Pia

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Privacy Impact Assessment Form
v 1.21
Status

Form Number

Form Date

Question

Answer

1

OPDIV:

CDC

2

PIA Unique Identifier:

TBD

2a Name:

03/13/23

mChoice: Improving PrEP Uptake and Adherence among Minori
General Support System (GSS)
Major Application

3

Minor Application (stand-alone)

The subject of this PIA is which of the following?

Minor Application (child)
Electronic Information Collection
Unknown

3a

Identify the Enterprise Performance Lifecycle Phase
of the system.

Initiation
Yes

3b Is this a FISMA-Reportable system?

4

Does the system include a Website or online
application available to and for the use of the general
public?

5

Identify the operator.

6

Point of Contact (POC):

7

Is this a new or existing system?

8

Does the system have Security Authorization (SA)?

No
Yes
No
Agency
Contractor
POC Title

Physician

POC Name

Mary Tanner

POC Organization NCHHSTP/DHP/HRB
POC Email

[email protected]

POC Phone

404.639.6376
New
Existing
Yes
No

8b Planned Date of Security Authorization
Not Applicable

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8c

Briefly explain why security authorization is not
required

TBD

10

Describe in further detail any changes to the system
that have occurred since the last PIA.

N/A

11 Describe the purpose of the system.

The purpose of the system is to collect and store data for the
mChoice research study. The information collected through
this study will be used to: 1) improve the overall pre-exposure
prophylaxis (PrEP) experience of providers and men who have
sex with men (MSM) patients by implementing evidence-based
education and support tools in clinical settings; and 2) increase
our understanding of provider and patient factors that
influence the choice of PrEP regimen by MSM in New York City
(NYC), New York (NY) and Birmingham, Alabama (AL). Findings
from the data collected during this study will be used to
support expanded use of effective provider PrEP tools and
increase understanding of PrEP use by MSM to inform the
future revisions of CDC PrEP recommendations and
interventions to increase PrEP use by persons in priority
populations.

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400 participants will be enrolled in a study to assess the
effectiveness of the mChoice clinical intervention to increase
PrEP adherence and persistence among young MSM using
PrEP. Serial assessments and interviews will be used to collect
information that will be used to assess attitudes, knowledge,
behavior, and experiences related to PrEP and risk factors for
HIV acquisition.
Other data to be collected will include eligibility (screening)
data, consent to participate and contact information (locator
form). Participants medication bottles will be fitted with a
CleverCap and participants will download the accompanying
CleverCap app to their mobile phones. CleverCap collects
information about participant medication adherence. In
addition, PrEP clinical care data will be collected from
electronic medical records to further assess medication
adherence.
PII, specifically name, will be included in the eligibility screener,
consent forms, and the linking document which links a unique
participant ID to a participant’s name. Contact information,
Describe the type of information the system will
specifically name, email, telephone number, and mailing
collect, maintain (store), or share. (Subsequent
12
questions will identify if this information is PII and ask address will be collected on the locator form. This information
will be used for the purposes of participant scheduling and
about the specific data elements.)
retention throughout the 18-month follow up period.
Participant DOB and employment status data will be collected
on the baseline survey form. Age and Employment type will be
aggregated and used in the analysis. Only aggregated age and
employment type will be reported. For healthcare providers,
job role (employment type) will be collected on the eligibility
form. This information will be used to confirm that the
participant meets study eligibility criteria (a PrEP provider at
one of the four participating clinics). Job role will be
aggregated and used in the analysis. Only aggregated
information about job roles will be reported. Electronic health
records (EHR) will be reviewed to gather PrEP clinic care data
and urine specimen data. These data will be used to evaluate
PrEP adherence and persistence.
Only study staff will have access to PII. The funded recipient
(Columbia University) will be responsible for data collection
and management. CDC will not collect nor manage data. CDC
will not have access to PII. Prior to securely transferring study
data to CDC, Columbia University will strip all PII from the data.
Patient and provider respondents will complete computerassisted self-administered web assessments on their computer,
phone, or tablet using a secure data collection platform,
REDCap, hosted by Columbia University Irving Medical Center
(CUIMC) Information Technology (IT). REDCap is a secure webbased system that provides an intuitive interface, audit trails,
and automated export. Staff at each site will have a link to the
secure web-based data collection survey tool and will be
present to assist participants in completing surveys. Data will
be stored using REDCap at each respective performance site,
encrypted data will be transferred to CUIMC and then the deidentified data will be stored on secure HIPAA-compliant
servers at the CUIMC campus.
Access to individually identified private information about
human subjects will be limited to research team members who
collect and manage the data, study staff, site principal
investigators and the Principal Investigator. The material,
records, and data obtained through participation in the study
will be specifically for research purposes. All surveys, case
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report forms (CRFs), and other study records will be identified
by a coded number (a participant identification number), and

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Yes

14 Does the system collect, maintain, use or share PII?

No

Indicate the type of PII that the system will collect or
15
maintain.

Social Security Number

Date of Birth

Name

Photographic Identifiers

Driver's License Number

Biometric Identifiers

Mother's Maiden Name

Vehicle Identifiers

E-Mail Address

Mailing Address

Phone Numbers

Medical Records Number

Medical Notes

Financial Account Info

Certificates

Legal Documents

Education Records

Device Identifiers

Military Status

Employment Status

Foreign Activities

Passport Number

Taxpayer ID

Employment status

Age

Employment type/job role

Other...

Other...

Employees
Public Citizens
16

Business Partners/Contacts (Federal, state, local agencies)

Indicate the categories of individuals about whom PII
is collected, maintained or shared.

Vendors/Suppliers/Contractors
Patients
Other

17 How many individuals' PII is in the system?

18 For what primary purpose is the PII used?

19

Describe the secondary uses for which the PII will be
used (e.g. testing, training or research)

100-499
Name, phone number, mailing address, and e-mail address will
be used only for the purposes of participant scheduling and
retention. PII will be stripped from data shared with CDC.
Medical notes (electronic health records [EHR]) will be accessed
to retrieve PrEP eligibility, PrEP adherence, and STI and HIV test
result data.
Date of birth and employment status will be aggregated and
used in the analysis. Only aggregated age and employment
type will be reported. No PII will be shared with CDC.

20 Describe the function of the SSN.

N/A No social security numbers are being collected.

20a Cite the legal authority to use the SSN.

N/A

Public Health Service Act, Section 301, "Research and
Identify legal authorities governing information use Investigation," (42 U.S.C. 241); and Sections 304, 306 and 308(d)
21
which discuss authority to maintain data and provide
and disclosure specific to the system and program.
assurances of confidentiality for health research and related
activities (42 U.S.C. 242 b, k, and m(d)).

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22

Yes

Are records on the system retrieved by one or more
PII data elements?

No
Published:

Identify the number and title of the Privacy Act
System of Records Notice (SORN) that is being used
22a
to cover the system or identify if a SORN is being
developed.

Published:
Published:
In Progress
Directly from an individual about whom the
information pertains
In-Person
Hard Copy: Mail/Fax
Email
Online
Other
Government Sources

23

Within the OPDIV
Other HHS OPDIV
State/Local/Tribal
Foreign
Other Federal Entities
Other

Identify the sources of PII in the system.

Non-Government Sources
Members of the Public
Commercial Data Broker
Public Media/Internet
Private Sector
Other
23a

Identify the OMB information collection approval
number and expiration date.

24 Is the PII shared with other organizations?

New ICR not yet approved
Yes
No
Within HHS

Identify with whom the PII is shared or disclosed and
24a
for what purpose.

Other Federal
Agency/Agencies
State or Local
Agency/Agencies
Private Sector

Describe any agreements in place that authorizes the
information sharing or disclosure (e.g. Computer
24b Matching Agreement, Memorandum of
Understanding (MOU), or Information Sharing
Agreement (ISA)).

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24c

Describe the procedures for accounting for
disclosures

Describe the process in place to notify individuals
25 that their personal information will be collected. If
no prior notice is given, explain the reason.
26

Is the submission of PII by individuals voluntary or
mandatory?

Describe the method for individuals to opt-out of the
collection or use of their PII. If there is no option to
27
object to the information collection, provide a
reason.
Describe the process to notify and obtain consent
from the individuals whose PII is in the system when
major changes occur to the system (e.g., disclosure
28 and/or data uses have changed since the notice at
the time of original collection). Alternatively, describe
why they cannot be notified or have their consent
obtained.
Describe the process in place to resolve an
individual's concerns when they believe their PII has
29 been inappropriately obtained, used, or disclosed, or
that the PII is inaccurate. If no process exists, explain
why not.

Describe the process in place for periodic reviews of
PII contained in the system to ensure the data's
30
integrity, availability, accuracy and relevancy. If no
processes are in place, explain why not.

Prior to data collection, participants will be notified in writing
in the consent form during the consent process that their
personal information will be collected.
Voluntary
Mandatory
Participants may opt out of the information collection during
either the screening or consent processes. Participants who are
eligible and interested in participation will be enrolled and
consent obtained during either the screening or consent
processes. Enrollees may end their study participation at any
time.
Participants may be notified in writing by study staff if major
changes occur to the system. Notifications will be signed by
the study Principal Investigator (grantee) and include contact
information if study participants have questions or concerns.
CDC will be notified in advance about any proposed changes
to the study and any notifications sent to study participants.
Participants will be provided contact information and
instruction to contact the grantee Principal Investigator and
the Columbia University Institutional Review Board (IRB).
Biweekly reports for the study sites will be created by the data
manager to review relevant app engagement data, barriers
with recruitment/enrollment and retention, laboratory and
medical records, compliance with the protocol, and accuracy
and completeness of the records. The investigative team will
schedule biweekly conference calls, and these reports will be
briefly reviewed by the team at these meetings. These regular
reviews will ensure close communication between the research
assistants, quickly identify missing data points, and ensure
consistent management of any issues with the protocol across
sites. Data quality will be examined before statistical analyses
are conducted, including examination of missing data,
assessment of distributional assumptions, and identification of
outliers. In addition to data quality, the comparability between
intervention and control groups will be carefully examined,
including baseline balance and differential attritions at all
waves of follow-up.
Ongoing monitoring will be conducted throughout the study
by the PIs and Data and Safety Monitoring Board. In addition,
the Columbia University IRB (as prime IRB) will conduct regular
reviews of study protocols, changes in study protocols, and
adherence to protocols in the field. Project PIs are required to
report any unexpected study-related adverse events to the IRB
and CDC.

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Users

Only research staff will have access to
PII in the system in order to collect

Administrators
31

Identify who will have access to the PII in the system
and the reason why they require access.

Developers
Contractors
Others

Only the research study team will have access to study data. No
other individuals will have access. REDCap accounts are
Describe the procedures in place to determine which password protected. Data will be stored on secure, HIPAA
32 system users (administrators, developers,
compliant, password protected, servers at Columbia University.
contractors, etc.) may access PII.
Data collection and management, and analysis will be carried
out by the funded recipient (Columbia University). CDC will not
receive nor have access to PII.
Describe the methods in place to allow those with
33 access to PII to only access the minimum amount of
information necessary to perform their job.

Access to sensitive Personally Identifiable Information (PII) will
be restricted to individuals trained in human subject
protections who are listed on the Institutional Review Board
(IRB) protocol. All PII is collected for a specific and identifiable
purpose with access restricted to specific job tasks and
individuals who perform those tasks.

Identify training and awareness provided to
personnel (system owners, managers, operators,
contractors and/or program managers) using the
34
system to make them aware of their responsibilities
for protecting the information being collected and
maintained.

Columbia University staff receive introductory information and
regular notices concerning their responsibilities to follow
security protocols and protect information stored on University
servers.

Describe training system users receive (above and
35 beyond general security and privacy awareness
training).

Training for all staff includes (but is not limited to) Human
Subjects Research Protection, Informed Consent, Good Clinical
Practice, Quality Management, Confidentiality, and Reporting
of Adverse Events.

Do contracts include Federal Acquisition Regulation
36 and other appropriate clauses ensuring adherence to
privacy provisions and practices?

Yes
No

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Describe the process and guidelines in place with
37 regard to the retention and destruction of PII. Cite
specific records retention schedules.

All data will be retained by the Columbia University Research
Team until analyses are complete and for up to three years
following study closure, in line with Columbia University IRB
guidelines. Study closure date will be determined by 1) final
reporting to the research sponsor; 2) final financial close-out of
a sponsored research award; 3) final publication of research
results; or 4) cessation of an academic or research project,
regardless of whether its results are published. At that time,
users must delete all data stored on their servers.
At the end of the study, study data shared with CDC will be
stripped of PII by the funded recipient Columbia University. Deidentified study data will be sent to CDC via secure file transfer.
De-identified data received by CDC will be retained in
accordance with the CDC Records Control Schedule 04-4-22
Family of HIV Surveys, Division of HIV/AIDS Prevention/
Surveillance and Epidemiology, (N1-442-02-3-4, Item 1). Data
will be archived according to guidance set forth by CDC
Records Management Policy, Policy # CDC-GA-2005-07
(updated 9/14/2021 ).

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Physical
Paper forms will be stored in locked cabinets in the research
offices. Study records will be recognized by a participant ID
number and stored in password-protected files on secure
servers. All laboratory specimens will be identified only by the
identification number. The code linking the participant
identification number to subject identifying information
(name, address, etc.) is maintained at the clinical sites through
REDCap, and only authorized site personnel have access to the
code. The code will be destroyed two years after publication of
study findings.

Describe, briefly but with specificity, how the PII will
38 be secured in the system using administrative,
technical, and physical controls.

Technical
RedCap, a HIPAA-compliant web-based platform, will be used
for data capture and storage. RedCap is supported by
Columbia University. Standard features of RedCap include
interactive data entry with real-time field validation, lab data
imports, audit logs to record database modifications, database
integrity checks, security (in logins, permissions based on need,
and encryption), reporting, forms inventory, and exports to
common statistical packages for analysis. Logging tracks all
data entered in REDCap so that it can be traced back to the
person who entered it. No data can be changed without
showing who has made the changes. This allows the study
team to ensure the security and integrity of the data collected
and submitted; therefore, there are controls surrounding this
aspect. REDCap also provides for principal investigator sign-off
on data, as required in FDA studies. Although users can modify
data based on their permissions, they cannot delete the
subject or history of that subject. Requests to delete a subject
must be made to the REDCap system administrator. RedCap
database system provides for secure web-based data entry
with the data stored on servers maintained by Columbia
University IT. The data is encrypted during transmission. The
servers are located in a secure campus area with all appropriate
physical security measures in place. The web and database
servers are monitored by University IT staff, patched
frequently, and scanned to ensure that they are protected
against known vulnerabilities. Access is by individual user ID
and is restricted to the forms and/or functions that the user
needs to have. The data is backed up to electronic media daily.
The electronic media is secured by IT staff and stored in a
secure area separate from the servers.
Administrative Controls: Participants are assigned a unique
identification number. Unique identifiers for each participant
will be a combination of letters and numbers. The letters will
be "MCH," short for "mChoice" and the number will indicate
what order the participant was enrolled in the study. For
example, the first participant will be "MCH001”. Documents
with participant’s names or other identifying information (such
as informed consent forms) will be stored separately from
other study documents and only research project staff will
have access to it.

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Reviewer Questions

Answer

REVIEWER QUESTIONS: The following section contains Reviewer Questions which are not to be filled out unless the user is an OPDIV
Senior Officer for Privacy.

Reviewer Questions
1

Are the questions on the PIA answered correctly, accurately, and completely?

Answer
Yes
No

Reviewer
Notes
2

Does the PIA appropriately communicate the purpose of PII in the system and is the purpose
justified by appropriate legal authorities?

Yes

Do system owners demonstrate appropriate understanding of the impact of the PII in the
system and provide sufficient oversight to employees and contractors?

Yes

No

Reviewer
Notes
3

No

Reviewer
Notes
4

Does the PIA appropriately describe the PII quality and integrity of the data?

Yes
No

Reviewer
Notes
5

Is this a candidate for PII minimization?

Yes
No

Reviewer
Notes
6

Does the PIA accurately identify data retention procedures and records retention schedules?

Yes
No

Reviewer
Notes
7

Are the individuals whose PII is in the system provided appropriate participation?

Yes
No

Reviewer
Notes
8

Does the PIA raise any concerns about the security of the PII?

Yes
No

Reviewer
Notes
9

Is applicability of the Privacy Act captured correctly and is a SORN published or does it need
to be?

Yes
No

Reviewer
Notes
10

Is the PII appropriately limited for use internally and with third parties?

Yes
No

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Reviewer Questions

Answer

Reviewer
Notes
11

Does the PIA demonstrate compliance with all Web privacy requirements?

Yes
No

Reviewer
Notes
12

Were any changes made to the system because of the completion of this PIA?

Yes
No

Reviewer
Notes

General Comments

OPDIV Senior Official
for Privacy Signature

Jarell
Oshodi -S

Digitally signed by Jarell
HHS Senior
Oshodi -S
Agency Official
Date: 2023.04.25
for Privacy
18:43:31 -04'00'

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