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:

0920-23AQ

2a Name:

02/22/23

Understanding HIV/STD Risk and Enhancing PrEP Implementatio
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

Project Coordinator

POC Name

Patricia Bessler

POC Organization NCHHSTP/DHP/HRB
POC Email

[email protected]

POC Phone

404.639.8239
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 activity is to collect and store data for the
"Understanding HIV/STD Risk and Enhancing PrEP
Implementation Messaging in a Diverse Community-Based
Sample of Gay, Bisexual, and Other Men Who Have Sex with
Men in a Transformational Era (MIC-DROP)" study, funded by
the Centers for Disease Control and Prevention under
cooperative agreement #U01PS005244.
1275 participants will be enrolled in a study designed to
develop knowledge about PrEP use and adherence. Data from
quantitative assessments, in-depth interviews, and focus group
will be used to collect information.

Data to be collected will include eligibility data (screening),
consent to participate, contact information, and biological
specimens for HIV and STI testing. Participants will also be
asked to download the SMaRT application on their mobile
phone. The SMaRT app supports key functions including
notifications, reminders, messages, survey administration, and
appointment scheduling.
PII, specifically name, will be included on the screener, consent
Describe the type of information the system will
forms, and the linking document which links a unique
collect, maintain (store), or share. (Subsequent
participant ID to a participant. Name, email address, telephone
12
questions will identify if this information is PII and ask number, and mailing address will be included on the locator
about the specific data elements.)
form. Data of birth and employment type, including military,
will be collected in the quantitative surveys. IP address will be
gathered during the online data collection process.
Name, email address, telephone number, IP and mailing
address will not be reported and will not be shared with CDC.
Participant date of birth (DOB) and individual employment
type will not be reported. DOB will be transformed to age
during the analysis. Only aggregated age and employment
type will be reported.

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Provide an overview of the system and describe the
13 information it will collect, maintain (store), or share,
either permanently or temporarily.

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

All online survey data will be collected using Alchemer, a
HIPAA compliant, encrypted electronic platform. Collected
data are automatically encrypted, with coded access only
available through the Data Manager and the Principal
Investigators. Study data stored by Alchemer are maintained
on a dedicated secure server. All web survey data will be
secured using an SSL 256-bit encryption. Assessment,
interview, focus group, and biospecimen data files will be
identified using numeric participant ID numbers unrelated to
the participant’s PII. Study data and personal information will
be secured with role-based security.
Participants will have the option of completing their focus
group or in-depth interview either in person or over a HIPAAcompliant video server. Focus groups and interviews will be
digitally audio-recorded. Recorded information will be
deidentified during the transcription process. Recordings and
transcripts will be stored on a secure computer. Audio
recordings will be destroyed 2 years after the end of the study.
Data collected through the SMaRT app will be stored on a
secure, HIPAA-compliant server housed at Emory University on
an Emory AWS RDS database using in-box AWS database
encryption. Data in transit will be encrypted with TLS 1.2. The
study team will not be able to access participants’ mobile
device activity, they will only be able to see their completion of
some activities in the study app through its admin web portal.
Participants will be required to log in to the application with a
username and password. Data are stored on the server and not
locally in the app. Per HIPAA requirements, sessions expire
after several minutes and require users to log back in. When
participants finish the study, we will help them remove the app
from their mobile device and they will no longer be able to log
in to the app.
CDC will not receive PII; all data received will be de-identified.
Six months after study completion, participant contact
information and all links between participant PII and
participant number will be destroyed. De-linked study data will
be retained by Emory University for up to 25 years after study
closure.
Yes
No

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15

Indicate the type of PII that the system will collect or
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

IP addresses will be
collected for internal
auditing purposes only (to
identify fraudulent or
duplicate web entries).

Other...

Other...

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)

500-4,999
Name, e-mail, phone number, and mailing address will be used
to maintain and track the participants throughout the study.
Name and e-mail address will be used to reimburse
participants (incentives) and for internal auditing purposes.
Mailing address will be used to ship biospecimen collection kits
to participants. IP addresses will be used only for the purposes
of identifying fraudulent or duplicate web entries and
authenticate unique trial participants to protect the integrity of
the sample and trial results. Name, email, phone number, IP
and mailing address will not be shared with CDC.
DOB and employment type (including military) will be
aggregated and used in the analysis. Only aggregated data will
be reported.

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

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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)).
22

Yes

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

No
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?
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.

New ICR not yet approved.
Yes
No
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 may
voluntarily withdraw from the study and end data collection
for any reason at any time.

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
Participants may be notified in writing by study staff if major
28 and/or data uses have changed since the notice at
the time of original collection). Alternatively, describe changes occur to the system.
why they cannot be notified or have their consent
obtained.

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Describe the process in place to resolve an
individual's concerns when they believe their PII has Participants will receive contact information for the principal
29 been inappropriately obtained, used, or disclosed, or investigator as well as the Columbia University Institutional
that the PII is inaccurate. If no process exists, explain Review Board (IRB).
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.

We will adopt a Data and Safety Monitoring Plan. Staff will be
trained in data collection procedures. All study staff will be
trained to recognize, document, and report any unusual events
or circumstances that occur during data collection immediately
to the PI and Emory IRB. The Principal Investigators and Project
Director will monitor staff closely. Staff deficient in any aspect
of performance will be re-trained or terminated.
Ongoing data monitoring will be conducted by the lead study
investigators and project directors throughout the study. In
addition, the primary IRB of record will conduct regular reviews
of study protocols, changes in study protocols, and adherence
to protocols in the field. The lead study investigators are
required to report any unexpected study-related adverse
events to the IRB and CDC.
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

Study content will be secured using role-based access. Access
to PII will be restricted to the Principal Investigators; the
Describe the procedures in place to determine which Retention Coordinator, who must contact participants to
schedule visits; the Study Director and Coordinator who will
32 system users (administrators, developers,
notify participants about test results; study staff who will
contractors, etc.) may access PII.
distribute and audit study tokens and confirm participant web
identity; and 3 graduate research assistants who will perform
data entry.

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. Access to PII in study data
collected for the purposes of analysis is limited to the study
investigators and data manager.

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.

All study personnel will have completed training and received
certification in Human Subjects Research Protection (CITI).
These trainings will be renewed in compliance with
institutional policies.

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

All study staff will be trained to recognize, document, and
report any unusual events or circumstances that occur during
data collection immediately to study managers and the IRB.

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

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

Yes
No
Six months after the study is completed, study ID numbers for
all participants will be de-linked from contact information in
the participant database. De-linked study data will be retained
for up to 25 years in accordance with Emory University
Libraries and Information Technology Records Management
Policy, Policy #5.21, Research Records: Clinical Trials, 21 CFR
312.62 (c); O.C.G.A. 9-3-24; (updated 10/1/2022).
All data shared with CDC will be stripped of PII. De-identified
study 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).
Physical Controls: Consents and contact information paper
forms will be stored in locked cabinets in the research offices at
Emory University. The servers are located in a secure area with
all appropriate physical security measures in place.

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

Technical Controls: The intervention content, questionnaires,
and personal information will be secured with role-based
security that will provide different types of users with different
access privileges. Data containing unique identifiers and data
containing the participants’ ID number will be maintained
separately on the secured server. A master list linking unique
identifiers and data will be stored separately, and access to
these confidential files will be limited to the Study Director and
Principal Investigators. Participant data will be stored by
Alchemer on a secure, HIPAA-compliant webserver in a secure
database within Emory’s firewall. Focus groups and interviews
will be digitally audio-recorded and de-identified during the
transcription process. Data collected through the SMaRT app
will be stored on the HIPPA-compliant server at Emory
University. All electronic files and records will be stored in a
firewall-protected Emory AWS RDS database using in-box AWS
at Emory University. Data in transit will be encrypted with TLS
1.2. The web and database servers are monitored by Emory
University IT staff, patched frequently, and scanned by a thirdparty vendor to ensure that they are protected against known
vulnerabilities. The data is backed up to electronic media daily.
The electronic media is secured and stored in a secure area
separate from the servers.
Administrative Controls: The Study Research Staff are
responsible for following their organization’s specific security
procedures, which at a minimum includes restricting access to
the PII to only authorized users. Assessment, interview, focus
group, and biospecimen data files will be identified using
numeric participant ID numbers unrelated to the participant’s
PII. All study data are only accessible by trained study staff and
password protected.

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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 N/A
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 N/A
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

Beverly E.
Walker -S

Digitally signed by
Beverly E. Walker -S
Date: 2023.04.04
14:56:26 -04'00'

HHS Senior
Agency Official
for Privacy

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