Non-research 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.
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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

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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: Message Testing on Adolescent Health
NCHHSTP Project Number: 7186

Division: Division of Adolescent and School Health (DASH)

Project Location/Country(ies):
United States

Telephone: (404) 718-8158

CDC Project Officer or CDC Co-Leads:

Kymber Williams, PhD

Project Dates:
Start 02/01/2019
End 09/14/2019
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.
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■

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:*

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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).

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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: Message Testing on Adolescent Health

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:
Kymber Williams, PhD
CDC/NCHHSTP/Division of Adolescent and School Health

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

Kymber Williams (CDC/NCHHSTP/DASH) will be serving as the program lead on this project
and will be consulted on all aspects of the project including design, data collection, analysis,
interpreting results, etc.. She will also serve as the back-up contracting officer’s representative
(COR) on the project (CDC contract #200-2014-61014, Task Order 0004).

3. Other CDC project members, branches, divisions, and other participating institutions, partners, and
staff:
Tracy Ingraham, CDC/NCHHSTP/DASH
Everly Macario, Sc.D., M.S., Ed.M., IQ Solutions, Inc.
Alejandra Brackett, MPH, IQ Solutions, Inc.
Rachael Picard, MPH, IQ Solutions, Inc.
Renee Clapsadle, MSB, IQ Solutions, Inc.
4. Institution(s) or other entity(ies) funding the project:
N/A; Project funded by CDC

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5. Project goals:
CDC’s DASH seeks to conduct focus groups with individuals with a stake in DASH’s work in adolescent
and school health—all influencers of policies and practices within schools that could protect youth who are
at risk for adverse health outcomes. The primary goal of the focus groups is to explore participants’
reactions to messages related to co-occurrence of risks across sexual behaviors and experiences,
substance use, mental health, and violence victimization; messages about DASH’s investment in healthy
youth and healthy communities; and DASH-recommended practices to improve youth health outcomes

6. Project objectives:
• To gather insights related to DASH messages (facts, information, and concepts) and terms (language and wording) that
are clear, effective, motivating, and appropriate for a given audience, as well as the best received tones for those messages.
• To garner a better understanding of the variances in knowledge, attitudes, and preferred terminology around high-risk
substance use, mental health, sexual risk, and violence victimization across audience segments.
• To identify effective audience-preferred communication channels and material formats for information materials, to be used
ultimately to develop and disseminate tailored resources to inform these youth influencers.

7. Public health (program or research) needs to be addressed:
Among currently sexually active high school students, 46 percent reported that neither they nor their partner had used a condom the last time they had sex, 14 percent reported that neither they nor their partner used any method
of birth control the last time they had sex, and 19 percent reported they had consumed alcohol or used drugs before they last had sex. These sexual risk behaviors place youth at risk not only for HIV infection but also for other
unintended health outcomes, including STDs and pregnancy.
Research suggests that well-designed and well-implemented school-based HIV and other STD prevention programs can decrease sexual risk behaviors among school-age adolescents, including delaying first sexual intercourse;
reducing the number of sex partners; decreasing the number of times adolescents have unprotected sex; and increasing condom use. Three specific factors known to promote behaviors that reduce HIV/STDs among young
people (e.g., delayed sexual initiation, condom use) include school connectedness; parental monitoring; and parent-adolescent communication, both generally and specifically about sex. Moreover, these factors have been linked
to reductions in substance use and violence victimization and perpetration, behaviors and experiences associated with adolescent sexual risk, as well as academic achievement, an outcome particularly salient for schools.
Recognizing that the nation’s schools are one of the primary settings for the development of youth, DASH aims to develop effective communication materials and strategies to support school-based prevention of HIV/STDs and
pregnancy, thereby providing youth with fundamental health knowledge and skills as well as helping them to establish healthy behaviors for a lifetime.
It is imperative that messages aimed at youth influencers resonate with their intended audience(s) —intermediaries that influence students and support high-risk populations. Therefore, CDC’s DASH seeks to test and solidify draft
message statements with representatives of each audience segment and learn their preferences for seeking information across different geographic locations.

8. Population(s) or groups to be included:
Focus groups will be conducted with:
1. Representatives from state and local education agencies (SEAs/LEAs), including school administrators, principals, superintendents, and state or local education department supervisors. The core SEA/LEA audiences are
DASH’s funded partners who provide health education and services through cooperative agreements. To obtain a diversity of perspectives, CDC DASH also plans to conduct focus groups with SEAs and/or LEAs not funded by
CDC.
2. Representatives from youth-serving organizations including nongovernmental youth-engaged organizations that provide a diverse range of opportunities and support and that serve some or all subpopulations of youth.
3. Representatives from external health organization s including professionals from nongovernmental organizations and other national stakeholder groups who focus on diverse health topics and disparities.
4. Policymakers including school board members. For this project, policymaking organizations will serve as proxies for policymakers. Policymaking organizations have direct contact with state and federal policymakers and focus
on providing accurate information on broad health and education topics, including school health policies, youth health concerns, and LGBTQ health or equity challenges.
5. Parents and caregivers including mothers and fathers, stepparents, other family caregivers, and legal guardians (such as foster parents). For this project, parents and caregivers will be defined as legal guardians living at least
half-time with at least one adolescent enrolled in grades six through 12.

9. Project methods:
We will conduct 15 in-person focus groups in five metropolitan areas in the United States. We will conduct focus groups with five total audiences with a stake in DASH’s work, including state, local, and national education agencies;
youth-serving organizations; external health organizations; policymakers and policymaking organizations; and parents and caregivers.
We will conduct between two and six focus groups in each of five metropolitan areas: Los Angeles, CA (West-2); Memphis, TN (South-3); Washington, DC (Mid-Atlantic/East-6); Chicago, IL (Midwest-2); and Houston, TX (South-2). We
selected these cities based on practicality and feasibility of reaching DASH-funded and unfunded stakeholder organizations for the professional groups (we currently have established contacts at some of the locations) and geographically
diverse representative metropolitan areas for the focus groups with parents and caregivers. These areas include some of the largest local education agencies in the United States (Los Angeles represents the second largest school district in
the country) as well as unfunded local education agencies abutting the funded local education agencies. Finally, these metropolitan areas include a diverse range of policy environments for sexual health education and HIV/sexual health
education; IQ Solutions selected states that mandate sexual health education (including states that specifically mandate medically accurate sexual health education) as well as states that do not mandate sexual health education.
Focus groups will be comprised of no more than nine participants each, and each discussion will last approximately 90 minutes.
We will test a total of 3 message themes/concepts/topic areas, with three to eight messages per theme, across the 15 focus groups. We will rotate themes and messages across focus groups (to test all messages while not overburdening any
one focus group).

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10. Selection, inclusion, or sampling of participants (persons or entities):
Parent/Caregivers. IQ Solutions will work with professional recruitment vendors that are based in each proposed focus group geographic location to recruit
all parent/caregiver focus group participants. We will recruit a mix of the following characteristics: age, gender, race/ethnicity, geographic type, education
level, total household income, grade/gender of adolescent(s), type of school attended by adolescent(s).
Professional Audiences. To recruit professionals affiliated with DASH partner and stakeholder organizations, DASH-funded education agencies, and
unfunded education agencies, we will work with DASH’s program staff and the partnership team at DASH to engage participants. For each professional
focus group, IQ Solutions will aim to recruit a mix of individuals with varying relevant professional titles and representing organizations of diverse sizes,
constituencies, missions, focus areas (e.g., health, education), and prior engagement with DASH.

11. Incentives to be provided to participants:
We will provide a financial incentive in the amount of $40 to each participant. Our team has recent
experience receiving approval from OMB on incentive amounts of this quantity for 90-minute in-person
focus groups. This quantity will allow the team to recruit the desired mix of participants within the limited
time frame we have to execute this project. A financial incentive lower than this amount could introduce
recruitment challenges, including securing recruitment vendors and identifying participants willing to
participate.

12. Plans for data collection and analysis:
We will hold the focus groups in focus group facilities with one-way mirrors for in-person viewing. Live video-streaming capabilities will also be available for remote “real-time” viewing (as requested
and as possible). We will audio-record each focus group discussion. In addition, we will provide transcriptions of each focus group immediately following each discussion. The moderator and
informed consent form will inform participants of the live video-streaming and audio-recording features in advance of the discussion. The moderator will explain to participants that the live
video-streaming will be terminated at the end of each discussion and that there will be no archived video-recording for future viewing.
Following the conclusion of all focus groups, and receipt of all verbatim transcripts, we will analyze the data systematically using the qualitative analysis tool, Atlas.ti. All project team members will
arrive at consensus with respect to the findings, conclusions, and recommendations.
We will develop a comprehensive report that summarizes the findings and presents action-oriented recommendations. We will also develop a PowerPoint presentation to spotlight high-level findings.

13. Confidentiality protections:
All participants will provide written and signed informed consent to participate in the focus groups prior to their
participation.
During the discussions, we will maintain participant privacy by using first names only (no last names). The moderator
will never see information connecting individual participants’ full names with their demographic characteristics or other
personally identifiable information. No personally identifiable information will be disclosed in the results or reporting.

14. Other ethics concerns (e.g., incentives, risks, privacy, or security):
Almost all, if not all, of the questions asked will not be of a sensitive nature. There will be no requests for participants' Social Security Numbers. Demographic questions (i.e., gender, age.,
level of education, race/ethnicity, income level)--collected only during the participant recruitment process to confirm participant eligibility, assure a diverse mix of participants per focus group,
and describe the focus group participant sample--could be considered sensitive, but not highly sensitive. The informed consent protocol will apprise participants of the topics to be covered in
the focus groups. This project includes a number of procedures and methodological characteristics that will minimize potential negative reactions to potentially sensitive questions, including
the following:
•
Participants will be informed that they need not answer any question that makes them feel uncomfortable or that they simply do not wish to answer.
•
Should participants have any questions or concerns about the discussion or their rights as a participant, participants will be provided with the telephone number of the project manager.
We will combine all focus group information collected in the aggregate when we report results in a summary report.
Raw data from this data collection effort will never become part of a system of records containing permanent identifiers that can be used for retrieval.
All data collection activities will be conducted in full compliance with CDC regulations to maintain the privacy of data obtained from participants.

15. Projected time frame for the project:
February 1, 2019 through September 14, 2019.

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16. Plans for publication and dissemination of the project findings:
DASH may wish to publish findings from thisproject in relevant journals, such as the Journal of
Adolescent Health, Journal of Health Communication, American Journal of Public Health,
Journal of School Health. DASH may also wish to submit conference abstracts for consideration
at relevant meetings, including the National Conference on Health Communication, Marketing,
and Media and the American Public Health Association Annual Meeting.

17. Appendices — including informed consent documents, scripts, data collection instruments, focus
group guides, fact sheets, or brochures:
A: Informed Consent Form
B: Moderator's Guides
C: Themes and Messages
D: Outreach Emails
E: Recruitment Screener
F: Fact Sheet

18. References (to indicate need and rationale for project):
Centers for Disease Control and Prevention. Table 153. Percentage of high school students who did not use any method to prevent pregnancy during last sexual intercourse, by sex, race/ethnicity, grade,
sexual identity, and sex of sexual contacts. Youth Risk Behavior Surveillance—United States, 2017. MMWR Surveill Summ. 2018;67(8):351. https://www.cdc.gov/healthyyouth/data/yrbs/pdf/2017/ss6708.pdf.
Published June 15, 2018. Accessed November 30, 2018.
Chin HB, Sipe TA, Elder R, et al. The effectiveness of group-based comprehensive risk-reduction and abstinence education interventions to prevent or reduce the risk of adolescent pregnancy, human
immunodeficiency virus, and sexually transmitted infections: Two systematic reviews for the guide to community preventive services. Am J Prev Med. 2012;42(3):272-294.
Mavedzenge SN, Luecke E, Ross DA. Effective approaches for programming to reduce adolescent vulnerability to HIV infection, HIV risk, and HIV-related morbidity and mortality: A systematic review of
systematic reviews. J Acquir Immune Defic Syndr. 2014;66:S154-S169.
Markham CM, Lormand D, Gloppen KM, et al. Connectedness as a predictor of sexual and reproductive health outcomes for youth. J Adolesc Health. 2010;46(3 Suppl):S23-41.
Dittus PJ, Michael SL, Becasen JS, Gloppen KM, McCarthy K, Guilamo-Ramos V. Parental monitoring and its associations with adolescent sexual risk behavior: a meta-analysis. Pediatrics. 2015;136(6):
e1587-1599.
Resnick MD, Bearman PS, Blum RW, et al. Protecting adolescents from harm. Findings from the National Longitudinal Study on Adolescent Health. JAMA. 1997;278(10):823-832.

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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

Rebecca L.
Payne -S

Digitally signed by Rebecca
L. Payne -S
Date: 2018.12.18 08:59:58
-05'00'

Branch Chief or Branch Science Officer

X

Stephen
Banspach -S

Digitally signed by Stephen
Banspach -S
Date: 2018.12.18 09:01:33
-05'00'

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

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NCHHSTP ADS/DEPUTY ADS OR ADLS REVIEW AND APPROVAL
Project Title: Message Testing on Adolescent Health

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:

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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: Message Testing on Adolescent Health

X

Alcia A.
Williams -S6

Digitally signed by Alcia A.
Williams -S6
Date: 2019.01.14 05:55:41
-05'00'

X

NCHHSTP ADS, Acting ADS, or Deputy ADS

NCHHSTP ADLS or Designee

Or

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