Clinical trial NCT05894655: Community-engaged Optimization of COVID-19 Rapid Evaluation and TEsting Experiences
Official title: CO-CREATE-Ex: Community-engaged Optimization of COVID-19 Rapid Evaluation and TEsting Experiences
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COVID-19
COVID-19 Pandemic
Keywords: covid-19 testing
vaccine hesitancy
implementation
vending machine
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: San Ysidro Health Center
First posted: 2023-06-08
Enrollment: 7500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
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

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.

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.

Primary outcomes:
measure: Identify solutions and evaluation methods to refine a multi-component implementation strategy bundle using a Community and Scientific Advisory Board.
timeFrame: 2 years
Secondary outcomes:
measure: Number of distributed rapid antigen tests within our target communities as measured by a proxy outcome.
timeFrame: 18 months
Other outcomes:
Locations:
city: San Ysidro
country: United States
facility: San Ysidro Health Centers
state: California
Study officials:
affiliation: University of California, San Diego
name: Louise Laurent, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References: