Community-engaged Optimization of COVID-19 Rapid Evaluation And TEsting Experiences
Purpose
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.
Conditions
- COVID-19
- COVID-19 Pandemic
Eligibility
- Eligible Ages
- All ages
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Intervention Model Description
- The investigators chose a roll-out implementation optimization (ROIO) design to implement the study. This is a novel implementation science study design that affords a balance of rigor and flexibility to rapidly and iteratively refine in response to dynamic contexts like the pandemic.
- Primary Purpose
- Health Services Research
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Placebo Comparator 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. |
|
Experimental San Ysidro Health Center - Logan Heights |
A vending machine and Community Health Worker (CHW) providing education will be available at Logan Heights |
|
Experimental San Ysidro Health Center - Lincoln Park |
A vending machine and Community Health Worker (CHW) providing education will be available at Lincoln Park |
|
Experimental San Ysidro Health Center - Chula Vista |
A vending machine and Community Health Worker (CHW) providing education will be available at Chula Vista |
|
Recruiting Locations
San Ysidro, California 92173
Breanna Reyes, MPH
More Details
- NCT ID
- NCT05894655
- Status
- Recruiting
- Sponsor
- University of California, San Diego
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.