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Community-Based COVID-19 Testing Strategies for COVID-19 (CO-CREATE-Ex Trial)
N/A
Recruiting
Led By Louise Laurent, MD/PhD
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
CO-CREATE-Ex Trial Summary
This trial will test a COVID-19 testing program in a predominantly Latino community in San Diego County. The goal is to refine and optimize the testing program to help protect the community from the virus.
Who is the study for?
This trial is for people who are patients at select San Ysidro Health clinics or live nearby in areas like San Ysidro and Chula Vista. Participants must speak English or Spanish. It's not open to those unable to consent, institutionalized for psychiatric reasons, developmental delays, or criminal activity.Check my eligibility
What is being tested?
The study tests a COVID-19 rapid evaluation and testing strategy led by Community Health Workers. It includes walk-up on-site testing, reminders about preventive care, and access to no-cost self-testing kit vending machines.See study design
What are the potential side effects?
Since this trial focuses on COVID-19 testing strategies rather than medication or vaccines, it does not have typical medical side effects. However, participants may experience discomfort from the test procedure itself.
CO-CREATE-Ex Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Identify solutions and evaluation methods to refine a multi-component implementation strategy bundle using a Community and Scientific Advisory Board.
Secondary outcome measures
Number of distributed rapid antigen tests within our target communities as measured by a proxy outcome.
CO-CREATE-Ex Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: San Ysidro Health Center - Logan HeightsExperimental Treatment2 Interventions
A vending machine and Community Health Worker (CHW) providing education will be available at Logan Heights
Group II: San Ysidro Health Center - Lincoln ParkExperimental Treatment2 Interventions
A vending machine and Community Health Worker (CHW) providing education will be available at Lincoln Park
Group III: San Ysidro Health Center - Chula VistaExperimental Treatment2 Interventions
A vending machine and Community Health Worker (CHW) providing education will be available at Chula Vista
Group IV: San Ysidro Health Center - Main ClinicPlacebo Group3 Interventions
At the main clinic all 3 strategies will be available: walk-up testing, vending machine, and Community Health Worker (CHW) providing education.
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Who is running the clinical trial?
San Ysidro Health CenterOTHER
6 Previous Clinical Trials
2,077 Total Patients Enrolled
2 Trials studying COVID-19
1,354 Patients Enrolled for COVID-19
University of California, San DiegoLead Sponsor
1,122 Previous Clinical Trials
1,513,544 Total Patients Enrolled
13 Trials studying COVID-19
10,069 Patients Enrolled for COVID-19
Louise Laurent, MD/PhDPrincipal InvestigatorUniversity of California, San Diego
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Research Study Groups:
This trial has the following groups:- Group 1: San Ysidro Health Center - Chula Vista
- Group 2: San Ysidro Health Center - Main Clinic
- Group 3: San Ysidro Health Center - Logan Heights
- Group 4: San Ysidro Health Center - Lincoln Park
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it feasible for potential participants to join this experiment presently?
"According to information posted on clinicaltrials.gov, this trial has ceased recruiting patients and is not currently seeking new candidates. Initially published in July of 2023, the study was last updated June 7th of the same year. Despite being closed for recruitment, 845 other trials are actively searching for participants at present."
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