NCT05894655

Community-engaged Optimization of COVID-19 Rapid Evaluation And TEsting Experiences

CO-CREATE-Ex: Community-engaged Optimization of COVID-19 Rapid Evaluation And TEsting Experiences

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6,527 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• COVID-19
• COVID-19 Pandemic

Interventions

Type	Name	Description
BEHAVIORAL	COVID-19 walk-up, on-site testing strategy	This strategy is a no-appointment, walk-up point-of-care PCR and rapid testing strategy for clinic patients and community members. It will be offered 5 days/week for 7 hours during the first 3 months of the trial at Clinic 1. The intensity will decrease over the trial ending with 1 SYH Medical Assistant overseeing the testing protocol. Bilingual research staff will be trained to oversee onsite testing.
BEHAVIORAL	Community Health Worker (CHW) leading testing navigation and general preventive care reminders	This strategy provides health counseling about when COVID-19 testing is recommended, which test to use, testing instructions, and how to interpret results. Community Health Workers (CHW) will also offer general preventive health care reminders such as flu shots, blood pressure checks, and A1c screenings. This strategy will be available full-time during the first 3 months of roll-out at each clinic and after 3 months, the CHW will be available as needed. Trained bilingual CHW will be supervised by a SYH employee.
BEHAVIORAL	No-cost self-testing kit vending machines	This strategy includes vending machines that will provide interactive instructions for accessing free self-testing COVID-19 kits located outside of clinics for patients and community members to use anytime. The vending machines will be available 24 hours/day, 7 days a week.

Timeline

• Start date: 2023-08-28
• Primary completion: 2025-03-31
• Completion: 2025-10-08
• First posted: 2023-06-08
• Last updated: 2025-11-04

Locations

1 site across 1 country: United States