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

University of California San Diego

Status: Completed

Conditions: COVID-19; COVID-19 Pandemic

Treatments: Behavioral: COVID-19 walk-up, on-site testing strategy; Behavioral: No-cost self-testing kit vending machines; Behavioral: Community Health Worker (CHW) leading testing navigation and general preventive care reminders

Study type: Interventional

Funder types: Other

Identifiers

NCT05894655

806121

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6,527 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

6,527 participants in 4 patient groups, including a placebo group

San Ysidro Health Center - Main Clinic

Placebo Comparator group

Description:

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

Treatment:

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

Behavioral: No-cost self-testing kit vending machines

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

San Ysidro Health Center - Logan Heights

Experimental group

Description:

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

Treatment:

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

Behavioral: No-cost self-testing kit vending machines

San Ysidro Health Center - Lincoln Park

Experimental group

Description:

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

Treatment:

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

Behavioral: No-cost self-testing kit vending machines

San Ysidro Health Center - Chula Vista

Experimental group

Description:

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

Treatment:

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

Behavioral: No-cost self-testing kit vending machines