IRB Project Determination

12/18/2015

REQUEST FOR NCHHSTP PROJECT DETERMINATION & APPROVAL
NCHHSTP ADS/ADLS Office on behalf of CDC (New, Continuation, or Amendment)

This form should be used to request NCHHSTP/OD/ADS or ADLS office review and approval on behalf of
CDC of a new, continued, or amended project for those projects for which NCHHSTP staff/employees,
branches, divisions, and center/OD/ADS or ADLS office are responsible.
Any NCHHSTP activity that meets the definition of a project (see the following section) and represents
one of the four project categories must be approved by the respective NCHHSTP branch and division and
by the NCHHSTP/OD/ADS or ADLS office. Approval by the NCHHSTP ADS or ADLS office
(nchstphs@cdc.gov) of these projects indicates approval by CDC. This review and approval process
complies with obligations for adherence of projects to federal regulations, state laws, ethics guidelines,
CDC policies, and publication requirements.
For research that involves identifiable human subjects in which CDC/NCHHSTP is engaged, use CDC
Human Research Protection Office forms and submit them to CDC Human Research Protection Office
through the NCHHSTP ADS human subjects email box after approval at the branch and division levels.

RELEVANT INFORMATION
What is a project?
A project is defined as a time-limited activity that is funded for a specific period of time, an activity with
specified funds for a limited time, or as a limited time responsibility by specific CDC employees or staff,
including projects that might be ongoing or continuous for an extended period. A project has defined
objectives, tasks (e.g., essential public health services), dedicated resources, and is funded for a specified
time. NCHHSTP reviews and approves projects for the four project categories listed on this form. Every
project officer, project team and staff, NCHHSTP branch, and NCHHSTP division or office is responsible
for submitting this form for each project and for obtaining NCHHSTP OD/ADS or ADLS approval on behalf
of CDC before project initiation, continuation, or amendment. Such programs as surveillance are
approved and funded as specific projects for certain periods.

What is research?
The federal regulations and CDC/OD/ADS office define research as a systematic investigation, including
research development, testing and evaluation, designed to develop or contribute to generalizable
knowledge. Activities that meet this definition constitute research, regardless if these activities are
conducted or supported under a program that is not considered research for other purposes. For
example, demonstration and service programs sometimes include research activities.

What is a human subject?
A human subject is a living individual about whom an investigator (whether professional or student)
conducting research obtains
1. data through intervention or interaction with the individual or
2. identifiable private information.

What is an intervention?
Intervention includes both physical procedures by which data are gathered (e.g., venipuncture) and
manipulations of the subject or the subject's environment that are performed for research purposes.
Interaction includes communication or interpersonal contact between investigator and subject.
Page 1 of 12

12/18/2015

What is private information?
Private information includes information about behavior that occurs in a context in which an individual
can reasonably expect that no observation or recording is occurring and information that has been
provided for specific purposes by an individual and that the individual can reasonably expect will not be
made public (e.g., a medical record). Private information identifies individuals (i.e., the identity of the
person is or might be readily ascertained by the investigator or associated with the information) for the
information to constitute research involving human subjects.

What does being “engaged” mean?
An institution becomes “engaged" in human subjects research when its employees or agents intervene
or interact with living individuals for research purposes, or obtains individually identifiable private
information for research purposes. An institution is automatically considered to be engaged in human
subjects research whenever it receives funding or resources (e.g., a direct award) to support such
research. In such cases, the awardee institution has the ultimate responsibility for protecting human
subjects under the award.

What is surveillance?
CDC defines surveillance as “the ongoing, systematic collection, analysis, and interpretation of health
data essential to the planning, implementation, and evaluation of public health practice, closely
integrated with the timely dissemination of these data to those who need to know. The final link of the
surveillance chain is the application of these data to prevention and control. A surveillance system
includes a functional capacity for data collection, analysis, and dissemination linked to public health
programs.”

What is program evaluation?
Program evaluation is the systematic collection of information about the activities, characteristics, and
outcomes of programs to make judgments about the program, improve program effectiveness, or inform
or guide decisions about future program development. Program evaluation should not be confused with
treatment efficacy, which measures how well a treatment achieves its goals and that can be considered
research.

Sources (links)
 http://intranet.cdc.gov/od/oads/osi/hrpo/
 http://www.hhs.gov/ohrp/index.html

Page 2 of 12

Project Title: Usability Testing to Inform Development of the CDC Division of Sexually Transmitted Disease Prevention’s Website
12/18/2015

PROJECT REQUEST
Project Stage
Choose one by selecting a checkbox:
New: Fill out entire form, even if a protocol is attached (approval is for work by CDC/NCHHSTP employees).
Continuation: For projects expected to continue beyond NCHHSTP approved date; include brief description
of changes and attach clean and marked copies of approved determination (approval is for continued work
by CDC/NCHHSTP employees).
Amendment: Include brief description of changes and attach relevant documentation and a copy of
approved project (approval is for continued work by CDC/NCHHSTP employees).

Project Information:
Project Title: Usability Testing to Inform Development of the CDC Division of Sexually Transmitted Disease Prevention’s Website
NCHHSTP Project Number: I do not have this information

Division: DSTDP

Project Location/Country(ies):
National

Telephone: (404) 639-4885

CDC Project Officer or CDC Co-Leads:

Tiffani Phelps

Project Dates:
Start 04/01/2020
End 04/01/2021
Laboratory Branch Submission:
If applicable, select the checkbox:

Project Categories
Select the corresponding checkbox to choose the category and subcategory.
I. Activity is not human subject research. The primary intent of the project is public health practice or a disease
control activity.
A. Epidemic or endemic disease control activity; collected data directly relate to disease control. If this
project is an Epi-AID; provide the Epi-AID number and documentation of the request for assistance,
per division policy. Epi-AID no.
B. Routine disease surveillance activity; data will be used for disease control program or policy
purposes.
C. Program evaluation activity; data will be used primarily for that purpose.
D. Post-marketing surveillance of effectiveness or adverse effects of a new regimen, drug, vaccine, or
device.
E. Laboratory proficiency testing.
Page 3 of 12

Project Title: Usability Testing to Inform Development of the CDC Division of Sexually Transmitted Disease Prevention’s Website
12/18/2015

II. Activity is not human subjects research. The primary intent is public health program activities.
A. Public health program activity (e.g., service delivery; health education programs; social marketing
campaigns; program monitoring; electronic database construction or support; development of patient
registries; needs assessments; and demonstration projects to assess organizational needs, management,
and human resource requirements for implementation).
B. Activity is purely administrative (e.g., purchase orders or contracts for services or equipment).
III. Activity is research but does NOT involve identifiable human subjects.
A. Activity is research involving collection or analysis of data about health facilities or other
organizations or units (i.e., not individual persons.)
B. Activity is research involving data or specimens from deceased persons.
C. Activity is research using unlinked or anonymous data or specimens: ALL (1–4) below are required:
1. No one has contact with human subjects in this project; and
2. Data or specimens are or were collected for another purpose; and
3. No extra data or specimens are or were collected for this project; and
4. Identifying information was (one of the following boxes must be checked)
a. not obtained;
b. removed before this submission, or before CDC receipt, so that data cannot be linked
or re-linked with identifiable human subjects; or
c. protected through an agreement (i.e., CDC investigators and the holder of the key
linking the data to identifiable human subjects enter into an agreement prohibiting
the release of the key to the investigators under any circumstances. A copy of the
agreement must be attached.)
IV. Activity is research involving human subjects, but CDC involvement does not constitute “engagement in
human subject research.” Select only one option by checking the box: A indicates the project has current
funding; B or C indicates no current funding is applicable.
A. This project is funded under a grant, cooperative agreement, or contract award mechanism. ALL of
the following 3 elements are required:
1. CDC staff will not intervene or interact with living individuals for research purposes.
2. CDC staff will not obtain individually identifiable private information.
3. Supported institution(s) must have a Federalwide Assurance (FWA), and the project must be
reviewed and approved by a registered IRB or an institutional office linked to the
supported institution’s FWA.*
Supported institution of primary investigator or co-Investigators/entity name:*

Page 4 of 12

Project Title: Usability Testing to Inform Development of the CDC Division of Sexually Transmitted Disease Prevention’s Website
12/18/2015

Supported institution/entity FWA Number:*
FWA expiration date:*
Expiration date of IRB approval:*
*Attach copy of IRB approval letter(s) supporting project review and approval.
B. CDC staff provide technical support that does not involve possession or analysis of data or interaction
with participants from whom data are being collected (no current CDC funding).
C. CDC staff are involved only in manuscript writing for a project that has closed. For the project, CDC
staff did not interact with participants and were not involved with data collection (no current CDC
funding).

Page 5 of 12

Project Title: Usability Testing to Inform Development of the CDC Division of Sexually Transmitted Disease Prevention’s Website
12/18/2015

Project Description
Participating project staff must complete all 18 elements of this section.
This is a required description from CDC employees or staff for review and approval of a project plan or
proposal (or for changes) for projects conducted by CDC or in which CDC is involved. All 18 elements
are required to standardize the review and approval process across NCHHSTP, document that all 18
elements have been addressed, expedite review and approval by the NCHHSTP ADS or ADLS office, and
minimize CDC/OD/ADS office audit requests for additional information. A protocol may be attached to
this form, but it does not eliminate the requirement to complete all 18 elements.
PROJECT TITLE: Usability Testing to Inform Development of the CDC Division of Sexually Transmitted Disease Prevention’s Website

Instructions: Use the following boxes to complete the 18 items. Each box will expand as you type, and you are not
limited in the length of your answers. Formatting features and symbols also may be used.
1. CDC Principal Investigator(s) or Project Directors and branch/division/office affiliations:
Tiffani Phelps, MPH
Health Communication Specialist
Division of STD Prevention
Centers for Disease Control and Prevention
12 Corporate Square Blvd, Mailstop H18-3
Atlanta, GA 30329
Phone: 404-639-4885
E-mail: itb0@cdc.gov

2. CDC Project Officer(s) and each person’s role and responsibilities and affiliations:

Kristen Chapman
OSTLTS Umbrella Cooperative Agreement CDC-OT13-1302
Centers for Disease Control and Prevention (CDC)
Office: 770-488-1513

3. Other CDC project members, branches, divisions, and other participating institutions, partners, and
staff:
Salina Smith
Division of STD Prevention
Centers for Disease Control and Prevention

4. Institution(s) or other entity(ies) funding the project:
CDC via OSTLTS Umbrella Cooperative Agreement CDC-OT13-1302

Page 6 of 12

Project Title: Usability Testing to Inform Development of the CDC Division of Sexually Transmitted Disease Prevention’s Website
12/18/2015

5. Project goals:
The proposed qualitative evaluation will explore the usability of the current CDC DSTDP website with three key
website audiences: adults disproportionately affected by STDs, healthcare providers, and public health professionals.
Usability refers to how easily users are able to engage with the website. This evaluation will provide information on
the needs and preferences for the website; satisfaction with the website, its organization, and its content; and the
ability of participants to complete specified tasks successfully and easily. The information collected will be combined
with the usability tester’s observations on the users’ experiences and will be immediately useful to the CDC DSTDP
team in revising the website.

6. Project objectives:
1. Evaluate user needs and preferences for the CDC DSTDP website.
2. Determine how well the current information architecture maps to how users think about the content.
3. Evaluate how easily users can navigate the site and find what they are looking for.

7. Public health (program or research) needs to be addressed:
Rapidly rising STD rates in the United States is an alarming public health problem that urgently requires awareness, attention, and action. Nearly 2.3 million
cases of chlamydia, gonorrhea, and syphilis were diagnosed in the United States in 2017. This surpassed the previous record set in 2016 by more than 200,000
cases and marked the fourth consecutive year of sharp increases in STDs.
To help reverse current STD trends, CDC offers online content and resources for public health professionals, healthcare providers, and the general public
through the CDC DSTDP website. This website includes in-depth prevention and education content for different audiences, including information on more than
15 STD-related conditions. The site is consistently one of the top 10 websites visited at CDC.gov. DSTDP has not had the opportunity to test the usability of their
website. This evaluation will allow the program to gain insight into user needs and preferences, user experience with the information architecture, and user
feedback on existing content. This information in turn will help CDC/DSTDP improve the website functionality, navigability, and usability to quickly deliver relevant
content to users of the website and connect them to CDC’s STD-related resources.

8. Population(s) or groups to be included:
To test the usability of a website, it is important to gather data from different types of users. For this evaluation will include healthcare providers and public
health professionals who are most likely to use CDC STD information for their patients or organizations, along with adults in populations disproportionately
affected by STDs who would use the website for their own purposes.
- Healthcare providers will include “lead providers” or those who are primarily responsible for patient care (e.g., physicians, physician assistants, nurse
practitioners), “support providers” (e.g., nurses, health educators), and STD specialists.
- Public health professionals will include STD directors or other relevant STD health department staff, public health information officers, and advocates.
- Adult populations disproportionately affected by STDs will include young adults (18 – 24 years of age), men who have sex with men (MSM), and
pregnant women. Each “adult” group will be segmented by education level: high school or less and some college or more.

9. Project methods:
Data will be collected through one-on-one interviews conducted by a moderator with experience in usability testing and
qualitative interviewing. Methods will include a card sort exercise based on existing website content to evaluate how well the
current information architecture maps to how users think about the content. Other interview questions will focus on user needs,
preferences, and feedback on content, as well as participants’ ability to complete specific tasks on the website. The sessions
will occur remotely using phone and screen-sharing software (ReadyTalk). In addition, the card sort will be conducted using an
online software (OptimalSort). Data will be collected from participants who represent the priority audiences of the CDC DSTDP
website—adults disproportionately affected by STDs, healthcare providers, and public health professionals.

Page 7 of 12

Project Title: Usability Testing to Inform Development of the CDC Division of Sexually Transmitted Disease Prevention’s Website
12/18/2015

10. Selection, inclusion, or sampling of participants (persons or entities):
As previously described, the three participant groups are selected to ensure that usability testing is conducted with different types of CDC DSTDP website users.
*Adults disproportionately affected by STDs*
The evaluation team will identify and recruit a total of 18 adults, aiming for a balanced split across the subgroups disproportionately affected by STDs (e.g., 6 young adults, 6 pregnant women, 6 MSM). Since lower education level likely affects health literacy in general and could impact the
user experience of CDC DSTDP’s website, half of those recruited will have an education level of high school or less and half will have some college or more. All participants will have had sexual contact in the past year, be likely to use the internet to access health information, and be able to
access the DSTDP website on a computer for the usability testing. Those recruited will include a mix of ages, race/ethnicity, and types of communities (urban, suburban and rural). Only one participant per household can be included in the evaluation.
*Healthcare providers*
To ensure that information is gathered from different types of providers, respondents will be segmented by their role (i.e., lead, support, and specialist providers). The team will recruit a total of 25 healthcare providers. Lead providers (10 individuals to be recruited) are those who are
primarily responsible for patient care and may include these roles: physicians, physician assistants, and nurse practitioners. Support providers (10 individuals to be recruited) are those who support patient care and may include these roles: nurses, health educators, or others who play a
significant health education role. Specialists (5 individuals to be recruited) are those who deal exclusively with STD prevention, testing, or treatment. Participants also will be screened to ensure a mix of urbanicity of their location, type of work setting (i.e. public vs. private), age, gender, and
familiarity with the CDC DSTDP site. This segmentation is based on several assumptions:
• Different types of providers (lead, support, and specialists) will have different reasons for visiting the website and thus use it differently. STD specialists are likely to know the subject matter deeply; therefore, we have designed the study to include their perspectives on the website as well.
• Providers in different settings may have different needs for, knowledge about, or access to CDC online resources. This evaluation include both providers in public and private settings, including clinic and hospital based settings, and in urban, suburban, and rural communities.
• People’s age correlates directly to their comfort and ability with navigating the internet to gather information.
• Including male and female healthcare providers will help ensure that gender bias does not influence the results.
• Including providers with varied degrees of familiarity with the site will provide information from the perspective of a new user as well as one with prior experience.

11. Incentives to be provided to participants:

We intend to recruit equal numbers of lead and support providers; however, we will screen for alternatives and collapse these categories if recruitment does not progress as expected.
To be included, providers will self-report that their work includes STD prevention, testing, or treatment, that they are likely to use the internet to access the type of content and information found on the CDC DSTDP website, and that they are able to access the CDC DSTDP website on a
computer for the usability testing.

Tokens of appreciation in the form of an online gift card, will be emailed to participants upon completion of their interviews. At-risk adults will receive a $50 gift card, healthcare providers will receive a gift card of $100, and public health professionals will
To ensure
with healthcare providers last no more than 30 minutes, while gathering data on all elements in the study, providers will be divided into two groups—each answering a different set of questions. All healthcare providers will be recruited as one group and after
receive
a that
gift interviews
card of $30.

recruitment is completed, we will select 15 providers to answer interview questions from Interview Guide A (Attachment C4) and 10 providers (4 lead providers, 4 support providers, and 2 STD specialists) to answer interview questions from Interview Guide B (Attachment C5). The “card
sort” exercise included in Interview Guide A requires 15 completed interviews to draw conclusions. The providers from each category will be selected to ensure as much diversity as possible (i.e. geographic, organizational affiliation).

We recognize that the proposed incentive amounts are below typical market incentive rates. Although the usability testing process is more intensive and requires more engagement on the part of the participant than a typical individual interview might
require,
the flexibility
that our interview methodology affords—such as no travel time to and from the facilities and being conducted around the participant’s schedules—offsets the lower honorarium.
*Public health
professionals*

To ensure that information is gathered from different types of public health professionals, respondents will be segmented by their role (STD directors, public health information officers, and advocates) and whether they work at the state or local level (although advocates may include those
working
at thebelow-market
national level as
well). “STD
directors”
are those
in a leadership
positionand
within
STD programs
state/territorial
or local recruitment
public health departments.
“Public
health information
officers” that
are those
state/territorial orare
local
departments
who can
implement public
To
address
incentive
rates
and ensure
successful
recruitment
fielding,
we will in
coordinate
to monitor
status closely.
Additionally,
we will ensure
otherinconsiderations
in public
place health
to increase
likelihood
of participation,
such
education campaigns and communication efforts that encourage STD prevention interventions. “Advocates” are those who work at national, state, or local non-profit organizations with STD prevention, testing, or treatment within their mission, such as community health centers, LGBT
as:
advocacy groups, etc. Table 3 presents the segmentation across all categories of public health professionals. Participants will also be screened to ensure a mix of urbanicity of their location, age, gender, and familiarity with the CDC DSTDP site. We intend to recruit equal number of state
and local public health professionals; however, we will screen for alternatives and collapse these categories if recruitment does not progress as expected.

1. Ensuring an adequate recruiting period before the start of fielding (as well as ongoing recruiting as needed during fielding period);

To be included, public health professionals will self-report that their work includes STD prevention, testing, or treatment, that they are likely to use the internet to access the type of content and information found on the CDC DSTDP website, and that they are able to access the CDC DSTDP

2.
Availability
of sessions
time slots
that, in our experience, have been popular among healthcare providers and others—for example, early morning, evenings, and lunch; and
website
on a computer
for theatusability
testing.
*Recruitment
strategies*
3.
Having the
flexibility and appropriate staff availability to run concurrent sessions to leverage popular session times.

The adult population will be recruited from across the United States using a panel provider for expediency and confidentiality given the sensitive nature of the topic. Panel providers have existing categorized lists of potential survey participants from which they will be able to select an
appropriate sample for recruitment for 18 in-depth telephone interviews (IDIs). Healthcare providers and public health professionals will be recruited from CDC partnerships with professional networks for 25 IDIs with providers and 15 IDIs with public health professionals. Using these
networks will help research contractors more easily identify providers who are familiar with the website. Healthcare provider organizations will include the National Association of Community Health Centers, the National Medical Association, the Society for Adolescent Health and Medicine,
National Coalition for Sexual Health, and the American Academy of Pediatrics. Public health professional organizations include the Association of State and Territorial Health Officials, National Association of County and City Health Officials, National Coalition of STD Directors, and National
Public Health Information Coalition. The National Network of STD Prevention Training Centers and others from curated CDC lists also may be a source for participants who have visited the CDC DSTDP website.

12. Plans for data collection and analysis:

The recruitment will include the use of CDC-approved recruitment copy (Attachment A), consent form (Attachment B2), and screener (Attachment C3).

All
data collection
activities will
will use
be conducted
by thecopy
appointed
evaluation
team.
We propose
to conduct
18 their
telephone
in-depth
withThis
members
of include
adult populations
disproportionately
by who
STDs,
telephonethe
in-depth
interviews To
withbehealthcare
andself-report
15 telephone
Professional
organizations
the recruitment
in email,
newsletters,
and/or
social media
to invite
members
to beinterviews
interviewed.
copy will
contact information
for study affected
recruiters,
will25
implement
study screening.
included, providers,
providers will
that:
in-depth
with public
healthtesting,
professionals.
Interviews
will likely
gathertoinformation
on user
needs and
preferences
for and
the CDC
DSTDP
website,
how
wellDSTDP
the current
information
architecture
to the
howCDC
users
think about
theon
content
(via a card sort activity), and how easily users can
their workinterviews
includes STD
prevention,
or treatment;
they are
use the internet
to access
the type
of content
information
found
on the
CDC
website;
and they
are able tomaps
access
DSTDP
website
a computer.
navigate the site and find what they are looking for. Respondents also will be asked about their need for and use of CDC’s DSTDP website and other similar sites and also about the content of the website.
As stated above, to limit the time required for any one healthcare provider to no more than 30 minutes, the full set of questions has been divided into two separate guides. One group of providers (15 people) will respond to questions about their need for and use of the CDC DTSTP website
and will conduct the card sort activity to capture how they would categorize the website’s information. Another group (10 people) will focus on site exploration, specified tasks requiring navigation of the site, and overall impressions of the site.
Information will be collected using standard open-ended questions along with two specific activities (card sorting and tasks) that will allow research staff to better understand the respondents’ interaction with the site as well as how they would expect information on the site to be organized.
To understand the user experience, evaluation staff will provide tasks to participants to learn how they use (or would use) the website and to receive feedback on content. Open-ended initial tasks are used to encourage free exploration (e.g., “What would you do first if you arrived on this
website?”) and some more general tasks are used to see how individuals approach common tasks (“Please show me how you would find fact sheets about STDs to share with your patients”). If time permits, an optional set of tasks will be included that are specifically selected for each of the
different respondent groups and focus on gaining insight on the existing site architecture and determining which content is most valuable.
A card sort activity is included to explore how participants think about and mentally organize the type of information the CDC DSTDP site provides. Staff will ask participants to sort online “cards” (topics) into groups that are most intuitive to them using an online card sorting tool (e.g.,
OptimalSort), which will provide the most efficient data collection and analysis process. Respondents will label the groupings of cards they’ve created.
The following data collection instruments will be used in this evaluation:
*Eligibility Screeners for Adults, Public Health Professionals, and Healthcare Providers: Eligibility screeners will be utilized to identify eligible respondents and take approximately 10 minutes to complete. If eligible, participants will be scheduled for an interview. (Attachments C1, C3, and
C6).

13. Confidentiality protections:

*In-Depth Interview Guides: All interviews will be conducted by study staff using semi-structured interview discussion guides. All audio-recordings will be transcribed and study staff will maintain all transcripts on password protected/encrypted computers. (Attachments C2, C4, C5, and C7).

Consent documents and data collection tools will be retained in password-protected computer files and will only be accessible to
senior investigators or designated staff. All participants will be identified by study ID numbers only. Participants’ names will not
be included on materials. A master list of participant names linked with study IDs will be kept in a password-protected computer
file. All computer records will be protected by standard measures that limit data access to authorized personnel, and will be
identifiable only by participants’ IDs. Digitally-recorded qualitative data will be stored on a secure password protected server
following interview; followed by the deletion of the original audio file. Transcription and data analysis will be done through secure
password-protected server. All of these procedures will be adhered to in the proposed evaluation.

14. Other ethics concerns (e.g., incentives, risks, privacy, or security):
This evaluation is an initiative aimed to improve the current CDC DSTDP website and communication strategies to prevent STDs and encourage testing and treatment. As the subject matter is sexual health, the interviews will
include information on sensitive topics; however, we will not ask participants to share their own personal experiences. Rather, the discussion will focus on feedback to the CDC website and information contained within. The
interviewer chosen will have deep experience in conducting usability testing and sensitive interviews and all respondents will be informed that they may skip any question or stop participation at any time for any reason.
Only individuals 18 years and older will be involved in the proposed evaluation. Written consent will be obtained for all participants in the proposed qualitative evaluation when confirming their participation. Consent forms will be
written in plain language. Details about participating in the evaluation will be described in the consent form and explained verbally. A copy of the consent form will be provided to all participants and includes telephone numbers of
the appropriate evaluation team members so participants can call them with questions or concerns. Before each interview, moderators will again inform participants that the session will be audio recorded for the purposes of
accurate reporting. Participants will be asked to verbally consent to being recorded. If any interview participants do not want to be recorded, they will be informed that they will still be able to participate in the study (and an audio
recording will not be made of the interview).
The procedures for this evaluation present low risks to participants. The possible risks include the possibility that participants will become stressed during the interview process and the potential loss of confidentiality. However,
multiple safeguards will be implemented to avoid these risks and participants will be made aware of risks during the consent procedure. The risks posed to participants in the proposed evaluation are reasonable in relation to the
anticipated benefits and in relation to the importance of the knowledge that may reasonably be expected to result.

15. Projected time frame for the project:
OMB Submission: February 2020
Recruitment: 1 month after OMB Approval
Data Collection: 2 months after OMB Approval
Data analysis finalized and report drafted: 3 months after OMB Approval
Final data set and final report submitted to CDC: 4 months after OMB Approval

Page 8 of 12

Project Title: Usability Testing to Inform Development of the CDC Division of Sexually Transmitted Disease Prevention’s Website
12/18/2015

16. Plans for publication and dissemination of the project findings:
Summary of findings and recommendations will be presented to DSTDP to inform improvements
to the website. All disseminated data will be de-identified and stripped of personal identifying
information.

17. Appendices — including informed consent documents, scripts, data collection instruments, focus
group guides, fact sheets, or brochures:
Appendices include the following:
Attachment A - Recruitment Copy
Attachment B - Consent Forms
B1. Adults Interview Consent
B2. Healthcare Providers Interview Consent
B3. Public Health Professionals Interview Consent
Attachment C - Data Collection Instruments
C1. Adults Eligibility Screener
C2. Adults Interview Guide
C3. Healthcare Provider Eligibility Screener
C4. Healthcare Provider Interview Guide A
C5. Healthcare Provider Interview Guide B
C6. Public Health Professional Eligibility Screener
C7. Public Health Professional Interview Guide

18. References (to indicate need and rationale for project):
Centers for Disease Control and Prevention. Sexually Transmitted Disease Surveillance 2017.
Atlanta: U.S. Department of Health and Human Services; 2018.

Page 9 of 12

Project Title: Usability Testing to Inform Development of the CDC Division of Sexually Transmitted Disease Prevention’s Website
12/18/2015

PROJECT APPROVAL
Choose one of the following options (Division or Center/OD Project)

DIVISION PROJECT

NCHHSTP BRANCH AND DIVISION ADS REVIEW AND APPROVAL (Sign electronically by clicking next to the X
and following the prompts)

X

X

Branch Chief or Branch Science Officer

Division ADS, Acting ADS, or Deputy ADS

CENTER/OD PROJECT

NCHHSTP OD OFFICE REVIEWS AND APPROVALS (Sign electronically by clicking next to the X and following
the prompts)

X

X

Office Associate Director or Designee

NCHHSTP ADS or Designee

Page 10 of 12

Project Title: Usability Testing to Inform Development of the CDC Division of Sexually Transmitted Disease Prevention’s Website
12/18/2015

NCHHSTP ADS/DEPUTY ADS OR ADLS REVIEW AND APPROVAL
Project Title: Usability Testing to Inform Development of the CDC Division of Sexually Transmitted Disease Prevention’s Website

Date received in NCHHSTP ADS or ADLS office:
Date received by NCHHSTP Deputy ADS or ADLS:
Select the checkbox for each applicable comment for Nos. 1–5 or select the checkbox for No. 6 if all of the comments apply.
Additional applicable comments may be added to No. 7. If additional information is required before approval can be
granted, select No. 8.

1. This project is approved by NCHHSTP/CDC and CDC (per CDC policies and federal regulations) for CDC staff
participation.
2. Participating partners and sites must obtain project review and approval, according to their institutional
policies and procedures and according to local, national, and international regulations and laws, including
45 CFR 46 regulations and state laws. CDC project officers must maintain a current copy of local sites’
approvals in project records.
3. CDC investigators and project officers need to adhere to the highest ethics standards of conduct and to
respect and protect the privacy, confidentiality, autonomy, data, welfare, and rights of participants and
integrity of the project. All applicable country, state, and federal laws and regulations must be followed.
4. Informed consent or script is needed as required by laws and regulations. Information conveyed in an
informed consent or script process needs to address all applicable required elements of informed consent.
Consent of employees in related projects about their institutions needs to include a statement that their
voluntary participation or withdrawal would not affect their employment status or opportunities.
5. OMB Paperwork Reduction Act determination by the NCHHSTP OMB/PRA Coordinator might be needed for
this project.
6. All previous comments apply.
7. Other applicable comments: Type your comment in the box. The space will expand as you type.

8. More information is required before approval is granted: Explain what additional information is requested by
typing in the box. The space will expand as you type.

Date Information was requested:
Date Information was received:

Page 11 of 12

12/18/2015

Approval must be granted by the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention Associate
Director for Science (ADS), Acting ADS, or Deputy ADS, or for laboratory-associated projects, by the Associate
Director for Laboratory Science (ADLS) or Acting ADLS.

Project Title: Usability Testing to Inform Development of the CDC Division of Sexually Transmitted Disease Prevention’s Website

X

X

NCHHSTP ADS, Acting ADS, or Deputy ADS

NCHHSTP ADLS or Designee

Or

Page 12 of 12