A Community Health Worker Intervention to Identify and Decrease Barriers to Pre-Procedural COVID 19 Testing Among Los Angeles County Department of Health Safety-Net Patients
Phase: NA
Conditions: Vaccine Hesitancy, COVID-19 Testing, Community Health Workers
Sponsor: Charles Drew University of Medicine and Science

Form 102, Rev. 9/2018a
Page 1 of 31
Charles R. Drew University of Medicine and Science
Office of Research Integrity and Compliance
Institutional Review Board
Application for Study Review 
Date: April 25, 2022 
Federal Funding:
 No       
 Yes    
IRBNet#:  1838914-1    
FDA-regulated Study:  
 No       
 Yes
CDU IRB#:  N/A
IND/IDE Study:
 No       
 Yes
Initial Approval Date:       
Clinicaltrials.gov 
Registration
Required?
 No       
 Yes
Principal Investigator is a 
 Faculty    
 Resident    
 Staff    
 Student    
 Other:  
This is a 
 New Project    
 Amendment    
 Other:       
Check all that applies:  
 This is a Principal Investigator (PI)-initiated project. 
   
 This is a Sponsor-initiated project.      
   
 This project is a course requirement.  Describe:           
   
 This project is a graduation requirement.  Describe:             
I. Project Information
Project Title: A Community Health Worker Intervention to Identify and Decrease Barriers to 
COVID-19 Testing and Vaccination among Los Angeles County Department of Health Safety-
Net Patients – Aim 3
Principal Investigator (PI):  Sheba George, PhD
Phone:  323-249-5733
E-mail:  shebageorge@cdrewu.edu      
Faculty Sponsor (required if PI is a resident, staff, or student):          
Phone:        
E-mail:          
Primary Contact Person (in addition to PI):  Denisse Ruiz, MPH    
Phone:  323-947-8045  
E-mail:  denisseruiz@cdrewu.edu   
II.  Study Personnel
Please use Appendix A to list all personnel involved in this project.
  Attached                       
  Not attached
 
IRBNet #: 1838914-1
Approved by: CDU IRB
Approval Period: April 29, 2022 to April 19, 2023

Form 102, Rev. 9/2018a
Page 2 of 31
III.  IRB Review and Reliance for Multi-institutional Projects
1.
Are you collaborating with researchers (or have faculty sponsor) from other 
institutions or organizations that have their own Institutional Review Board (IRB)?
  No                   
  Yes   
2.
If yes, please check the IRB reliance mechanism that might be applicable to the 
project.
  CTSI MOU (CDU to rely on IRB review by UCLA, CSMC, LA BioMed/HUMC, USC)
  RTRN IAA (CDU to review or rely with any of the 18 RCMI institutions)
  DHS MOU (CDU to review or rely with many of the LA County DHS facilities)
  WIRB (CDU to rely on commercial Western IRB for industry-sponsored, multi-
center studies)
  SMART IRB (CDU to review or rely with many of the SMART IRB participating 
institutions)
  Not applicable.  Please obtain IRB approval from the collaborating institution or 
organization.
3.
If you are requesting single IRB to review a multi-institutional project, please call 323-
563-4966 or write to irb@cdrewu.edu for consultation. 
IV. Research Site(s)
1.
List all research site(s) that will be used to conduct this project.  
Educational intervention and access to ORCHID electronic health record from LAC 
Department of Health Services (DHS)
2.
You should have the necessary letters of support, approvals, or permissions from the 
research site(s).  Research sites might include external facilities, agencies, hospitals, 
clinics, schools, community organizations and centers, community health fairs, 
internal departments, programs, dean’s office, Ministry of Health, internet chat rooms, 
etc.
Number of letters of support, approvals, or permissions attached:  0  
 
IRBNet #: 1838914-1
Approved by: CDU IRB
Approval Period: April 29, 2022 to April 19, 2023

Form 102, Rev. 9/2018a
Page 3 of 31
V. Project Types and Methods
If the project involves any of the following, check the appropriate box(es).
 Audiotapes/videotapes/Zoom recordings
 Alcohol and drug abuse research
 Behavioral observations
 Biohazardous waste
 Children (Ages 16 and 17)
 Clinical trial (Phase I)
 Collection of biological specimens for banking
 Collection of data for repository
 Collection of surgical or biological specimens
 Controlled substances
 Data Safety Monitoring Board (DSMB)
 Deception
 Education records
 Genetic research
 HIV/AIDS
 HIV screening
 International research
 Internet
 Interviews, focus group
 Investigational new drugs (IND)
 Investigational device exemption (IDE)
 Multicenter clinical trial
 Magnetic Resonance Imaging (MRI)
 National Cancer Institute Trial (NCI)
 NIH Cooperative Groups (i.e., RCMI)
 Other, describe: Non-clinical Trial (non-
FDA), health educational presentations and 
handouts
 Participants who may be vulnerable to 
undue influence or coercion
 PI or co-PI is the treating clinician
 PI is sponsor and investigator
 Placebo
 Pregnancy testing
 Pregnant women, fetuses, neonates
 Prisoner research
 Protected Health Information (PHI)
 Radiation (CT or DEXA scans, X-rays)
 Reportable information or disease
 Social media use
 Surveys, questionnaires, psychological 
testing 
VI. Protocol Summary 
Purpose, Background, and Design
1.
Purpose of the study:  What are the scientific aims of this study?
With the current pandemic, COVID-19 testing for patients has become an essential first step in 
the provision of critical procedural care. However, the range of reasons why patients refuse 
COVID-19 testing and vaccination is little understood. To this end, we propose to explore the 
obstacles to COVID-19 testing and vaccination, and provide COVID-19 specific training to 
LACDHS Community Health Workers (CHWs) from these same communities to effectively 
increase COVID-19 testing and vaccination for individual patients, and to facilitate needed 
healthcare in a timely manner for the safety net health system, and to develop a sustained 
public health presence in these communities to build trust and preparedness for critical 
COVID-19 related future needs.
 
IRBNet #: 1838914-1
Approved by: CDU IRB
Approval Period: April 29, 2022 to April 19, 2023

Form 102, Rev. 9/2018a
Page 4 of 31
This study has the following specific aims: 
Aim 1- Utilize machine learning methods to assess whether there are characteristics that 
define African American and Latinx LACDHS safety-net patients who engage in or refuse 
COVID-19 testing and vaccination; 
Aim 2 - Conduct in-depth interviews with African American and Latinx LACDHS patients who 
either declined or accepted COVID testing and vaccination to explore contextual, behavioral, 
and attitudinal factors shaping patient circumstances and concerns; 
Aim 3 - Develop, implement, and pre-test a CHW intervention with the information from Aims 
1 and 2, utilizing a randomized control design among African American and Latinx safety net 
patients to assess the effect of the CHW hypothesis-driven intervention on trust, self-efficacy, 
and intent to participate in COVID-19 testing and vaccination
This IRB application will address Aim 3 only.  The data obtained from Aims 1 and 2 
informed the researchers on the Aim 3 design and methodology.
  
2.
Background:  State the background of the study, including a critical evaluation of existing 
knowledge and the information gaps that this research proposes to fill.  Describe previous work in 
animal and/or human studies that provides a basis for the proposed research and that supports the 
expectations of obtaining useful information without undue risk to research participants.  Please 
include relevant citations.
COVID-19 testing and vaccination uptake have remained sparse in many low-
income/minority neighborhoods, even though African American and Latinx communities in 
the U.S. bear a disproportionate COVID-19 burden of positive cases and deaths.1 Members of 
these communities are also not taking part in COVID-19 testing for a wide range of 
understudied reasons, even though it has been universally established that early and 
widespread COVID-19 testing is essential to help identify, treat, or isolate people who are 
infected and to identify and isolate contacts of infected people. Testing is also important for 
public health mitigation efforts to characterize the prevalence, spread, and contagiousness of 
the disease. Any plan to contain the virus will depend on fast and accurate testing, which can 
identify newly infectious people before they set off new outbreaks, as well as widespread 
vaccinations to tame the spread of the virus and the emergence of newer more dangerous 
variants. Vaccination uptake in African American and Latinx communities lags other US 
communities. The Kaiser Family Foundation/KFF states that “As of September 21, 2021, CDC 
reported that race/ethnicity was known for 59% of people who had received at least one dose 
of the vaccine. Among this group, nearly two thirds were White (60%), 10% were Black, 17% 
were Hispanic, 6% were Asian, 1% were American Indian or Alaska Native, and <1% were 
Native Hawaiian or Other Pacific Islander, while 5% reported multiple or other race. However, 
CDC data also show that recent vaccinations are reaching larger shares of Hispanic, and Black 
populations compared to overall vaccinations. Among vaccines administered in the past 14 
days, 23% have gone to Hispanic people and 14% to Black people. [Source: 
https://www.kff.org/coronavirus-covid-19/issue-brief/latest-data-on-covid-19-vaccinations-race-
ethnicity/]
The Importance of COVID-19 Testing and Vaccination in the Los Angeles County 
Department of Health Services (LACDHS):  LACDHS is the second largest publicly 
operated safety net health care system in the United States, serving more than 750,000 
patients annually.3 Timely access to health care in this under-resourced, high-need setting has 
been an ongoing challenge for its majority Latinx and African American patients.4,5 With the 
current pandemic, COVID-19 testing for patients has become integral to receiving critical 
health care, from treatment for symptomatic disease to the first step in providing procedural 
care. Because racial and ethnic minority patients with underlying chronic conditions make up 
 
IRBNet #: 1838914-1
Approved by: CDU IRB
Approval Period: April 29, 2022 to April 19, 2023

Form 102, Rev. 9/2018a
Page 5 of 31
a large percentage of LACDHS patient populations, LACDHS has a growing challenge of 
managing and addressing the healthcare needs of such patients who are especially vulnerable 
in the pandemic.6 It is thus an invaluable site for engaging in research to understand how to 
improve patient acceptance and uptake of COVID-19 testing and vaccination. 
Our community partner from LACDHS, MPI on this project, Dr. Lauren Daskivich, has 
experienced growing concern from County physicians about patients’ declination rates for 
COVID-19 testing and vaccination. From the reports of her colleagues, Dr. Daskivich estimates 
that about 68% of empaneled LACDHS patients do not have a completed COVID-19 
vaccination status for undocumented reasons. Based on the number of LACDHS empaneled 
patients, Dr. Daskivich estimates about 289,400 patients over the age 16 do not have a 
completed COVID-19 vaccination status. However, the reasons for declination have not been 
clearly documented and understood at an actionable level. Patient refusal to complete either 
lab orders for COVID-19 testing or vaccinations can have serious consequences for both 
patient health outcomes and for the health system’s efficient management of resources. 
Understanding COVID-19’s effect on patients’ decisions to either complete COVID-19 testing 
and vaccination is critical for reaching herd immunity and reducing the spread of the virus in 
vulnerable communities7. 
Low vaccination and testing rates among typically comorbid chronic conditions among such 
patients could result in an avoidable worsening of patient health status, a heightened patient 
vulnerability to developing COVID-19. Understanding and addressing the reluctance of African 
American and Latinx patients to be tested and vaccinated can have profound implications in 
safety-net health care settings like LACDHS where such patients oftentimes come from low-
socioeconomic communities.
How our proposal will address potential testing and vaccination barriers with a 
CHW intervention 
To address the barriers to COVID-19 testing and vaccination for safety net patients, we 
propose to train and use LACDHS CHWs from these same communities to engage safety net 
African American and Latinx patients, aiming to address the barriers outlined above as well 
as others we may identify through our exploratory mixed-methods research. There is a 
strong body of scientific research, both nationally and internationally, that has 
demonstrated the effectiveness of CHWs in improving not only health outcomes,30,31 quality 
of care,32 addressing social determinants of health and cost effectiveness,33 but also in 
effectively engaging marginalized populations in disease testing and screening for a range 
of diseases34 and in immunization.35 Our team has contributed to this evidence base of CHW 
research with a variety of projects led by Co-I Balcazar and MPI George.36-44 CHWs have a 
long history of functioning as frontline public health staff who conduct outreach and build 
trust with vulnerable populations in federally qualified health centers (FQHCs), hospitals, 
public health agencies, and through community-based organizations. They have played an 
increasingly important role in health interventions/programs, often bridging the gap 
between clinic and community by facilitating care coordination,45,46 health promotion,47 and 
communication between clinicians and patients/program participants48 in a manner that is 
generally assumed to be more acceptable to the care recipients and ultimately improving 
health outcomes.49-51 CHW interventions have been identified as an essential strategy to 
address health disparities for patient-centered medical home (PCMH)52-54 by the NHLBI55 and 
the Centers for Disease Control and applauded for their contributions to the Institute for 
Healthcare Improvement’s Triple Aim objectives.46,56-58 Thus, with the onset of COVID-19, on 
March 19, 2020, the Department of Homeland Security’s Cybersecurity and Infrastructure 
Security Agency issued a memorandum which included CHWs in the list of “essential critical 
infrastructure workers who are imperative during the response to the COVID-19 emergency 
for both public health and safety as well as community well-being.”59 Sen. Kirsten Gillibrand 
(D-NY) and Sen. Michael Bennet (D-CO) have proposed creating a national Health Force, 
inspired by the Depression- era Works Progress Administration, to recruit, train, and employ 
 
IRBNet #: 1838914-1
Approved by: CDU IRB
Approval Period: April 29, 2022 to April 19, 2023

Form 102, Rev. 9/2018a
Page 6 of 31
“hundreds of thousands” of community health workers to perform contact tracing and 
testing and provide a range of services.60
Because CHWs are often embedded in the community and are uniquely able to bridge the 
gap between healthcare organizations and the safety net patients in the community, CHWs 
are in a great position to address  known potential obstacles to COVID-19 testing and 
vaccination. From our recent systematic review of patient feedback on CHWs’ care 
provision36 and from other related literature, is it evident that CHWs are well positioned to 
build trust surrounding COVID-19 testing and vaccination, provide credible testing, 
vaccination, and healthcare information, address testing and vaccination barriers related to 
the social determinants of health, and facilitate patient access to telehealth environments. 
One of the key criteria for CHWs is that they come from the same communities as those 
they serve and thus CHWs tend to be trusted by their patients because of shared 
backgrounds (culture, religion, language),61 shared life experiences, such as immigration 
experiences,62 shared health conditions,63 etc. Second, the health information provided by 
CHWs was seen as credible because CHWs, while representatives of the health system, had 
more time with patients than physicians to answer questions,62,64 had direct access to 
physicians to clarify patient questions and had continuity with patients.65 66Third, when it 
came to social support, CHWs, unlike anyone else on the healthcare team, had the lived 
experience to uniquely understand challenges faced by patients, well beyond the medical 
realm and consequently, patients shared challenges with CHWs that they may not have 
shared with physicians.66,67 Consequently, CHWs not only provided various types of 
instrumental social support to patients (assisting them with accessing food, transportation, 
childcare etc.), 68,69 but they were also able to provide empathetic support 70,71 and model 
healthy behaviors.72,73 Finally, CHWs have also helped patients with technological literacy, 
by modeling the use of technology for health education (digital storytelling for health 
promotion,74 using tablets for health education,75) and by helping patients who experience 
the digital divide use technology to better access and manage care.76,77
Conceptual Framework: The research study is guided by a conceptual framework78 to 
explicate the processes through which CHWs facilitate the adoption of healthy behaviors 
among their patients. In this framework shown in Figure 1, there are four components 
that synergistically influence patients’ intention to adopt healthy behaviors: (1) CHWs 
leverage their cultural congruence with patients, (2) CHWs employ interpersonal 
communication techniques to build trust and rapport, (3) CHWs provide social support, 
and (4) CHWs assist with adopting healthy behaviors. Much like The CHWs and Patient 
Partners in Health Study Framework, our intervention also will leverage the same four 
components in using CHWs to influence safety-net patients’ intention to participate in 
COVID-19 testing and vaccination.
 
IRBNet #: 1838914-1
Approved by: CDU IRB
Approval Period: April 29, 2022 to April 19, 2023

Form 102, Rev. 9/2018a
Page 7 of 31
With this project, we will provide a training for CHWs already working in the LACDHS to 
enhance 
their abilities to 1) build trust when communicating virtually with patients based on their 
shared identities, geographies, and histories; 2) provide accurate and credible health 
information about COVID-19 testing, vaccination, prevention, and care, 3) provide social 
support based on specific understanding of patient socioeconomic challenges and 
concerns surrounding COVID-19 testing and vaccination, and d) address their patients’ 
gaps in technological               literacy and help them maneuver through new health care 
processes in a telehealth environment. Once they  have received our enhanced training, 
they will, in turn, facilitate a series of six group classes on COVID-19 testing and 
vaccination related barriers/facilitators to intervention patient groups and six 
personalized support sessions to intervention patients to address obstacles to COVID-19 
testing and vaccination.
Summary of the Significance of our Approach: The research project is timely and 
important because 1) while COVID-19 testing is essential for public health mitigation efforts of 
the pandemic, vulnerable safety-net minority patients are not completing lab orders for 
COVID-19 testing and vaccination; 2) research on barriers suggests potential leverage points; 
and 3) linguistically and ethnically matched Community Health Workers working in the safety 
net health system are in ideal positions to lead intervention efforts. The project will draw on 
these data, resources, and opportunities to use multiple methods to enhance and test a 
proven community-engaged approach for addressing obstacles to COVID-19 testing for safety 
net patients.
References 
Please note references 1-29 were also referenced in IRB Application #1682977 for Aims 1 and 2. 
1.
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36. George S, Dixon LZ, Carrasco E, Romo O, Vides L, Balcazar H. Talk to PAPA A Systematic 
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Chronic Disease. 2012;9:E35-E35.3310145 
41. Balcazar HG, Byrd TL, Ortiz M, Tondapu SR, Chavez M. A Randomized Community 
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Underserved. 2009;20(4):1079-1094
42. Balcazar HG, Wise S, Redelfs A, et al. Perceptions of Community Health Workers 
(CHWs/PS) in the US-Mexico Border HEART CVD Study. International Journal of 
Environmental Research and Public Health. 2014;11(2):1873-1884
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de Salud Cardiovascular Disease–Prevention Trial Among At-Risk Hispanic Adults. Health 
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48. Brownstein JN, Bone LR, Dennison CR, Hill MN, Kim MT, Levine DM. Community health 
workers as interventionists in the prevention and control of heart disease and stroke. 
 
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American Journal of Preventive Medicine. 2005;29(5):128-133
49. Norris SL, Chowdhury FM, Van Le K, et al. Effectiveness of community health workers in 
the care of persons with diabetes. Diabet Med. 2006;23(5):544-556
50. Gibbons MC, Tyus NC. Systematic review of US-based randomized controlled trials using 
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52. Daaleman TP, Fisher EB. Enriching Patient-Centered Medical Homes Through Peer Support. 
Annals of Family Medicine. 2015;13(Suppl 1):S73-S78.PMC4648135
53. Rosenthal TC. The medical home: growing evidence to support a new approach to primary 
care. J Am Board Fam Med. 2008;21(5):427-440
54. Rogers EA, Manser ST, Cleary J, Joseph AM, Harwood EM, Call KT. Integrating Community 
Health Workers Into Medical Homes. Annals of Family Medicine. 2018;16(1):14-
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55. The Community Health Worker Health Disparities Initiative National Heart, Lung and Blood 
Institute, National Institutes of Health. 
https://www.nhlbi.nih.gov/health/educational/healthdisp/chw-healthdisparities-
initiative.htm. Published 2014. Accessed September 20, 2018, 2018.
56. Berwick DM, Nolan TW, Whittington J. The triple aim: care, health, and cost. Health Aff 
(Millwood). 2008;27(3):759-769
57. Achieving the Triple Aim: Success with Community Health Workers. Massachusetts: 
Massachusetts Department of Public Health;2015.
58. Taking Innovation to Scale: Community Health Workers, Promotores, and the Triple Aim. 
California Health Workforce Alliance;2013.
59. Memorandum on Identification of Essential Critical Infrastructure Workers during Covid-19 
Response 2020. https://www.cisa.gov/sites/default/files/publications/CISA-Guidance-on-
Essential-Critical-Infrastructure-Workers-1-20-508c.pdf Retrieved August 21, 2020
60. US Senate. Press release, Gillibrand, Bennet announce “Health Force” to recruit, train, and 
employ Americans as United States battles coronavirus pandemic. 2020 Available from: 
https://www.gillibrand.senate.gov/news/press/release/gillibrand-bennet-announce-health-
force-torecruit-train-and-employ-americans-as-united-states-battles-coronavirus-
pandemic.
61. Islam NS, Zanowiak JM, Wyatt LC, et al. A randomized-controlled, pilot intervention on 
diabetes prevention and healthy lifestyles in the New York City Korean community. J 
Community Health. 2013;38(6):1030-1041.PMC3964609
62. Katigbak C, Van Devanter N, Islam N, Trinh-Shevrin C. Partners in health: a conceptual 
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healthy behaviors. Am J Public Health. 2015;105(5):872-880.PMC4386525
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in an urban primary care practice. J Ambul Care Manage. 2012;35(1):38-49
65. Heisler M, Spencer M, Forman J, et al. Participants' Assessments of the Effects of a 
Community Health Worker Intervention on Their Diabetes Self-Management and 
Interactions with Healthcare Providers. American Journal of Preventive Medicine. 
2009;37(6):S270-S279
66. Collinsworth A, Vulimiri M, Snead C, Walton J. Community health workers in primary care 
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67. Nguyen TU, Tran JH, Kagawa-Singer M, Foo MA. A qualitative assessment of community-
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recommendations for developing a navigator training curriculum. Am J Public Health. 
 
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2011;101(1):87-93.PMC3000717
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Health Policy. 2007;82(2):153-166
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71. Gimpel N, Marcee A, Kennedy K, Walton J, Lee S, DeHaven MJ. Patient perceptions of a 
communitybased care coordination system. Health Promot Pract. 2010;11(2):173-181
72. Albarran CR, Heilemann MV, Koniak-Griffin D. Promotoras as facilitators of change: Latinas' 
perspectives after participating in a lifestyle behaviour intervention program. Journal of 
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73. McCorkle BH, Dunn EC, Yu Mui W, Gagne C. Compeer friends: a qualitative study of a 
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77. Katigbak C, Van Devanter N, Islam N, Trinh-Shevrin C. Partners in health: a conceptual 
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healthy behaviors. Am J Public Health. 2015;105(5):872-880.PMC4386525
3.
Study Design:  Describe the study design (e.g., double blind, crossover, etc.) and sequentially 
list all procedures, drugs or devices to be used on research participants.   Describe any use of 
placebos and indicate whether participants will be randomized in this study.  If there are any 
investigational drugs or biologic agents used in this study, please complete and include Form-132 
(Investigational Drug Information) with this application.
A key objective of this study is to use the results from the combination of machine learning 
and qualitative methods to implement a CHW-based intervention among African American and 
Latinx safety-net patients who declined COVID-19 testing and/or vaccination. Specifically, we 
will use a CHW-led health education intervention to provide information on COVID-19 
resources and services in LA County to LACDHS safety-net patients and to address barriers to 
knowledge and access, and improve perceptions and intentions on COVID-19 testing and 
vaccination.  
This aim will be a randomized control study; the control arm will consist of the standard 
treatment of LACDHS Vaccine Hesitancy Outreach Group calling participants to remind them 
to get COVID-19 vaccinated; the intervention arm will consist of a CHW-based health 
educational program via Zoom, where participants will be provided with information about 
COVID-19, COVID-19 resources and services in Los Angeles County, and engagement with 
LACDHS CHWs who will be available to answer the questions of the patients in the 
intervention arm. 
Study Population
 
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4.
Study Population:  Describe the characteristics of the participant population including, 
anticipated number, age range, gender, ethnic background and health status.  Provide a candid 
discussion of potential problems related to the study population.  Explain the rationale for the use of 
special classes such as fetuses, pregnant women, children, prisoners, or other vulnerable 
populations.  If women, minorities or children are excluded, provide written justification.
a.
Anticipated number of participants to be enrolled:  
Aim 3: We will recruit a total of 142 patients to allow for approximately 10% attrition 
from each group. The final number of enrollees we require to successfully complete the 
study is 128 LACDHS patients composed of 32 African American and 96 Latinx patients 
who have not completed COVID-19 testing and/or vaccination, according to LACHDS 
records. 
Each arm will have at least 64 LACDHS patients, comprised of at least 16 African 
American and 48 Latinx patients who have not completed COVID-19 testing and/or 
vaccination 
b.
Age range:  16 years old and older for Aim 3
c.
Gender:  all genders for Aim 3
d.
Racial/ethnic background:  African American and Latinx for Aim 3
e.
Describe health status:  LACDHS patients who did not complete a lab order for COVID-
19 testing or COVID-19 vaccination from Aims 1 and 2
f.
Foreign language translation and interpreter required?  None
g.
Other population characteristics:  None
h.
Potential problems related to study population:  None
i.
Vulnerable populations included in the study and the rationale:  None
j.
If excluding women, minorities, and children, please provide justification:  
We will exclude children (those under the ages of 16) from this study. 
Moreover, we are excluding patients under the age of 16 because a) they were not yet 
eligible for COVID-19 vaccination as of April 19, 2021 and b) decision making on 
COVID-19 testing and vaccination for children is usually made by their adult 
caregivers. 
5.
Inclusion/Exclusion Criteria:  Indicate the criteria for exclusion and inclusion and explain the 
system for equitable selection of participants. 
Aim 3
Inclusion Criteria:

Age 16 years and older

Self-identify as African American or Latinx

English Speaking 

Receives primary or specialty care treatment at an LACDHS facility 

Has either not completed lab orders for COVID-19 testing and/or vaccination at an 
LACDHS facility

Have reliable internet access
Exclusion criteria: 

Not meeting the inclusion criteria listed above 
6.
Eligibility:  How and by whom will it be determined that interested individuals meet the inclusion 
and exclusion criteria? 
 
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Our community partner and Multiple PI (MPI) Dr. Daskivich, along with the LACDHS Vaccine 
Hesitancy Outreach Group, will generate a list of LACDHS patients who have been offered but 
not taken up the opportunity to get the COVID-19 test and/or vaccine, and who meet other 
inclusion/exclusion criteria from LACDHS ORCHID. This list will include names of patients and 
contact information such as phone number, email, address, etc. which study staff will use to 
ensure that selected patients meet our inclusion criteria by a) cross referencing our data list 
from Aim 1 to ensure they are LACDHS empaneled patients, b) checking each potential 
candidate’s medical record to see if they meet the inclusion criteria, and c) calling each 
potential candidate by telephone to confirm eligibility for inclusion before presenting the 
opportunity for participation in the study. 
7.
Participant Identification and Recruitment:  Describe the methods used to identify and 
recruit potential participants.  This section should include how, where, when, and by whom the 
potential participant is approached.   Attach a copy of all planned scripts, advertisements, flyers and 
letters, etc. to the potential participants.
Table 1 below gives our recruitment goals for Aim 3 with a breakdown of the number of 
participants that will be assigned to the case and control arm: 
Table 1. 
Patients not 
vaccinated
Patients who did not complete 
lab orders for COVID test
Total
Control
32
32
64
Intervention
32
32
64
Total Study Participants
128
Identification Strategy
We will need to enroll at minimum total of 128 participants to successfully complete the 
study, with a breakdown of 32 African American and 96 Latinx patients to reflect the LACDHS 
patient population in our study. 
Our community partner and Multiple PI (MPI) Dr. Daskivich, along with the LACDHS Vaccine 
Hesitancy Outreach Group, will generate a list of LACDHS patients who have been offered an 
appointment to be vaccinated and who have not taken the COVID-19 test and/or vaccine, and 
who meet all other inclusion criteria. The patient list from the DHS Vaccine Hesitancy 
Outreach Group, is a filtered list of the empaneled patients we obtained from Aim 1. The 
patient list provided by the DHS Vaccine Hesitancy Outreach Group a list of current patients 
from DHS County records showing which patients who do not have a completed vaccination 
status on their record.
Our study staff (Denisse Ruiz, project coordinator and Jacqueline Carranza, research 
assistant), will work with the support of our two consultant-specialist LACDHS CHWs, who will 
provide additional insight on recruitment strategies. 
For our recruitment process: The two CHW specialists and the intervention CHWs will help us 
identify and recruit participants by assisting in circulating the patient recruitment flyer within 
their CHW networks and DHS facilities. By using the CHW’s existing CHW and DHS network, it 
can assist with quick identification and recruitment of vaccine-hesitant patients. CHWs who 
work with these identified vaccine-hesitant patients can talk to the patients about the study 
and validate our research project is a legitimate study to overcome any initial patient 
skepticism.  
The study team will work with the Intervention CHWs and CHW specialists, and follow a 
standardized referral process. By having a standardized referral process with the CHW 
network, CHWs can assist with a soft hand off for patients that are interested in learning more 
about the study. Using CHWs in the referral process can also assist the study team, where the 
 
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Form 102, Rev. 9/2018a
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CHWs can measure and assess the patients’ interest in wanting to join the study and help with 
patient retention. 
CHW’s can confirm if patients they work with are not vaccinated. CHW-identified patients will 
most likely be in the vaccine hesitant list provided by the LACDHS Vaccine Hesitancy 
Outreach Group, as their records are obtained from ORCHID and updates from California 
Immunization Registry System (CAIRS). After streamlining the referral process, the study team 
will cross reference the referred patient with the patient list provided by the LACDHS Vaccine 
Hesitancy Outreach Group and the patient list from Aim 1. This will work in tandem with the 
process we have identified with the vaccine outreach group list because the CHWs that work 
with them will be able to do a soft hand off. The hand off will provide a stronger connection 
between the patient and the study, and will validate the project simultaneously. 
In addition to using CHWs as the preferred source of identification and recruitment of patients 
for the study, we will have an additional process of recruiting patients by virtual 
communication methods such as phone calls, texts, and emails. Using the list of vaccine-
hesitant patients from the LACDHS Vaccine Hesitancy Outreach Group, the study staff will 
filter the list of LACDHS patients to ensure only include patients who meet the inclusion 
criteria (16 years and older, self-identify as Latinx or African American) are on the list.
Preferred method:

CHW network will assist in identifying vaccine-hesitant and non-vaccinated people they 
work with at LACDHS facilities 

CHWs will talk to patients they work with about the study and provide them a flyer in 
case they are interested in participating. If a patient expresses they are interested in 
the study, the CHW will notify the study team with the patient’s contact information.

Study team will cross reference the lists of vaccine-hesitant patients provided by 
LACDHS Vaccine Hesitancy Outreach Group and Aim 1 data pull. 

If the patient is in the list, the study team can follow up with the referred patient to talk 
to them about the study and provide them additional details about the study. 

If the patient is interested in participating in the study, the study team will send them 
the consent forms and continue with study enrollment process. 
Recruitment Strategy – telephone script
Our study staff will contact the patients via telephone, ascertain their self-reported eligibility 
to participate in the study, present the study and invite them to participate in our 6-week 
study, where they will be randomly assigned to one of two groups. The study staff will explain 
what will be required of the participant, and answer any questions the potential participant 
may have about the study. If participants agree to be in the study, the study staff will send 
the participant a copy of the consent forms and follow up with them at a separate time to 
provide them time to review the consent forms with family or friends. During the phone call, 
the study staff will notify the participant they will be randomly assigned to one of two 
following groups:

Group 1 (Control Arm): will consist of two phone calls where participants are to 
complete a total of 4 surveys (demographic, pre-study and post-study survey, and CDE 
survey). The pre- and post- surveys will be completed six weeks apart at a time that is 
convenient for them. 

Group 2 (Intervention Arm): in addition to the surveys listed in Group 1, the group will 
consist of a six-week COVID-19 educational program, where participants will 
participate in a weekly 1.5 – 2-hour virtual classroom, and weekly 30-60 minute 
personal session with an assigned and IRB-approved Intervention CHW. 
o
Only the weekly group session will be recorded for further analysis and program 
evaluation, the personal session with the CHW will not be recorded. The Zoom 
recording feature asks participants to consent to being recorded. If participants 
do not agree to being recorded, the Zoom feature automatically disconnects the 
 
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Form 102, Rev. 9/2018a
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participant from the Zoom meeting. As such, participants must agree to being 
recorded during the consent phone call if they are randomly assigned to this 
group. Therefore, we will only include one option on the consent form saying 
they agree to being recorded during the weekly group only if they are assigned 
to Group 2. 
The approach for recruitment is based on our previous consultation with the LACDHS partners. 
The study staff created telephone recruitment scripts, patient recruitment flyers, and a 
recruitment strategy to illustrate what the study staff will be communicating with participants, 
and attached to the IRB application. The approaches below are overviews and will refer to the 
recruitment materials. 
Our primary and strongest recruitment effort will be for CHW specialists and their CHW 
network to introduce the study to potential participants and then let them know that if 
interested, the patient can contact the study team. 
A second approach will be the study team introducing the study with a patient recruitment 
flyer by mail from our LACDHS MPI and follow-up with a phone call using the telephone 
recruitment script the study team will use to introduce the study  to interested potential 
participants. 
A third approach is to distribute the flyer in LACDHS facilities and have participants call the 
study staff if they are interested in participating. After a screening and determination if the 
patient qualifies for the study, research staff will send the consent forms via email or mail and 
begin the consenting and enrollment process. 
Our recruitment strategies are detailed below:

We will distribute the patient recruitment flyer among the LACDHS CHW networks. 
CHWs will hand their patients a recruitment flyer (see attached) to assist with the 
recruitment for Aim 3. When they hand the flyer to their patients, they will explain to 
their patients this is a legitimate study, and their decision to participate or not will not 
affect the care they receive from the CHWs or LACDHS; we want the CHWs to 
emphasize that patients should not feel coerced to participate in the study if they do 
not want to. If participants express that they are interested in learning more about the 
project, they will be asked to contact the study staff on the phone number in the flyer 
for more information. After a line of communication is established between the 
prospective participant and research staff, the research staff will cross-reference the list 
from Aim 1 Data Pull to confirm if this is a patient that meets study inclusion criteria 
and continue explaining what the study entails. If the patient qualifies for the study, 
research staff will send a copy of the informed consent form via mail or email, 
according to the patient’s preference. Study staff will follow up with the patient one-
week later and review the consent form, answer questions, and obtain verbal consent. 
A summary of this recruitment strategy is found in Figure 1 Document: “Aim 3 
Patient recruitment strategy – flow chart.” 

Create a patient recruitment flyer and distribute the flyers by mail to potential 
candidates identified from Aim 1 data pull. After one week, study staff will follow up 
with the potential candidates via phone call, and using the telephone recruitment script 
(see attached), re-introduce the research study to see if the patient is eligible and 
interested in participating in the study. In this strategy, we aim to reach out to at least 
600 potential candidates for the study to account for patient retention rates. We are 
estimating about a third of potential candidates will answer the phone. Within that 
group of potential study participants, we estimate about half of the group will agree to 
participate and consent to the study. 

Similarly, to the approach above, we will reach out to patients via text messaging 
(using a non-personal phone number such as Google Voice) with a link to the patient 
recruitment flyer. If participants are interested to learn more, they can text back or call 
the number from where it was sent. In this strategy, we aim to reach out to at least 600 
 
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Form 102, Rev. 9/2018a
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potential candidates for the study in case they are not as receptive to phone calls and 
mail. We are estimating about a quarter of participants will respond (150) and 
potentially half of those who respond will enroll (75)

Distribute the patient recruitment flyer around LACDHS facilities and have participants 
call study staff if they are interested. If patients call study staff, study staff will establish 
a line of communication. The research staff will cross-reference the list from Aim 1 Data 
Pull to confirm if the patient meets criteria, study staff will continue to explain what the 
study entails using the telephone recruitment script. If the patient qualifies for the 
study, research staff will send a copy of the informed consent form via mail or email, 
according to the patients’ preference. Study staff will follow up with the patient one-
week later and review the consent form, answer questions, and obtain verbal consent.
Our approach for recruitment may be modified based on additional input from the LACDHS 
CHWs considering the dynamic nature of COVID-19 in communities of color. If our recruitment 
materials or approach are modified, we will submit any additional or modified recruitment 
materials as an IRB amendment (e.g. scripts, flyers, any –mail or letter to be sent by the 
LACDHS, etc. to notify the patient.)
Research Methods and Procedures
8.
Methodology and Procedures: Describe the research procedures that will be followed.  Please 
indicate those that are experimental and those that may be considered to be standard treatment. 
Describe all activities involving research participants and explain the frequency and duration of 
each activity.
Recruitment of CHWs: 
Currently, there are 76 CHWs working across the LACDHS health system and officially they are 
allowed to work 24 hours/week outside of their allotted weekly County work hours. Using our 
MPI’s and CHW networks, we will recruit 3 African American and 9 Latinx CHWs from the pool of 
currently employed LACDHS CHWs to participate and provide the intervention in this study. We 
estimate that each CHW will spend 24 hours over 2 weeks for the enhancement training pre-
intervention, 6 hours/week for group classes with patients and 10 -14 hours/week for 
personalized patient encounters over the two months of intervention implementation. 
Training of CHWs: 
We developed a training curriculum for the Intervention CHWs on how to implement the patient 
modules that address COVID-19 testing, vaccination, and care overall. The patient modules are 
based on our preliminary findings from Aims 1 and 2. 
Leveraging the resources of the CDU CHW Academy, study staff will train the Intervention CHWs 
virtually via Zoom. The training will take about 24 hours and will be delivered over the course of 
a month, allowing flexibility to CHW participants. Intervention CHWs will receive CITI training to 
ensure that they are compliant with IRB protocols and be IRB approved. 
Table 2 provides the training outline of how some barriers will be addressed systematically in 
the CHW training, in terms of the content of the curricular modules and the learning objectives. 
We developed the training curricula and with input from our two CHW specialists, they provided 
their assessments in tandem with the implementation and analysis of Aims 1 and 2.  
Table 2: CHW Training Plan
Identified Barriers to 
COVID-19 testing and 
vaccinations from
Aims 1+2
How CHW Training 
Addresses Barriers
Curriculum  Content
Learning Objectives
Barrier #1
Patient Mistrust of 
Demonstrate ways of building 
trust virtually with patients based 
on their shared identities, 
Building Trust in Virtual 
Communication Settings/ 
Historical Mistrust and 
1. Explain why trust is important in the 
patient relationship
2. Review and apply the steps for 
 
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Health Care 
Organizations and 
Providers
geographies, and histories
Addressing Barriers to Trust
building-trust virtually
Barrier #2
Patient Lack of Reliable  
COVID-19 Health 
Information
Highlight the importance of timely, 
accurate, credible health 
information about COVID-19 
testing, vaccination, prevention, and 
care
COVID-19 health information 
challenges and sources of 
culturally relevant COVID-19 
information for all reading 
levels
1. Address frequently asked 
questions and explain the facts and 
myths about COVID-19
2. Use information from official 
sources, including local, state, and 
federal health agencies
Barrier #3
Patient Lack of Social 
Support and Resources 
Compounded by COVID-
19
Demonstrate ways of providing 
Social support based on a better 
understanding of patient 
socioeconomic challenges and 
concerns with COVID-19 testing and 
vaccination 
Description of Social Support 
Resources for COVID-19 testing, 
vaccination, and care specific 
needs and other health-related 
needs.
1. Identify specific social determinants of 
health that are obstacles to COVID-19 
testing, vaccination and access to care.
2. Review community resources 
available for referrals
Barrier #4 
Patient Lack of Facility 
with Accessing Health 
Information Technology
Address gaps in technological 
literacy and help them maneuver 
through new health care processes
Description of digital divide 
related inequities for safety-net 
patients, changes in telehealth 
environment and practice using 
and explaining use of Health 
Technology Tools
1. Discuss patients’ challenges with 
accessing & using health information 
technologies 
2. Identify local telehealth resources 
that assist patients.
3. Review and apply the steps for 
building technological literacy. 
After completing the intervention training, each Intervention CHW will be assigned to support 5-
8 patients, who were randomly assigned to the case arm, by delivering a remote intervention of 
hosting a health class on COVID-19, at a time that is convenient for the both the participants and 
the Intervention CHW. 
Intervention Design: 
We will utilize a randomized control design consisting of one treatment arm and a control arm. 
African American and Latinx patients who did not complete COVID-19 testing or vaccination will 
be recruited from the patient list obtained from Aim 1 data pull of the LACDHS EHR. The patient 
list obtained by the data pull will be filtered by the patient list provided by the LACDHS Vaccine 
Hesitancy Outreach Group. Based on the inclusion criteria, we will recruit a total of 142 patients 
to allow for approximately 10% attrition from each group. Patients who meet the inclusion 
criteria and agree to participate in the 2-month intervention will be randomly assigned to either 
the intervention or control arm. 
We will stratify the randomization on the basis of race/ethnicity and we will use permuted blocks 
(see table 3). We will use a scheme such as found at randomization.com. Here we will define a 
block size of 4 subjects and determine a random permutation of 2 treatment and 2 control 
assignments employed the scheme in question. This is repeated to cover the request number of 
blocks in each stratum in order to randomize the total number of required subjects. We expect 
our study sample to reflect LACDHS patient population race/ethnicity stratification (9% African 
American and 68% Latinx).
Table 3 – Stratified Random Sampling 
Block 
Category 
Number of participants to 
enroll
Block 1
African American + control
18
Block 2
African American + case
18
Block 3
Latinx + control
53
Block 4
Latinx + case 
53
We will refer the control arm as “Group 1” and the intervention arm as “Group 2” for 
the purposes of explaining to prospective participants they will be randomly assigned 
to a group without compromising the integrity of the study. 
Participants will need to complete the consenting process, complete a basic demographic 
survey, and wait to be randomly assigned to either Group 1 or 2. Once assigned to a group, the 
study staff will notify the participant of which group they were assigned to. The methodologies of 
 
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each respective group are detailed below after the participants are notified which group they 
were randomly assigned to.
Control Arm- Standard Treatment (Group 1):
The standard care for the control arm will be: the LACDHS Vaccine Hesitancy Outreach Group 
calling patients once every month to remind patients of the need to be vaccinated and tested if 
needed. During the duration of the six weeks, the study participants will be exposed to the call 
from the LACDHS Vaccine Hesitancy Outreach Group.
Participants will receive two phone calls six-weeks apart, where they will complete a pre-survey 
in the first phone call, and 2 surveys (post-survey and CDE survey) in the second phone call. The 
survey will measure their trust in medical institutions, rate their self-efficacy, and intention, 
knowledge, and perceptions on COVID-19 testing and vaccination. Each survey will take about a 
half hour to complete, with the total time commitment for participants in Group 1 is about 1-1.5 
hours. A copy of the surveys will be sent to the study participant either by email (preferred) or 
postal mail, prior to the telephone call. 
An outline of the activities in Group 1 will look like: 
1.
Complete the pre- survey
2.
Wait 6 weeks, where the LACDHS Vaccine Outreach Group will call one time in the month 
to remind them about getting the vaccine
3.
After the 6 weeks have passed, the study staff will follow up with the participant to 
complete the post-survey and the CDE survey. 
Study staff will use the REDCap Calendar feature to track events (such as when to administer 
the pre- and post- surveys) and will be used for data entry. The filters and reminders on the 
calendar feature assist study staff with adding events to adhere to study follow up times for 
study staff to call participants six-weeks later. If participants do not answer the phone calls to 
complete the post-survey, we will add a note on the patient’s chart, follow up three times to 
provide additional opportunities for patients to complete the study, and mark the patient’s chart 
as “Incomplete”. Once phone calls and post- surveys are complete, study staff will mark the 
participants’ charts as “Complete.” 
Intervention Arm – CHW-led curriculum (Group 2)
Participants assigned to the intervention group will be asked to participate in the virtual 
intervention, consisting of six-weekly group classes via Zoom, and six-weekly personalized 
teleconsultations (via phone call or Zoom) at a suitable time for both participants and CHWs. 
Study participants will receive 6 linguistically and ethnically concordant weekly two-hour group 
classes and personalized teleconsultations led by CHWs. The total time commitment for Group 2 
will be a maximum of 20 hours (6 two-hour group classes, + 6 one hour personal session, + 2 
half hour phone calls), over the next 6 weeks. 
Table 4 outlines the group classes that will be used in the intervention. The findings from Aims 
1 and 2 are incorporated in the curriculum and address the four barriers to COVID-19 testing and 
vaccination (mistrust, COVID-19 knowledge, social support, and health & technological literacy). 
The list of topic areas for the group sessions, which incorporate findings from Aim 1 and 2, were 
validated by the study CHWs specialists. The complete list of topics and learning goals under 
each module is found in “Attachment 2 – Aim 3 Curriculum Module Outline.” These topic 
areas are grouped into curricular tracks as summarized below:
Table 4: Summary of Group Classes for Intervention Arm 
Week 1
1) Introduction and Exploration CHWs will introduce process, 
build rapport and elicit the key needs/ concerns of the patient 
group (topics: previous pandemics, current pandemic, how 
 
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current pandemic affected them)
Week 2
2) Misinformation, Information, and Prevention (topics: where 
do they get their news, understanding misinformation, social 
distancing in housing contexts with limited space, mask wearing 
and handwashing, contact tracing, vaccination etc.)
Week 3
3) COVID-19 Testing, and General Vaccine Information 
(topics: types of tests, locations and  processes around testing 
and vaccination, fears about testing, and general vaccination 
information.)
Week 4
4) COVID-19 Vaccination (topics: types of vaccines, locations 
and   processes around vaccination, fears about vaccination etc.)
Week 5
5) Building Social Support (topics: caring for a sick member of 
the family; managing self-isolation; social services and mental 
health resources; hospitalization and treatment; managing chronic 
illnesses, accessing specialty care, accessing telehealth-based 
care etc.).
Week 6
6) Closure: CHWs will ask patients to reflect on their learning and 
address any additional concerns
Barriers to COVID-19 testing and vaccination: 
1) Misinformation, Information, and Prevention (topics: identifying misinformation, 
mask wearing and handwashing, vaccination, etc.)
2) Testing and Vaccination (topics: types of tests and vaccines, locations and 
processes around testing and vaccination, fears about testing and vaccination 
etc.)
3) Building Social Support (topics: caring for a sick member of the family; managing 
self-isolation; social distancing in housing contexts with limited space, social 
services and mental health resources; hospitalization and treatment etc.), 
4) Ongoing healthcare in the age of COVID-19 (topics: managing chronic illnesses, 
accessing specialty care, accessing telehealth- based care etc.). 
Furthermore, participants will receive six one-hour weekly teleconsultations via phone calls, 
after they attend the group class (at a time that is both convenient for the participant and CHW) 
from their assigned CHWs to discuss progress toward personalized goals, the social support 
group experience, and resolve barriers to testing, vaccination, and accessing care. The 
Intervention CHWs will be asked to complete a patient encounter form on REDCap (See 
attached: Patient Encounter Form) after each of the six personalized patient interactions, 
documenting the nature of the interaction, the types of concerns raised by the patient and the 
types of information and support that was provided by the CHW. These forms will capture the 
participants’ behavior and willingness to be open with the CHW and to document the 
participants’ behavioral progress throughout the program. The forms will also be used as an 
evaluation tool, where study staff and PIs will review to provide the CHWs with feedback and 
support. 
An outline of how the activities in the intervention group will be performed are the following:

Complete pre-survey 

Complete intervention activities: 
o
Attend weekly group online classes, via Zoom. Each online class will take around 
90 minutes – 2 hours each. 
o
Participants will be asked to complete surveys (See attached: Knowledge 
Checks) and participate in group discussions 
o
Attend a weekly personal session with the Intervention CHW (via phone call or 
Zoom). Each personal session with the CHW will take between 30 minutes to an 
hour. The CHW will facilitate a discussion for the participant to share their 
thoughts, feelings, and experiences with COVID-19 testing, vaccination, and 
healthcare. 

Have participant complete the post-survey and the CDE survey 
 
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Once there are groups of 5-8 participants assigned to the intervention arm, the groups of 
participants will be assigned to an Intervention CHW to start the intervention. Depending on 
recruitment of participants, the intervention arm start dates will be staggered. 
A note for the Intervention Group: 
Participants will be notified during the consent process that if they are randomly assigned to 
Group 2 (intervention group), then participants will need to have a reliable internet connection 
and a device with a screen larger than 7 inches to attend the classes. 
To remove any barriers to connecting to the group classes, if participants state they do not have 
a large enough device to use to log into the zoom meetings, participants will be provided with an 
android tablet with the Zoom application installed. The study staff will not require the 
participants to return the tablets. The study staff do not believe giving the tablets might inflict a 
sense of unfairness to the participants that end up being in the control arm. It is not unfair to 
provide the tablets to the participants in the intervention arm for the following reasons:
1.
The time commitment is different, 20 hours for intervention and up to 2 hours for the 
control arm.
2.
Intervention arm participants need the tablet to join the classes, the control arm 
participants don’t need a tablet to complete the activity.
In addition, the tablets would be an older model and are worth $100 each, not an expensive 
device such as an iPad. The tablets would quickly lose their values and would not be able to be 
repurposed for another study. We believe it is best that we give the tablets to the participants so 
they can feel they can be trusted and it can help with participant retention in the study.
A note about the NIH’s Common Data Element Survey
Once the project is completed, both groups will be asked to complete a Common Data Element 
Survey as requested by the NIH’s terms and conditions. A priority of the RADx initiative is to 
build the RADx Data Hub, the NIH’s resources of RADx-generated research data that can help 
other researchers and public health officials better understand the impact of the COVID-19 
pandemic, including outcomes, disparities, and possible solutions. RADx-UP projects collect data 
for the RADx Data Hub and simplify the analysis of that data, the NIH defined a set of Common 
Data Elements (CDEs). The NIH RADx-UP CDEs provide a standard set of study questions that 
RADx-UP projects are required to use in their COVID-19 studies. Additional information can be 
found at https://radx-up.org/learning-resources/cdes/ 
9.
Surveys, questionnaires, or psychological tests:  If your study uses surveys, 
questionnaires, or psychological tests, please list and describe the setting, mode of administration, 
the length of administration time, number of repeats, and if special training or qualifications are 
necessary to administer the study instruments.  Describe provisions for maintaining privacy and 
confidentiality.  
All the following surveys and questionnaires will be comprehensible to participants by 
ensuring readability checks on the type of language used, simplicity of language, and 
additional explanation of concepts. 
A basic demographic survey (see attached: Basic Demographic Survey) will be 
administered on a phone call when the patient has been consented and enrolled in the study. 
In this demographic survey, the survey consists of demographic questions such as age, race 
and ethnicity, education level, and other sociodemographic questions and will take about 10 
minutes to complete. 
Pre- and post- surveys (see attached: Pre- and Post- RADxUP Survey) will be 
administered telephonically by study staff to enrolled study participants. These surveys will be 
provided to both control and case arms, to measure three key measures: trust, self-efficacy, 
 
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and intent to participate in COVID-19 testing and vaccination. Secondary measures included 
will use brief measures from the RADxUP and Phenx database of COVID protocols such as 
worry about COVID-19, knowledge, attitudes, behaviors, social support, perceived COVID-19 
threat, and sources of information about COVID-19. 

Pre- surveys will be administered by IRB-approved study staff, after study 
participants are consented and enrolled into the study and at a convenient time for the 
study participant. The survey should take about 30-60 minutes to complete (see Pre- 
and Post- RADxUP Survey). The survey questions and answers will be sent via email 
or mail prior to the phone call, and read and answered over the phone by the study 
staff to overcome any misinterpretation of the survey questions. The participant’s 
response will be input by the study staff directly into REDCap under the subject ID#. 
No special training will be required to administer the survey.

Post- surveys will take between 30-60 minutes to complete (see Pre- and Post- 
RADxUP Survey). The survey questions and answers will be read and answered over 
the phone by study staff to overcome any misinterpretation of the survey questions. 
The participant’s response will be input by the study staff directly into REDCap under 
the subject ID#. No special training will be required to administer the survey. 
o
The post survey will be administered by study staff telephonically (similar to the 
pre-survey process) after:

Control arm – 6 weeks from the first survey

Case arm – after they complete the 6th group class and 6th personal phone 
call with the CHW 
As part of the intervention arm, the modules will incorporate weekly formal “Knowledge 
Checks” (see Knowledge Checks) a comprehension questionnaire administered via email 
survey (sent by REDCap) sent after each module, which all participants will complete before 
their personal phone call with the CHW. The purpose of these Knowledge Checks is for the 
study team to measure patients’ comprehension after each group session and throughout the 
course of the study. If patients score low in the Knowledge Checks, the CHW will review with 
the patients during their personal sessions to increase comprehension of the materials 
presented during the group session. There will be a total of 5 Knowledge Checks for Modules 
1-5 (the Post- survey will be administered in lieu of a Knowledge Check for Module 6), each 
with 5-10 multiple-choice questions.
The study team will administer the Common Data Elements (CDE) Survey as provided by 
the funding partner, RADxUP (see RADxUP CDE Survey attached), the survey will be sent 
via email at the end of the project. Participants will be asked to complete it once. The survey 
can take up for 45minutes to an hour, no special training is required. In the RADxUP website, 
the reason for collecting the CDE’s is “… to ensure consistency in how RADx-UP projects 
collect data for the RADx Data Hub and simplify the analysis of that data, the NIH defined a 
set of Common Data Elements (CDEs). The NIH RADx-UP CDEs provide a standard set of study 
questions that RADx-UP projects are required to use in their COVID-19 testing studies.” More 
information can be found at https://radx-up.org/learning-resources/cdes/ 
10. Data Collection, Storage and Confidentiality:  Please complete the following questions 
regarding data.
a.
How will the data be collected and recorded?  How will the data be coded to protect 
personal privacy?
Data Collection: 
The different types of data that will be collected in this aim are: 

Verbal Consents 

Basic Demographic Survey

CDE survey (NIH’s required survey)
 
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
Pre- and post- surveys

Knowledge Checks (comprehension questionnaires for intervention arm) 

Patient Encounter Forms (CHW reports for personal encounters in intervention arm)
 
Verbal consents – will be obtained telephonically by study staff before participants are 
enrolled in the study, and will be reviewed, recorded, and collected at a time that is 
convenient for the study participant. The study staff, who are IRB approved, will save the 
audio recordings on REDCap under the subject ID# with a date and time stamp, 
documenting when the participant provided their verbal consent. 
Basic Demographic Survey – The survey will be administered and obtained 
telephonically with study staff at the end of the study, and will be reviewed and collected at 
a time that is convenient for the study participant. The answers to the survey will be input 
directly into REDCap under the subject ID# with a date and time stamp, documenting when 
the participant completed the survey.
CDE Survey - The questions on this survey are required to be collected, as noted in the 
NIH’s terms and conditions of funding the project. The project staff is in the process of 
requesting an exemption review for the Alcohol and Tobacco questions. However, the CDCC 
instructed the project staff to include all of the Common Data Elements as created by the 
NIH until our request is reviewed and approved. Selected CDE questions are used in the 
basic demographic survey that will be asked once (See Basic Demographic Survey). 
Additional information about the CDE’s and a copy of the CDE survey can be found on the 
RADx-UP website at: https://radx-up.org/learning-resources/cdes/ 
Due to the sensitive nature of select questions, the study team will provide this survey to 
the study participants at the end of the project to give the project team additional time to 
have the questions reviewed and approved to be exempted. The study staff will notify the 
participants during the consent they will have to complete this additional survey at the end 
of the project. The survey will be sent out via REDCap to the participant’s email and explain 
to participants they are also given the option to not answer any questions they do not want 
to answer. The answers to the survey will be saved on REDCap and shared via a secure 
portal to the NIH’s RADxUP data sharing hub. 
Pre- survey – will be administered telephonically with study staff after the study 
participant is consented and enrolled in the study, at a time that is convenient for the study 
participant. The study staff, who are IRB approved, will send the survey to the participant 
to review prior to data collection, and will read the questions and answer choices aloud and 
input the participant’s answer directly into REDCap under the Subject ID#. If participants 
state they are comfortable with completing the survey on their own, the study staff will 
send the survey via REDCap to the email Participants enrolled in both control and case arm 
will complete this survey. Participants in the case arm will complete the survey before they 
attend the group classes and phone calls with the CHW.
Post- survey – like the pre- survey, the post- survey will be administered telephonically 
with study staff, at a time that is convenient for the study participant. The study staff, who 
are IRB approved, will resend the survey out before the phone call to read the questions 
and answer choices aloud and input the participant’s answer directly into REDCap under 
the Subject ID#. Participants enrolled in both control and case arm will complete this 
survey. Participants in the control arm will complete the post- survey 6 weeks after they 
complete the pre- survey. Participants in the case arm will complete the survey after they 
attend the 6th group class and 6th phone call with the CHW.
Knowledge checks – this survey will only be administered to study participants randomly 
assigned to the case arm on a weekly basis, after they attend a group session. The survey 
will be sent out via email using the REDCap survey feature. If participants are not able to 
complete the survey via email, study staff will follow up with the participants via phone call 
to complete the survey where study staff will read the questions and answers aloud. The 
 
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study staff will then enter the answers directly into REDCap. This survey will need to be 
completed before the participants complete their personal phone calls with the CHW. 
Patient encounter forms – this data collection tool will only be used on study 
participants randomly assigned to the case arm during their weekly teleconsultations. 
Intervention CHWs will complete these forms after each of their teleconsultations (personal 
phone calls) with their assigned study participants and enter their notes on REDCap. Each 
participant will have six completed patient encounter forms in their subject file on REDCap 
by the end of the study. The teleconsultations will be scheduled at a time that is 
convenient for both the participants and the CHWs. 
One of the MPI and software programmer will strip personally identifiable information from the 
clinic data and substitute with a random code (Subject ID#). A master code list will be created 
separately that will link the code with the patient. This master code list will reside in a 
separate file in REDCap. 
b.
Where will the data be stored and how will it be secured during the study?
The data from Aim 3 will be stored in REDCap electronic data capture resource administered 
by the Biomedical Informatics Core function of AXIS (Accelerating Excellence in Translational 
Research) and the UCLA Clinical and Translational Science Institute (CTSI). REDCap (Research 
Electronic Data Capture) is a secure, web-based application designed to support data capture 
for research studies, providing: (1) an intuitive interface for validated data entry; (2) audit 
trails for tracking data manipulation and export procedures; (3) automated export procedures 
for seamless data downloads to common statistical packages; and (4) procedures for 
importing data from external sources.
CDU’s REDCap servers are hosted by the University of California, San Diego Supercomputer 
Center. Vanderbilt University, with collaboration from a consortium of institutional partners, 
developed REDCap specifically around HIPAA-Security guidelines. REDCap can be used to 
easily build and manage online surveys and databases and all web-based information 
transmission is encrypted. REDCap currently has over 4641 collaborating institution in 139 
countries wide with over 1.5 million end-users conducting 1 million projects (www.project-
redcap.org). CDU’s implementation of REDCap can be found at https://redcap.cdrewu.edu.
1Paul A. Harris, Robert Taylor, Robert Thielke, Jonathon Payne, Nathaniel Gonzalez, Jose G. 
Conde, Research electronic data capture (REDCap) – A metadata-driven methodology and 
workflow process for providing translational research informatics support, J. Biomed Inform, 
2009 Apr; 42(2):377-81.
c.
Who will have access to the data and/or the data codes?  If data with participant 
identifiers will be released, specify the person(s) or agencies to whom this information 
will be released.
The core study team (the MPIs, Machine Learning Specialist, Study Coordinator, and Research 
Assistant) will have access to the data and the data codes. The Biostatistician will have access 
to the data for data analysis, but not the data codes. 
We will not release data with participant identifiers. 
d.
What will happen to the data when the study is completed?  How long will the data be 
kept and what kind of identifiers will be associated with the data for long-term storage? 
The data will be stored in REDCap for continued analysis and publication of manuscripts for up 
to six years after the overall study has been completed. During the six years, the coded link 
 
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will be maintained, as well as the master code that identifies the code with a particular 
patient.
The data from Aim 3 will be shared with NIH RADxUP program, who has funded this study and 
requires that de-identified data be shared as part of a national database for collective 
learning. The data will be submitted to the RADx-UP CDCC on a regular schedule as required 
by the funder, the NIH. The RADx-UP CDCC has chosen the Duke Research Center Institute 
(DCRI) to manage the data and be responsible for submitting de-identified datasets to the 
RADx Data Hub. The following link describing an overview of this process can be found:  
https://radx-up.org/learning-resources/cdes/#files and the following link describes the DCRI as 
the data collaborator with the RADx initiative 
https://reporter.nih.gov/project-details/10233289 . Detailed information on this process can be 
found: https://radx-up.org/wp-content/uploads/2021/01/RADx-
UP_Data_Harmonization_Guidance_CDEs.pdf 
Risk/Benefit Assessment
11. Potential Risks and Discomforts:  Describe any potential risks (physical, psychological, 
social, legal, or financial) and discomforts that may be associated with the study, including likely 
adverse effects of the drugs, biologics, devices, research procedures, or interventions.  If possible, 
assess their likelihood (quantitative and qualitative descriptors) and seriousness (permanent or 
transient condition).
Aim 3
The level of risk associated with this study for Aims 3 is minimal; therefore, we do not 
anticipate any major risk as a result of participating in this study. However, the potential risk 
and discomfort for the participant may include inadvertent 1) breach of confidentiality and 
anonymity; 2) violation of privacy, 3) embarrassment, and discomfort. There is a risk that 
some of the conversations during the intervention may make participants feel uncomfortable, 
embarrassed, or upset. However, the risk is minimal. The intervention does not include any 
intrusive conversation or invasive procedure; thus the risk of harm is minimal. There is also 
some minimal risk to study participants feeling uncomfortable discussing reasons for why they 
did or did not accept COVID-19 testing and/or vaccination. Nonetheless, if the participants do 
become upset, they have the option to stop their participation. They also can stop answering 
any question that makes them feel uncomfortable. All investigators on the study have 
completed Human Subjects Training and any new staff hired to work on the study will have to 
undergo this training prior to commencing work. 
12. Risk Classification:  Please check the level of risk* associated with this study.
*HHS/FDA regulations defines minimal risk as, “The probability and magnitude of harm or discomfort 
anticipated in the research are not greater in and of themselves than those ordinarily encountered in 
daily life or during the performance of routine physical or psychological examinations or tests.”  
When the risks that are associated with a new procedure or product are unknown, they cannot be 
classified as minimal. 
 Minimal                        
 Greater than minimal                        
 Unknown
13. Safety Precautions for Minimizing Risks: Describe the procedures for minimizing any 
potential risks.  Where appropriate, discuss provisions for ensuring necessary medical or 
professional intervention in the event of adverse effects to the participants.  For greater than 
minimal risk studies, describe the data safety monitoring plan (DSMP) to monitor the data collected 
and to ensure the safety of the participants.
Please see the attached data safety monitoring plan (DSMP)
Aim 3 – Case-control study 
In data collection activities in Aims 3 (group class discussions, personal discussions, 
comprehension questionnaires, demographic and pre/post surveys), there is a chance that 
respondents may be uncomfortable with some of the questions in the surveys or open-ended 
 
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interviews, which ask about their attitudes towards COVID-19 testing and vaccination. 
However, the interviewers, who will be study staff, will have the training to respond to such 
discomfort and provide respondents with the option to not answer a question. If participants 
do become upset, they will have the option to stop their participation. They also can stop 
answering any question that makes them feel uncomfortable.
We will make every effort to prevent unauthorized access to patient identifying information by 
using a secure password protected computer and limiting the number of study personnel who 
can access the list. Whenever possible and particularly once all data collection is complete, 
we will use participants’ unique study ID code, so that they are de-identified for data analysis. 
All study staff, including CHWs and all those with any contact with study participants or with 
collected data will have met all ethics certification requirements of the CDU IRB and have 
received training in how to ensure confidentiality and privacy of study participants and any 
identifiable data.
For Aim 3, all data collected on the patients will be stripped of confidential identifying 
information (e.g., name, medical record number, address, etc.) that could directly connect it 
back to a particular patient. However, each patient will be assigned a unique study ID code 
that allows us to link the data back to a particular patient, so that during data cleaning, we 
can check for additional information. A separate file linking unique identifiers and information 
about a patient will be created, and stored securely in CDU’s instance of REDCap. Only the 
MPI overseeing this aim, Project Coordinator, and Machine Learning Specialist will have access 
to this master code list with the linking unique identifiers.
Additional safeguards includes having a regular meetings with the study team to review 
subject safety and data integrity, data security plan, implementing DSMP (see attached), 
keeping close communication with the participants, and resolving adverse events in a timely 
manner.
14. Potential Benefits to Participants and Society:  Describe the potential benefits to the 
participants by being in the research and the potential benefits that the society might expect from 
this study.  
Aim 3
Participants who are patients in medically underserved settings at risk of COVID-19 could 
benefit from obtaining additional information about resources and services about COVID 19 
including information on how to access COVID testing or vaccinations, get additional support 
from CHWs, including increased technological literacy. They may also not get direct benefit. 
But, we have minimized the risk and have safeguards in place. The principle risk is breach of 
confidentiality and discomfort or anxiety in sharing information with the investigators in group 
and personal session, and surveys. However, we aim to minimize the risk in several ways, 
(e.g. limiting who has access to the data, the use of REDCap to collect data, the use of unique 
study ID# on the participant’s data and keeping the master code list in a separate location). 
We have additional safeguards in place, such as regular meetings with the study team to 
review subject safety and data integrity, data security plan, implementing DSMP, keeping 
close communication with the participants, and resolving adverse events in a timely manner. 
Therefore, the risk to participants are reasonable in relation to anticipated benefits.
Given the unprecedented nature of the disease and severity of health outcomes related to 
COVID-19, there is an urgent need to increase COVID-19 testing and vaccine uptake in 
communities of color. The LACDHS, one of the largest safety net systems in the country, is not 
unique in facing declination of COVID-19 testing and vaccination in their safety net patient 
population. We propose that development and testing of a community engaged, CHW- based 
intervention could be useful for other similar safety net settings. This proposal has the primary 
goal of a) increasing COVID-19 testing and vaccine uptake for individual patients, and the 
secondary goal of b) developing a sustained public health presence in these communities to 
build trust and preparedness for critical future needs.
 
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15. Therapeutic Alternatives:  What therapeutic alternative(s) are reasonably available to 
potential participants should they choose not to participate in the study?  These may be research or 
non-research-based alternatives.
This study does not involve therapy. Therefore, there are no therapeutic alternatives. 
16. Risk/Benefit Ratio:  What is the risk benefit ratio of this research, compared with available 
alternatives? 
The potential benefits of the research must justify the risks to research participants.  The risk/benefit  
ratio of the research must be at least as favorable for the participants as that presented by standard 
treatments for their condition. When comparing the risk/benefit ratio of research with that of 
available alternatives, the alternative of doing nothing should be included in the analysis.
The risk/benefit ratio of this research is favorable, because this is a low risk study and we aim 
to minimize the risk in several ways, (e.g. limiting who has access to the data, the use of 
REDCap to collect data, the use of unique study ID# on the participant’s data and keeping the 
master code list in a separate, secure location). While there is no direct benefit to the 
individual participant, there may be a benefit to society in that the information gained in the 
study. Findings from this study may help identify barriers to COVID 19 testing, vaccination, 
and health care for African American and Latino patients in the Los Angeles County 
Department of Health Services, which may also inform the challenges faced by African 
American and Latino patients in similar County health care systems in other cities. The risks to 
the participants are reasonable in relation to the importance of knowledge to be gained.
Financial Considerations
17. Payment for Participation:  Describe all plans to compensate participants, including provision 
of services, and other reimbursements.  Describe the conditions that participants must fulfill to 
receive full or partial payment.
Study participants in the case arm will receive a $599 compensation (71 participants), and 
study participants in the control arm will receive $100 compensation (71 participants) for 
their time and effort.
Control arm: 
Participants in the control arm will be compensated with a $100 gift card at the end of the 
study, after they complete the basic demographic, CDE, pre- and post- surveys. If the 
participant starts the surveys and cannot complete the required pre-, post-, and 
demographic surveys, then the participant will get the partial payment of $50. 
Case arm: 
Participants will be compensated in weekly installments, after completing the first week of 
the 6-week program, the participant will receive a $99 gift card, and subsequent weeks 
with $100 gift cards for every successful week of completion (group session and personal 
session with CHW). 
If the participant cannot complete participation requirements for the case arm of the 
study for any given week (completion of the group session and personal session, or if the 
study personnel decides that the participant cannot continue), then the participant will 
get the partial payment of $50. If the participant drops out the study, they will not receive 
further payment.
18. Financial Obligations of Participants:  Will participants have to pay for any of the tests or 
treatments that they receive as part of the research?  Please clarify who will pay for the procedures 
associated with the study as well as procedures that may be part of standard clinical care. Clarify 
that insurance and other third party payers may not cover standard procedures if they are 
associated with a research project.
 
IRBNet #: 1838914-1
Approved by: CDU IRB
Approval Period: April 29, 2022 to April 19, 2023

Form 102, Rev. 9/2018a
Page 27 of 31
The participants do not have to pay to take part in this study. There are no financial 
obligations to the participants. 
19. Emergency Care and Compensation for Research-Related Injury:  If the research 
presents a greater than minimal risk, the financial liability for the costs of care associated with 
potential research related illness/injury must be specified.  (if no funds are available, please see the 
consent form template for the standard language to explain this to potential participants)
Not applicable. This study is minimal risk. 
Informed Consent
If you are requesting (1) waiver or alteration of consent, (2) waiver of parental permission, or (3) 
waiver of documentation of consent, please attach Form 115 to this application.
20. Capacity to Consent:  Will all participants have the capacity to give informed consent?  If not, 
describe the likely range of impairment and explain how, and by whom, their capacity to consent 
will be determined.
Aim 3: We expect that the participants will have the capacity to give informed consent. 
However, it is possible that older adults may have hearing problems. If they are not evaluated 
and considered incapable of giving consent due to hearing problem or if they are not able to 
confirm information given before, then we will move on to another participant. The person 
obtaining the informed consent will usually determine the potential participant’s capacity to 
consent by using a teach-back approach and asking the participant to tell us what they 
understand to be the requirements for participation. If there are any issues, the final 
determination as to whether the potential participant is capable of consenting will be done by 
an MPI. 
Lastly, this study aim has the potential to recruit participants ages 16 and 17. Due to their 
minor status, we will ask their parent or guardian to give their permission and informed 
consent for the minor to participate in the study. If the parent or guardian provides their 
informed consent, the person obtaining the informed consent will discuss describe the study 
and participation requirements with the minor participant and obtain their assent. However, if 
the minor refuses to participate after their parent or guardian provides their permission, the 
minor will not be recruited for the study. 
21. Study Personnel Administering the Consent Process:  Who will describe the research 
and invite the potential participants or their legally authorized representatives (LARs) to participate? 
Please identify the authorized individuals by name and describe their past training or experience in 
the research consent process. To insure that participants give complete informed consent and are 
able to ask and have answered all questions regarding the nature of their participation, the 
personnel administering the consent must have appropriate training and background.
Aim 3 - CDU study staff, who are IRB approved for this study, will describe the research 
project and obtain consent from potential participants. All study team members will have 
completed CITI online training on Human Subject Research, Health Information Privacy and 
Security, Good Clinical Practice For Behavioral Clinical Trials, and Conflict Of Interest training. 
The MPIs who have conducted collaborative research in the past and have experience in 
obtaining informed consent from potential participants will ensure that study team members 
obtaining informed consent will be trained and supervised for the study-specific processes of 
recruitment and obtaining of consent.
22. Process of Consent:  Please discuss the consent process that promotes participants to make 
voluntary, informed consent without coercion or undue influence.  Consider the following elements:
a.
The environment and location where the informed consent will be solicited 
The informed consent process will occur as follows:
1.
Study staff will send the consent forms ahead of time to potential participants via 
mail or email before study staff follow up with the participants with a phone call. 
 
IRBNet #: 1838914-1
Approved by: CDU IRB
Approval Period: April 29, 2022 to April 19, 2023

Form 102, Rev. 9/2018a
Page 28 of 31
2.
Once the study staff confirms the study participants (or study participants’ 
parents) have received and reviewed the consent form, we will answer any 
questions they might have and as a walkthrough of the consent form with them 
over the telephone. Study staff will also conduct a teach-back to ensure 
comprehension. After the teach back method, study staff will ask the participant 
to record the participants’ consent to which we will ask them to state their name 
and agree to consent to being recorded for the following: initial recording of the 
consenting phone call, agreeing to being recorded during the group classes in 
Group 2 program (if assigned to the intervention arm), and to agree being 
enrolled in the study. The audio of the consent will be saved in REDCap as proof 
of consent. 
a.
On the consent form, it will only provide that they agree to being recorded if 
assigned to Group 2. The recordings will be done via Zoom and the Zoom 
recording feature automatically disconnects participants from the meeting if 
they do not agree to being recorded. By design, participants cannot disagree 
with being recorded because if they are randomly assigned to Group 2 and do 
not agree with being recorded, they will not be able to participant in the group 
meetings via Zoom. The Zoom recordings will serve as a back-up to ensure 
participants are able to review the class if they find themselves unable to 
attend the group class with the CHW.  
3.
For minors, consent/assent will be reaffirmed when the interviewer calls the 
participants after obtaining parental consent. The study staff will review the 
assent form with the minor participants and to obtain assent, the study staff will 
also ask the participant to be recorded for the following items: assent phone call, 
they agree to being recorded during the study, and consent to being enrolled in 
the study. The audio of the consent will be saved in REDCap as proof of consent. 
b.
When the consent is solicited (e.g., in relation to stressful events, hospital admission, 
surgery)
The consent will be solicited at a time of convenience to the potential participants
c.
Opportunities for the potential participants to discuss their participation with family or 
others before signing the consent form 
Study staff will send the consent and assent forms to participants via mail or email and 
allow some time for participants to discuss their participation with family or others 
before deciding to take part in the study by providing their verbal consent. Study staff 
obtaining verbal consent will specifically check with potential participants to see if they 
want to discuss their decision with family members or others before providing their 
verbal consent.
d.
Use of individuals other than the investigators to explain the research 
Only the investigators and study staff who are designated to obtain consent will 
contact the potential participants to explain the research project
e.
Types of forms used (e.g., adult consent form, assent form for ages 7-12, parental 
consent form, youth simplified consent form for ages 13 to 17, foreign language 
translations) 
We will use a parental consent form and assent form for participants ages 16 and 17. 
We will only use an English adult consent form. 
The adult and parental consent form, and assent form will be comprehensible to 
participants by ensuring readability checks on the type of language used, simplicity of 
language, and additional explanation of concepts.
We request for a waiver of documentation of the consent form by the CDU IRB. Due to 
the COVID-19 pandemic, we will be conducting all research activities remotely. The 
 
IRBNet #: 1838914-1
Approved by: CDU IRB
Approval Period: April 29, 2022 to April 19, 2023

Form 102, Rev. 9/2018a
Page 29 of 31
research is minimal risk and involves no procedures for which written consent is 
normally required outside of the research context. The procedures for this study 
involve demographic surveys, pre- and post- surveys, group and personal discussions. 
To obtain an effective verbal consent over the phone, we will send the consent form to 
the potential participants by e-mail or postal mail so that they can review the consent 
document before the phone call. After we go over every element of the consent, we 
will do a teach-back and/or Q&A to assess the individual’s understanding of the study. 
We will ensure that all the individual’s questions about the research have been 
answered to their satisfaction before they make their decision. The potential 
participant’s decision to enroll or not enroll into the study will be recorded and logged 
into their study file along with the date and time. 
23. Comprehension of the Information Provided:  How will it be determined whether or not 
the participant or their legally authorized representatives understood the information provided?
We will use a “teach back” method to determine that the participants understood the 
information in the consent. In particular, we will ensure that the questions in the 
evaluation to provide verbal consent are clear to the participants by conducting a 
question-and-answer process as well.
24. Information Withheld from Participants:  Will any information about the research purpose 
and design be withheld from participants?  If so, please explain the non-disclosure and describe 
plans for post-study de-briefing.
No information will be withheld from the participants. 
Data Analysis
25. Data Analysis:  Please describe the data analysis plans for this study.  Include planned statistical 
analyses and explanation of sample size determination.
Aim 3 - After data cleaning, we will assess psychometric properties of all scaled measures, 
calculate descriptive statistics to ensure quality of the data (check distributions, examine 
outliers) and to describe study participants. Bivariate analyses will include independent t-tests 
models (or their nonparametric equivalents, e.g. Wilcoxon rank-sum test, differences between 
the groups in trust and self-efficacy. Paired-tests (or Wilcoxon signed-rank test) will be used to 
assess change within groups. Contingency table analyses will address intention to participate 
in COVID-19 testing and vaccination. We will then fit multiple regression models predicting 
change in COVID-19 testing- and vaccine-related knowledge, trust, and self-efficacy as a 
function of intervention group, racial/ethnic group, and possible interactions. We will use 
covariate adjustment approaches such as multiple linear and logistic regression models for 
the three outcomes (trust, self-efficacy, intent to participate) while controlling for 
demographic characteristics (e.g. age, gender, education, health status) and other potential 
covariates that will be identified a priori. We do not anticipate many missing data, given the 
format of completion. However, if we do have 10% or more missing, we will impute data using 
SAS PROC MI and SAS PROC MIANALYZE to implement these multiple imputation procedures. 
With respect to sample size, with 64 subjects in each of the two study groups, it will be 
possible to detect an effect size of 0.5 standard deviations in a quantitative outcome (a 
medium effect size in Cohen’s terminology) with 80% power and 2-sided 5% significance level.
VII. Funding
4.
Check all types of funding sources for this study.
  Federal Grant/Contract      
  State, Local Government   
  International
  Private
  Internal Grant Program
  Departmental
 
IRBNet #: 1838914-1
Approved by: CDU IRB
Approval Period: April 29, 2022 to April 19, 2023

Form 102, Rev. 9/2018a
Page 30 of 31
  Industry
  Other:       
2.
Name of Funding Source (e.g. NIH)
NIH/National Library of Medicine
3.
Grant/Contract Title* 
A Community Health Worker Intervention to 
Identify and Decrease Barriers to COVID-19 
Testing and Vaccination among Los Angeles 
County Department of Health Safety-Net Patients 
(Title of the Supplement to parent R01)
4.
Grant/Contract #
We are submitting the IRB application as part of 
the Just in Time for NOT-OD-20-119 (NOSI: 
Emergency Competitive Revisions for Social, 
Ethical, and Behavioral Implications (SEBI) 
Research on COVID-19 testing among 
Underserved and/or Vulnerable Populations
5.
PI of Grant/Contract
Omolola Ogunyemi, PhD (parent RO1), Sheba 
George, PhD, Lauren Daskivich, MD. This 
supplement is a Multiple PI (MPI) grant. 
6.
Funding Status
  Funded        
  Pending        
  No Funding
7.
Expected Award Period
11/2020 to 11/2022
8.
Is the funding received as part of a 
subcontract with another institution?
 No                 
 Yes, name of institution:         
9.
Please indicate whether the study 
under review is being conducted 
under the auspices of a larger 
umbrella grant. 
 Center grant    
 Training grant     
 Program projects/multiple project grant
 Not applicable
 Other: Supplement to RO1
10. Name of larger umbrella grant (e.g., AXIS, CTSI, RTRN):  
Supplement to R01 grant, Predicting Diabetic Retinopathy from Risk Factor Data and 
Digital Retinal Images (Parent Grant PI: Omolola Ogunyemi) (PA-20-135)
VIII. Statement of Financial Interest or Commitment
1. Does the Principal Investigator or any personnel on this project or their spouses/domestic 
partners, or dependent children have any significant financial interests related to this 
research?
  No          
 Yes (attach Form 133 Financial Disclosure Form)
2. Does the Principal Investigator or any personnel on this project or their spouses/domestic 
partners, or dependent children have any significant financial interest or commitment 
with any company, entity, or government agency that sponsors this research? 
  No          
 Yes (attach Form 133 Financial Disclosure Form)
 
IRBNet #: 1838914-1
Approved by: CDU IRB
Approval Period: April 29, 2022 to April 19, 2023

Form 102, Rev. 9/2018a
Page 31 of 31
IX. Ancillary Approvals
1.
Identify the entity that provided scientific or scholarly review for this project.  
a.
Name of reviewer/review committee:  NIH/NLM
b.
Date of review or approval:  11-18-2020
2.
Will you be requesting services from CDU Clinical and Translational Research Center 
(CTRC)?
  No               
  Yes.  Please contact CTRC for their services at (323) 568-3359.
3.
Will you collect biological specimens from participants (e.g., blood, tissue, urine, body 
fluids, etc.)?
  No
  Yes.  Date application submitted to Institutional Biosafety Committee (IBC):       
or IBC approval period:            (please attach approval notice)
4.
Will you be using radioactive material or radio-emitting equipment?
  No
  Yes.  Date application submitted to Radiation Safety Committee (RSC)/Radioactive 
Drug Research Committee (RDRC):       
or RSC/RDRC approval period:            (please attach approval notice)
 
IRBNet #: 1838914-1
Approved by: CDU IRB
Approval Period: April 29, 2022 to April 19, 2023