CDC 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
([email protected]) 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 Title: 2018 Congenital Syphilis Study
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PROJECT REQUEST
Project Stage
Choose one by selecting a checkbox:
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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: 2018 Congenital Syphilis Study
NCHHSTP Project Number: 7088

Division: DSTDP

Project Location/Country(ies):
East Baton Rouge, LA and Kern County, CA

Telephone: (404) 718-8958

CDC Project Officer or CDC Co-Leads:

Jennifer Ludovic and Lori Elmore

Project Dates:
Start 02/01/2018
End 08/31/2018
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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Project Title: 2018 Congenital Syphilis Study
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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:*
University of California at San Diego
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Project Title: 2018 Congenital Syphilis Study
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Supported institution/entity FWA Number:* FWA00004495
FWA expiration date:* 03/03/2020
Expiration date of IRB approval:* 10/17/2018
*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 Title: 2018 Congenital Syphilis Study
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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: 2018 Congenital Syphilis Study

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:
Jennifer Ludovic, DrPH, MPH
Lori Elmore, MPH
Office of Policy, Planning, and External Relations
Division of STD Prevention

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:
CDC, Division of STD Prevention: Virginia Bowen, PhD; Rachel Powell; Salina Smith
March of Dimes Foundation: Kathy Harris, Principal Investigator; Karyn Lee, Project Manager; Janis Biermann
University of California San Diego: Jennifer Wagman, Co-Principal Investigator; David Smith, Co-Principal Investigator; Erika Bonnevie,
Project Manager, Janet Armentor, PhD, Consultant
Tulane University: Emily Harville,PhD, Principal Investigator; Pierre Buekens, MD, Co-Investigator; Gloria Giarratano, PhD, Consultant

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

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Project Title: 2018 Congenital Syphilis Study
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5. Project goals:
March of Dimes sub-contracted with the University of California at San Diego (UCSD) in partnership with Tulane
University to assess the knowledge, attitudes, and factors that influence behavioral practices surrounding the
prevention, treatment, and transmission of congenital syphilis among high-risk pregnant women and prenatal care
providers in Kern County, California and East Baton Rouge Parish, Louisiana. The proposed study will expand on
what is already known about the epidemiology of the incidence in distinct settings and population groups in the United
States, and lessen the existing gap in knowledge on how to effectively communicate with patients at highest risk for
syphilis infection/transmission and the health care providers who can offer prevention and treatment services.

6. Project objectives:
1. Assess prenatal care provider knowledge, attitudes, and practices around congenital syphilis and its prevention.
2. Assess how prenatal care providers and high-risk pregnant women learn about congenital syphilis and where they seek
information.
3. Evaluate high-risk pregnant women’s knowledge of STDs and syphilis; patient decision making around whether to seek
prenatal care and patient use of prevention behaviors during pregnancy.
4. Seek recommendations for improving outreach to this population.
5. Generate ideas for a culturally appropriate way to engage high-risk pregnant women in the use of prenatal care services.

7. Public health (program or research) needs to be addressed:
Congenital syphilis has become an alarming problem that urgently requires awareness, attention, and action. Data from the most recent CDC STD Surveillance Report found that
the number of CS cases spiked for the fourth year in a row. From 2015-2016 alone, there were a total of 628 cases – a rise of nearly 30% over the previous year. Thirty-seven states
reported at least one case of CS; however, the majority of cases are concentrated in just a few areas. Evidence from CDC suggests that cases of congenital syphilis are
concentrated geographically and certain population groups are disproportionately affected. Congenital syphilis can lead to fetal loss, infant death, or a life of major health problems.
Congenital syphilis is completely preventable through effective antenatal screening, and treatment of infected pregnant women.
Findings from these interviews and focus groups will help inform congenital syphilis prevention efforts, including how to communicate effectively with patients and providers about the
infection, more information is needed about patient knowledge of sexually transmitted diseases (STDs), syphilis during pregnancy, patient decision-making around whether to seek
prenatal care, and patient use of congenital syphilis prevention behaviors during pregnancy. Additionally, more information is needed about provider awareness of the resurgence of
congenital syphilis, provider attitudes and practices related to syphilis testing/re-testing during pregnancy, and provider information-seeking related to congenital syphilis .

8. Population(s) or groups to be included:
Prenatal care providers and high-risk pregnant women in Kern County, CA and East Baton
Rouge Parish, LA.

9. Project methods:
Staff from USCD and Tulane will conduct in-depth interviews with prenatal care providers
working in Kern County, California and East Baton Rouge Parish, Louisiana. Additionally, they
will conduct focus group discussions with high-risk pregnant women in these same geographic
areas.

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Project Title: 2018 Congenital Syphilis Study
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10. Selection, inclusion, or sampling of participants (persons or entities):
Selection criteria for in-depth interview participants in Kern County, CA, and East Baton Rouge Parish, LA is outlined below:
(1) Prenatal care provider (including obstetricians/gynecologists, family practice doctors, maternal-fetal medicine specialists, certified nurse-midwives, and family nurse practitioners/women’s health nurse practitioner) that has worked in either Kern County,
CA or East Baton Rouge Parish, LA for at least 6 months; (2) Currently working directly with high-risk pregnant women (at least half of their patients); (3) Having a phone or some other way of being contacted; and (4) Consenting to involvement in the study.
In depth interviews will be conducted with up to 20 prenatal care providers, 10 providers per site.
Selection criteria for focus group participants:
Focus groups will involve pregnant women at “high risk” for being infected with syphilis and thus at high risk for mother-to-child transmission of syphilis. Kern County, CA and East Baton Rouge Parish, LA are two of the most hard-hit, high-morbidity syphilis
counties in the United States. Thus, pregnant women living in these two areas are considered to be high-risk (for both acquisition and transmission of syphilis).
Minimum eligibility criteria for focus group discussion participants includes: (1) Adult women (18 years and older) living in either Kern County, CA or Baton Rouge Parish/County, LA for at least 6 months; (2) Currently pregnant; (3) Having a phone or some
other way of being contacted; and (4) Consenting to involvement in study. Up to 10 focus group discussion will be conducted in total. Each focus group will include 6-8 participants, thus a total of up to approximately 80 focus group participants will be
enrolled, ~40 per site.

11. Incentives to be provided to participants:

Prenatal care providers will receive a gift card up to $50 for their participation in the in depth
interviews . Focus group participants will receive a gift card up to $25 for their participation.
These tokens of appreciation will be given after the completion of the interviews and focus
groups.

12. Plans for data collection and analysis:
Data collection
In-depth interviews: Interviews will be conducted among individuals with knowledge of the local setting and dynamics, and the challenges faced by high-risk pregnant women regarding congenital syphilis and use of health services. In order to understand the perspectives
of different specialized providers, interview participants may include providers across various departments. Interviews will be conducted by experience qualitative researchers, all of whom are trained (and will have supplemental training) in qualitative research, safe and
ethical research with pregnant women, and research ethics, and all have a deep understanding of the sensitive nature of research related to vulnerable populations. All interviews will be conducted in private and will last 60-90 minutes.
Focus group discussions: Focus group discussions will be conducted to complement the in-depth interviews and will benefit from group discourse surrounding the exploration of key concepts related to congenital syphilis, prenatal care, and hardships faced by high-risk
women related to pre- and post-natal care. focus group discussions will allow for discussion of general themes, including awareness of sexually transmitted infections, challenges in accessing healthcare while pregnant and how these might be overcome, and ideas for
ways that health messaging can best resonate with them. Focus groups will be led by a moderator and notes will be taken by an assistant who will tape each session (with all participants’ consent). All discussions will be structured by use of a guide and will last 1-2 hours.
Analysis
Interview and focus group notes will be transcribed and imported into QSR NVivo V10 (7) or analyzed through identification of recurrent themes following Crabtree and Miller’s 5 step “interpretive process”. Transcripts will be read to identify common themes, codes will be
developed and ~10% of data will be double coded and inter-rater reliability assessed. Coded text will be extracted and organized and read to identify emergent themes. A sequential, empirically-informed approach will be used to synthesize findings to develop
recommendations to better inform congenital syphilis outreach and prevention efforts.

13. Confidentiality protections:
Consent documents and data collection tools will be retained in locked filing cabinets in the PI’s office at UC San Diego or
Tulane University, 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 study 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. CDC will only receive transcripts that
do not include any identifiable information about participants and will not have access to the master list of participants.

14. Other ethics concerns (e.g., incentives, risks, privacy, or security):
Written consent will be obtained for the proposed qualitative research. Consent forms will be written in simple language at a fourth-grade reading level. Details of study
participation will be described in the consent form and explained verbally. If a potential participant decides he/she does not wish to participate, his/her decision will be honored
regardless of how well the study information is comprehended. A copy of the consent form, which includes a description of the study, will be provided to all participants and
includes telephone numbers of the PI where participants can call with questions or concerns. All team members have been trained in research ethics and undergo refresher
training prior to the onset of this study.
Risks: The research procedures for the proposed study present low risks to the study participants. The possible risks include the possibility that participants will become
emotionally distressed 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 study 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:
February 1, 2018-August 31, 2018

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Project Title: 2018 Congenital Syphilis Study
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16. Plans for publication and dissemination of the project findings:
Summary of findings and recommendations will be presented to the March of Dimes and CDC.
All disseminated data will be de-identified and stripped of personal identifying information. With
support from March of Dimes and CDC, USCD and Tulane will develop findings into scientific
manuscripts or reports for dissemination to populations of interest.

17. Appendices — including informed consent documents, scripts, data collection instruments, focus
group guides, fact sheets, or brochures:
Appendices include the following:
IRB Approval
Research Plan
Focus Group Consent
Interview Consent
Recruitment flyer
Provider screening and interview guides
Pregnant women screening and focus group guide

18. References (to indicate need and rationale for project):
1. Bowen V, Su J, Torrone E, Kidd S, Weinstock H. Increase in incidence of congenital syphilis - United States,
2012-2014. MMWR Morb Mortal Wkly Rep. 2015 Nov 13;64(44):1241-5. doi:10.15585/mmwr.mm6444a3.
2. Centers for Disease Control and Prevention (CDC). The 2006 National Plan to Eliminate Syphilis from the United
States - Executive Summary. 2007. Accessed from: https://www.cdc.gov/stopsyphilis/SEEexec2006.htm
3. Workowski KA, Bolan GA. Sexually transmitted diseases treatment guidelines, 2015. MMWR
Recomm Rep 2015; 64 (No. RR-3).
4. Morbidity and Mortality Weekly Report (MMWR). Dear Colleague Letter - Congenital Syphilis. November 12, 2015.
Accessed from: https://www.cdc.gov/std/dstdp/dcl-csmmwr-nov-12-2015.pdf

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Project Title: 2018 Congenital Syphilis Study
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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

Raul
Romaguera -S

Digitally signed by Raul
Romaguera -S
Date: 2018.02.15 09:43:27
-05'00'

Branch Chief or Branch Science Officer

X

Jami Leichliter
-S

Digitally signed by Jami
Leichliter -S
Date: 2018.02.15 08:29:59
-07'00'

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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Project Title: 2018 Congenital Syphilis Study
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NCHHSTP ADS/DEPUTY ADS OR ADLS REVIEW AND APPROVAL
Project Title: 2018 Congenital Syphilis Study

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: 2018 Congenital Syphilis Study

X

Alcia A.
Williams -S6

Digitally signed by Alcia A.
Williams -S6
Date: 2018.02.22 08:56:56
-05'00'

X

NCHHSTP ADS, Acting ADS, or Deputy ADS

NCHHSTP ADLS or Designee

Or

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