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Completed

NCT Number: NCT05894655

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.

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Key information

Conditions

COVID-19 Behavior COVID-19 Pandemic Coronaviridae Infections Coronavirus Infections Health Behavior Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Treatment Adherence and Compliance Treatment Refusal Vaccination Hesitancy Vaccination Refusal Virus Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Ysidro Health Centers

San Ysidro, California, 92173, United States

About this study

CO-CREATE-Ex will roll-out our implementation using 3 strategies:

  • keeping the current, walk-up free testing protocol
  • Offering Community Health Worker (CHW) to lead COVID-19 test counseling, preventive care reminders, and offer testing support
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

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

Treatment and study plan

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

Behavioral

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.

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

Behavioral

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.

No-cost self-testing kit vending machines

Behavioral

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.

Primary outcomes

  1. Identify solutions and evaluation methods to refine a multi-component implementation strategy bundle using a Community and Scientific Advisory Board.

    Time frame: 2 years

    The primary objective is to refine and operationalize the multi-component implementation strategy bundle and measures of implementation and sustainment success for rapid FDA-authorized COVID-19 rapid testing using the partnership with the Global Arc and Community and Scientific Advisory Board. Each session will be recorded while Global Arc partners guide the board to identify potential failures in the implementation design. Measures of success will be collected by partner engagement surveys, which will be administered and analyzed after each meeting.

Secondary outcomes

  1. Number of distributed rapid antigen tests within our target communities as measured by a proxy outcome.

    Time frame: 18 months

    The secondary objective is to implement and evaluate the impact of our multicomponent implementation strategy bundle to optimize COVID-19 rapid testing among underserved, Latino communities. Implementation strategies include a vending machine, Community Health Workers, and walk-up testing tables. Each strategy will be rolled-out across four clinics over 18 months.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • San Ysidro Health Center

Registry information

Official study title

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

Acronym: CO-CREATE-Ex

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 8, 2023
Registry last updated
Nov 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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