跳至主要内容
临床试验/NCT05315908
NCT05315908终止不适用

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

Jesse Nodora2 个研究点 分布在 1 个国家目标入组 9,120 人开始时间: 2020年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
9,120
试验地点
2
主要终点
Percentage of Tested Patients

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Under age 21, inability to communicate in English and other study languages, inability to complete anterior nasal swab sampling for COVID-19

结局指标

主要结局

Percentage of Tested Patients

时间窗: 1 month

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)

Timeliness of Testing

时间窗: 1 month

From time of contact to testing

Number (%) Infected (Total and by Clinic)

时间窗: 1 month

Number (%) of patients with positive COVID-19 test (total and by clinic)

Number (%) Tested (Total and by Clinic)

时间窗: 1 month

Number (%) of patients who complete COVID-19 test (total and by clinic)

次要结局

  • Number Vaccinated With Flu Vaccine(1 month)
  • Number of Household Members Referred for Testing(1 month)
  • Proportion of Patients Who Refer for Testing(1 month)

研究者

发起方
Jesse Nodora
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jesse Nodora

Assoc Adjt Professor

University of California, San Diego

研究点 (2)

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