Presentation on the RADx-Underserved Populations Coordination and Data Collection Center with an emphasis on how it will help understand and reduce the disparities associated with the COVDI-19 pandemic

1. RADx Underserved Populations (RADx-UP)
Warren Kibbe
January 29th for IDIG
@wakibbe

2. OVERVIEW OF RADX PROGRAM

3. 3
Project Description
RADx Tech Highly competitive, rapid three-phase challenge to identify the best candidates for
at-home or point-of-care tests for COVID-19.
RADx-Advanced Technology
Technology Platforms
(RADx-ATP)
Rapid scale-up of advanced POC technologies and laboratories to accelerate,
enhance and validate utility of ultra-high throughput machines and facilities.
RADx-Radical
(RADx-rad)
Develop and advance novel, non-traditional approaches or new applications of
existing approaches for testing.
RADx-Underserved
Populations (RADx-UP)
Interlinked community-engaged projects focused on implementation strategies to
enable and enhance testing of COVID-19 in underserved and/or vulnerable
populations.
Rapid Acceleration of
Diagnostics (RADx) Overview

4. 4
Overarching Goal
Establish a robust pipeline of innovative diagnostic technologies to increase
national testing capacity.
Innovate Across the Testing Landscape
Expand the number, type, access, and throughput of testing technologies.
Optimize Technology Performance
Develop technology for a range of essential “Use Cases”
 At-home
 Point of Care (POC)
 Hospital
 Testing Laboratory
RADx Tech

5. 5
Overarching Goal
Increase testing capacity and throughput by identifying existing and late-
stage testing platforms to achieve rapid scale-up or expanded
geographical placement.
 Emphasize differential POC testing to distinguish SARS-Cov-2 vs.
influenza.
 Establish rapid collaborations with key industry partners.
RADx-Advanced Technology Platforms
(RADx-ATP)
Support Scale-Up of High-Throughput Labs to
Add Capacity
Scale-up Late-Stage Technologies

6. 6
Overarching Goal
Support new, non-traditional approaches and new applications of existing tools
that address gaps in COVID-19 testing and develop platforms that can be deployed
in future outbreaks of COVID-19 and other, yet unknown, diseases.
Example Research Technologies of Interest
 Wastewater-based detection of SARS-COV-2
 Single vesicle, exosome, and exRNA isolation for the detection of SARS-CoV-
2
 Chemosensory testing for COVID-19 screening
 Predicting viral-associated inflammatory disease severity in children with
laboratory diagnostics and artificial intelligence
 Multimodal COVID-19 surveillance methods for high-risk populations
RADx-Radical (RADx-rad)

7. 7
Phase I: $300M Phase II: $200M
Build infrastructure Rapidly implement
testing, other capabilities
Integrate new
advances
Expand studies/
populations
September – November 2020 2021
RADx-Underserved Populations (RADx-UP)
Overarching Goals
 Enhance COVID-19 testing among underserved and vulnerable populations across the US.
 Develop/create a consortium of community-engaged research projects designed to rapidly implement
testing interventions.
 Strengthen the available data on disparities in infection rates, disease progression and outcomes, and
identify strategies to reduce these disparities in COVID-19 diagnostics.

8. INTRODUCTION OF RADX-UP

9. 9
RADx-UP Strategies
• Expand capacity to test broadly for SARS-CoV-2 in highly affected
populations, including asymptomatic persons.
• Deploy validated point of care tests as available, including self-test
and saliva-based methods.
• Inform implementation of mitigation strategies based on isolation
and contact tracing to limit community transmission.
• Understand factors that contribute to COVID-19 disparities and
implement interventions to reduce these disparities.
• Establish infrastructure that could facilitate evaluation and distribution
of vaccines and therapeutics.

10. 10
Overview
 Awarded 29 sites in FY20, 1 site in FY21
o Approximately 500,000 participants/tests
 Testing methods include a range of POC, pooled, & lab-based; PCR, antigen, and Ab:
o Abbott ID NOW, Roche cabas, Cepheid GeneXpert, Hologic Aptima/Panther Fusion, Advanta Dx, Quest Diagnostics LDT,
ThermoFisher, Infinity BiologiX, LabCorp, and custom tests
 Testing at prisons, mental health programs, in public housing & community centers
o Focus on rural and urban, Tribal, and aging communities
 Understand the factors associated with COVID-19 morbidity and mortality disparities and to lay
the foundation to reduce disparities for those underserved and vulnerable populations
 Closely partner with communities to develop and implement interventions to increase access
and uptake of testing
 Provide large-scale testing and collaborate across the consortium of projects to serve as a
resource for future studies and outreach
Program Information: $5M per site over 2 years; 30 sites
NOT-OD-20-121
Testing Research Projects: Large Networks, Consortia &
Research Centers

11. 11
Overview
 Awarded 4 sites in FY20, 19 in FY21
 Testing methods include a range of POC, pooled, & lab-based; PCR, antigen, and Ab:
o Abbott ID NOW, Abbott Architect IgG Assay, Applied BioSystems, Cellex Rapid Test, KorvaLabs Curative SARS-Cov-2 Assay,
Cepheid GeneXpert, Cellex Rapid Test, Healgen, Quidel Sofia SARS antigen test, ThermoFisher, TaqPath, LabCorp, Inno
Diagnostics, and custom tests
 Testing at mobile-sites, community health centers, in public housing & at home
o Focus on individuals with medical comorbidities, substance use disorders or mental illness, and community
dwelling older adults
 Strengthen available data on disparities in infection rates and disease progression and
outcomes among underserved and vulnerable populations across the US
 Understand differences in testing access and uptake patterns
 Partner with communities to build the evidence-base of approaches to identify and address
disparities in diagnostic testing uptake and effectiveness
NOT-OD-20-120
Testing Research Projects: Community Collaborations &
Partnerships
Program Information: $2M per site over 2 years; 23 sites

12. 12
Overview
 Awarded 5 projects in FY20, 11 in FY21
 Research conducted through community health centers, online surveys, public housing developments, and Tribal communities
o Focus on individuals with medical comorbidities, migrant and immigrant populations, Tribal populations, and rural and remote
communities
 Assess ethical, historical, healthcare, social, economic, and contextual factors surrounding
COVID-19 testing
 Investigate influence of cultural beliefs and attitudes, perceived expectations, and preferences
 Inform development of interventions and tools to increase access to and acceptability of testing
Social, Ethical and Behavioral Implications
Program Information: $1.2M per site over 2 years; 16 sites
NOT-OD-20-119

13. 13
Overview
 Awarded to Duke/UNC
 Innovative ideas for data management, hub and spoke models of networked testing, and outreach to underserved communities
 Experience in developing new SARS-CoV-2 testing technologies
o Provide strong technical assistance to testing protocols and adoption/distribution of new, emerging technologies
 Serve as a national resource to coordinate across the RADx Consortium
 Provide overarching support and guidance in: (1) Administrative Operations and Logistics, (2)
COVID-19 Testing Technology, (3) Community and Health System Engagement and (4) Data
Collection, Integration and Sharing
 Support the pilot project programs: (1) Rapid pilot studies, (2) Community collaboration grants
RFA-OD-20-013
RADx-UP Coordinating Center (CDCC)
Program Information: $80M over 4 years

14. This Is RADx-UP:
Our Projects & The Communities We Serve

15. Projects Overview
Total Number Projects 69
Total Number of States and Territories 56 *includes Washington DC
Total Target Enrollment 683,220
Total Participants to be Tested 362,000
First Study Enrollment July 2020
Last Study Enrollment November 2022

16. States or Territories the Projects will Serve

17. 17
NOT-OD-20-121, NOT-OD-20-120, NOT-OD-20-119 & RFA-OD-20-013
Together, funded sites and research projects propose to serve a diverse population set, with many projects serving
Hispanic/Latino and African American populations, as well as Asian Americans and American Indians/Alaska Natives.
RADx-UP Phase I Snapshot: 70 Funded Sites and Research Projects
3
5
15
19
24
25
33
41
Native Hawaiians and other Pacific Islanders
Underserved Rural Populations
Socioeconomically disadvantaged populations
Sexual and Gender Minorities
American Indians/Alaska Natives
Asian Americans
Blacks/African Americans
Hispanics/Latinos/as
Target Health Disparity Population Projects
Note: Some projects/sites address multiple target populations.
Number of Awards

18. 18
NOT-OD-20-121, NOT-OD-20-120, NOT-OD-20-119 & RFA-OD-20-013
Together, funded sites and research projects propose to serve a diverse population set, with many projects serving
individuals with medical comorbidities known to increase risk of severe COVID-19, rural and remote communities, and
migrant and immigrant populations.
8
10
11
11
11
12
15
23
25
Residents of tribal lands or reservations
Public housing residents
Children and adolescents
Community dwelling older adults
Essential workers
Individuals with substance use disorders or serious mental illness
Migrant and immigrant populations
Rural and remote communities
Individuals with medical comorbidities known to increase risk of severe COVID-19
Target Vulnerable Population Projects (1/2)
RADx-UP Phase I Snapshot: 70 Funded Sites and Research Projects
Note: Some projects/sites address multiple target populations.
Number of Awards

19. 19
NOT-OD-20-121, NOT-OD-20-120, NOT-OD-20-119 & RFA-OD-20-013
RADx-UP Phase I Snapshot: 70 Funded Sites and Research Projects
Funded sites and research projects also propose to serve the following additional vulnerable populations.
3
4
5
5
6
7
7
Residents of nursing homes and assisted living facilities
Individuals with disabilities, cognitive impairment or dementia, or communication disorders
Individuals living in congregate housing
Pregnant and post-partum women
Individuals involved with the criminal or juvenile justice systems
Communities exposed to high rates of air pollution or other toxic exposures
Homeless populations
Target Vulnerable Population Projects (2/2)
Note: Some projects/sites address multiple target populations.
Number of Awards

20. Number of Projects with Specific Target Population
46
42
31
21
18
17
17
16
5
2
2
1

21. Project Settings

22. Primary Languages of the Communities

23. Community Outreach Methods to be Used
community-based

24. COVID-19 Testing

25. 25
Social, Ethical and Behavioral Implications (SEBI) Institutions
RADx-UP Phase I Awards
Note: There are two awards located in Los Angeles, CA and New York, NY each.

26. 26
Social, Ethical and Behavioral Implications (SEBI) Participant Locations
RADx-UP Phase I Awards
Note: Cities listed are not exhaustive, as some projects only provided state-level information.

27. OVERVIEW OF RADX-UP CDCC

28. Coordination & Data Collection
Center
The RADx-UP CDCC is funded through NIH emergency cooperative agreement 1U24MD016258

29. Welcome from the RADx-UP CDCC Team
Duke Clinical Research
Institute (DCRI)
UNC Center for Health
Equity Research
Duke Department of
Biostatistics and Bioinformatics

30. 30
 The RADx-UP Coordination and Data
Collection Center (CDCC) serves as a hub for all
RADx-UP funded projects
The RADx-UP CDCC
 Provides steadfast assistance to RADx-UP projects to optimize
engagement, outreach, testing strategies, data collection and
integration, and co-learning opportunities between and among
projects and to the communities that we serve
• Is led by the Duke Clinical Research Institute (DCRI),the Center
for Health Equity Research at UNC-Chapel Hill with support from
a key partner, Community-Campus Partnerships for Health

31. 31
RADx-UP CDCC
Goals
Accelerate COVID-19 community implementation
science via an agile, flexible, participatory,
transparent and sustainable CDCC.
Support data collection, integration, and
sharing while preserving necessary data
protections.
Amplify and disseminate community best practices
for successful implementation of COVID-19 testing
strategies and vaccines.
Utilize RADx-UP infrastructure to
support COVID-19 research.

32. 32
Communities are at the center of our
work.
Data sovereignty protections and
sharing with communities and
participants are essential in building
trust and being trustworthy.
Intentional support of study teams is
critical to streamline results and
troubleshoot.
Broad dissemination of program
activities, data, and best practices are
key.
Strategic partnerships will augment
community benefits from the program.
Impact will be broad and will inform
national guidance, strategy, and
response to COVID-19.
*To be collaboratively informed by NIH and the community
RADx-UP CDCC Guiding Principles – Draft*

33. 33
RADx-UP CDCC
Principal Investigator Leadership: Michael Cohen‐Wolkowiez, MD, PhD, Giselle Corbie‐Smith, MD, MSc, Warren Kibbe, PhD, FACMI
Operations Director: Renee Pridgen
Program Director: Susan Knox
ADMINISTRATION AND COORDINATION CORE
Operational Lead: Donna Parker
ENGAGEMENT IMPACT TEAMS
COVID‐19 TESTING CORE
Core Leadership:
Chris Woods, MD, Thomas Denny, MSc, MPhil
Program Lead: Tim Veldman, PhD
Operational Lead: Barrie Harper
COMMUNITY ENGAGEMENT CORE
Core Leadership:
Al Richmond, Krista Perreira, PhD
Program Lead : Renee Leverty
Operational Lead: Crystal Cannon
DATA SCIENCE AND BIOSTATISTICAL CORE
Core Leadership:
Keith Marsolo, PhD, Lisa Wruck, PhD
Program Lead : Bhargav Adagarla
Operational Lead: Laura Johnson
RADx-UP
STEERING COMMITTEE &
EXTERNAL ADVISORY
BOARD
RADx-UP Awardees
SERVICES: Project Leadership, Communications, Evaluation
NIH Program Officers:
Dottie Castille, PhD
Beda Jean-Francois, PhD
NIH Project Scientist:
Fabienne Santel, MD, MPH
NIH Project Scientist:
Nadra Tyus, Dr.PH, MPH
NIH Project Scientist:
Partha Bhattacharyya, PhD

34. 34
Administration &
Coordination
 Communication
 Committee oversight
 Processes, policies,
procedures
 Partnerships
 Evaluation
Community
Engagement
 Best practices
 Engagement Resource
Library
 COVID-19 Equity
Evidence Academy
 Community of Practice
 Community
Collaboration Grants
COVID-19 Testing
 Technical support
 Repository of emerging
technologies
 Testing selection &
implementation
 Research pilot studies
Data Science &
Statistics
 Data harmonization
 Security, privacy, and
protections
 Data exchange
 Data representation and
visualization
ENGAGEMENT IMPACT TEAMS
CDCC Cores

35. 35
CDCC Engagement Impact Teams
• EIT Members: project management + community
engagement
• Single point of contact to awardees
• Support awardees
•Coordination, testing, community engagement, and data
collection and sharing
•Identify challenges and collaboratively generate solutions
•Testing and supplies, timeline management, community
access and engagement, recruitment and retention
challenges, and data use limitations, etc.
• Assist with troubleshooting
• Monitor progress

36. 36
CDCC Awardee
Communication Objective:
Communication
Channels
Welcome via
Email
Data Exchange
Engagement
Impact Team
Outreach
Newsletters
Orientation
Session
Project-wide
Meetings
COVID-19 Equity
Evidence Academy
Provide regular communications
to RADx-UP awarded projects to:
• Support engagement, testing,
and data collection/integration
• Promote co-learning between
and among projects and the
communities that we serve
RADx-UP Draft Communication Plan

37. Program Activity Timeline
What’s
New
• The final Common Data Elements (CDEs) and Informed Consent Data Sharing (ICF)
Template Language are available on the RADx-UP Toolkit, http://radx-up.org/toolkit/
• Check in with your CDCC Engagement Impact Team to discuss questions or concerns
related to implementation on your project
• Steering Committee members have been invited and will meet Jan. 25
• RADx-UP website includes Resource Library
What’s
Next
• Details and RFAs for the Community Collaboration Mini-Grant Program and the Rapid
Research Pilot Project Grant Program will be announced
• COVID-19 Equity Evidence Academy “Translating Innovations in Testing” (Feb. 24-25)
• Team directory and collaboration space coming soon!

38. News, Deadlines & Reminders
It’s as Easy as 1, 2, 3 to Stay Connected…
1. Read the RADx-UP newsletter
2. Participate in RADx-UP Monthly Project-Wide Team
Meetings
3. Establish regular connections with your Engagement
Impact Team or contact us at RADx-UP-
CDCC@dm.duke.edu.

39. RADx-UP Website & Toolkit
• Visit Radx-up.org/ to find:
• Project Profiles
• News
• Grant Opportunities (forthcoming)
• Visit Radx-up.org/toolkit/ to find:
• Communication Materials
• A Data Toolkit
• Engagement Impact Team Directory
• Meeting Recordings
• And More!

40. RADx-UP Common Data Elements (CDEs):
Why Collect CDEs?

42. Givens: Community Impact
• The COVID-19 pandemic is having a dramatic impact on people’s lives, livelihoods,
and community interactions.
• It has highlighted health disparities. Many communities across the country are
facing more difficulties than others as they confront the pandemic.
• Underserved populations are concerned about research and how science and
government collects information from individuals, how that information is shared,
and how a participant’s identity could be exposed and exploited.
• Communities, including those serving Tribal Nations, have additional data rights
and responsibilities.

43. Givens: Notice of Special Interest (NOSI) Terms
• RADx-UP members are required to collect and share data, as outlined in NOSI terms:
• NIH is developing common data elements, which are standardized for multiple data sets across
different studies. Study data must be compatible to submit in required formats for person-
specific elements, such as demographics, social determinants of health and
characteristics; and COVID-19-specific elements.
• Recipients are expected to include the minimum NIH COVID-19 common data elements.
• Core common data elements are requested in a common format…
• NIH is requiring data sharing for all COVID-19 projects, where it is not prohibited (e.g., Tribal
data sovereignty).
• Recipients are expected to coordinate and share data with the CDCC and other projects
supported by the RADx-UP initiative and with considerations under tribal IRB processes.
• The NIH expects and supports the timely release and sharing of final research data from NIH-
supported studies for use by other researchers to expedite the translation of research
results into knowledge, products, and procedures to improve human health.

44. Purpose: Fight COVID-19 – Together
• RADx-UP is part of the $1.4 billion dollar NIH RADx initiative to help speed innovation in
the development and implementation of COVID-19 testing, vaccines, and related
technologies.
• One of the top priorities of the RADx initiative is creating the RADx Data Hub, a national
resource of RADx COVID-19 research data. Data collection and sharing is critical to the
success of the RADx initiative.
• NIH expects RADx-UP projects to participate as one consortium of interlinked community-
engaged research projects to understand, address, and solve COVID-19 health
disparities.
• Community centered research across all RADx projects will help to expedite the
translation of results into knowledge to improve the health of our communities.
• The RADx-UP CDCC is expected to provide the best guidance and support to RADx-UP
projects and the communities you serve, recognizing your experience, perspectives,
and project-specific requirements for data sharing.

45. Common Data Elements

46. Goals for the discussion
• Finalize CDEs for RADx-UP
• Sense of urgency, project
enrollment delays
• Agree on data sharing scenarios
• Align on next steps
IRB status as of
12/21/2020
Number of
projects
Not yet submitted 11
Some approvals received, more pending 8
Submitted, not approved 20
Approved, not yet enrolling 23
Enrolling, collecting begun 7

47. Tensions between RADx-UP goals
Lay foundation
to reduce
disparities
Understand
testing patterns
& factors
associated with
health
disparities
Need
to
build
trust
Need
to
collect
data

48. Collecting needed data while developing trust
1. NIH published the RADx-UP Data Harmonization Guidance
2. CDCC met with NIH, NLM, DR2 to discuss recommended RADx and RADx-UP
CDEs – initial Tier 1 version had 752 items
3. CDCC revised CDE and sent to NIH, NLM, DR2 for review
4. CDCC updated CDE based on feedback – version had 66 items
5. CDE survey sent to the Projects for their review and feedback
6. Met with Projects to review survey results and proposed CDE lists
7. Incorporated feedback and CDCC recommendations

49. Summary of Community/Participant Challenges
• CDE may impact participants’ comfort, willingness to getting tested
• Community trust will be impacted by collection of sensitive CDE (ex. identity)
• Participant burden due to length of CDE
• Wording of some CDE are not culturally sensitive
• Data sovereignty and sharing concerns associated with specific communities

50. Summary of Project Challenges
• Design of the project does not support CDE
• Survey is anonymous, so not obtaining consent
• Not enrolling individual participants / only have aggregate data
• High volume of visits per hour won’t allow for full CDE collection
• Staff burden
• Training needed for interviewers to administer the CDE as an oral interview
• Already IRB approved / started project / enrolling participants
• IRB or institution will not approve sharing some CDE with RADx-UP CDCC
• CDE do not align with the project’s specific goals or hypotheses
• Already asking similar questions/topics in project’s questionnaires
• Terminology in some CDE needs to be defined (ex. “stable housing”)
• CDE focus should be more on conditions and situations directly related to COVID-19
• Collecting extensive CDE to create a standard, long-standing, epidemiological dataset may impact the ability to
actually meet the project’s goals and the testing goals of RADx-UP

51. Common Data Elements:
We’ve heard you – let’s talk about your feedback

52. Will you be able to complete all of the RADx-UP
Common Data Elements questions with your study
participants?

53. 13
52
13
52
0
10
20
30
40
50
60
Yes No

54. For which categories do you have recommendations
for alternative Common Data Elements?

55. 4
1
8
10
5
10
4
7
11
4
7 7
0
2
4
6
8
10
12
Identity Consent Symptoms
(COVID-19)
Demographics Disability Employment Health
Insurance
Health Status Housing Medical
History
Medications Vaccine
Hesitancy

56. Specific Recommendations
Category/Question Source
Sexual orientation Projects’ community engaged work
Gender identity MTPC, PhenX
COVID-19 testing practices and beliefs Phen-X
Housing – house size (# rooms), density, age
groups of occupants
Kreuter & McQueen papers; projects
Ethnicity – expand categories for Pacific
Islander, Indigenous Mexicans
State of Hawaii; projects
Phone Number – change “work” to “other” Projects
Employment – add “part-time” and
“seasonal”
Projects
Health Insurance – include insurance type Projects

57. Next Steps
• Share template ICF language to enable data sharing w/RADx-UP
• Finalize the CDEs with NIH input
• Separate required and strongly recommended CDEs:
• Tier 1 (required)
• Tier 2 (strongly recommended, aligned with DR2 and PhenX toolkit CDEs)
• Distribute CDEs to RADx-UP projects for IRB submission and implementation
• Testing and Evaluation CDEs are forthcoming

58. Which category or categories contain questions you
anticipate not being able to collect?

59. 31
10
7 8
25
9 8
19 18
22
42
8
0
5
10
15
20
25
30
35
40
45
Identity Consent Symptoms
(COVID-19)
Demographics Disability Employment Health
Insurance
Health Status Housing Medical
History
Medications Vaccine
Hesitancy

60. Specific Concerns
• Community/Participant Concerns:
• CDE may impact participants’ comfort, willingness to getting tested
• Community trust will be impacted by collection of sensitive CDE (ex. identity)
• Participant burden due to length of CDE
• Wording of some CDE are not culturally sensitive
• Data sovereignty and sharing concerns associated with specific communities

61. Specific Concerns
• Project Concerns:
• Design of the project does not support CDE
• Survey is anonymous, so not obtaining consent
• Not enrolling individual participants / only have aggregate data
• High volume of visits per hour won’t allow for full CDE collection
• Staff burden
• Training needed for interviewers to administer the CDE as an oral interview
• Already IRB approved / started project / enrolling participants
• IRB or institution will not approve sharing some CDE with RADx-UP CDCC
• CDE do not align with the project’s specific goals or hypotheses
• Already asking similar questions/topics in project’s questionnaires
• Terminology in some CDE needs to be defined (ex. “stable housing”)

62. Specific Concerns
• Relatedness to RADx-UP Goals
• CDE focus should be more on conditions and situations directly related to COVID-19
• Collecting extensive CDE to create a standard, long-standing, epidemiological dataset
may impact the ability to actually meet the project’s goals and the testing goals of
RADx-UP

63. QUESTIONS & ANSWERS