Privacy Impact Assessment

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Privacy Impact Assessment Form
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Status

Form Number

Form Date

Question

Answer

1

OPDIV:

CDC

2

PIA Unique Identifier:

0920-18AQQ

2a Name:

HIV Prevention Among Latina Transgender Women Who Have S
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 Officer

POC Name

Thomas Painter, PhD

POC Organization Division of HIV/AIDS Prevention (
POC Email

[email protected]

POC Phone

404-639-6113
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

Not applicable

10

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

Not applicable

11 Describe the purpose of the system.

The purpose of the system is to evaluate the efficacy of ChiCAS
(Chicas Creando Acceso a la Salud [Chicas: Girls Creating
Access to Health]), a two-session Spanish language
intervention that provides human immunodeficiency virus
(HIV) prevention services to Hispanic/Latina adult transgender
women who have sex with men.
The type of information the system will collect, maintain, and
share includes name, Email address, phone numbers, Facebook
name/alias, gender identity, race/ethnicity, employment status,
mailing address, contact information for two personal contacts,
sex at birth, age, education history, country of origin, and
number of years of United States (US) residency.

Describe the type of information the system will
collect, maintain (store), or share. (Subsequent
12
questions will identify if this information is PII and ask
about the specific data elements.)

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

The system will also collect information on participant
identifications (IDs), participants' experienced barriers to
accessing health care, results of their most recent HIV test, use
of hormone therapy and location and contact information for
the prescribing physician and supplying pharmacy, knowledge
about HIV, other sexually transmitted diseases and preexposure prophylaxis (PrEP), their sexual experiences and drug
and alcohol use, and their social support systems in the US, and
consistent condom use and the use of PrEP and medically
supervised hormone therapy, participant attendance at
intervention sessions, and digital recordings of interviews.
Any and all contact information will be collected, maintained,
and/or shared to facilitate contacting study participants during
the course of the study as well as to administer interviews and
follow-up assessments. Contact information of participants'
friends and family will be used should participants become
difficult to find.
All data will be collected, maintained, and shared in order to
analyze and examine participant exposure to the intervention
during its implementation.
Participant's digital recordings of interviews will be maintained
temporarily until transcribed. Once transcribed, digital
recordings are destroyed.

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

Yes
No

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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

Facebook name/alias

Race/ethnicity

Age

Sex at birth

Country of origin

Employees
Public Citizens
16

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

Business Partners/Contacts (Federal, state, local agencies)
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
The primary purpose of using PII is to facilitate contacting
study participants during the course of the study as well as to
administer interviews and follow-up assessments.
The secondary use of PII is to describe the socio-demographic
characteristics of study participants (e.g., gender identity, race/
ethnicity, etc.).

20 Describe the function of the SSN.

Not Applicable

20a Cite the legal authority to use the SSN.

Not Applicable

21

Identify legal authorities governing information use
Public Health Service Act, Title III, Section 301
and disclosure specific to the system and program.

22

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

Yes
No

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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?

TBD
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)).
24c

Describe the procedures for accounting for
disclosures

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Potential study participants will receive a consent form as part
of an informed consent process.
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?

Grantees also will describe data types that will be collected to
participants before study activities begin.
All information collection and maintenance will be done by
grantees; Centers for Disease Control and Prevention (CDC)
project staff will neither interact with study participants nor
participate in the collection of participants' information.
Voluntary
Mandatory

Describe the method for individuals to opt-out of the
Grantees will explain that participants have the right to decline
collection or use of their PII. If there is no option to
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participation at the time of consent and at any time during any
object to the information collection, provide a
study activity.
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.

Grantees will explain to participants that it is the grantees who
will be in possession of participants' contact information, and
that they will contact participants in the event of major
changes to the system and/or use of participant's PII.
Should major system changes actually occur, an Institutional
Review Board (IRB) amendment will be drafted and a
determination made about whether the system changes
necessitate (1) updating the consent form and/or (2)
contacting participants to update them about protocol
changes.
Grantees will explain to participants during the informed
consent process ways participants can raise any concerns
about the handling of their PII at any time during the study.
Individuals concerned about breaches in confidentiality or
misuse of PII may contact the Wake Forest School of Medicine
or the Chairman of the IRB. These individuals' phone numbers
are provided to participants during the informed consent
process.

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 After being informed of study-related privacy issues, the
why not.
institutional chief privacy officer charges a team of staff to
investigate privacy-related issues. This investigation includes
interviews with the PI, study team, and research participant/
complainant; and review of all study procedures, consent
procedures, and deviations. Subsequently, the chief privacy
officer writes a report that is filed with the grantee and meets
with the study team to review the report. The team in turn
adheres to the recommended actions.

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Integrity: Data access will be limited strictly to grantees based
on secure storage procedures for all paper forms and
electronic files handling.

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.

Accuracy: Each paper assessment questionnaire is scanned and
immediately validated by comparing the scanned document to
the original questionnaire to ensure no mistakes or errors are
made during the scanning process. Once validated, the dataset
will be non-editable. Transcripts of all digital recordings will be
compared to the recordings to ensure no mistakes or errors
occurred. Corrections will be made as needed. Once validated,
the dataset will be non-editable.
Availability: PII, datasets, and transcripts will be maintained by
grantees. CDC will receive a copy of de-identified aggregate
study data at the end of the study, and we will make the
aggregate data available for potential analysis by third parties
based on conditions specified in a data sharing agreement.
Relevancy: CDC will collaborate with grantees to identify
variables and measures needed for the study, thereby avoiding
the collection of data that are not relevant to study objectives.
Users
Administrators

31

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

Grantees

Developers
Contractors
Others

Describe the procedures in place to determine which
Elements of PII in the system are accessible only by grantee
32 system users (administrators, developers,
administrators with authorized credentials.
contractors, etc.) may access 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.

Separate locked cabinets will house paper forms with PII. The
hard-copy-only document linking PII to datasets is stored and
locked separately from all other data, accessible by one senior
administrator authorized to handle and view it.

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.

Before any data are collected, grantees will be trained in IRB,
informed consent procedures, conducting the rapid INSTI test,
and collecting sensitive health data. Also, all study staff
conducting human subjects research are required to complete
an online certification every three years.

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

Grantees will receive supplemental training on collecting data
on issues specific to transgender persons. Team members also
will attend agency-specific human subjects and client
confidentiality trainings.

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.

Study records containing PII will be destroyed no later than
three years following the closure of the study in accordance
with the study protocol.
Administrative: Assessment data cannot be accessed based on
PII, and access to study data will be limited to key grantees.
Public access to de-identified study data after completion of
the study and the reporting of study results will be determined
by a study data sharing and data use agreement.

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

Technical: Digital recordings of interviews will be destroyed by
erasing after the recording transcriptions are verified.
Completed assessments will be scanned, uploaded, and saved
in a password-protected, secure network. No PII will be linked
to participants' assessment data, and assessment data will be
stored separately using randomly assigned, unique
identification numbers for each participant. Only authorized
study staff with credentials will be able to access study data
housed electronically. Once logged into the system with
credentials, the system will automatically logout a user if a
period of inactivity occurs. Network servers are equipped with
back-up servers, two firewalls, and encryption for added
security.
Physical: All systems are securely controlled in new state-ofthe-art data center, which has limited access through badge
access. PII portions of the system are paper-based and will not
be stored electronically. Paper forms will be de-identified and
uploaded and stored electronically. Only de-identified data will
be stored in electronic format. Documents containing PII will
be locked in a file cabinet, accessible only by authorized study
staff. Records containing PII will be destroyed no later than
three years after closure of the study in accordance with the
study protocol.

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

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Reviewer Questions
4

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

Answer
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

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

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OPDIV Senior Official
for Privacy Signature

Jarell
Oshodi -S

Digitally signed by Jarell
HHS Senior
Oshodi -S
Agency Official
Date: 2019.02.07
for Privacy
14:45:35 -05'00'

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