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

NCT ID: NCT05894655

Last Updated: 2025-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6527 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-28
• Study Completion Date: 2025-10-08

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

San Ysidro Health Center - Main Clinic

At the main clinic all 3 strategies will be available: walk-up testing, vending machine, and Community Health Worker (CHW) providing education.

Group Type: PLACEBO_COMPARATOR

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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.

San Ysidro Health Center - Logan Heights

A vending machine and Community Health Worker (CHW) providing education will be available at Logan Heights

Group Type: EXPERIMENTAL

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

Intervention Type: 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

Intervention Type: 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.

San Ysidro Health Center - Lincoln Park

A vending machine and Community Health Worker (CHW) providing education will be available at Lincoln Park

Group Type: EXPERIMENTAL

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

Intervention Type: 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

Intervention Type: 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.

San Ysidro Health Center - Chula Vista

A vending machine and Community Health Worker (CHW) providing education will be available at Chula Vista

Group Type: EXPERIMENTAL

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

Intervention Type: 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

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

San Ysidro Health Center

OTHER

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Louise Laurent, MD/PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Louise Laurent, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

San Ysidro Health Centers

San Ysidro, California, United States

Countries

United States

References

Stadnick NA, Laurent LC, Cain KL, Seifert M, Burola ML, Salgin L, Watson P, Oswald W, Munoz FA, Velasquez SF, Smith JD, Zou J, Rabin BA. Community-engaged optimization of COVID-19 rapid evaluation and testing experiences: roll-out implementation optimization trial. Implement Sci. 2023 Oct 2;18(1):46. doi: 10.1186/s13012-023-01306-y.

Reference Type: DERIVED

PMID: 37784200 (View on PubMed)

Other Identifiers

806121

Identifier Type: -

Identifier Source: org_study_id