Summary

Healthy Volunteers
healthy people welcome
Location
at San Ysidro, California
Dates
study started
completion around
Principal Investigator
by Louise Laurent, MD/PhD

Description

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.

Official Title

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

Details

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.

Keywords

COVID-19, COVID-19 Pandemic, covid-19 testing, vaccine hesitancy, implementation, vending machine, COVID-19 walk-up, on-site testing strategy, No-cost self-testing kit vending machines, San Ysidro Health Center - Main Clinic, San Ysidro Health Center - Logan Heights, San Ysidro Health Center - Lincoln Park, San Ysidro Health Center - Chula Vista

Eligibility

You can join if…

  • Speak English and/or Spanish
  • Affiliated with San Ysidro Health as a patient at select clinics (San Ysidro, Chula Vista, 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).

You CAN'T join if...

  • Institutionalization for psychiatric disorder, developmental delay, or criminal activity.
  • Unable to provide informed consent.

Location

  • San Ysidro Health Centers accepting new patients
    San Ysidro California 92173 United States

Lead Scientist at UCSD

  • Louise Laurent, MD/PhD
    Professor, Ob/Gyn & Reproductive sciences, Vc-health Sciences-schools. Authored (or co-authored) 99 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT05894655
Study Type
Interventional
Participants
Expecting 7500 study participants
Last Updated