Community-engaged Optimization of COVID-19 Rapid Evaluation And TEsting Experiences
CO-CREATE-Ex
CO-CREATE-Ex: Community-engaged Optimization of COVID-19 Rapid Evaluation And TEsting Experiences
1 other identifier
interventional
6,527
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable covid19
Started Aug 2023
Longer than P75 for not_applicable covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 2, 2023
CompletedFirst Posted
Study publicly available on registry
June 8, 2023
CompletedStudy Start
First participant enrolled
August 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 8, 2025
CompletedNovember 4, 2025
October 1, 2025
1.6 years
March 2, 2023
October 31, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Identify solutions and evaluation methods to refine a multi-component implementation strategy bundle using a Community and Scientific Advisory Board.
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.
2 years
Secondary Outcomes (1)
Number of distributed rapid antigen tests within our target communities as measured by a proxy outcome.
18 months
Study Arms (4)
San Ysidro Health Center - Main Clinic
PLACEBO COMPARATORAt 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
EXPERIMENTALA vending machine and Community Health Worker (CHW) providing education will be available at Logan Heights
San Ysidro Health Center - Lincoln Park
EXPERIMENTALA vending machine and Community Health Worker (CHW) providing education will be available at Lincoln Park
San Ysidro Health Center - Chula Vista
EXPERIMENTALA vending machine and Community Health Worker (CHW) providing education will be available at Chula Vista
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- Institutionalization for psychiatric disorder, developmental delay, or criminal activity.
- Unable to provide informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, San Diegolead
- San Ysidro Health Centercollaborator
Study Sites (1)
San Ysidro Health Centers
San Ysidro, California, 92173, United States
Related Publications (2)
Salgin L, Reyes BJ, Bojorquez MB, Lomeli A, Velasquez S, Cain KL, Seifert M, Laurent LC, Stadnick NA, Rabin BA. Using multi-method approaches to document and assess adaptations in a community-driven COVID-19 testing program. Implement Sci Commun. 2026 Feb 5. doi: 10.1186/s43058-026-00871-9. Online ahead of print.
PMID: 41639712DERIVEDStadnick 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.
PMID: 37784200DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Louise Laurent, MD/PhD
University of California, San Diego
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 2, 2023
First Posted
June 8, 2023
Study Start
August 28, 2023
Primary Completion
March 31, 2025
Study Completion
October 8, 2025
Last Updated
November 4, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share