COVID-19 Testing in Underserved and Vulnerable Populations

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05315908
• Other study ID #: 201505
• Secondary ID: 3UH3CA233314-02S
• Status: Terminated
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: November 15, 2021

Study information

• Verified date: February 2024
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9120
• Est. completion date: November 15, 2021
• Est. primary completion date: November 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Cancer
• Chronic Kidney Diseases
• COPD
• Coronary Artery Disease
• Diabetes Mellitus, Type 2
• Heart Failure
• Kidney Diseases
• Obesity
• Renal Insufficiency, Chronic
• Sickle Cell Disease

Intervention

Other:
• Community outreach method
The method includes automated call and text messaging to increase testing for COVID-19

Locations

Country	Name	City	State
United States	University of California, San Diego	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
Jesse Nodora	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Tested Patients	The percentage 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 month
Primary	Number (%) Tested (Total and by Clinic)	Number (%) of patients who complete COVID-19 test (total and by clinic)	1 month
Primary	Number (%) Infected (Total and by Clinic)	Number (%) of patients with positive COVID-19 test (total and by clinic)	1 month
Primary	Timeliness of Testing	From time of contact to testing	1 month
Secondary	Number Vaccinated With Flu Vaccine	Number of patients who receive flu vaccine	1 month
Secondary	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 month
Secondary	Number of Household Members Referred for Testing	The number of household members referred for COVID-19 testing	1 month