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

Last updated: November 1, 2024
Sponsor: University of California, San Diego
Overall Status: Active - Recruiting

Phase

N/A

Condition

Covid-19

Treatment

COVID-19 walk-up, on-site testing strategy

No-cost self-testing kit vending machines

Community Health Worker (CHW) leading testing navigation and general preventive care reminders

Clinical Study ID

NCT05894655
806121
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Speak English and/or Spanish

  • Affiliated with San Ysidro Health as a patient at select clinics (San Ysidro, ChulaVista, Lincoln Park, and Logan Heights) OR

  • A member of a community near a San Ysidro Health clinic (San Ysidro, Chula Vista,Lincoln Park, and Logan Heights).

Exclusion

Exclusion Criteria:

  • Institutionalization for psychiatric disorder, developmental delay, or criminalactivity.

  • Unable to provide informed consent.

Study Design

Total Participants: 7500
Treatment Group(s): 3
Primary Treatment: COVID-19 walk-up, on-site testing strategy
Phase:
Study Start date:
August 28, 2023
Estimated Completion Date:
February 28, 2025

Study 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.

Connect with a study center

  • San Ysidro Health Centers

    San Ysidro, California 92173
    United States

    Active - Recruiting

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