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COVID-19 Testing in Underserved and Vulnerable Populations

Primary Purpose

Heart Failure, Coronary Artery Disease, Cancer

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Community outreach method
Sponsored by
Jesse Nodora
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Heart Failure

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, San Diego

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Automated call

Text messaging

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)
Number (%) tested (total and by clinic)
Number (%) of patients who complete COVID-19 test (total and by clinic)
Number (%) infected (total and by clinic)
Number (%) of patients with positive COVID-19 test (total and by clinic)
Timeliness of testing
From time of contact to testing

Secondary Outcome Measures

Number vaccinated with flu vaccine
Number of patients who receive flu vaccine
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
Number of household members referred for testing
The number of household members referred for COVID-19 testing

Full Information

First Posted
January 22, 2022
Last Updated
April 5, 2022
Sponsor
Jesse Nodora
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1. Study Identification

Unique Protocol Identification Number
NCT05315908
Brief Title
COVID-19 Testing in Underserved and Vulnerable Populations
Official Title
COVID-19 Testing in Underserved and Vulnerable Populations Receiving Care in San Diego Community Health Centers
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Terminated
Why Stopped
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.
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
November 15, 2021 (Actual)
Study Completion Date
November 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jesse Nodora

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Coronary Artery Disease, Cancer, Chronic Kidney Diseases, COPD, Obesity, Sickle Cell Disease, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Automated call
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Text messaging
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Community outreach method
Intervention Description
The method includes automated call and text messaging to increase testing for COVID-19
Primary Outcome Measure Information:
Title
Proportion of tested patients
Description
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)
Time Frame
1 year
Title
Number (%) tested (total and by clinic)
Description
Number (%) of patients who complete COVID-19 test (total and by clinic)
Time Frame
1 year
Title
Number (%) infected (total and by clinic)
Description
Number (%) of patients with positive COVID-19 test (total and by clinic)
Time Frame
1 year
Title
Timeliness of testing
Description
From time of contact to testing
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Number vaccinated with flu vaccine
Description
Number of patients who receive flu vaccine
Time Frame
1 year
Title
Proportion of patients who refer for testing
Description
The proportion of study participants with eligible household members who refer household member(s) for COVID-19 testing
Time Frame
1 year
Title
Number of household members referred for testing
Description
The number of household members referred for COVID-19 testing
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena Martinez, PhD
Organizational Affiliation
Moores Cancer Center, University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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COVID-19 Testing in Underserved and Vulnerable Populations

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