NJ HEROES TOO (New Jersey Healthcare Essential Worker Outreach and Education Study - Testing Overlooked Occupations)
Phase: NA
Conditions: Covid19, Health Care Seeking Behavior, Health Behavior
Sponsor: Rutgers, The State University of New Jersey

Protocol Title: NJ HEROES TOO
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INTERVENTIONAL
RESEARCH PROTOCOL 
(HRP-503a)
STUDY INFORMATION

Title of Project: 
NJ HEROES TOO (New Jersey Healthcare Essential Worker Outreach and Education 
Study - Testing Overlooked Occupations)

Principal Investigator Name:
Shawna Hudson, Ph.D.
 

Principal Investigator Div. & Dept.: 
Department of Family Medicine and Community Health
Rutgers Robert Wood Johnson Medical School

Principal Investigator Contact Info: 
WORK ADDRESS:
Institute for Health, Health Care Policy and Aging Research
Rutgers, The State University of New Jersey
112 Paterson Street, Room 446
New Brunswick, NJ 08901
PHONE: 848-932-0215
EMAIL: hudsonsh@rutgers.edu 

Protocol Version and Date:
V5.0 10/21/2021
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Table of Contents
Skip To Section: Hold CTRL + Click (Below) To Follow Link in Blue
1.0
Research Design
1.1
Purpose/Specific Aims
1.2
Research Significance
1.3
Research Design and Methods
1.4
Preliminary Data
1.5
Sample Size Justification
1.6
Study Variables
1.7
Drugs/Devices/Biologics
1.8
Specimen Collection
1.9
Data Collection
1.10
Timetable/Schedule of Events
2.0
Project Management
2.1
Research Staff and Qualifications
2.2
Research Staff Training
2.3
Resources Available
2.4
Research Sites
3.0
Multi-Center Research
4.0
Subject Considerations
4.1
Subject Selection and Enrollment Considerations
4.2
Secondary Subjects
4.3
Number of Subjects
4.4
Consent Procedures
4.5
Special Consent Populations
4.6
Economic Burden and/or Compensation For Subjects
4.7
Risks of Harm/Potential for Benefits to Subjects to Subjects
5.0
Special Considerations
5.1
Health Insurance Portability and Accountability Act (HIPAA)
5.2
Family Educational Rights and Privacy Act (FERPA)
5.3
Code of Federal Regulations Title 45 Part 46 (Vulnerable Populations)
5.4
General Data Protection Regulation (GDPR)
5.5
 NJ Access to Medical Research Act (Surrogate Consent) 
6.0
Data Management Plan
6.1
Data Analysis
6.2
Data Security
6.3
Data Safety And Monitoring
6.4
Reporting Results
6.5
Secondary Use of the Data
7.0
Research Repositories – Specimens and/or Data
8.0
Approvals/Authorizations
9.0
Bibliography
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1.0 Research Design
1.1 Purpose/Specific Aims
A.  Objectives 
NJ HEROES TOO (New Jersey Healthcare Essential Worker Outreach and Education Study Testing 
Overlooked Occupations) proposes to approach underrepresented minority healthcare workers (HCW) 
who will act as ambassadors to help expand testing in their households and extended networks. In Aim 
1, using qualitative methods we co-design, develop and implement an innovative, HCW-centric 
outreach intervention strategy to engage Black and Latinx minority HCW and their communities. We 
explore community perceptions about COVID-19 testing, treatment, and vaccination to design COVID-
19 testing materials and messages that are culturally tailored to address concerns of Black and Latinx 
minority communities. In Aim 2, we conduct a mixed methods study to evaluate the effectiveness and 
cost of: (1) the HCW-focused outreach intervention strategy versus (2) standard community engaged 
outreach, working with community based organizations (CBOs). We will explore contextual factors 
(individual, family, and community) affecting COVID-19 testing implementation outcomes and 
scalability. The primary outcome is uptake of COVID-19 testing in the targeted populations. We propose 
testing with the novel Rutgers Clinical Genomics Laboratory/RUCDR saliva test, the first FDA-
authorized diagnostic test using saliva to detect SARS-CoV-2 for non-invasive, home based self-
testing. We hypothesize that a participatory outreach strategy approach focused on identified index 
HCWs will mobilize quicker uptake of testing within community settings than best-practice CBO 
recruitment approaches. We also hypothesize that recruitment through index HCWs will be more 
successful for hard to reach participants compared to a traditional CBO approach. The strategy focusing 
on HCWs could easily be expanded to other front-line and essential workers, making the strategy 
generalizable and sustainable.
B.  Hypotheses / Research Question(s)
Aim 1: Co-design, develop, and implement an innovative, user-centered HCW outreach intervention 
strategy to engage Black and Latinx minority communities while assessing pre-implementation COVID-
19 testing context. Phase 1 includes an iterative, theory-guided formative evaluation process involving 
a needs assessment using target population interviews and stakeholder input through advisory 
committees to understand the COVID-19 testing context and inform design and implementation of the 
intervention. 
Question 1A: What are the most acceptable and easily understood ways to present materials and 
messages to HCWs, as well as, their family members and networks? 
Question 1B: Are the same messages appropriate for Black and Latinx minority communities? 
Question 1C: How can available intervention materials be best adapted to optimize acceptability to 
Black and Latinx minority communities? 
Aim 2: Conduct a mixed methods study to evaluate the effectiveness and cost of a HCW focused 
outreach intervention strategy versus standard community engaged outreach to explore contextual 
factors (individual, family, and community) affecting COVID-19 testing implementation outcomes and 
scalability. In Phase 2, lower-income index HCWs (from our cohorts, as well as, the Visiting Nurse 
Association, and Parker Health) serve as ambassadors to offer testing to their “spheres of influence” 
(households/contacts). 
Hypothesis 2A: A participatory outreach strategy approach focused on identified index HCWs will 
mobilize quicker uptake of testing within community settings than best practice, community 
recruitment approaches. 
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Hypothesis 2B: Recruitment through index HCWs will be more successful for hard to reach 
participants compared to a traditional community based organization approach. 
Question 2A: What are the costs of implementing NJ HEROES TOO for healthcare and community 
organizations? 
Question 2B: What lessons have we learned about implementation and opportunities for 
sustainment?
1.2 Research Significance
COVID-19 in New Jersey
With a population of 8.9 million people, New Jersey (NJ) is the 11th largest in the US, and is the most 
densely populated, with 1,215 persons/square mile (compared to California [256], Texas [113], Florida 
[410], and New York [413]). Population density likely contributes to COVID-19 transmission.1,2 As of Aug 
3rd, there were 188,466 cases and 15,921 deaths from COVID-19 in NJ, the 2nd highest per capita death 
rate in the USA (after New York). NJ has the 2nd highest proportion of state residents who were in fact 
positive (2.0%) after New York (2.1%). Based on CDC estimates, moreover, there are likely 3-10 people 
who are truly positive for every test-confirmed positive. Thus, the incidence of COVID-19 in NJ is likely to 
be between 6% and 20%.
COVID-19 Challenges for NJ Underserved and Socially Vulnerable Populations
Nearly 20% of those who have died of COVID-19 in NJ have been Black (18.5%) and Latinx (19.4%) and 
there is considerable overlap between the areas in the state with substantial COVID-19 cases, poverty, and 
under-represented minorities (URMs).3-5
Healthcare HEROES TOO: Nationally over 80% of healthcare support, service, and direct care 
workers are poor women and disproportionately people of color.
Nationally over 80% of healthcare support, service, and direct care workers are poor women and 
disproportionately people of color. For example, the national average earnings for home health aides and 
medical assistants range from $24,000-$33,000. Nationally, wages are so low that nearly 20% of home 
health aides and personal care aides live in poverty and more than 40% rely on some form of public 
assistance.6 These low-income healthcare workers (HCWs) need support and their families and 
communities are at increased risk for COVID-19 exposure by virtue of multigenerational living situations. In 
the Northeast, NJ and NY are above the national level for multigenerational households (MGH). 7 In NJ, 
50% of MGHs include a householder, their child, a grandchild, parent or in-law.7 These social structures 
make a household-based strategy for improving testing important for HCW populations. 
COVID-19 challenges facing outreach efforts for communities.
The devastation caused by COVID-19 in NJ and the limits on inter-personal interaction have imposed 
challenges to engaging diverse communities and healthcare stakeholders in translational and population 
health research.8,9 Both the illness and the response have strained the limits of co-learning opportunities 
that are central to participatory and patient-centered approaches. Our community, HCWs, healthcare 
organization stakeholders, and research partners have identified a need for novel/effective virtual strategies 
that make use of community education, mass media, and social media to expand our continued outreach 
and engagement efforts. Programs are needed that work from relationships with trusted sources of 
information to build mutual respect, inform and educate, and provide opportunities for individuals, 
organizations, and populations to actively engage with COVID-19 testing education. Therefore, we propose 
NJ HEROES TOO as a potential outreach intervention strategy to approach URM HCWs identified as index 
individuals to expand testing in their households and extended networks.
1.3 Research Design and Methods
This project will proceed in two phases. Phase 1 consists of an iterative, theory-guided formative evaluation 
process involving a needs assessment using stakeholder interviews, evidence-based content review, pilot 
testing, and stakeholder input through advisory stakeholder committees to inform design and 
implementation of the intervention. Phase 2 will recruit HCWs and their family members from our ongoing 
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HCW cohorts, as well as, from the Visiting Nurse Association, Parker Health and staff from University 
Hospital Newark and Robert Wood Johnson University Hospital and compare their rates of COVID-19 
testing with a community recruited control group. We will evaluate the effectiveness of a participatory 
outreach approach focused on identified index HCWs to test the hypothesis of whether it will mobilize 
greater uptake of testing within community settings than best practice, community recruitment approaches. 
We will additionally assess factors such as participant trust, health literacy, English proficiency, and patient 
activation that may impact testing in URM communities. Rapid cycle qualitative methods will explore other 
potential factors at the community and healthcare setting levels that may impact testing rates, as well as, 
assess which implementation approaches and strategies that are most effective in increasing the reach, 
access, uptake, and sustainability of COVID-19 testing. 
A.
Research Procedures
This project will not involve medical records, blood draws, or any physical contact with 
participants. All information is collected using the Rutgers Zoom secure platform or over the 
phone. Data collected will only consist of survey procedures, online focus groups, virtual (via 
Zoom) community conversations or key informant interviews, audio/video recordings from Zoom, 
and saliva samples provided by participants. No sensitive information will be collected. 
Audio/visual Zoom recording will begin as soon as the moderator begins the Zoom session. The 
resulting mp4 recordings will be temporarily stored on a secure, encrypted, password-protected 
Rutgers server and uploaded to a transcription company, ADA Transcription, via a secure web 
portal. The transcripts will be returned to the research team through the same portal. The mp4 files 
will be destroyed after a research team member has checked the transcripts for accuracy. Only the 
research team and the transcription company will have access to the audio files and transcripts.   
Aim 2 procedures include a one-time baseline survey followed by saliva testing. After enrollment 
and completion of online questionnaires, saliva test kits are ordered and mailed to the participant 
by Vault Health, Inc., a fee for service vendor that is not engaged in research, with a prepaid 
envelope to return the sample. Vault Health remotely supervises participants while they collect their 
saliva sample (via Zoom video call if needed) and reports results to participants. Participant’s role 
in the study ends in phase 1 at the completion of the virtual community conversation/focus 
group/key informant interview and for phase 2 after receipt of their test result. 
B.
Data Points
N/A—No long term follow-up is planned. 
C.
Study Duration
The proposed project will be conducted over a 2-year period (See Section 1.10 for timeline). Aim 1 
will be completed by Month 6. Aim 2 will be completed by Month 18. Final data analyses, 
preparation of manuscripts, and final dissemination materials will be completed by Month 24.
D.
Endpoints
N/A
1.4 Preliminary Data
Community and stakeholder engaged research 
The NJ HEROES TOO team builds on existing New Jersey Alliance for Clinical and Translational 
Science (NJACTS, our CTSA Hub) infrastructure and brings proven capacity in community and 
stakeholder engaged research. Rutgers has a rich history of scientific achievement through 
community and stakeholder engaged research. NJACTS Community Engagement Core in 
partnership with The Rutgers Office of University-Community Partnerships (OUCP) provide the 
established infrastructure and community partnerships that are necessary for the proposed work and 
sustainability for future pandemic mitigation efforts. Founded and led by Hill, OUCP is a unique 
institutionalized office at Rutgers dedicated to advancing university-community partnerships. OUCP 
has long-term and extensive ties to organizations serving a variety of consumers. Renowned for her 
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expertise in building community relations, Hill’s community engagement portfolio and work with 
vulnerable populations spans the life course from early childhood through aging adults. The NJACTS 
Community Engagement Core extends this expertise. The Core Leadership and Advisory Council 
consists of citizen scientists and established investigators with expertise in community engagement. 
The Core is co led by Hudson and Tallia with Hill, Jimenez and Crabtree on various workgroups. 
We have a strong history of collaborative community engaged research with vulnerable populations 
using innovative methods to conduct this work including Hudson’s work with recruitment of minority 
participants in clinical trials,10-12 engaging Houses of Worship in health promotion ,13 disparities in 
tobacco use (R01CA231139, MPI: Hudson) and engaging community members in design of 
community education and screening programs.11,14,15 Jimenez and Tallia’s community engaged 
needs assessment among homeless individuals culminated in a New Brunswick based medical 
student run health clinic that has operated in partnership with a local social service agency for 15 
years. 16 Collaborative work between Jimenez, Hudson, and Crabtree uses qualitative research 
methods to engage community leaders and low-income Latinx families in intervention development 
and then conducting a hybrid effectiveness implementation randomized trial overseen by a 
stakeholder advisory board to test the intervention. This has led to an ongoing community engaged 
research program that tests structural interventions designed to reduce inequities in developmental 
and behavioral health for young Latinx children including families with limited English proficiency 
(1R01HD099125, PI: Jimenez, co-Is Hudson, Crabtree) as well as a cross sector partnership 
between RWJMS and a local charter school to improve school readiness among dual language 
learners. 
Healthcare organization interventions and mixed methods research 
Members of our collaborative team have exceptional experience conducting organizational change 
interventions, project evaluation, and mixed-methods research. Over the past 20 years, Crabtree, 
Hudson, Tallia, and Ferrante have collaborated on multiple NIH and foundation funded healthcare 
intervention and practice-based research studies (R01HL070800, R01CA112387, R01CA176838, 
R01CA176545). Crabtree, Hudson, Tallia, and Ferrante are all adept using the data 
collection/analyses planned in this mixed methods project. We have cultivated expertise in user 
centered design and rapid ethnography methods including focus groups and key informant 
interviews.17-20 12-14,21-28 Our studies use a mixed methodology that include qualitative analyses 29,30 
that inform quantitative interpretations of intervention evaluations. 26,27,30-35
Ongoing studies of SARS-CoV-2 among HCW cohorts 
As described above, our team (Panettieri, 
Blaser, Carson, Barrett, Horton, Roy) 
built the RCC and RWJSS, large-scale 
studies of SARS-CoV-2 to ensure the 
safety of our vulnerable frontline HCWs 
and their families (A.4). Participants in 
these studies are among the index 
participants in our intervention strategy 
(Aim 2). As detailed below, our success in 
the RCC and RWJSS demonstrates our 
team’s ability to engage and test HCW. 
This success, combined with our team’s 
experience in community engaged research, health equity research and dissemination and 
implementation science, will provide the critical relationships underlying our innovative HCW-centered 
outreach approach.
  
Figure 6. The established Rutgers Corona Cohort Study 
Schematic
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The RCC is an intensive longitudinal 
study of 829 participants recruited at 
the start of the local COVID-19 
epidemic and tested over 6 months 
(Figure 6). The funded aims of the 
RCC (NIAID 3U01AI122285-05S1) 
include assessment of prevalence, 
incidence, and clinical and 
occupational risk factors of SARS-
CoV-2 infection and COVID-19. 
Additional translational studies based 
on this cohort are ongoing (NCATS 
3UL1TR003017-02S1). 191 
participants (23.0%), including 136 
HCW (24.8%) are underrepresented 
minorities. 36 RCC retention has been 
exceptional, with >98% of the cohort 
completing the 4th study visit; the 5th 
study visit is ongoing. 
 The RWJSS involves 3904 hospital 
employees and affiliated clinicians who 
received 
SARS-CoV-2 
virus 
and 
antibody testing at a single time-point and are being followed for self-reported COVID-19 prospectively. 
1202 (30.8%) tested participants are URM. A total of 9.8% of participants tested positive for SARS-
CoV-2 virus or antibodies, with higher rates observed among Black (14.8%) and Latinx (15.5%) HCW. 
Notably, compared to non-Hispanic White participants, the odds of a positive test were twofold higher 
among Black (OR: 2.15, 95% CI: 1.55, 2.97) and Latinx participants (OR: 1.94, 95% CI: 1.42, 2.66). 
Importantly, infection rates were especially high among lower status medical roles (e.g., technicians, 
phlebotomists) as well as hospital support roles (dining/food, maintenance /housekeeping, 
security/support) (Figure 7).
1.5 Sample Size Justification
 For Phase 1,Virtual Community Conversations we will convene 8-10 community focus group 
conversations of 10-12 ethnically homogenous participants each representing Black and Latinx 
stakeholders (i.e., healthcare workers, family members and community organizers). The literature 
suggests that for our purposes, 2-3 focus groups are sufficient to capture 80% of themes, including 
the most prevalent themes, and three to six groups for 90% of themes in a homogeneous study 
population using a semistructured discussion guide. 37 To reach the desired number of 15-20 
healthcare workers we will supplement community conversations with individual key informant 
interviews with healthcare workers given they have not been able to 
participate in group meetings.  Hennick et al suggest code saturation 
can be established with as few as 6 interviews with full saturation 
reached at nine interviews.38 They determined the first interview 
conducted contributes more than half (53%) of new codes and three 
quarters (75%) of high-prevalence codes, with subsequent interviews 
adding a few new codes each until saturation. 38
For Phase 2, to test our Aim 2A hypothesis which compares testing 
uptake between the two arms power calculations are based on the 
primary outcome measure, testing uptake rate. We report power for rate ratios (RR; ratio of rate in 
comparison arm relative to intervention arm) of 1.15, 1.2, and 1.3, when expected tests per month in 
the intervention arm range from 80 to 120 (Table). We will have about 80% power or greater for RR of 
1.15 or greater. To test hypothesis 2B, we will compare participants in the two arms on key 
Rate (expected #/month) in NJ 
HEROES TOO arm
RR
80
100
120
1.15
0.78
0.82
0.81
1.2
0.94
0.96
0.95
1.3
0.99
0.99
0.99
Notes: ED, emergency department; EMT, emergency medical technician; 
NP, nurse practitioner; OR, operating room; PA, physician's assistant; 
PT, physical therapist; OT, occupational therapist; RT, respiratory 
therapist; ST, speech therapist
Figure 7. Prevalence of SARS-CoV-2 infection based on role in 
the hospital and direct patient care responsibilities
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characteristics that may be barriers to testing (participant trust, health literacy, English proficiency and 
patient activation). We will do so through linear regression models, adjusting for covariates including 
participant age, race/ethnicity, sex, and highest level of educational attainment. 
1.6 Study Variables
In Aim 1, we will co-design, develop and implement an innovative, HCW-centric outreach intervention 
strategy to engage Black and Latinx minority communities. We will explore community perceptions 
about COVID-19 testing, treatment, and vaccination to design COVID-19 testing materials and 
messages that are culturally tailored to address concerns of Black and Latinx minority communities. In 
Aim 2, we will conduct a mixed methods study to evaluate the effectiveness and cost of: (1) the HCW-
focused outreach intervention strategy versus (2) standard community engaged outreach, working with 
community based organizations (CBOs). We will explore contextual factors (individual, family, and 
community) affecting COVID-19 testing implementation outcomes and scalability. The primary outcome 
will be uptake of COVID-19 testing in the targeted populations.
A.   Independent Variables, Interventions, or Predictor Variables 
RADxUP has provided a list of common data elements that include PhenX Toolkit items with 
Spanish translations that will be collected across funded consortia projects.  Data elements 
include demographics, medical history, health status, vaccine acceptance, COVID-19 testing 
experience and trusted information sources. We will also assess trust in healthcare using the 
Revised Healthcare System Distrust Scale; 9 items. 
B.  Dependent Variables or Outcome Measures 
Our primary outcome, testing, will be measured through Vault’s receipt of a saliva kit from the 
participant with virus test results provided directly to participants as well as to the study team.
1.7 Drugs/Devices/Biologics 
A.
Drug/Device Accountability and Storage Methods
N/A
1.8 Specimen Collection
A.
Primary Specimen Collection
Saliva is collected at home by participants (under remote supervision via Zoom as needed) using 
GCP compliant test kits prepared by Infinity BiologiX and mailed to participants by Vault Health. 
The kits are then mailed via prepaid return labels to the Infinity BiologiX where they will test for 
SARS-CoV-2 using our novel FDA-authorized saliva test. Testing results will be reported to 
participants by Vault Health clinical providers and will be received by the study team as well.
B.
Secondary Specimen Collection
N/A
1.9 Data Collection
A.
Primary Data Collection
Aim 1: 
The main data source will be audio/video recordings of the virtual focus groups and community 
conversations. Supplemental key informant interviews that use the approved focus group guide 
questions and script will be conducted with HCW. Digital recordings of conversations will be 
transcribed verbatim and imported into ATLAS.ti™to facilitate coding and analysis. 
Aim 2: There are four main sources of materials: 
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1.
COVID-19 testing data derived from saliva samples provided at home by participants 
(See section 1.8).  Saliva will be collected from participants ages 4 and above.
2.
Questionnaire data provided by participants through REDCap: Questionnaire data will 
be completed by participants aged 18 and older. Parents or legal guardians will be 
responsible for completing questionnaires for children ages 4 to 17. Questionnaires will 
include items regarding demographics, possible COVID-19 exposures and testing history, 
overall health and lifestyle. Additional REDCap questionnaires related to acceptance of 
testing will query health literacy, English language proficiency, patient activation, 
attentional style, and patient trust. Survey data will be automatically downloaded from 
REDCap for direct import into a statistical analysis software program, e.g., SAS.
3.
Focus group data from virtual community conversations and community 
engagement virtual salons: Focus groups of virtual community conversations and 
community engagement virtual salons as well as key informant interviews will be conducted 
via Zoom.
4.
Key informant data provided by select HCW ambassadors, community and 
healthcare organization stakeholders regarding implementation of the outreach 
strategies. Field notes, meeting minutes and an activity tracker from administrative 
meetings with members of the participating organizations will be collected. 
Data storage: All study data will be stored on a Rutgers secure server (located at Liberty Plaza, 335 George 
St., 2nd floor, New Brunswick, NJ 08901). Qualitative audiofiles will be downloaded from Zoom and stored 
on the server as well as their transcripts. Quantitative data will be entered into the study REDCap database. 
REDCap is a secure, password-protected web-based application designed to support data capture for 
research studies. A unique study participant ID will be assigned in REDCap at the time of screening. All 
data used for analysis will be fully de-identified upon data export from REDCap and stored on an encrypted, 
password-protected computer network to which only study investigators and staff have access. De-
identification of data will consist of removal of all personal identifiers from analytic files as well as random 
shifting of dates to preserve participants’ anonymity. Audits of REDCap data access will be completed 
regularly to ensure there is no unauthorized access of REDCap data. 
B.
Secondary Data Collection 
N/A
1.10 Timetable/Schedule of Events
The project will be conducted over a 2-year period (See Table below). Start-up activities took ~ 1 month. 
Aim 1 data collection is complete.  Dissemination is ongoing with an abstract accepted for presentation at 
Acadamy Health in June 2021, a manuscript under review at JAMA Open Network and 3 other manuscripts 
in development. Aim 2 will be completed by Month 18. Final data analyses, preparation of manuscripts, and 
final dissemination materials will be completed by Month 24.
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2.0 Project Management
2.1 Research Staff and Qualifications
This project brings together a team of 
investigators at Rutgers partnered with 
citizen 
scientists 
representative 
of 
community based organizations (CBOs), 
healthcare organizations, and HCWs (Figure 
X). This MPI team led by Hudson, Barrett, 
Blaser, Hill, Jimenez, and Panettieri is truly a 
team 
science 
initiative 
that 
leverages 
exceptional 
combined 
expertise 
in 
community engagement and health equity 
(Hill, Hudson, Jimenez, Pellerano), infectious 
disease (Blaser), biospecimen-based cohort 
studies (Barrett, Carson, Horton, Panettieri), 
bioethics 
(Eyal, 
Budolfson), 
enviro-
informatics 
(Georgopoulous), 
mixed 
methods 
research 
and 
implementation 
science 
(Crabtree, 
Hudson, 
Jimenez), 
healthcare organizational change (Crabtree, 
Ferrante, Tallia), cost analyses (Pizzi) and 
biostatistics (Roy). The MPI team has divided 
scientific leadership for various components 
of the study aims. Hudson has scientific 
oversight and responsibilities that involve 
coordinating the mixed method evaluation activities across the development and implementation of Aims 1 
and 2. Hill and Jimenez co-lead our community engagement efforts. Barrett, Blaser and Panettieri lead the 
RCC and RWJSS cohorts and will oversee the COVID-19 testing and laboratory aspects of the science.
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2.2 Research Staff Training
Staff are CITI trained and receive continuous training and professional development in the conduct of 
human subjects research.  Weekly project administration meetings focused on data collection, quality and 
management are employed.
2.3 Resources Available
A.
Facilities
This research is supported by a multi-disciplinary collaboration of faculty from the NJ Alliance for 
Clinical and Translational Science (NJ ACTS) inclusive of Robert Wood Johnson Medical School, 
Rutgers School of Public Health, Center for Advanced Biotechnology and Medicine and the Rutgers 
Office of University-Community Partnerships. NJ ACTS is funded by the National Center for 
Advancing Translational Sciences (NCATS), an institute of the National Institutes of Health (NIH).  
The NJ ACTS CTSA is designed to provide infrastructure and resources to promote and foster an 
institution’s capacity for conducting clinical and translational research. The overall goal of the CTSA 
program is transform the translational science process in an effort to speed the delivery of new 
drugs, diagnostics and medical devices to patients and to use those research discoveries to change 
public policy, impact healthcare delivery and improve population health. NJ ACTS provides 
infrastructure for our faculty and staff as well as   quantitative data collection/management (e.g., 
automated survey data collection using Redcap) and qualitative data collection (e.g., depth 
interviews, field observations, participant observation, focus groups) and management using 
ATLAS.ti software.
2.4 Research Sites
Rutgers Biomedical and Health Sciences is the research site for this study. Rutgers staff will conduct all 
research activities. 
While we are working with Vault Health, Inc. to collect study specimens and Parker Health, the Visiting 
Nurse Association, University Hospital and Robert Wood Johnson University Hospital and 18 community 
based organizations to inform potential participants about the availability of the research, their engagement 
in the project does not meet the definition of engaged in human subjects research under items #1 (Vault) 
and #4 of the section entitled: Institutions Not Engaged in Human Subjects Research: 
https://www.hhs.gov/ohrp/regulations-and-policy/guidance/guidance-on-engagement-of-
institutions/index.html 
Vault Health meets the criteria of non-engagement under stipulation #1: It is an organization whose 
employees perform commercial services for investigators (i.e., COVID testing) and their services for this 
project: (1) do not merit professional recognition or publication privileges; (2) their COVID testing services 
are typically performed for non-research purposes for the NJ Department of Health and direct to 
consumers; and, (3) the outreach materials and strategies in this protocol are the intervention not the 
COVID test; therefore, Vault’s employees or agents do not administer any study intervention being tested 
or evaluated under the protocol.
Similarly, the healthcare and community based organizations meet the criteria of non-engagement under 
stipulation #4: These organizations employees or agents will only be engaged in: (1) informing 
prospective subjects about the availability of the research; (2) providing prospective subjects with 
information about the research (which may include a copy of the relevant informed consent document and 
other IRB approved materials) but do not obtain subjects’ consent for the research or act as 
representatives of the investigators; (3) providing prospective subjects with information about contacting 
investigators for information or enrollment; and/or (4) seeking or obtaining prospective subjects’ 
permission for investigators to contact them.
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3.0 Multi-Center Research
This project is funded by the NIH RADxUP program and is coordinating data collection with the RADxUP 
Coordination and Data Collection Center at Duke University. A draft of the data use agreement which is in 
final signature process and awaiting approval of the Aim 2 consent form by the Rutgers IRB has been 
included as an attachment.
4.0 Subject Considerations
4.1 Subject Selection and Enrollment Considerations 
A.
Method to Identify Potential Subjects
We will work with 18 community based organizations, Parker Health,  the Visiting Nurse Association, 
University Hospital Newark and Robert Wood Johnson University Hospital to develop strategies to 
identify and engage potential research participants. To ensure that the NJ HEROES TOO intervention 
is relevant to healthcare worker families and their communities, we will engage them and their 
advocates in a co-design process. Based on the results of this process in Aim 1, we will widely 
implement recruitment strategies engaging low income HCWs as ambassadors to recruit their 
families/contacts into the NJ HEROES TOO arm as well as general community members through the 
traditional arm of the study. 
B.
Recruitment Details
Recruitment of Aim 1 participants. The purpose of Aim 1 is to Co-design and develop innovative, user 
centered outreach intervention strategies that will then be used in Aim 2. To recruit participants for the 
virtual community conversations and key informant interviews that will inform Aim 1, we will use 
snowball sampling methods, as we have done in previous studies, drawing on confirmed participants 
to identify additional potential participants who will serve confirming and disconfirming roles. As needed, 
we will work with our collaborating healthcare institutions and community-based organizations to 
identify potential participants. They will advertise the virtual community conversation opportunity 
through their preferred standard community outreach channels (e.g. posted flyers (see recruitment 
flyers), mailings with flyers enclosed and announcements at community events using language from 
the flyers) as well as through additional multimedia approaches such as attaching the flyers to emails 
sent to list serves. Interested individuals will initiate contact with the Rutgers study team via email or 
phone using information included in the flyer. A Rutgers research staff member will screen participants 
for eligibility.  Aim 1 participants will be Black and Latinx individuals who are knowledgeable and able 
to speak about their experiences and the factors that are important and impact COVID testing from 
diverse perspectives. We will convene 8-10 community focus group conversations, consisting of 10-12 
ethnically homogenous participants each, representing Black and Latinx stakeholders. We will also 
recruit 15-20 HCW for key informant interviews. The literature suggests that for our purposes, 2-3 
groups per strata and 6-10 interviews are sufficient to reach full saturation. We will offer a $30 gift card 
incentive to all participants. 
Recruitment of NJ HEROES TOO arm (Aim 2). In this arm of study aim 2, we will recruit low income 
health care workers (HCW) employed at several NJ healthcare centers in affected counties to be 
“ambassadors” to help extend recruitment to their family members and community contacts. We will 
do so through our two current HCW cohorts, the Rutgers Corona Cohort (RCC) and the Robert Wood 
Johnson Screening Study (RWJSS) (total Black and Latinx n~1300) which have recruited participants 
at University Hospital and Robert Wood Johnson University Hospital. Additionally, to increase the 
reach of our HCW intervention beyond academic medical and healthcare system settings, we have 
partnered with Parker Health (representing nursing home and assisted living facility HCWs) based in 
Middlesex county and the Visiting Nurse Association Health Group (VNA), which is a statewide home 
healthcare organization with significant activities in Essex, Union and Passaic counties. Specifically, 
the organizations will: (1) inform prospective subjects about the availability of the research (e.g., 
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announce the study at meetings with their staff, post links to the study website on their website, on 
their list serves, in their newsletters and social media); (2) provide prospective subjects with 
information about the research (i.e., share recruitment materials with their staff); (3) provide 
prospective subjects from their staff with information about contacting investigators for information or 
enrollment; and/or (4) ask their staff permission for investigators to contact them.
 These approaches leverage trusted relationships (with the HCW), use culturally and linguistically 
responsive materials, and reduce the burden of testing by using mailed saliva kits to address common 
barriers encountered by the targeted populations. Campaign materials will also include lists of 
community resources that can provide support in the event of positive test result, since the potential 
effects of a positive result and quarantine on employment and a person’s ability to meet basic needs 
are themselves significant barriers.  Where applicable (such as in our ongoing cohorts), we will send 
e-mail blasts/flyers, and place posters and informational kiosks in key hospital and clinical locations. 
Recruitment materials in English have been developed are part of this protocol amendment.  Once they 
have been approved we will submit Spanish translations for IRB for approval prior to their use.
Electronic survey data collection: Interested individuals can click active hyperlinks, scan QR codes or 
type in URLs from recruitment materials to obtain more information on the study and assess their 
eligibility. Informed consent will be collected electronically after which consented individuals will 
complete demographic questionnaires about themselves and their households. They will then be asked 
to extend the invitation to their “spheres of influence” (household and other family members/community 
contacts) to reach populations who would not otherwise have access to testing. The ambassadors will 
receive an e-mail and/or text message with an URL link to forward to their contacts. By clicking that 
link, the household and other family member/community contact will be taken to a webpage with 
information on NJ HEROES TOO testing, including contact information for study staff. 
Telephone data collection: For individuals who are not able to enter their own information electronically, 
a phone number will be provided for the study.  They can use it to reach a research staff member who 
will consent them, administer the survey by phone and set them up with Vault Health for testing.
Recruitment of the community-based comparison group arm (Aim 2). For the traditional, community 
based arm of study aim 2, recruitment will be channeled through extant community-based organizations 
focused on underserved communities in the counties of interest. These partner organizations will 
advertise the testing opportunity through their preferred standard community outreach channels (e.g. 
mailings, flyers, community events) as well as through additional multimedia approaches identified and 
developed during Aim 1. As in the NJ HEROES TOO arm, interested individuals can either opt for 
electronic or telephone data collection.  
C.
Subject Screening

Eligibility Criteria
Aim 1: (1) self-identification as Black or Latinx; (2) age 18 or older; and, (3) have access to 
phone, internet and/or email/text messages; and, (4) ability to speak, understand, and/or read 
English or Spanish. 
. 
Aim 2 Healthcare Workers: (1) self-identification as Black or Latinx; (2) employment at one of 
the participating health care settings (Parker Health, Robert Wood Johnson University Hospital, 
University Hospital, Visiting Nurse Association); (3) resident of Union, Passaic, Middlesex, or 
Essex County, NJ; and, (4) age 18 or older.. 
Aim 2 Healthcare Worker household members/contacts: (1) self-identification as Black or 
Latinx; (2) resident of Union, Passaic, Middlesex, or Essex County, NJ; (3) age 4 or above; (4) 
able to provide informed consent/assent; and (5) ability to speak, understand, and/or read 
English or Spanish. 
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Aim 2 Community members: (1) residence in the counties of interest (Union, Passaic, 
Middlesex, or Essex County, NJ); (2) self-identification as Black or Latinx; (3) age 18 or older; 
(4) ability to speak, understand, and read English or Spanish; (and, (5) ability to provide 
informed consent. 
Aim 2 Community household members/contacts: 1) self-identification as Black or Latinx; (2) 
resident of Union, Passaic, Middlesex, or Essex County, NJ; (3) age 4 or above; and (4) able 
to provide informed consent/assent; and (5) ability to speak, understand, and/or read English 
or Spanish.
Aim 2 Children: (1) Age 4 or above; (2) Parent/ legal guardian able to provide permission to 
participate
4.2 Secondary Subjects
N/A
4.3 Number of Subjects
A. Total Number of Subjects
We anticipate a total of 3000 participants will be enrolled across the two study aims.
Aim 1: We recruited 13 groups and 8 individual interviews with stakeholders who identified as Black 
and/or Latinx (n=111 individuals).
Aim 2: The goal is to enroll approximately 1000 participants in each of the two study arms (N=2000) 
over a 12 month period.  
We are experiencing a high loss to follow-up rate in Aim 2. Though interest, consent rates and survey 
completion are high there is also a high rate of loss to follow-up. COVID-19 testing is the study 
outcome and uptake among participants is low. Therefore, we may need to enroll more than 1000 
per arm.
B. Total Number of Subjects If Multicenter Study
N/A
C. Feasibility
For Aim 1 and Aim 2 community based organization arm, drawing from long-established 
relationships and community partners of MPIs Hill, Hudson, and Jimenez we have engaged 18 
community organizations in the design and  development of this project. Organizations serve the 
cities of Newark, Elizabeth, Irvington, Hillside, Caldwell, Paterson, New Brunswick, Perth Amboy, 
and their surrounding areas. They range in size, scope and focus from faith-based organizations to 
large social service groups.
For the Aim 2 HCW arm, our current COVID-19 surveillance cohorts include nearly 4000 HCWs, of 
whom we estimate 32% (n~1300) meet criteria to serve as ambassadors. We anticipate that 
approximately 1000 more HCWs from Parker Health and the Visiting Nurse Association will be 
eligible.
4.4 Consent Procedures
A. Consent Process
Informed consent/assent will be obtained prior to participation. Electronic Consent: Potential 
participants will be sent a web link where they are presented a document that lists all elements of 
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informed consent, including: (a) that activities involve research; (b) that participation is voluntary; (c) 
the purpose, procedures, and duration of the research; (d) any reasonably foreseeable risks, 
discomforts, and benefits of the research; (e) how confidentiality/privacy will be maintained; (f) 
circumstances when the investigator may withdraw their participation; (g) how many people will be in 
the study; (h) incentive for participating; (i) ability to withdraw at any time; (j) that the de-identified data 
may be shared with other researchers; and (k) name and contact information for Principal Investigator. 
Consent will be obtained from adults 18 and over and parents/guardians will provide consent for their 
children if they wish to have them tested. Children age 7 and older will be asked to provide assent in 
addition to the parental consent. Verbal Consent: Research staff will read the consent document and 
initial the document.  A copy of the consent document will be sent to the participant via email or regular 
US mail.  
B.
Waiver or Alteration of Consent Process 

Waiver or Alteration Details
N/A

Destruction of Identifiers
Aim 1 and 2  identifiers will be destroyed at the close of the study. Aim 1 data will be de-
identified prior to analysis once transcripts have been generated.  Aim 1 de-identification of 
data will consist of removal of all personal identifiers from analytic files and substitution of 
pseudonyms for participant names.  Aim 2 data used for analysis will be fully de-identified 
upon data export from REDCap and stored on an encrypted, password-protected computer 
network to which only study investigators and staff have access. De-identification of Aim 2 
data will consist of removal of all personal identifiers from analytic files as well as random 
shifting of dates to preserve participants’ anonymity. Audits of REDCap data access will be 
completed regularly to ensure there is no unauthorized access of REDCap data.  

Use of Deception/Concealment
N/A
C.
Documentation of Consent

Documenting Consent
For Aim 2 we will provide both electronic and verbal consent options.  Electronic Consent: 
Individuals will receive an electronic survey with a check a box on an electronic consent form 
agreeing to participate before starting the survey (Aim 2). At the end of the survey, 
participants must check a box confirming agreement to submit a saliva sample and enter their 
address where the saliva testing kit will be sent. 

Waiver of Documentation Of Consent (i.e., will not obtain subject’s signature)
For Aim 1 and Aim 2 verbal consent procedure we are requesting a waiver of 
documentation of consent.  For Aim 1, we will read an information sheet with the 
elements of consent at the beginning of each virtual zoom focus group (see script 
uploaded).  Those participants who choose to stay in the meeting will be recorded by 
study staff as providing consent. For Aim 2, we will read the electronic consent at the 
beginning of the phone call and input the participant’s information in the system.  For 
those participants with email, they will receive copies of their consent electronically.  For 
participants without email, a paper of copy of the electronic consent will be mailed.
 
4.5 Special Consent/Populations
A.
Minors-Subjects Who Are Not Yet Adults 
Our study population includes healthcare workers, age 18 and over, as well as their household and 
community members. Children age 4 and older will be included. Children age 7 or greater will 
provide assent in addition to parental consent. There will be no upper age limit. The parent/legal 
guardian permission and assent process will follow a similar procedure as outlined above. 
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Parents/legal guardians with children between age 4 and 18 years will receive an electronic parent 
permission form before starting the survey with a checkbox providing permission for the child to 
participate. For children age 7 and older, there will be an electronic assent form with a simplified 
description of the study procedures and language that offers an option to not participate. Given that 
this is a minimal risk study and parental/legal guardian permission will be electronically 
documented, waiver of documentation of assent is requested.
B.
Wards of the State
Wards of the state will not be enrolled.
C.
Non-English-Speaking Subjects
Spanish

Process for Non-English-Speaking Subjects

Participants who identify Spanish as their preferred language will be recruited. The 
research team includes individuals who speak Spanish fluently and we will use translated 
informed consent documents.

Short Form Consent for Non-English Speakers
N/A
D.
Adults Unable to Consent / Decisionally Impaired Adults
N/A
4.6 Economic Burden and/or Compensation for Subjects
A.
Expenses 
N/A
B.
Compensation/Incentives
Aim 1: We will offer a $30 gift card incentive to all focus group and key informant interview 
participants. 
Aim 2: We will offer a $35 Target gift card incentive to all survey/COVID-19 testing participants. 
Target gift cards were chosen because they can be used for a variety of items for adults and 
children including the purchase of age appropriate games, toys or books inclusive of shipping 
costs. A 2004 NAM report on the ethical conduct of clinical research with children describes gift 
certificates and cash payments ranging from $10-100 as median incentive amounts for pediatric 
studies.39 
The incentive for Aim 2 is slightly higher than the aim 1 incentive given the additional saliva data 
collection proposed.
C.
Compensation Documentation
For Aim 1 our staff documented the name and address of the participant receiving the card, the 
cash value of the card, serial number on the card and date of mailing and initialed each entry. For 
Aim 2, our research staff has identified a gift card management system Rybbon for that interfaces 
with REDCap and maintains a log that documents distribution of gift cards. 
 
4.7 Risks of Harm/Potential for Benefits to Subjects
A.
Description of Risks of Harm to Subjects
This is a minimal risk study, which means that risks from study procedures are similar to those 
ordinarily encountered in daily life or during the performance of routine physical or psychological 
examinations or tests. There are no test articles (investigational new drugs, devices, or biologics) 
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to be used in this study. No risks are anticipated from completion of the virtual focus groups, 
community conversations, surveys, or self collection of saliva samples. Breach of confidentiality of 
participants is the main potential risk. However, safeguards are in place at Rutgers University to 
ensure that confidentiality is maintained through the use of unique study IDs, password protected 
encrypted computers, and software, as well as other techniques described above. Information is 
provided to participants regarding the handling and the identification process involved with the data. 
Information that identifies subjects and subject number will be kept in secure servers. Antivirus 
software and firewalls are updated regularly to prevent any potential virus infection or hacking 
attempts. Only study staff that has contact with participants will have access to this information. 
None of the information being asked would pose any physical, psychological, financial, legal or 
other risk to participants. 
Another potential risk is receipt of a positive COVID-19 test, with potential psychological (e.g., 
distress) and financial effects (e.g., due to mandatory quarantine on employment). These risks are 
described in the consent and explained by study personnel prior to enrollment. The protocol poses 
no other physical, psychological, financial, legal or other risk to participants. The protocol 
incorporates several steps to minimize all of these risks. 
Finally, an additional potential risk may be receipt of an inaccurate test result. Our saliva test was 
the first saliva-based test to detect SARS-CoV-2 that was granted emergency use authorization by 
the FDA, and it is the only one authorized for at-home self-collection in the U.S. To date, 200,000 
tests have been performed. The test is very sensitive for the presence of SARS-CoV-2, with 98% 
of tests providing either a positive or a negative result, and only 2% of tests providing an 
inconclusive result. The test can detect fewer than 10 copies of viral genes per milliliter of saliva, 
and it can detect the presence of virus in the saliva within 2 days of infection and up to 28 days 
after infection. Across all known gene sequences of SARS-CoV-2, the test detects the ones in the 
genes of interest ~100% of the time, making it highly sensitive and specific for those genes. While 
false positive and false negative rates for this test cannot be calculated currently (the lab does not 
receive data on what happens to patients after they receive the test), emerging data about false 
negative rates of saliva-based COVID tests are showing that the false negative rate may be closer 
to 10%, which is significantly lower than those of nasopharyngeal swab-based tests, which are in 
the 25-35% range.
B.
Procedures which Risk Harm to Embryo, Fetus, and/or Pregnant Subjects
N/A
C.
Risks of Harm to Non-Subjects
N/A
D.
Assessment of Social Behavior Considerations
N/A
E.
Minimizing Risks of Harm
The investigative team will abide by the protocols laid out by our ongoing IRB-approved cohort 
surveillance studies. All data used for analysis will not contain any PHI. Data will be transferred 
according to safe data transfer policies utilized by both studies and stored on password protected, 
encrypted computers. All co-investigators will also sign a confidentiality agreement to prevent both a 
breach of confidentiality and deductive identification of the de-identified data. All study personnel have 
been trained in methods of maintaining confidentiality and have passed the Rutgers educational 
program requirement on the protection of human subjects (CITI training), Good Clinical Practice, and 
HIPAA regulations at regular intervals. In addition, audit trails, reports for monitoring and other checks 
will be made to ensure data integrity. These checks will be overseen by the study PIs and research 
team. 
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Finally, saliva specimens sent to the lab for analysis will be coded by study ID; no PHI will be provided 
to these laboratories. The laboratory data will then be merged with other study research data by study 
ID. These merged files will be securely e-mailed using the study’s safe data transfer protocol by the 
study staff to the study PIs and statisticians for analysis. Again, at no time will PHI be e-mailed or 
provided to investigators conducting data analysis. Antivirus software and firewalls are updated 
regularly to prevent any potential virus infection or hacking attempts. 
Vault Health, Inc provides administrative and physician services to RUCDR Infinite Biologics for 
ordering the saliva test, remotely supervising people while they collect their sample (via Zoom video 
call if needed), and reporting results. When ordering the test, people are asked whether they wish to 
receive results over email or not. Results are provided within 24-48 hours after the sample is received 
at the lab. For those who agree to email notification, they receive an email with the test result (positive, 
negative or inconclusive). Otherwise, they receive an email notification with a link to the results in their 
Vault account when the results are ready to view. Positive results are communicated via phone by a 
clinician from Vault, and people are given general CDC recommendations and advised that they need 
to contact their healthcare provider for follow up care. In the event that participants do not have a 
primary care provider, they will be referred to an RWJ Barnabas Health Partners provider or a Federally 
Qualified Health Center (in the case of no insurance) near their residence for follow-up care for COVID 
symptoms and any psychological distress. Vault reports test results as required by the applicable 
healthcare government authorities.
F.
Potential Benefits to Subjects
The immediate benefit to study participants in Aim 2 is that they will learn if they are SARS-CoV-2 
positive or negative. Larger scale benefits to society include potential reduction of transmission through
identification of virus-positive individuals. Additional benefits to society are anticipated through the 
identification of strategies to better engage underserved communities in testing efforts and subsequent
COVID-19 vaccination efforts, which can be implemented in NJ and beyond.
5.0 Special Considerations
5.1 Health Insurance Portability and Accountability Act (HIPAA)
The study informed consent provides direct authorization for Vault Health to share COVID testing 
results and PHI information in the participant’s Vault health record with the research team  in 
accordance with this research protocol. 
5.2 Family Educational Rights and Privacy Act (FERPA)
N/A
5.3 Code of Federal Regulations Title 45 Part 46 (Vulnerable Populations)
A.
Special Populations
Health care employees will be recruited as health care “ambassadors” for this study, however 
it is solely the individual’s choice as to whether or not to participate. No study results will be 
reported to the employers.
Children will be enrolled in Aim 2 of the study after approval of the appropriate 
consent/assent forms and data collection instruments. Given that children are susceptible to 
SARS-CoV-2 infection, this study includes children and their parents as subjects. No greater 
than minimal risk to participating children is presented in this study. Children will only 
participate with the permission of their parent or guardian as outlined above. Children age 7 
and older will provide assent. Assent would not be developmentally appropriate for younger 
children.
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5.4 General Data Protection Regulation (GDPR)
N/A
5.5 NJ Access to Medical Research Act (Surrogate Consent)
N/A
6.0 Data Management Plan
6.1 Data Analysis
Aim 1
Qualitative data analysis of Zoom transcripts: Data collected will be analyzed to understand and process 
perspectives of participants’ and to adapt and tailor materials and messaging that is meaningful to HCWs, 
their families, and community participants. Transcripts and fieldnotes will be managed using ATLAS.ti 
software. Independent data coding will be conducted by 2 team members with discrepancies reviewed at 
team meetings and resolved through consensus. We will compare and contrast data in the transcripts and 
fieldnotes within and across stakeholder groups as part of an iterative cycling process of reading, 
summarizing, and re-reading the data using qualitative interpretive analysis.
 Aim 2
Quantitative: To compare participation rates in the two arms, our primary outcome, we will use data on the 
number of tests performed per month (over the up to 12 month study period). For each intervention, the 
start time is the date of first attempted contact with potential participants and the end date is either the end 
of the study period, or the date at which the 1000th individual was tested (whichever comes first). We 
assume that the number tested follows a Poisson distribution within 
the time period. We will test the null hypothesis that there is no 
difference between the two interventions, and also report a 95% 
confidence interval for the rate ratio. Secondarily, we will examine 
the proportion of tested participants from vulnerable and 
underserved populations of interest (e.g. Black and Latinx, 
immigrants, children, and low-income households) in each arm 
through logistic regression models. We will additionally examine proportion of positive tests in the two study 
arms to examine whether recruitment through index HCWs taps into more highly exposed participant 
groups, as hypothesized. To do so we will fit logistic regression models, where the outcome is positive test 
results (yes/no) and the primary predictor is study arm, adjusting for covariates including participant age, 
race/ethnicity, sex, occupation, and highest level of educational attainment. Power calculations for this aim 
are based on the primary outcome measure, testing uptake rate. We report power for rate ratios (RR; ratio 
of rate in comparison arm relative to intervention arm) of 1.15, 1.2, and 1.3, when expected tests per month 
in the intervention arm range from 80 to 120 (Table X). We will have about 80% power or greater for RR of 
1.15 or greater. To test hypothesis 2B, we will compare participants in the two arms on key characteristics 
that may be barriers to testing (participant trust, health literacy, English proficiency, and patient activation). 
We will do so through linear regression models, adjusting for covariates including participant age, 
race/ethnicity, sex, and highest level of educational attainment.
Cost Analysis: The cost of the intervention components will be calculated using wage rates for personnel 
at the healthcare organizations and CBOs involved in distribution of materials multiplied by time recorded 
in time logs. Fringe benefit costs (healthcare, disability, and life insurance) will be added to wages by 
applying the prevailing fringe benefit rate. The value of time will be calculated as the present value of 
earnings: (number of hours spent delivering NJ HEROES TOO components) x (interventionist’s reported 
wage rates + fringe benefits). Staff training time will be captured and converted to costs based on 
application of hourly wage rates. Material costs will include the salivary test, educational print materials 
provided to study participants, and any other required supplies. 
Table X: Rate (Expected #/month) in 
NJ HEROES TOO arm
RR
80
100
120
1.15
0.78
0.82
0.81
1.2
0.94
0.96
0.95
1.3
0.99
0.99
0.99
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Qualitative/Process Analysis: We will conduct an ongoing mixed methods process evaluation to gather data 
on how the interventions are implemented while gaining critical insight into factors that influence 
implementation from multiple perspectives. We will collect quantitative and qualitative data on key 
intervention components to understand reach, engagement, and adoption of the interventions. Data on 
reach will assess number of family members/contacts per HCW enrolled. Data on engagement will include 
data on participation rates for HCWs and families participating across the four counties. Data on adoption 
will include distribution of educational materials and testing uptake across the four counties. Throughout 
the intervention, we will purposefully identify and select key informants, individuals with direct experience 
and knowledge about the intervention, including both those implementing the intervention and recipients of 
the intervention. 
6.2 Data Security
Data will be accessed from the Family Medicine Research Division Offices located in the Rutgers Institute 
for Health, Healthcare Policy and Aging Research at 112 Paterson Street, New Brunswick NJ 08901. We 
will utilize standard Rutgers procedures and infrastructure for data and safety monitoring to ensure the 
security of our study participants’ data (see section 6.3 for details). De-identified electronic data will be 
stored on the university’s secure server for at least 6 years after completion of the study. Saliva specimens 
are completely used for the SARS-CoV-2 assay; there is no residual saliva, therefore, there will be no 
specimen banking.
Data stored for future use will only be accessible by the Principal Investigator and co-Investigators and the 
RADxUP Coordination and Data Collection Center at Duke University which serves as the national 
coordination site for all RADxUP grantees. Release of de-identified data or specimens, irrespective of 
whether the Principal Investigator has ownership of the research project(s) that require the banked data, 
will need to obtain separate IRB approvals. We will make the de-identified data available to other 
researchers only under a data-use sharing agreement (see Resource Sharing Plan for details). When the 
banked data are transferred or shared, they will not be associated with any identifiable data, personal 
information of the research participants, or the master code identifier for deciphering the codes. 
6.3 Data and Safety Monitoring
For this study, we will employ the following data safety and monitory plan. On an ongoing basis, the data 
team will monitor study record, questionnaire completion, and laboratory results. They will conduct regular 
spot checks of the data, checking records of 10% of the data housed in the password-protected database 
for data quality and accuracy. If inaccuracies are found, then the data team will meet with the study’s PIs 
and operations team to discuss data collection processes, identify reasons for inaccuracies, and improve 
data entry and management systems. In addition, a data check will be conducted approximately one month 
after the identification of any inaccuracies to ensure that any issues involving the data entry and 
management systems have been resolved. 
All adverse events (including those related to receipt of a positive test) will be recorded by study staff and 
reviewed by the PIs upon report. As we are leveraging already-ongoing data collection in our COVID 
surveillance cohorts, the present study will be in keeping with existing ongoing data collection protocols, 
currently approved by the studies’ individual IRBs. As such, any adverse events, such as psychological 
distress, will be reported to the Rutgers IRB within 72 hours as per our institution’s monitoring plan. 
Outcomes of adverse events will be reported in annual progress reports to NIH. Adverse events reporting 
will include: (a) a description of the adverse event, (b) the severity of the adverse event, and (c) whether 
the adverse event was associated with the research study. 
We will utilize standard Rutgers procedures and infrastructure for data and safety monitoring to ensure the 
security of our study participants’ data. 
Qualitative data will be entered into the firewall-protected Rutgers secure servers. Rutgers employs Virtual 
Local Area Networks (VLAN) and Virtual Private Networks (VPN), in conjunction with Intrusion Detection 
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Systems (IDS), encryption techniques and virus protection and detection controls. Access to the server is 
only allowed for authorized users with a password. The data kept on this server are in a folder with the 
project’s name. Access to this folder is restricted to the PI and system administrator. Access by anyone 
else to this folder has to be specifically authorized by the PI and executed by the system administrator. All 
subsets of the original database that are created for analyses will be created on this server. Research 
personnel conducting data analysis may be granted permission to download the dataset to his/her 
workstation. These workstations are connected to the Rutgers server and are password protected. As soon 
as analyses are completed, the dataset will be moved to the project data folder on the server and removed 
from the workstation. 
Survey data will be stored on a Rutgers secure server via data entry into the study REDCap database. 
REDCap is a secure, password-protected web-based application designed to support data capture for 
research studies.40 A unique study participant ID will be assigned in REDCap at the time of screening. All 
data used for analysis will be fully de-identified upon data export from REDCap and stored on an encrypted, 
password-protected computer network to which only study investigators and staff have access. De-
identification of data will consist of removal of all personal identifiers from analytic files as well as random 
shifting of dates to preserve participants’ anonymity. Audits of REDCap data access will be completed 
approximately every 2 weeks to ensure there is no unauthorized access of REDCap data. Investigators will 
keep the data, including links to personal identifiers, for at least 6 years, and longer if we have scientific 
justification, funding, and regulatory approvals to continue working with these data.
All study personnel have been trained in methods of maintaining confidentiality and have passed the 
Rutgers educational program requirement on the protection of human subjects (CITI training) and HIPAA 
regulations at regular intervals.
6.4 Reporting Results
A.
Individual Subjects’ Results 
N/A
B.
Aggregate Results
We will make aggregate results available by sending electronic newsletters, posting research 
briefs, white papers, infographics and blog communications on the NJACTS website.  We will also 
host virtual zoom forums where investigators will be available to answer community questions. 
C.
Professional Reporting
Data generated from the proposed study will be shared with the research community through 
presentations at scientific meetings and publications in peer-reviewed journals.
D.
Clinical Trials Registration, Results Reporting and Consent Posting
This study has been registered as NCT04766333 at ClincalTrials.gov. Final and aggregate results 
including basic results will be reported in a publicly accessible manner within twelve (12) months 
of the trial’s primary completion date
6.5 Secondary Use of the Data   
N/A
7.0 Research Repositories – Specimens and/or Data
N/A
8.0 Approvals/Authorizations
N/A
9.0 Bibliography
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1.
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Goudsward AJ, Bogues A, Contreras GM. Coronavirus NJ: Why are 'people surprised that this is 
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Health NJDo. New Jersey COVID-19 Dashboard.  05/12/2020 2020.
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7.
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Physicians. Ann Fam Med. 2020;18(3):202-209.
8.
Dorn AV, Cooney RE, Sabin ML. COVID-19 exacerbating inequalities in the US. Lancet. 
2020;395(10232):1243-1244.
9.
Nunez A, Madison M, Schiavo R, Elk R, Prigerson H. Responding to Healthcare Disparities and 
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10.
Orzano AJ, Scott J, Hudson SV, et al. Strategies for conducting complex clinical trials in diverse 
community practices. Med Care. 2007;45(12):1221-1226.
11.
Evans KR, Lewis MJ, Hudson SV. The role of health literacy on African American and 
Hispanic/Latino perspectives on cancer clinical trials. J Cancer Educ. 2012;27(2):299-305.
12.
Hudson SV, Harris-Haywood S, Stange KC, Orzano AJ, Crabtree BF. Recruiting minority primary 
care practices into practice-based research. Med Care. 2006;44(7):696-700.
13.
Evans KR, Hudson SV. Engaging the community to improve nutrition and physical activity among 
houses of worship. Prev Chronic Dis. 2014;11:E38.
14.
Fyffe DC, Hudson SV, Fagan JK, Brown DR. Knowledge and barriers related to prostate and 
colorectal cancer prevention in underserved black men. J Natl Med Assoc. 2008;100(10):1161-
1167.
15.
Natale-Pereira A, Marks J, Vega M, Mouzon D, Hudson SV, Salas-Lopez D. Barriers and 
facilitators for colorectal cancer screening practices in the Latino community: perspectives from 
community leaders. Cancer Control. 2008;15(2):157-165.
16.
Jimenez M, Tan-Billet J, Babineau J, et al. The Promise Clinic: a service learning approach to 
increasing access to health care. J Health Care Poor Underserved. 2008;19(3):935-943.
17.
Bromley E, Mikesell L, Khodyakov D. Ethics and Science in the Participatory Era: A Vignette-
Based Delphi Study. J Empir Res Hum Res Ethics. 2017;12(5):295-309.
18.
Crabtree BF, Miller WL. Doing qualitative research. 2nd ed. Thousand Oaks, Calif.: Sage 
Publications; 1999.
19.
Leach CR, Alfano CM, Potts J, et al. Personalized Cancer Follow-Up Care Pathways: A Delphi 
Consensus of Research Priorities. Journal of the National Cancer Institute. In press.
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20.
Khodyakov D, Mikesell L, Schraiber R, Booth M, Bromley E. On using ethical principles of 
community-engaged research in translational science. Transl Res. 2016;171:52-62 e51.
21.
Crabtree BF, Miller WL, Howard J, et al. Cancer Survivorship Care Roles for Primary Care 
Physicians. Ann Fam Med. 2020;18(3):202-209.
22.
Jimenez ME, Hudson SV, Lima D, Crabtree BF. Engaging a Community Leader to Enhance 
Preparation for In-Depth Interviews With Community Members. Qual Health Res. 
2019;29(2):270-278.
23.
Christian AH, O'Malley D, Barac A, Miller SM, Hudson SV. Cardiovascular risk and communication 
among early stage breast cancer survivors. Patient Educ Couns. 2017;100(7):1360-1366.
24.
O'Malley DM, Davis SN, Devine KA, et al. Development and usability testing of the e-EXCELS tool 
to guide cancer survivorship follow-up care. Psychooncology. 2020;29(1):123-131.
25.
Rubinstein EB, Miller WL, Hudson SV, et al. Cancer Survivorship Care in Advanced Primary Care 
Practices: A Qualitative Study of Challenges and Opportunities. JAMA Intern Med. 
2017;177(12):1726-1732.
26.
Shaw EK, Howard J, Etz RS, Hudson SV, Crabtree BF. How team-based reflection affects quality 
improvement implementation: a qualitative study. Qual Manag Health Care. 2012;21(2):104-
113.
27.
Shaw EK, Ohman-Strickland PA, Piasecki A, et al. Effects of Facilitated Team Meetings and 
Learning Collaboratives on Colorectal Cancer Screening Rates in Primary Care Practices: A 
Cluster Randomized Trial. Ann Fam Med. 2013;11(3):220-228.
28.
Tsui J, Howard J, O'Malley D, et al. Understanding primary care-oncology relationships within a 
changing healthcare environment. BMC Fam Pract. 2019;20(1):164.
29.
Crabtree BF, Miller WL, Stange KC. Understanding practice from the ground up. J Fam Pract. 
2001;50(10):881-887.
30.
Balasubramanian BA, Chase SM, Nutting PA, et al. Using Learning Teams for Reflective 
Adaptation (ULTRA): insights from a team-based change management strategy in primary care. 
Ann Fam Med. 2010;8(5):425-432.
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Davis SN, O'Malley DM, Bator A, et al. Rationale and design of extended cancer education for 
longer term survivors (EXCELS): a randomized control trial of 'high touch' vs. 'high tech' cancer 
survivorship self-management tools in primary care. Bmc Cancer. 2019;19.
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Shaw EK, Chase SM, Howard J, Nutting PA, Crabtree BF. More black box to explore: how quality 
improvement collaboratives shape practice change. J Am Board Fam Med. 2012;25(2):149-157.
33.
Shaw EK, Howard J, West DR, et al. The role of the champion in primary care change efforts: 
from the State Networks of Colorado Ambulatory Practices and Partners (SNOCAP). J Am Board 
Fam Med. 2012;25(5):676-685.
34.
Balasubramanian BA, Cohen DJ, Davis MM, et al. Learning Evaluation: blending quality 
improvement and implementation research methods to study healthcare innovations. 
Implement Sci. 2015;10:31.
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Balasubramanian BA, Marino M, Cohen DJ, et al. Use of Quality Improvement Strategies Among 
Small to Medium-Size US Primary Care Practices. Ann Fam Med. 2018;16(Suppl 1):S35-S43.
36.
Barrett ES, Horton DB, Roy J, et al. Prevalence of SARS-CoV-2 infection in previously undiagnosed 
health care workers at the onset of the U.S. COVID-19 epidemic. medRxiv. 2020.
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Focus Group Research. Qual Health Res. 2019;29(10):1483-1496.
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38.
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Interviews Are Enough? Qual Health Res. 2017;27(4):591-608.
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Field MJ, Behrman RE, Institute of Medicine (U.S.). Committee on Clinical Research Involving 
Children. Ethical conduct of clinical research involving children. Washington, D.C.: National 
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