Community-Based COVID-19 Testing Strategies for COVID-19

(CO-CREATE-Ex Trial)

Overseen By Louise Laurent, MD/PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Disqualifiers: Psychiatric disorder, Developmental delay, others

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve COVID-19 testing in the San Diego area, focusing on Latino communities heavily impacted by the pandemic. It will evaluate different strategies, such as providing free self-test kits from vending machines and offering guidance from Community Health Workers (CHW) for testing navigation and general preventive care reminders, to determine the most effective methods for easy and efficient testing. Participants can expect on-site testing and preventive care reminders to enhance their health safety. Patients or community members near specific San Ysidro Health clinics who speak English or Spanish may be eligible to participate. As an unphased trial, this study allows participants to contribute to innovative community health solutions.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems unlikely that you would need to stop, but please check with the trial coordinators for confirmation.

What prior data suggests that these COVID-19 testing strategies are safe?

Research has shown that community health workers (CHWs) play a vital role in sharing COVID-19 information and services. They help people understand health details and connect with needed support, proving essential during the pandemic, especially in combating misinformation.

Studies indicate that free self-testing kit vending machines offer easy access to COVID-19 tests without requiring appointments. Available 24/7, these machines allow people to get tested whenever needed. The self-tests from these machines have quickly identified both symptomatic and asymptomatic individuals with COVID-19.

Although the trial treatments are not new drugs, they employ methods that have been successful and well-accepted in similar situations. This suggests that these testing strategies are safe and well-received by the community. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these strategies because they offer accessible and community-centered approaches to COVID-19 testing. Unlike traditional testing methods that can be inconvenient or costly, this trial explores innovative solutions like no-cost self-testing kit vending machines, which provide easy, 24/7 access to tests. Additionally, having Community Health Workers (CHWs) lead testing navigation and provide preventive care education can enhance community trust and engagement, making it easier for people to get tested and stay informed. By integrating these methods, the trial aims to improve testing rates and early detection, ultimately helping to control the spread of COVID-19.

What evidence suggests that this trial's testing strategies could be effective for COVID-19?

Research has shown that community health workers (CHWs) have played a vital role during the COVID-19 pandemic by sharing accurate information and connecting people to necessary resources. In this trial, some participants will access CHWs who assist with testing and provide reminders about preventive care. Other participants will access no-cost self-testing kit vending machines, which studies indicate can quickly detect COVID-19 in symptomatic and asymptomatic individuals. These vending machines offer easy access and use, with simple instructions provided. This trial tests both strategies to evaluate their potential for improving COVID-19 testing and control. ^{1 2 4 5 6}

Who Is on the Research Team?

Louise Laurent, MD/PhD

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You are a patient at specific clinics or live near certain community clinics.

Exclusion Criteria

You are living in a specialized facility for a mental health condition, have a developmental delay, or have been involved in criminal activities.

I am unable to understand and give consent for treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of a multi-component strategy bundle including walk-up testing, Community Health Worker-led counseling, and vending machines for self-testing kits

18 months

Follow-up

Participants are contacted up to three times over a course of 4 weeks to return their results and complete a survey about their COVID-19 experiences

4 weeks

Evaluation

Evaluation of the implementation strategy bundle and measures of success through partner engagement surveys

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Community Health Worker (CHW) leading testing navigation and general preventive care reminders
• COVID-19 walk-up, on-site testing strategy
• No-cost self-testing kit vending machines

Trial Overview 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.

How Is the Trial Designed?

Group I: San Ysidro Health Center - Logan Heights Experimental Treatment 2 Interventions

A vending machine and Community Health Worker (CHW) providing education will be available at Logan Heights

Group II: San Ysidro Health Center - Lincoln Park Experimental Treatment 2 Interventions

A vending machine and Community Health Worker (CHW) providing education will be available at Lincoln Park

Group III: San Ysidro Health Center - Chula Vista Experimental Treatment 2 Interventions

A vending machine and Community Health Worker (CHW) providing education will be available at Chula Vista

Group IV: San Ysidro Health Center - Main Clinic Placebo Group 3 Interventions

At the main clinic all 3 strategies will be available: walk-up testing, vending machine, and Community Health Worker (CHW) providing education.

Community Health Worker (CHW) leading testing navigation and general preventive care reminders is already approved in United States for the following indications:

Approved in United States as Community Health Worker-led testing navigation for:

• COVID-19 testing navigation
• General preventive care reminders

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

San Ysidro Health Center

Collaborator

Trials

7

Recruited

9,600+

Published Research Related to This Trial

This study aims to develop and test community-centered COVID-19 testing strategies, including no-cost walk-up testing, community health worker-facilitated care, and vending machines for self-testing kits, involving 7,500 participants across four clinics over 18 months.

The implementation will be guided by a co-designed Theory of Change and the PRISM model, with a focus on evaluating both quantitative and qualitative data to optimize testing strategies and ensure they are sustainable and equitable for the community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-engaged optimization of COVID-19 rapid evaluation and testing experiences: roll-out implementation optimization trial. Stadnick, NA., Laurent, LC., Cain, KL., et al.[2023]

Community health workers (CHWs) play a crucial role in promoting health equity and social justice, especially during the COVID-19 pandemic, as they leverage their trusted relationships with underresourced populations.

A focus group with CHW leaders identified key themes such as CHW resiliency and the need for better resources and training, highlighting the pandemic's impact on their ability to support communities facing health disparities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insights on COVID-19 From Community Health Worker State Leaders. Mayfield-Johnson, S., Smith, DO., Crosby, SA., et al.[2022]

This scoping review protocol aims to gather evidence on how digital health interventions can support community health workers (CHWs) in low-middle-income countries during the COVID-19 pandemic, addressing both pandemic-related tasks and routine healthcare services.

The review will systematically analyze studies from major health databases to identify effective digital tools for CHWs, highlighting current knowledge gaps and providing insights for future research and practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring digital health interventions to support community health workers in low-and-middle-income countries during the COVID-19 pandemic: a scoping review protocol. Feroz, AS., Valliani, K., Khwaja, H., et al.[2021]

Community health workers (CHWs) are being recognized for their potential to enhance health outcomes for vulnerable populations and to bridge clinical and community health services, as demonstrated by initiatives in Massachusetts.

Three key initiatives in Massachusetts include state certification for CHWs, integrated chronic disease programs, and a pilot program to evaluate the financial benefits of community-based prevention, which could inform health care reform across the country.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community Health Worker Integration in Health Care, Public Health, and Policy: A Partnership Model. Wilkinson, GW., Mason, T., Hirsch, G., et al.[2019]

The 'Protecting Our Community' study, involving 400 participants from Native American and Hispanic/Latino communities in rural Montana and Washington, aims to assess the effectiveness of home-based COVID-19 testing and the role of community health workers in improving participation.

Initial findings suggest that additional support from trusted community health workers may be crucial for overcoming barriers to home-based testing in underserved populations, highlighting the need for community-driven approaches to enhance testing accessibility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pragmatic randomized trial of home-based testing for COVID-19 in rural Native American and Latino communities: Protocol for the "Protecting our Communities" study. Thompson, MJ., Drain, PK., Gregor, CE., et al.[2023]

The COVID-19 pandemic has led to over 37 million cases and 1 million deaths, highlighting the urgent need for accessible testing, especially in vulnerable communities with limited healthcare access.

A decentralized point-of-care testing model using the GeneXpert platform has been successfully implemented in remote Australian communities, suggesting it could be an effective strategy for improving COVID-19 testing access in socially vulnerable areas worldwide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A decentralised point-of-care testing model to address inequities in the COVID-19 response. Hengel, B., Causer, L., Matthews, S., et al.[2022]

A survey of 775 Community Health Workers (CHWs) in Brazil revealed that the COVID-19 pandemic has intensified challenges in their roles, particularly due to a rise in misinformation and denial about the virus, which hampers public health efforts.

The study highlights that the unique difficulties faced by CHWs in low-income communities during the pandemic have been largely overlooked in Brazilian health policies, suggesting a need for more tailored support and strategies for these essential workers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community health workers' attitudes, practices and perceptions towards the COVID-19 pandemic in brazilian low-income communities. do Rosário Costa, N., Bellas, H., da Silva, PRF., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11191347/

Community health worker perspectives: examining current ... This study examines the perspectives of experienced CHWs in Chicago about their current work and strategies for success.

2. outbreak.info outbreak.info/resources/search?q=%22community+health+worker+(CHW)%22

COVID-19 Research Library | Search COVID-19 walk-up, on-site testing strategy. Community Health Worker (CHW) leading testing navigation and general preventive care reminders. No-cost self ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10544564/

Community-engaged optimization of COVID-19 rapid ... This study will refine and test implementation strategies prioritized by community partners: (1) walk-up no-cost testing, (2) community health worker ( ...

4. bmchealthservres.biomedcentral.com bmchealthservres.biomedcentral.com/articles/10.1186/s12913-024-11165-y

Community health workers' dissemination of COVID-19 ... We described how CHWs supported the dissemination of COVID-19 information and services during the early pandemic response.

5. journals.lww.com journals.lww.com/ambulatorycaremanagement/fulltext/2023/07000/community_health_workers_during_covid_19_.4.aspx

Community Health Workers During COVID-19 Community health workers have been instrumental during the COVID-19 pandemic in addressing misinformation and connecting people to social support.

6. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2021.674858/full

The Community Health Worker (CHW) Common Indicators ... This manuscript details the current work being done by the CI Project, demonstrating how CHWs are able to contribute to the integrity, sustainability, and ...