Initial CDEs developed by NIH, DCRI, UNC - Version 1.0 released for feedback • Oct. 16, 2020: RADx-UP CDCC launched - Began collecting feedback from projects • Nov. 2020: Version 1.1 released incorporating feedback - Continued feedback collection • Jan. 2021: Version 1.2 released with Spanish translation - Added new elements based on project needs - Began testing data collection tool prototypes • April 2022: Version 1.5 released - Major revision based on 2 years of implementation experience - Streamlined elements and response options - Added new elements (e.g., vaccination

1. November 18, 2022
RADx® Underserved
Populations

2. RADx Underserved
Populations
(RADx-UP)
Understand and reduce the
disparities in COVID-19
morbidity and mortality for
those disproportionately
affected by COVID-19
This is us
BUDGET
$533 Million
RADxTech
Speed innovative point-of-
care, home-based, and
clinical laboratory tests for
COVID-19
BUDGET
$908 Million
RADx Advanced
Technology Platforms
(RADx-ATP)
Identify testing platforms
that are far enough advanced
for rapid scale-up or
expanded geographical
placement
BUDGET
$230 Million
RADx Radical
(RADx-rad)
Support new, non-
traditional approaches
to address current testing
gaps, and non-traditional
applications of existing
approaches
BUDGET
$187 Million
RADx-UP is Part of a $1.4 Billion NIH Initiative

3. RADx-UP is Community-Engaged Research
• Overarching goal is to evaluate strategies to increase uptake
and access to COVID-19 tests in underserved populations
• NIH started RADx-UP in September 2020, with awards in phases:
– Fall 2020: Phase 1 (69 projects) and CDCC
– Spring/Summer 2021: SayYes! COVIDTest and the Safe Return
to School DiagnosticTesting Initiative (16 projects)
– Fall/Winter 2021: Phase 2 (21 projects) and Supplemental (21 projects)
– Fall 2022: Additional Phase 3 projects expected
• RADx-UP projects build on existing community-academic
infrastructure, processes, and relationships

4. Take home messages
• The RADx-UP Coordination and Data Collection Center (CDCC) is a joint
collaboration of DCRI, UNC Chapel Hill, and the Community-Campus
Partnerships for Health. Started in September 2020.
• RADx-UP CDCC leverages the Secure Duke Azure Cloud
• We coordinate 135+ NIH funded projects and 40 funded pilot projects
• We are partnering with many communities throughout the country and use
data to drive and enhance those relationships
• Meetings: weekly with every project, project-wide every month, NIH every two
weeks, working groups, committees, hold scientific meetings, and organize an
annual equity evidence academy meeting

5. 5
Program Overview
 Phase I: Established a consortium of community-engaged research projects focused primarily on
increasing access to and uptake of COVID-19 diagnostic testing
 Phase II: Expanded Phase I infrastructure, built in projects with an emphasis on interventions, including
a specific focus on school settings, and incorporated research to address vaccine hesitancy and
uptake
 Target Population: populations with health disparities, underserved and vulnerable groups
Overarching Goal
The overarching goal of RADx-UP is to understand factors that have led to the
disproportionate burden of the pandemic on underserved populations, so that COVID-
19 testing interventions can be developed and implemented to decrease these
disparities.
RADx-UP Phase I and II

6. RADx-UP Phase III
Leverage rapid, self-
administeredCOVID-19
testing to understand and
address COVID-19
morbidity and mortality
disparities among the
underserved and vulnerable
populations, given the
availability of COVID-19
vaccines
Study secondary impacts of
mandates for mitigation
measures associated with
COVID-19 and support
psychological and
communication science
interventions to improve
uptake of testing and
vaccination
Expand the evidence base of
scalable and sustainable
approaches to safely maintain
students in school. Integrate
new “Test-to-Stay” models that
reduce or avoid quarantine and
disruptions to the school
environment
TESTING SEBI SAFE IN SCHOOL
Goal: Address the evolving challenges of the pandemic with a focus on developing rapid testing
strategies for use with other mitigation efforts (e.g., vaccination, physical mitigation measures) to reduce
COVID-19 disparities.

7. Course of the Pandemic in the US

8. Case Rates for Vulnerable Populations
CDC COVID Data Tracker
Race/Ethnicity
https://covid.cdc.gov/covid-data-tracker/#demographicsovertime
alpha
delta
omicron

9. Death Rates for Vulnerable Populations
CDC COVID Data Tracker
Race/Ethnicity
https://covid.cdc.gov/covid-data-tracker/#demographicsovertime
alpha
delta
omicron

10. 10
RADx-UP CDCC
Goals
Accelerate COVID-19 community implementation
implementation science via an agile, flexible,
flexible, participatory, transparent and sustainable
sustainable CDCC.
Support data collection, integration, and
integration, and sharing while preserving
preserving necessary data protections.
Amplify and disseminate community best practices
practices for successful implementation of COVID-
COVID-19 testing strategies and vaccines.
Utilize RADx-UP infrastructure to
support COVID-19 research.

11. 11
Sept – Nov 2020
Phase I Phase II
Build
infrastructure
Rapidly
implement
testing, other
capabilities
Integrate
new
advances
Investigate social,
ethical, &
behavioral barriers
to testing
RADx-UP Phases and Timeline
Phase III
Expand
studies/
populations
2022
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
 Through better testing, RADx-UP will help researchers see a clearer picture of how COVID-19 affects these populations and how to improve
health outcomes around the virus
 Expand the evidence base of scalable and sustainable approaches to safely maintain students in school
Emphasis on
Rapid Testing
and Testing in
Schools
Jan – Nov 2021
School based
studies

12. Communities Served by RADx-UP Projects

13. 13
Communities served by RADx-UP projects
Self-reported data reflects RADx-UP Phase I and II projects as of 10/20/2021

14. 14
The RADx-UP Coordination
and Data Collection Center (CDCC)
 The CDCC serves as a hub for all RADx-UP funded projects.
 The CDCC supports RADx-UP projects to optimize engagement, outreach,
testing strategies, data collection and integration, and co-learning
opportunities between and among project teams and to the communities
that we serve.
 The CDCC is led by the Duke Clinical Research Institute (DCRI), and the
Center for Health Equity Research at UNC-Chapel Hill with support from
a key partner, Community-Campus Partnerships for Health.

15. 15
 RADx-UP is the largest single NIH investment in understanding the factors
that protect or harm underserved communities.
 RADx-UP projects are required to collect the NIH RADx-UP Common Data
Elements (CDEs) in order to capture consistent data for comparison across
studies.
 The CDCC supports projects in aligning your activities with requirements to
make data findable, accessible, interoperable and reusable (FAIR).
 The RADx-UP aggregated data will be a resource for NIH, communities, and
researchers to understand the impact of COVID-19 on the well-being, risk,
resilience, and disparities in underserved and vulnerable communities.
NIH Vision for RADx-UP Data

16. The RADx-UP Coordination and Data Collection Center (CDCC)
Al Richmond, MSW
Community
Engagement Core
Community-Campus
Partnerships for Health
Susan Knox, MBA
CDCC Program Manager
Chris Woods, MD
COVID-19 Testing Core
Michael Cohen-
Wolkowiez,
MD, PhD
Duke Clinical Research
Institute (DCRI)
Principal Investigators
Giselle Corbie,
MD, MSc
UNC Center for Health
Equity Research
Warren A. Kibbe,
PhD, FACMI
Duke Department of
Biostatistics and
Bioinformatics
Core Leaders
100+ operational
& support staff
- Experienced
- Diversity of
backgrounds
and training
- Dedicated
Engagement Impact
Teams
Keith Marsolo, PhD
Data Science &
Biostatistics Core
Lisa Wruck, PhD
Data Science &
Biostatistics Core
Krista Perreira, PhD
Community
Engagement Core
Operations Key Partner
Al Richmond, MSW
Community-Campus
Partnerships for Health

17. 17
RADx-UP CDCC - Guiding Principles
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.

18. 18
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

19. RADx-UP CDCC Engagement ImpactTeams
• Single point-of-contact between CDCC and project teams with
project management & community engagement support
– Coordinating testing, community engagement, and data
collection and sharing resources
– Identifying challenges, collaboratively generating solutions,
sharing best practices
– Collecting required forms (data use agreements, IRB-approved
Informed Consent Forms, etc.)
– Connecting projects with translation services
– Monitoring progress

20. How CDCC and NIH collaborate to support projects
CDCC Engagement
ImpactTeams
• The primary point of
contact at CDCC for each
RADx-UP project
• Community engagement
and project management
NIH Project Officers
& Scientists
• Support in data forms and
grant-related questions
• First point of escalation
CDCC Informaticists
• Coordinate data uploads
by projects
• Perform quality reviews of
project data uploads
• EIT and PO/PS relationships are critical
to RADx-UP success
• EITs copy POs on messages to projects
• POs include EITs in communications
to projects
• When escalation is necessary,
EIT engages PO to facilitate

21. RADx-UP CDCC Community Engagement
• To date
– 450+ participants at COVID-19 Equity Evidence Academy events
– 20+ best practices/guidance documents
– 23 community collaboration grants
– 5+ channels for Community of Practice: Slack, newsletters,
meetings, CCPH consults, working groups
• Key CDCC lesson for this and future pandemics
– Deploying community-engaged projects during a pandemic requires
robust, trusted, and effective research-community partnerships

22. RADx-UPWorking Groups
• RADx-UP projects meet to tackle
topics and challenges that may
commonly occur among similar
populations across the country
• Recently added: Social, Ethical and
Behavioral ImplicationsWorking
Group
is gr7306@comcast.net.

23. Project publications on RADx-UP.org
Highlighting
RADx-UP
publications with
research briefs,
blog posts, video
explainers, and
more

24. RADx-UP Resources
• CDCC continues to collect and create resources
for community-engaged researchers and
community partners
• 132 resources in the collection
• Search by
– Audience
– Topic
– Resource type
• Start at https://radx-up.org/resources/RADx-UP

25. Strategies from the RADx-UP Initiative
• A new policy framework based on
experiences from RADx-UP project teams
• Identifies 5 key actions to address health
inequities in COVID-19 and beyond
• Learn more at
https://radx-up.org/research/health-equity-
framework/

26. Analysis Concepts & Proposals
• Initiative to support the preparation of
collaborative research articles and
presentations that analyze RADx-UP data.
• Consortium members are collaborating in
writing teams with CDCC statistical
support.
• Their publications will help community
leaders and policy makers identify effective
strategies for reducing disparities in COVID-
19 testing and addressing other health
needs of their communities.

27. 2021
MAY
OCT NOV DEC JAN FEB MAR APR
SEP JUN
2022
RADx-UP Key Milestones: Sept. 2021–June 2022
12/2021
Launch of RADx-UP
Colectiv data capture tool
12/1/2021
NEW Community
Consultation
Studio Sessions
1 4
1 2 4
10/2021
RADx-UP Data
Quality Resolution
Policy and Process
1/20/2022
Guidance and Testing Information
re: Delta/Omicron surges
Launch of RADx-UP
Community
Connections Series
10/21/2021
RADx-UP
Scientific
Meeting
11/2021
Guidance and Testing
Information re Ellume
home test recall
NIH RADx-UP CDEs
v1.2 in Spanish
11/17–11/18/2021
RADx-UP COVID-19
Equity Evidence Academy
11/18/2021
You & Me COVID-Free
Program
1 2 3 4
1 2 3 4
1 2 3 4
1 3
1 2 4
1 2 4
1 4
1 2 3
1/2022
RADx-UP Image Bank
Orientation Session
1 2
5/16/2022
RADx-UP Partnering
for Impact
1 4
5/11/2022
RADx-UP Health
Equity Policy
Framework
1 2 3 4
5/3/2022
RADx-UP Scientific
Meeting
1 2 3 4
4/6/2022
NIH RADx-UP
CDEs v1.5
1 4
2/3/2022
Webinar: A Community Engaged
Approach to COVID-19 Testing in
African-American Churches
1 2 3 4
2/14/2022
CDCC New Project
Orientation Session
1 2 3 4
2/17/2022
Engaging Black/
African American Working
Group virtual town hall
1 2 3 4
2/28/2022
67 projects uploaded CDE data to CDCC
4
3/10/2022
RADx-UP Data Dashboard
1 4
3/17/2022
RADx-UP Area-Level
Data Linkage Dashboard
1 4
3/25/2022
RADx-UP.org Redesign
1 2 3 4
Create a community-centered, flexible program infrastructure.
Support a participatory and inclusive community engagement program.
Support research projects with COVID-19 testing guidance and emerging science.
Collect, harmonize, integrate and disseminate data to scientific and local communities.
SPECIFIC
AIMS:
1
2
3
4
4/7/2022
First Data
Transfer to
RADx Data Hub
(data from 2
projects)
4
6/9/2022
Second Transfer to
RADx Data Hub
(data from 53 projects)
4
⭐️
⭐️
⭐️
⭐️

28. Data as of 10/18/2022
at a glance
49
CommunityCollaboration
Mini Grants
127
COVID-19 testing
and SEBI projects
113
Published
research articles
56
States, territories,
and D.C.
1
Coordination & Data
Collection Center
>319,000
Enrolled participants
(prospectively)
16
Rapid Research
Pilot Awards
86
Projects submitting
CDEs to CDCC
>389,000
COVID-19 tests conducted
(prospectively)

29. 29
Key Outcomes per Target Population (Testing + SEBI)
Schools
 Participation in weekly testing increases
conscious mitigation behavior
 When mitigation strategies are followed,
in-school transmission is low (<1%)
Black and Latino Communities
 Latino populations present with greater proportions
of asymptomatic cases as compared to national
average
 Black/African Americans in rural areas have lower
testing rates, biasing positivity rates
 Black and Latino community populations display
greater vaccine hesitancy – Local leaders should
be engaged to facilitate acceptance and uptake
Lower Socioeconomic
Status
 Lower income populations have
reduced motivation to self-test and
distribute testing kits to contacts

31. Common Data Elements Development, Evolution,
Implementation and Lessons Learned

32. CDE Development
• Oct. 9, 2020: NIH’s RADx-UP Data Harmonization Guidance received by CDCC, which
included the original RADx-UP Common Data Elements
• Oct. 16, 2020: CDCC team met with the DR2 team to discuss coordination and the CDEs
• Based on initial discussions with NIH RADx-UP leadership, it became clear that the
original CDEs needed to be modified to meet the project and pandemic circumstances:
– Staff and participants were practicing social distancing, with masks
– Vaccines were in development but not yet available
– Moving into winter 2020, with a surge in cases and deaths expected
– Many of the Projects had finalized their protocols and were awaiting IRB approval
• CDEs needed to collect key data while also limiting risk and burden for the
participants and Project teams

33. CDE Development
• Oct. & Nov. 2020: CDCC and NIH worked to revise and pare down the
number of CDEs
• Dec. 3, 2020: draft version of the CDEs shared with the projects
RADx-UPCDE Categories
• Sociodemographics and consent
• Housing, Employment and Insurance
• Medical History
• Medications
• Symptoms
• Health Status (includingAlcohol andTobacco)
• Disability
• Vaccine Hesitancy
• Identity

34. CDE Development
• Dec. 8, 2020: CDE Feedback survey sent to the Projects
• Dec 14, 2020: Deadline for Projects to complete the survey
• Dec. 15, 2020: CDCC reviewed and consolidated feedback and
recommendations
• Dec. 17, 2020: RADx-UP Project-wide Meeting at which
CDE feedback was discussed

35. 13
52
Feedback Survey Questions and Results (Dec 2020)
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
Which category or categories contain
questions you anticipate not being able
to collect?

36. CDE Development
• Dec. 18, 2020 – Jan. 2021: CDCC and NIH incorporate Project feedback
and finalize the CDEs. Major changes included:
– Ethnicity (subcategories added for Asian, Native Hawaiian/Pacific Islander, and Hispanic),
– Sexual orientation and gender identity questions added and terminology better aligned with
communities
– Housing questions clarified and made more relevant to RADx-UP populations
– Employment questions made more relevant to COVID-19 pandemic conditions
– Health insurance question expanded to include type of insurance
– COVID-19 pandemic-related questions added (hardship, PPE, distancing, COVID testing,
COVID symptoms, vaccine acceptance)
– Spoken language questions added
– Medical history questions focused on items relevant to COVID-19
– Medications, vaccine hesitancy, and most of the disability and alcohol/tobaccos questions
were moved toTier 2.
Sources of these CDEs included PhenX, DR2, NIH CDE Repository, and the RADx-UP Projects

37. Tier 1 CDEs
Required from
all testing
Projects
• Consent
• Location (new)
• Sociodemographics
• Housing, Employment and
Insurance
• Work PPE and Distancing (new)
• Medical History
• Health Status
• VaccineAcceptance
• Testing (new)
• COVIDTest (new)
• Symptoms
• Alcohol &Tobacco
• Identity
Tier 2 CDEs
Recommended
additionalCDEs
• Sociodemographics
• Medical History
• VaccineAcceptance
• Testing
• Medications
• Alcohol andTobacco
• Drug Use
• Disability
• Food Insecurity
• Housing
• Trust
• Identity – SSN and MRN
• Two components:
• CDEs recorded by the participants or Project teams
• CDEs recorded by the Project teams
• Available as REDCap codebook PDF or CSV data dictionary, or PDF forms for paper data collection

38. CDE Development
• Jan. 4, 2021: CDEs v.1.0 released to the Projects and
made publicly available on RADx-UP.org
• Feb. 9-17, 2021: NIH CDETracking Form released,
which the Projects could use to request individual or
group CDE exceptions and wording changes.
• Feb. 2021: CDCC’s Data Submission Guidance
document v1.0 released.
• EITs and Informaticists began training and providing
support for CDE implementation.

39. CDE Revisions
Version Release Date Major Changes
1.1 Aug. 12, 2021 Wording, responses, and branching logic fixes
1.2 Sep. 28, 2021 Added vaccine acceptance and administration questions
1.3 Incorporated into 1.4
1.4 Feb. 9, 2022 Added “prefer not to answer” to more questions, existing CDEs
modified for pediatric use, and new Pediatric CDEs
1.5 Apr. 6, 2022 Wording, responses, and branching logic fixes
1.6 Oct. 27, 2022 Additional disability questions moved toTier 1
Any new or revisedTier 1 CDEs are only required for projects that were awarded after the CDE release date

40. CDE Intake and Quality Checks
• The REDCap codebooks along with the NIH CDE
Tracking Form have been the basis around which we
have built our repository, data quality and
conformance checks, reporting and dashboards, and
analysis datasets.
• Projects upload their data through our portal
(myRADx-Uphome) and get immediate, detailed
data quality reports that they use to identify and
resolve issues in their CDE data.

41. RADx-UP Data Intake Status
• As of Nov 1, 2022:
– 99 Projects have uploaded CDE data files
– 641,404 participants’ data in our database (not including EHR data)
– Using 5,310 project participants’ zip codes, the CDCC has linked to
external social determinants of health datasets:
Area deprivation index (ADI)
Agency for Healthcare Research and Quality (AHRQ)
SocialVulnerability Index (SVI)
ChildOpportunity Index (COI)
PandemicVulnerability Index (PVI)
Minority Health SVI
vaccination data from cdc.gov

42. Benefits of the RADx-UP CDEs
• The CDEs allowed for accelerated intake, harmonization, and use of data:
– January 2021: CDEs released
– March 2021: First data upload to CDCC
– March 2022: RADx-UP Data Dashboard launched (visualizations using CDE data)
– April 2022: First data upload from CDCC to the RADx Data Hub
– September 2022: Core Analytic Datasets available usingTier 1 CDE data
– October 2022: First consortia datasets delivered to writing team for analysis
• For the most part, projects were able to quickly understand and resolve data
quality and conformance issues. After a few uploads the number of data issues
drop significantly.
• We have given all newer versions of a CDE its own identifier, so we can trace
exactly which version of a CDE was given to a participant and allow projects to
update to new versions of the CDEs on their own timeline.

43. 43
To date:
•NIH, CDCC, and RADx-UP (Phase I) projects collaborated to
develop the NIH RADx-UP Common Data Elements, from 700+ →
60+
•Currently, 99 projects are transferring study data and RADx-UP
NIH CDEs to the CDCC data repository
•CDE Dashboard provides a window to the aggregated data, will
inform consortium publications
Key CDCC lesson for this and future pandemics
•Developing CDEs during a pandemic is challenging
•Engaging projects and community partners is critical to
success
RADx-UP CDCC Data Science & Biostatistics Core

44. RADx-UP Dashboards

45. CDE Utilization: RADx-UP CDE Data Dashboard
This
Dashboard is
an example of
what’s been
possible using
the
harmonized
CDE data.

46. Periodic DataWorkshops

47. RADx-UP CDE Data Journey

48. CDE and Data ManagementTakeaways
• For community-engaged research, bidirectional communication and
collaboration between researchers, communities, and participants helps
with understanding, acceptance, and uptake of CDEs
• Collaboration also ensures that the CDEs accurately reflect the people
and communities who are taking part in the research
• Participant and study staff burden and risk are important concerns for
data collection in a pandemic
• CDEs are the foundation – however ingesting data from multiple
independent projects with many different experimental designs and
scientific goals still requires robust data quality and conformance
training, education, monitoring, and review processes

49. • For encouraging testing and vaccination, culturally appropriate
education is important to increase trust in official sources of
COVID-19 information
• Community Advisory Boards have provided key
recommendations and support
• Community engagement and trust are essential to ensure the
success of COVID-19 testing and vaccination programs
• Flexibility and the ability to adapt is critical
• Partnerships with community health clinics provide a
necessary connection to underserved populations
Lessons Learned for Future Success

50. Thank you.
Warren Kibbe
warren.kibbe@duke.edu