COVID-19 Testing in Underserved and Vulnerable Populations

Study Overview
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Brief Summary
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As part of National Institutes of Health Rapid Acceleration of Diagnostics-Underserved Populations (RADx-UP) program, the goal of the RADxUP study is to develop, test, and evaluate a rapid, scalable capacity building project to enhance COVID-19 testing in three regional community health centers (CHCs) in San Diego County, California. In collaboration with CHC partners, their consortium organization, Health Quality Partners (HQP), investigators are pursuing the following Specific Aims: 1) Compare the effectiveness of automated calls vs text messaging for uptake of COVID-19 testing among asymptomatic adult patients with select medical conditions and those 65 years of age and older receiving care at participating CHCs. Secondarily, investigators will invite all study participants to receive flu vaccination and will assess feasibility and acceptability of study participants to refer adult family household members who are essential workers for COVID-19 testing. 2) Gather patient, provider, CHC leadership, and community stakeholder insights to establish best practices for future scale-up of COVID-19 testing sustainability and vaccination.

Detailed Description
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Pronounced inequities and disparities in coronavirus disease (COVID-19)COVID-19 morbidity and mortality have been reported, largely due to comorbid conditions and social determinants of health. Approximately 95% of COVID-19 related deaths occur among individuals with underlying medical conditions. Of all racial/ethnic groups, Hispanic/Latino communities in San Diego County have experienced the greatest burden of COVID-19 disease and deaths. Furthermore, testing challenges to date are evident, including long turnaround of test results and longer waiting times for African American and Hispanics compared to whites. The goal of this community-engaged proposal is to develop, test, and evaluate a rapid, scalable capacity building project to enhance COVID-19 testing in three regional community health centers (CHCs) in San Diego County. In collaboration with CHC partners, their consortium organization (Health Quality Partners), and community stakeholders, investigators propose the following Specific Aims: 1) Compare the effectiveness of automated and live prompts and reminders and their combination for uptake of COVID-19 testing among adult patients with select medical conditions or those 65 years of age and older receiving care at participating CHCs. Secondarily, investigators will invite all study participants to receive flu vaccination and will assess feasibility and acceptability of study participants to refer adult family household members who are essential workers for COVID-19 testing. 2) Gather patient, provider, CHC leadership, and community stakeholder insights to establish best practices for future scale-up of COVID-19 testing sustainability and vaccination. This community-engaged project includes underserved (socioeconomically disadvantaged and large proportion of Hispanic/Latinos) as well as COVID-19 vulnerable individuals (patients with medical comorbidities and 65 years of age and older). The approach considers regional COVID-19 morbidity and mortality disparities to identify strategies to address disproportionate infection rates and follow-up. By working in partnership with health care providers, health care system leaders, and community stakeholders, the research team has the potential to build the evidence-base approaches and identify sustainable solutions to understand and address the current and future pandemics in underserved and vulnerable populations.

Official Title
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COVID-19 Testing in Underserved and Vulnerable Populations Receiving Care in San Diego Community Health Centers

Conditions
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Heart Failure, Coronary Artery Disease, Cancer, Chronic Kidney Diseases, COPD, Obesity, Sickle Cell Disease, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Other: Community outreach method


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible participants will include asymptomatic men and women receiving care at participating community health centers with at least one clinic visit in the last year, age 21 years and over, with co-morbid conditions deemed by the Centers for Disease Control and Prevention to increase risk for severe COVID-19 illness, including heart failure, coronary artery disease, cancer, chronic kidney diseases, COPD, obesity, sickle cell disease and type 2 diabetes mellitus, and those 65 years of age and older. Exclusion Criteria: Under age 21, inability to communicate in English and other study languages, inability to complete anterior nasal swab sampling for COVID-19

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Eligible patients who don't opt out will be randomized to one of two arms (automated call vs text messaging)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Automated call<br>Patients receive up to two automated phone calls in English or Spanish depending the patients' language indicated in their electronic health record (EHR), between the hours of 10:00am and 9:00pm Monday through Friday. | Other: Community outreach method<br>* The method includes automated call and text messaging to increase testing for COVID-19<br>|
| Active Comparator: Text messaging<br>Patients receive up to two text messages in English or Spanish depending the patients' language indicated in their electronic health record (EHR), between the hours of 10:00am and 9:00pm Monday through Friday. | Other: Community outreach method<br>* The method includes automated call and text messaging to increase testing for COVID-19<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of tested patients | The proportion of patients who undergo testing within one month of initial contact (automated call vs text messaging) and by the end of the study period (to consider individuals who could not come to the clinic within one month) | 1 year | 
| Number (%) tested (total and by clinic) | Number (%) of patients who complete COVID-19 test (total and by clinic) | 1 year | 
| Number (%) infected (total and by clinic) | Number (%) of patients with positive COVID-19 test (total and by clinic) | 1 year | 
| Timeliness of testing | From time of contact to testing | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number vaccinated with flu vaccine | Number of patients who receive flu vaccine | 1 year | 
| Proportion of patients who refer for testing | The proportion of study participants with eligible household members who refer household member(s) for COVID-19 testing | 1 year | 
| Number of household members referred for testing | The number of household members referred for COVID-19 testing | 1 year |