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COVID-19 Testing in Underserved and Vulnerable Populations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05315908
Recruitment Status : Terminated (Because of low testing uptake, slow accrual at participating health centers and continuously changing COVID pandemic, research investigators had to terminate the original study and consider alternate strategies.)
First Posted : April 7, 2022
Last Update Posted : April 7, 2022
Sponsor:
Information provided by (Responsible Party):
Jesse Nodora, University of California, San Diego

Study Description
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Heart Failure Coronary Artery Disease Cancer Chronic Kidney Diseases COPD Obesity Sickle Cell Disease Diabetes Mellitus, Type 2 Other: Community outreach method Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Other
Official Title: COVID-19 Testing in Underserved and Vulnerable Populations Receiving Care in San Diego Community Health Centers
Actual Study Start Date : November 1, 2020
Actual Primary Completion Date : November 15, 2021
Actual Study Completion Date : November 15, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Automated call
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
The method includes automated call and text messaging to increase testing for COVID-19
Active Comparator: Text messaging
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
The method includes automated call and text messaging to increase testing for COVID-19


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of tested patients [ Time Frame: 1 year ]
    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)

  2. Number (%) tested (total and by clinic) [ Time Frame: 1 year ]
    Number (%) of patients who complete COVID-19 test (total and by clinic)

  3. Number (%) infected (total and by clinic) [ Time Frame: 1 year ]
    Number (%) of patients with positive COVID-19 test (total and by clinic)

  4. Timeliness of testing [ Time Frame: 1 year ]
    From time of contact to testing


Secondary Outcome Measures :
  1. Number vaccinated with flu vaccine [ Time Frame: 1 year ]
    Number of patients who receive flu vaccine

  2. Proportion of patients who refer for testing [ Time Frame: 1 year ]
    The proportion of study participants with eligible household members who refer household member(s) for COVID-19 testing

  3. Number of household members referred for testing [ Time Frame: 1 year ]
    The number of household members referred for COVID-19 testing


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05315908


Locations
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United States, California
University of California, San Diego
La Jolla, California, United States, 92093
Sponsors and Collaborators
Jesse Nodora
Investigators
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Principal Investigator: Elena Martinez, PhD Moores Cancer Center, University of California, San Diego
More Information
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Responsible Party: Jesse Nodora, Assoc Adjt Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT05315908    
Other Study ID Numbers: 201505
First Posted: April 7, 2022    Key Record Dates
Last Update Posted: April 7, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Coronary Artery Disease
Anemia, Sickle Cell
Diabetes Mellitus, Type 2
Heart Diseases
Cardiovascular Diseases
Urologic Diseases
Coronary Disease
Myocardial Ischemia
Arteriosclerosis
Arterial Occlusive Diseases
 Vascular Diseases
Renal Insufficiency
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn