex) will extend work with the Phase I community and clinical partners to refine, specify, implement, and evaluate an implementation strategy bundle that optimizes COVID-19 testing, expanding beyond current polymerase chain reaction (PCR) testing to FDA-authorized COVID-19 rapid antigen testing.
CO-CREATE-Ex will roll-out our implementation using 3 strategies: 1. keeping the current, walk-up free testing protocol 2. Offering Community Health Worker (CHW) to lead COVID-19 test counseling, preventive care reminders, and offer testing support 3. Installing vending machines that will dispense FDA-authorized self-testing kits. For each strategy, participants will consent into study, provide demographics and test history, and receive a free rapid antigen test (RAT) kit. After receiving the test kit, participants will be prompted to return their results and fill out a survey about their COVID-19 experiences. Study subjects will be contacted up to three times over a course of 4 weeks to return their results and complete the survey. Study coordinators will use participants' preferred method of contact.
Age
All ages
Sex
ALL
Healthy Volunteers
Yes
San Ysidro Health Centers
San Ysidro, California, United States
Start Date
August 28, 2023
Primary Completion Date
March 31, 2025
Completion Date
October 8, 2025
Last Updated
November 4, 2025
6,527
ACTUAL participants
COVID-19 walk-up, on-site testing strategy
BEHAVIORAL
Community Health Worker (CHW) leading testing navigation and general preventive care reminders
BEHAVIORAL
No-cost self-testing kit vending machines
BEHAVIORAL
Lead Sponsor
University of California, San Diego
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06631287