COVID-19 Testing in Underserved and Vulnerable Populations Receiving Care in San Diego Community Health Centers
Phase: NA
Conditions: Heart Failure, Coronary Artery Disease, Cancer, Chronic Kidney Diseases, COPD, Obesity, Sickle Cell Disease, Diabetes Mellitus, Type 2
Sponsor: Jesse Nodora

PROJECT TITLE: 
COVID-19 Testing in Underserved and Vulnerable Populations Receiving Care in San Diego 
Community Health Centers     
NCT: 05315908 
Date: 4/6/2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

RESEARCH DESIGN AND METHODS 
Community Partner Program and Study Setting   
The proposed testing project will leverage existing community health center (CHC)-academic 
partnerships under the NCI-funded Accelerating Colorectal Cancer Screening and Follow-up 
through Implementation Science (ACCSIS) Cancer Moonshot grant (UG3CA233314), whose 
goal is to improve colorectal cancer (CRC) screening among medically underserved populations. 
This partnership include UCSD and Health Center Partners (HCP) and its subsidiary, Health 
Quality Partners (HQP).  HCP/HQP is a non-profit consortium of 16 CHCs that provide primary 
care to meet the health needs of communities in Southern California. HCP members collectively 
operate over 160 clinic sites that include urban, rural, agricultural worker, and US-Mexico border 
populations, and serve over 858,000 vulnerable patients with 3.6 million patient visits each 
year.  CHCs have been at the front lines of health care in the nation's poorest neighborhoods for 
decades. High risk asymptomatic patients served by these centers are not getting proper testing, 
include essential workers, and could contribute to further spread of the virus.  For these reasons, 
HCP/HQP, our community partner, approached the academic partner with interest in submitting 
this application.   
Participating CHCs. CHC participation involved a process of several presentations that outlined 
the concept and deliverables and elicited feedback from the medical directors, providers, and 
staff. Following these, three CHCs indicated interest and capacity to participate:  Neighborhood 
Healthcare (Neighborhood), Vista Community Clinic (Vista), and La Maestra CHC (La 
Maestra).  
Study Methodology 
AIM 1: Compare the effectiveness of automated call 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. 
We will include asymptomatic CHC patients with at least one clinic visit in the last year, age 21 
years and over, with medical conditions deemed by the Centers for Disease Control and 
Prevention to increase risk for severe COVID-19 illness8, 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. We estimate that ~40% of CHC patients will have 
at least one medical condition (~35,000 eligible). We will use our team’s extensive experience 
with existing protocols from our ongoing ACCSIS colorectal screening mailed stool testing 
intervention as models for the COVID-19 testing project, which have been culturally adapted and 
tailored for CHC patients.12,13  CHC staff will mail an introductory letter to eligible individuals 
describing the importance of COVID-19 testing, inviting them to receive a test, offering opt out 
instructions, and noting that follow-up contact (phone call, SMS text message) will take place if 
they do not opt out.  Patients who do not opt out, and those whose mail is not returned, will be 
randomized one week after the introductory letter is mailed.  

Randomization. CHC patients will be randomized to one of two arms (see Figure 2). 
Stratification by CHC will not be done due to large sample size. 
 
1) Patients in the Automated call condition will 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.  
2) Patients in the text (SMS) condition will receive up to two text messages in English or Spanish  
The automated call and text messaging will instruct patients to call a staff member at the health 
center’s COVID-19 testing center to schedule COVID-19 test. 
COVID-19 Testing and Capacity                                                                                                                            
Randomized patients who are reached will be provided with information on the study and invited 
to make a clinic appointment for testing. We will use a rapid, high-throughput SARS-CoV-2 
qRT-PCR-based diagnostic assay certified for clinical use under FDA Emergency Use 
Authorization (EUA) that was developed at the UCSD Biochemical Genetics and Metabolomics 
Laboratory (BCG), a CLIA/CAP certified laboratory. Our process requires 24-48 hours from 
receipt of samples to reporting of results. Anterior nares swabs will be collected by the patient 
and placed into automation-ready collection tubes containing PrimeStore Molecular Transport 
medium, which inactivates pathogens (including the SARS-CoV-2 virus) and stabilizes RNA. 
We will use Redox middleware to integrate testing laboratory information system (LIS) with the 
CHC EHR systems. Redox is also set up for required reporting to local, state, and federal 
agencies through the California Reportable Disease Information Exchange - Electronic Lab 
Reporting (CalREDIE ELR). Per state guidelines, the testing laboratory is required to report 
positive and negative test results to the County health department using a standard morbidity 
report. Positive cases are followed by the County for contact tracing.   
Two novel features embedded in this study.  
1) In an opportunistic way, we will offer the flu vaccine to patients as part of standard of care at 
the time of COVID testing.  Given recent reports of possible reluctance by individuals to re-
engage in health care, including flu vaccination,14 and with flu season underway, we must 
prepare for the challenges of its usual dangers combined with novel impacts of COVID-19. This 
provides an ideal educational opportunity to promote COVID-19 vaccination through positive 
messaging.   
2) We will also assess feasibility and acceptability of COVID-19 testing of study participants’ 
adult household members who are essential workers. When a CHC patient contacts a clinic to 
make a testing appointment, clinic staff will ask him/her if he/she lives with an essential worker, 

as defined by the state of California.15 If essential workers reside in the home, the participant will 
be asked if they are willing to refer the household member for COVID-19 testing.  
Data Collection, Harmonization and Reporting.  
Data collection via EHR and patient surveys will include the PhenX Toolkit core elements 
including age, sex, race and ethnicity, address, access to health services, income, employment 
status, education, English proficiency, food insecurity, gender identity, sexual orientation, health 
insurance, health literacy, and occupation. We will also include household size, foreign-born 
status, and job type, given that these factors contribute to higher infection rates in Latinx 
communities,6 as well as trust in healthcare16 and discrimination, which are important for our 
Latinx population. We will work with our advisory board members, community collaborators, 
stakeholders, the health center leaderships to select additional data elements from the PhenX 
Specialty collections.  
Primary Study Endpoints.  
For efficacy assessment, our primary study outcome will be the proportion of patients who 
undergo testing within one month of initial contact (automated call and text messaging).  We will 
also assess the proportion of patients who undergo testing by the end of the study period (to 
consider individuals who could not come to the clinic within one month).  Secondary endpoints 
of interest include: number (%) tested (total and by clinic), number (%) infected (total and by 
clinic).  We will also assess the timeliness of testing (from time of contact to testing). 
Secondary Study Endpoints.  
For flu vaccination, our endpoint will be number vaccinated. For essential worker referral to 
COVID-19 testing, we will measure Feasibility by: a) ascertainment of essential worker status; 
and b) willingness to offer testing invitation to eligible household member(s). Acceptability will 
be assessed by: a) the proportion of study participants with eligible household members who 
refer household member(s); and b) the number of household members referred for testing.  
Sample Size and Study Power.   
Number of study participants was driven by budget, capacity to deliver as many tests as possible, 
and number of eligible patients at the participating CHCs.  Since routine testing of asymptomatic 
patients is not taking place at the CHCs, we expect that most eligible patients (~35,000) will not 
be tested.  Based on our prior work, we expect ~5% undeliverable calls due to wrong numbers. 
The exact number of participants randomized in each arm to derive at 9,000 (4,500 per arm) 
will be determined by testing uptake rates and an estimated 10% drop off rate due to no shows 
for testing, with assumption of missing completely at random. To our knowledge, there are no 
existing data to inform effect size. We thus estimated power for a series of proportion of testing 
completion between two arms Our study has >80% power with a two-sided alpha=0.05 to detect 
proportion of testing completion as high as 0.5 in the automated call and  0.7 in the text 
messaging , and as low as 0.3 and 0.5, respectively, in each corresponding arm. 
Statistical Analysis.  
Baseline sociodemographic and other clinical characteristics will be assessed for imbalance 
among the 2 study arms using t-test or chi-square tests for categorical variables. In our primary 
analysis, we will compare proportion of patients who undergo COVID-10 testing within one 
month following initiation/randomization between the two study arms using an intention-to-treat 
approach. For our primary analysis, will use Fisher’s exact test for an overall comparison of 
testing completion between two groups using a P<.05 as statistical significant threshold.We will 
estimate risk ratios and 95% confidence intervals as the measure of association between 

intervention groups and testing completion. We will also explore testing rates between groups 
stratified by social determinants of health factors and other key factors using a likelihood ratio 
test, recognizing that these analyses will be better suited for the total consortium.  
 
AIM 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.   
We will use a mixed-methods approach to evaluate our COVID-19 testing strategies, materials 
and outcomes (acceptability, feasibility, appropriateness, sustainability). We will gather 
information on implementation and sustainability facilitators and barriers from individuals 
receiving/declining testing. Using structured interviews and a coded directed content analysis 
approach to analyze transcripts, we will collect comparable information for feasibility, 
acceptability, appropriateness, and sustainability for select providers (1 per clinic), chief medical 
officers in 3 participating CHCs, and 3 key community stakeholders. Measures include survey 
items guided by the Practical, Robust Implementation and Sustainability Model (PRISM) and 
(Reach Effectiveness, Adoption, Implementation and Maintenance) RE-AIM framework, and 
include the Feasibility of Intervention Measure (FIM), Acceptability of Intervention Measure 
(AIM), and Intervention Appropriateness Measure (IAM).