Community-engaged Optimization of COVID-19 Rapid Evaluation and TEsting Experiences
- Conditions
- COVID-19COVID-19 Pandemic
- Interventions
- Behavioral: COVID-19 walk-up, on-site testing strategyBehavioral: Community Health Worker (CHW) leading testing navigation and general preventive care remindersBehavioral: No-cost self-testing kit vending machines
- Registration Number
- NCT05894655
- Lead Sponsor
- University of California, San Diego
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 7500
- 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).
- Institutionalization for psychiatric disorder, developmental delay, or criminal activity.
- Unable to provide informed consent.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description San Ysidro Health Center - Main Clinic No-cost self-testing kit vending machines At the main clinic all 3 strategies will be available: walk-up testing, vending machine, and Community Health Worker (CHW) providing education. San Ysidro Health Center - Logan Heights No-cost self-testing kit vending machines A vending machine and Community Health Worker (CHW) providing education will be available at Logan Heights San Ysidro Health Center - Main Clinic COVID-19 walk-up, on-site testing strategy At the main clinic all 3 strategies will be available: walk-up testing, vending machine, and Community Health Worker (CHW) providing education. San Ysidro Health Center - Lincoln Park No-cost self-testing kit vending machines A vending machine and Community Health Worker (CHW) providing education will be available at Lincoln Park San Ysidro Health Center - Main Clinic Community Health Worker (CHW) leading testing navigation and general preventive care reminders At the main clinic all 3 strategies will be available: walk-up testing, vending machine, and Community Health Worker (CHW) providing education. San Ysidro Health Center - Chula Vista Community Health Worker (CHW) leading testing navigation and general preventive care reminders A vending machine and Community Health Worker (CHW) providing education will be available at Chula Vista San Ysidro Health Center - Logan Heights Community Health Worker (CHW) leading testing navigation and general preventive care reminders A vending machine and Community Health Worker (CHW) providing education will be available at Logan Heights San Ysidro Health Center - Lincoln Park Community Health Worker (CHW) leading testing navigation and general preventive care reminders A vending machine and Community Health Worker (CHW) providing education will be available at Lincoln Park San Ysidro Health Center - Chula Vista No-cost self-testing kit vending machines A vending machine and Community Health Worker (CHW) providing education will be available at Chula Vista
- Primary Outcome Measures
Name Time Method Identify solutions and evaluation methods to refine a multi-component implementation strategy bundle using a Community and Scientific Advisory Board. 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 Outcome Measures
Name Time Method Number of distributed rapid antigen tests within our target communities as measured by a proxy outcome. 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.
Trial Locations
- Locations (1)
San Ysidro Health Centers
🇺🇸San Ysidro, California, United States