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: Assessment of STD Service Needs and Provisions
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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: Assessment of STD Service Needs and Provisions
NCHHSTP Project Number:

Division: Division of STD Prevention

Project Location/Country(ies):
25 STD clinics across the U.S.

Telephone: (404) 639-6459

CDC Project Officer or CDC Co-Leads:

William S. Pearson, Ph.D.; Thomas L. Gift, Ph.D.

Project Dates:
Start 04/01/2018
End 12/30/2018
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: Assessment of STD Service Needs and Provisions
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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:*

National Association of City and County Health Officials (NACCHO); NORC at the University of Chicag
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Project Title: Assessment of STD Service Needs and Provisions
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Supported institution/entity FWA Number:* FWA00000142 (NORC)
FWA expiration date:* 07/10/2018
Expiration date of IRB approval:* 03/18/2019
*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: Assessment of STD Service Needs and Provisions
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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: Assessment of STD Service Needs and Provisions

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:
William S. Pearson, Ph.D. and Thomas L. Gift, Ph.D., Health Services Research and Evaluation
Branch (HSREB), Division of STD Prevention (DSTDP), National Center for HIV, Hepatitis, STD,
and TB Prevention (NCHHSTP)

2. CDC Project Officer(s) and each person’s role and responsibilities and affiliations:
William S. Pearson is the CDC lead for this project. His role is to lead the design of the survey
methodology, design of the survey instruments, collaboration with NACCHO and NORC on the
collection of the data, conduct/lead/supervise the analysis of the data, and to lead the writing of
manuscripts based on the data collected.
Thomas L. Gift is the branch chief for HSREB and will supervise all activities.

3. Other CDC project members, branches, divisions, and other participating institutions, partners, and
staff:
National Association of City and County Health Officials (NACCHO). Ms. Gretchen Weiss is the
NACCHO contact for this project. NACCHO is subcontracting the data collection to NORC at the
University of Chicago (NORC). Ms. Sara Walsh is the NORC contact for this project.

4. Institution(s) or other entity(ies) funding the project:
This project is solely funded through CDC's Division of STD Prevention (DSTDP). DSTDP has
contracted with NACCHO, who in turn has subcontracted with NORC for the survey data
collection.

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Project Title: Assessment of STD Service Needs and Provisions
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5. Project goals:
This project is being conducted as a Formative Research and Development Tool project. The goal of this project is
to gain a better understanding of the needs of patients attending STD clinics and the services provided by these
clinics through the use of a refined clinic user questionnaire and a newly developed clinic administration
questionnaire. This information will help CDC/DSTDP provide technical guidance to STD clinics and help STD
clinics meet the STD service demands of the public. These goals will be accomplished by conducting a survey of
5,000 people seeking care at 25 STD clinics across the U.S. as well as a survey of 25 STD clinic administrators.

6. Project objectives:
The first objective is to collect information from patients attending STD clinics across the United States
(n=5,000 patients) to determine their reasons for choosing care at the clinic as well as their insurance status
and willingness to use their insurance for care at the clinic.
The second objective is to collect information from STD clinics (n= 25 STD clinic administrators) to determine
the types of services provided at the clinics and their ability to bill insurance companies for services provided.

7. Public health (program or research) needs to be addressed:
This project will help DSTDP better understand the public demand for STD services in the U.S.,
including why people seek care at STD clinics; the type of care they are seeking at the clinic;
and other places they may seek care. This project will also determine the current services being
provided by STD clinics. The information that is collected will help DSTDP to be able to consult
with STD clinics on how best to meet public demands for STD services through the organization,
financing and delivery of STD services.

8. Population(s) or groups to be included:
This project will focus on patients seeking care at 25 STD clinics across the U.S. This will be a
convenience sample of people seeking care at an STD clinic. This project will also collect
information from 25 STD clinic administrators.

9. Project methods:
DTSDP will identify 25 metropolitan statistical areas (MSA) in the United States with high rates of STDs. NACCHO will then identify STD
clinics within the major cities of those MSAs for inclusion in the sample. Once identified, NORC will send surveyors to the clinics to
collect a convenience sample of 200 surveys at each clinic (100 male and 100 female) along with a survey administered to a clinic
administrator. The patient survey includes 20 multiple choice and "yes" or "no" questions that can be completed within 5 minutes. The
clinic survey contains approximately 13 multiple choice and "yes" or "no" questions that can be completed within 10 minutes and will be
administered to a clinic administrator by a field interviewer. Once the surveys are collected, NORC will enter this data into a
spreadsheet and deliver to CDC for analysis. There is no personally identifiable information (PII) collected on any of the surveys.

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Project Title: Assessment of STD Service Needs and Provisions
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10. Selection, inclusion, or sampling of participants (persons or entities):
DTSDP will identify 25 metropolitan statistical areas (MSA) in the United States with high rates of
STDs based on surveillance data. NACCHO will then identify STD clinics within the major cities of
those MSAs for inclusion in the sample. Once identified, NORC will send surveyors to the clinics to
collect a convenience sample of 200 surveys at each clinic (100 male and 100 female) along with
one survey completed by clinic administrative staff.

11. Incentives to be provided to participants:

There are no incentives provided for the completion of the surveys.

12. Plans for data collection and analysis:
NORC will send field surveyors to the clinics to collect a convenience sample of 200 surveys at each clinic (100
male and 100 female) along with one survey completed by clinic staff. The patient survey includes 20 multiple
choice and "yes" or "no" questions that can be completed within 5 minutes. The clinic survey contains 13 multiple
choice and "yes" or "no" questions that can be completed within 10 minutes. Once the surveys are collected,
NORC will enter this data into a spreadsheet such as an Excel spreadsheet or a SAS database and deliver to
CDC for analysis. NORC will also provide CDC/DSTDP with the completed paper copies of the surveys.

13. Confidentiality protections:
This survey requires the collection of age, race, sex, sexual orientation and 5-digit ZIP code
because these demographic characteristics are core to recommendations for STD service
delivery. However, no line listed data will be provided to clinics. Therefore, it will not be possible
to match any personally identifiable information (PII) to medical records and individuals will not
be able to be identified. All data presented to CDC will not contain names or addresses of any
persons.

14. Other ethics concerns (e.g., incentives, risks, privacy, or security):
There are no incentives provided for completing this survey.
Age, race, sex, sexual orientation, and ZIP code, will be collected from each participant to be used for
data analysis. None of this information will be able to be merged with any medical record information and
no line listed data will be supplied to any of the participating clinics. All data will be analyzed in an
aggregate form in order to provide demographic descriptions of the populations and their specific needs.

15. Projected time frame for the project:
Data is scheduled to be collected in late Spring and early Summer of 2018. All data collection is
planned to end by September 30, 2018.

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16. Plans for publication and dissemination of the project findings:
Once data is analyzed, presentations of the results will be made to participating STD clinics
through "webinars" and clinic specific reports. Aggregated data will be presented in
peer-reviewed publications in public health and STD journals.

17. Appendices — including informed consent documents, scripts, data collection instruments, focus
group guides, fact sheets, or brochures:
1.IRB Approval Letter
2. Waiver of documentation consent
3. Research that involves children
4. Clinic User Survey
5. Clinic Administrative Survey
6. List of identified cities for clinic selection.

18. References (to indicate need and rationale for project):
Publications from previous survey:
1. Hoover KW, Parsell BW, Leichliter JS, et al. Continuing Need for Sexually Transmitted Disease Clinics
After the Affordable Care Act. 2015. Am J Pub Health; 105:S690-S695.
2. Pearson WS, Cramer R, Tao G. et al. Willingness to Use Health Insurance at a Sexually
Transmitted Disease Clinic: A Survey of Patients at 21 US Clinics. 2016. Am J Pub Health;
106:1511-1513.
Other supporting references:
1. Golden MR, Kerndt PR. Improving clinical operations: can we and should we save our STD clinics? Sex
Transm Dis. 2010; 37:264-265.

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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

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

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Project Title: Assessment of STD Service Needs and Provisions
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NCHHSTP ADS/DEPUTY ADS OR ADLS REVIEW AND APPROVAL
Project Title: Assessment of STD Service Needs and Provisions

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: Assessment of STD Service Needs and Provisions

X

X

NCHHSTP ADS, Acting ADS, or Deputy ADS

NCHHSTP ADLS or Designee

Or

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