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

7500 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the idea that Community-Based COVID-19 Testing Strategies for COVID-19 is an effective treatment?

The available research shows that Community-Based COVID-19 Testing Strategies, such as walk-up no-cost testing and community health worker-facilitated testing, are effective because they make testing more accessible, especially in underserved and remote communities. For example, the decentralised point-of-care testing model has been successfully implemented in remote Aboriginal and Torres Strait Islander communities in Australia, helping to address testing access issues. Additionally, home-based testing supported by community health workers has shown potential to reduce healthcare disparities in rural Native American and Latino communities in the U.S. These strategies help ensure that more people can get tested, which is crucial for controlling the spread of COVID-19. ^{1 2 3 4 5}

What safety data exists for community-based COVID-19 testing strategies?

The safety data for community-based COVID-19 testing strategies, including CHW-led initiatives and no-cost testing options, is not explicitly detailed in the provided research. However, the studies highlight the importance of community-centered approaches, the role of CHWs in promoting health equity, and the potential benefits of decentralized testing models. These strategies aim to improve access to testing in underserved communities, suggesting a focus on safety and effectiveness in these contexts. ^{2 3 5 6 7}

Is the treatment involving community health workers and free COVID-19 testing strategies promising?

Yes, this treatment is promising because it makes COVID-19 testing more accessible and convenient for communities. Community health workers help guide people through testing and provide health advice, which can build trust and encourage more people to get tested. Free testing options, like walk-up sites and vending machines with self-testing kits, make it easier for everyone to get tested, especially in areas where healthcare access is limited. This approach can help reduce health disparities and ensure more people know their COVID-19 status, which is important for controlling the spread of the virus. ^{2 3 4 5 6}

Research Team

Louise Laurent, MD/PhD

Principal Investigator

University of California, San Diego

Eligibility Criteria

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.

I can communicate in English or Spanish.

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.

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Community Health Worker Integration in Health Care, Public Health, and Policy: A Partnership Model. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Community-engaged optimization of COVID-19 rapid evaluation and testing experiences: roll-out implementation optimization trial. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

A decentralised point-of-care testing model to address inequities in the COVID-19 response. [2022]

4. England 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. [2021]

5. United States 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. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Insights on COVID-19 From Community Health Worker State Leaders. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Community health workers' attitudes, practices and perceptions towards the COVID-19 pandemic in brazilian low-income communities. [2021]