COVID-19CO-CREATE-ExNCT05894655
Community-engaged Optimization of COVID-19 Rapid Evaluation And TEsting Experiences
A study testing COVID-19 walk-up, on-site testing strategy, Community Health Worker (CHW) leading testing navigation and general preventive care reminders and No-cost self-testing kit vending machines in people with COVID-19 and COVID-19 Pandemic, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- COVID-19, COVID-19 Pandemic
- What is being tested?
- COVID-19 walk-up, on-site testing strategy, Community Health Worker (CHW) leading testing navigation and general preventive care reminders and No-cost self-testing kit vending machines
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6,527 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2023to 8 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Institutionalization for psychiatric disorder, developmental delay, or criminal activity.
- Unable to provide informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
San Ysidro Health Centers
San Ysidro, California, 92173
About this study
Official title: CO-CREATE-Ex: Community-engaged Optimization of COVID-19 Rapid Evaluation And TEsting Experiences
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.
Read the detailed description
CO-CREATE-Ex will roll-out our implementation using 3 strategies:
- keeping the current, walk-up free testing protocol
- Offering Community Health Worker (CHW) to lead COVID-19 test counseling, preventive care reminders, and offer testing support
- 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.
- Conditions
- COVID-19, COVID-19 Pandemic
- Being tested
- COVID-19 walk-up, on-site testing strategy, Community Health Worker (CHW) leading testing navigation and general preventive care reminders, No-cost self-testing kit vending machines
- Keywords
- covid-19 testing, vaccine hesitancy, implementation, vending machine
- Medical subject headings
- COVID-19, Vaccination Hesitancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 walk-up, on-site testing strategyBehavioural
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.
Community Health Worker (CHW) leading testing navigation and general preventive care remindersBehavioural
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.
No-cost self-testing kit vending machinesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| San Ysidro Health Center - Main Clinic | Placebo comparator | At the main clinic all 3 strategies will be available: walk-up testing, vending machine, and Community Health Worker (CHW) providing education. Receives: Behavioral: COVID-19 walk-up, on-site testing strategy; 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 - Logan Heights | Experimental | A vending machine and Community Health Worker (CHW) providing education will be available at Logan Heights Receives: 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 | A vending machine and Community Health Worker (CHW) providing education will be available at Lincoln Park Receives: 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 | A vending machine and Community Health Worker (CHW) providing education will be available at Chula Vista Receives: Behavioral: Community Health Worker (CHW) leading testing navigation and general preventive care reminders; Behavioral: No-cost self-testing kit vending machines |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (1)
Number of distributed rapid antigen tests within our target communities as measured by a proxy outcome.
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start28 Aug 2023
- Primary completion31 Mar 2025
- Study completion8 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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.
- Masking
- None (open label)
- Enrolment
- 6,527 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- San Ysidro Health Center
- Responsible party
- Principal investigator, Louise Laurent, MD/PhD, University of California, San Diego
- Investigators
- Louise Laurent, MD/PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05894655
- Sponsor's protocol ID
- 806121
- Acronym
- CO-CREATE-Ex
- Status last verified
- Oct 2025
- First submitted
- 2 Mar 2023
- Last updated
- 4 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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;7(1):47. doi: 10.1186/s43058-026-00871-9.
PubMed 41639712Stadnick 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.
PubMed 37784200
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CO-CREATE-Ex: Community-engaged Optimization of COVID-19 Rapid Evaluation And TEsting Experiences
- ClinicalTrials.gov ID
- NCT05894655
- Acronym / sponsor ID
- CO-CREATE-Ex / 806121
- Conditions
- COVID-19, COVID-19 Pandemic
- Keywords
- covid-19 testing, vaccine hesitancy, implementation, vending machine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,527 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- San Ysidro Health Center
- Study start
- 28 Aug 2023 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 8 Oct 2025 (actual)
- First posted
- 8 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- keeping the current, walk-up free testing protocol
- Offering Community Health Worker (CHW) to lead COVID-19 test counseling, preventive care reminders, and offer testing support
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| San Ysidro Health Center - Main Clinic | Placebo comparator | Behavioral: COVID-19 walk-up, on-site testing strategy, Behavioral: Community Health Worker (CHW) leading testing navigation and general preventive care reminders, Behavioral: No-cost self-testing kit vending machinesAt 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 | Experimental | Behavioral: Community Health Worker (CHW) leading testing navigation and general preventive care reminders, Behavioral: No-cost self-testing kit vending machinesA vending machine and Community Health Worker (CHW) providing education will be available at Logan Heights |
| San Ysidro Health Center - Lincoln Park | Experimental | Behavioral: Community Health Worker (CHW) leading testing navigation and general preventive care reminders, Behavioral: No-cost self-testing kit vending machinesA vending machine and Community Health Worker (CHW) providing education will be available at Lincoln Park |
| San Ysidro Health Center - Chula Vista | Experimental | Behavioral: Community Health Worker (CHW) leading testing navigation and general preventive care reminders, Behavioral: No-cost self-testing kit vending machinesA vending machine and Community Health Worker (CHW) providing education will be available at Chula Vista |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (2 listed)
- Institutionalization for psychiatric disorder, developmental delay, or criminal activity.
- Unable to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 walk-up, on-site testing strategyThis 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. | Behavioural | San Ysidro Health Center - Main Clinic |
| Community Health Worker (CHW) leading testing navigation and general preventive care remindersThis 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. | Behavioural | San Ysidro Health Center - Chula Vista, San Ysidro Health Center - Lincoln Park, San Ysidro Health Center - Logan Heights, San Ysidro Health Center - Main Clinic |
| No-cost self-testing kit vending machinesThis 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. | Behavioural | San Ysidro Health Center - Chula Vista, San Ysidro Health Center - Lincoln Park, San Ysidro Health Center - Logan Heights, San Ysidro Health Center - Main Clinic |
Primary outcome
Identify solutions and evaluation methods to refine a multi-component implementation strategy bundle using a Community and Scientific Advisory Board.
Time frame: 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.
1 secondary outcome
Number of distributed rapid antigen tests within our target communities as measured by a proxy outcome.
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2025.
- Derived from this study: PubMed 41639712Salgin 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;7(1):47. doi: 10.1186/s43058-026-00871-9.
- Derived from this study: PubMed 37784200Stadnick 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louise Laurent, MD/PhD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COVID-19 walk-up, on-site testing strategy, Community Health Worker (CHW) leading testing navigation and general preventive care reminders and No-cost self-testing kit vending machines in people with COVID-19 and COVID-19 Pandemic, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify solutions and evaluation methods to refine a multi-component implementation strategy bundle using a Community and Scientific Advisory Board. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05894655, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2025.