Att 3_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.
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: Navigating Insurance Coverage Expansion (NICE): A collaboration to increase access to care for black and Hispanic
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: Navigating Insurance Coverage Expansion (NICE): A collaboration to increase access to care for black and Hispanic m
NCHHSTP Project Number:

Division: DHAP

Project Location/Country(ies):
Chicago, IL

Telephone: (404) 639-1928

CDC Project Officer or CDC Co-Leads:

Mary Neumann

Project Dates:
Start 08/31/2016
End 08/30/2020
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: Navigating Insurance Coverage Expansion (NICE): A collaboration to increase access to care for black and Hispanic
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:*
University of Chicago Medicine
Page 4 of 12

Project Title: Navigating Insurance Coverage Expansion (NICE): A collaboration to increase access to care for black and Hispanic
12/18/2015

Supported institution/entity FWA Number:* 00005565
FWA expiration date:* 03/14/2022
Expiration date of IRB approval:* 12/19/2017
*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: Navigating Insurance Coverage Expansion (NICE): A collaboration to increase access to care for black and Hispanic
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: Navigating Insurance Coverage Expansion (NICE): A collaboration to increase access to care for black and Hispanic

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:
Mary Spink Neumann, PhD, Project Officer. NCHHSTP, Division of HIV/AIDS Prevention,
Prevention Research Branch
Kate Roland, MPH, Co-Project Officer. NCHHSTP, Division of HIV/AIDS Prevention, Prevention
Research Branch

2. CDC Project Officer(s) and each person’s role and responsibilities and affiliations:
Mary Spink Neumann, PhD, will be responsible for the monitoring and oversight of the technical and programmatic aspects of the cooperative
agreement. She will consult regularly with the project PI from the University of Chicago. Dr. Neumann will oversee the dataset received from the
grantee and the publications and manuscripts prepared from project data.
Kate Roland, MPH, will be responsible for supporting the monitoring and oversight of the technical and programmatic aspects of the intervention
development and data collection. Ms. Roland will participate in preparation of publications and manuscripts from project data.
CDC project officers will not be involved in data collection, will not interact with study participants, and will not receive data that includes study
participant personally identifiable information (PII).

3. Other CDC project members, branches, divisions, and other participating institutions, partners, and
staff:
Adrienne Herron, PhD, Program Manager and Evaluation Advisor. CDC, NCHHSTP, DHAP, Prevention Research Branch
Craig Borkowf, PhD, Statistical Advisor. CDC, NCHHSTP, DHAP, Quantitative Sciences and Data Management Branch
Ram Shrestha, PhD, Economist. CDC, NCHHSTP, DHAP, Quantitative Sciences and Data Management Branch
Jarvis Carter, PhD, Subject Matter Expert. CDC, NCHHSTP, DHAP, Prevention Research Branch
John A. Schneider, MD, MPH, University of Chicago Medicine – Principle Investigator
Rebecca Eavou, LCSW, Project Manager, University of Chicago Medicine
Chuanhong Liao, MS, Biostatistician, University of Chicago Medicine
Harold Pollack, PhD, Co-Investigator, University of Chicago Medicine
Howard Brown Health Center, Chicago, IL
Chicago House and Social Services Agency Inc., Chicago, IL

4. Institution(s) or other entity(ies) funding the project:
Project funding provided by the U.S. Department of Health and Human Services (DHHS),
Secretary's Minority AIDS Initiative Fund (SMAIF) and CDC/NCHHSTP's Division of HIV/AIDS
Prevention.

Page 6 of 12

Project Title: Navigating Insurance Coverage Expansion (NICE): A collaboration to increase access to care for black and Hispanic
12/18/2015

5. Project goals:
The goal of this study is to test whether providing in-person assistance in enrolling in private health insurance or Medicaid
for the first time, changing to a different insurance plan, or understanding how to use current insurance policies following
HIV testing will (1) increase the proportion of participants who obtain health insurance; (2) result in better health outcomes
among participants (e.g., achieving viral suppression, remaining HIV negative); (3) improve the linkage and retention rates
for HIV care (i.e., HIV treatment, Pre-exposure Prophylaxis (PrEP)) and other HIV-associated health services (e.g., mental
health counseling, substance use treatment) of participants, especially those diagnosed with HIV; and (4) increase HIV care
linkage and retention rates sufficiently to justify the cost of implementing the intervention (cost-benefit analysis).

6. Project objectives:
Project objectives are to (1) evaluate the effects of the in-person health insurance enrollment assistance
intervention on successful insurance enrollment, types of insurance coverage, and rates of linkage to and
retention in HIV-related health care (i.e., HIV treatment, PrEP), referrals to HIV-associated health services (e.g.,
mental health counseling, substance use treatment), and health outcomes (e.g., achieving viral suppression,
remaining HIV negative) among Black and Hispanic MSM and Transgender persons age 18 or older; and (2)
assess whether the in-person health insurance enrollment assistance intervention increases linkage and
retention rates sufficiently to justify the cost of implementing the intervention (cost-benefit analysis).

7. Public health (program or research) needs to be addressed:
Men who have sex with men experience the greatest burden of HIV in the United States, and from 2010 to 2014, HIV diagnoses increased among Black and
Hispanic MSM. Black and Hispanic MSM and Transgender women face obstacles in seeking preventive or medical care and following through with referrals or
appointments. This project, set in Chicago, will implement and evaluate provision of an in-person assistance intervention to help eligible Black MSM, Hispanic
MSM, and Black or Hispanic Transgender participants, regardless of their HIV status, to enroll in private health insurance or Medicaid for the first time, changing
to a different insurance plan, or understanding how to use current insurance policies at the end of their HIV testing session. Recent sources indicate that 48% of
Black MSM and 39% of Hispanic MSM in Chicago are uninsured. An intervention to help Black MSM, Hispanic MSM, and Black or Hispanic Transgender
persons overcome socioeconomic obstacles to health care can improve the health and health care seeking of Black MSM, Hispanic MSM, and Black or Hispanic
Transgender persons regardless of their HIV status, and can prevent transmission and acquisition of HIV among at-risk Black MSM, Hispanic MSM, and Black or
Hispanic Transgender persons. This study is a test of a structural intervention, and analyses will be used to assess the efficacy of the intervention as an
emerging practice.

8. Population(s) or groups to be included:
The primary audience for the intervention will be Black MSM and Hispanic MSM age 18 or older who are
residents of the Chicago, IL metropolitan statistical area (MSA) and who are receiving HIV tests in clinics and
in outreach settings (e.g., parks, clubs, other events). The secondary audience for the intervention will be
Black Transgender persons and Hispanic Transgender persons age 18 or older who are residents of the
Chicago MSA and who are receiving HIV tests from the partner agencies in the same settings. These
persons are at high risk for acquiring HIV infection or who are HIV-infected and in need of HIV care and
treatment services.

9. Project methods:
This randomized controlled trial aims to enroll and randomize 800 participants over a 12 month period, randomizing 400 into the intervention arm and 400
into the control arm. A minimum of 800 participants will be Black MSM or Hispanic MSM. Black or Hispanic Transgender persons can be enrolled in the
study, but will not be counted towards the total 800 enrollment goal. All data collected on Transgender persons will be analyzed separately. Participants will
be recruited to the study during community-based HIV testing events and from walk-in testing clinics provided by three partner agencies in the north, west,
and south sides of Chicago. However, participants recruited at these events and clinics will not be a representative sample of the entire Chicago MSA.
Intervention participants will receive in-person health insurance enrollment assistance at the end of their HIV testing session, and control arm participants
will receive a handout with instructions for enrolling in Medicaid or private health insurance. Participant data will be collected at study enrollment through a
survey, and then through medical record abstraction over a 12 month period. Process evaluation and cost data will also be collected during the intervention
period.

Page 7 of 12

Project Title: Navigating Insurance Coverage Expansion (NICE): A collaboration to increase access to care for black and Hispanic
12/18/2015

10. Selection, inclusion, or sampling of participants (persons or entities):
Study participants will be recruited to the study during HIV testing events hosted by the grantee (University of Chicago
Medicine) partner agencies (Chicago House and Howard Brown Health). After an individual receives an HIV test, their
HIV test results, and referrals to HIV-related health care, they will be invited to participate in the study. Inclusion criteria
include identifying as Black or Hispanic, MSM or Transgender, aged 18 years and older, and intending to reside in the
Chicago metropolitan area for the 12 months following enrollment. Participant eligibility, consent, and sociodemographic,
risk behavior, and insurance coverage information will be collected at study enrollment.

11. Incentives to be provided to participants:
A 25 dollar cash token of appreciation will be provided to participants in this study after study enrollment
to offset the costs associated with transportation and their time spent engaged in study activities. Every
recipient will complete a receipt which includes their unique participant ID, the date of the study visit,
the amount provided and the name of the staff member providing the token of appreciation. All token of
appreciation payments will be logged and tracked through the partner agencies’ procedures.

12. Plans for data collection and analysis:
Participant data collected at study enrollment will be entered into encrypted, password-protected handheld tablet directly into the study database. Participant electronic medical record data will be downloaded by partner agency staff into the
REDCap study database every three months over a 12 month period. Process evaluation and cost accounting data will be entered into the study database for every study recruitment event. The data manager will use Stata and R to manage
and clean the participant profile, survey, and medical data. The data manager will create the required reports for CDC to download with the necessary data. The data accessible for CDC to download will have all personally identifiable
information (PII) removed. Stata and R will be used to analyze the participant data, and SAS and Stata will be used to analyze the cost-effectiveness data.
Data management and access:
This study will collect a variety of data: (1) patient data―demographics, opinion survey, health insurance coverage, VL, HIV test results, retention in care, ART initiation and adherence, PrEP ignition and adherence, primary care visits; (2)
aggregate intervention data―completion rates, handouts delivered, etc.; and (3) clinic-specific data―process information, implementation/labor costs. Each patient will sign a consent form indicating that the data received and analyzed by
CDC will not contain PII, and each person’s data will be identified only by study participant ID.
A data management and analysis plan will be developed, including documentation and data retention requirements. Documentation will, at a minimum, include a data dictionary, description of data collection methods, data preparation
procedures, what the data represent (including time period covered by the data), and potential limitations for use.
Public access to the data will be provided to the extent feasible, within the constraints of available resources. It is anticipated that the data collected through this study will be shared as (1) summary data table(s) and (2) restricted use dataset
(s) (i.e. available under certain use restrictions). Supporting documentation will be provided along with shared data. If needed, a data use and/or data sharing agreement will be developed. The agreement(s) will describe in detail how data
access will be provided and the provisions for protection of privacy, confidentiality , security, intellectual property, or other rights.

13. Confidentiality protections:
Participant data will be housed in REDCap, a secure, HIPAA compliant database system utilized by research institutions nationally. Each individual who has access to the
database will have a unique username and password to log-in, enter data and access previously entered data. Each individual will be assigned to their partner agency data
access group, which will limit access to participant data by enrollment agency. Only the University of Chicago Medicine PI and program and data managers will have access
to the full data set including PII. This is required in order to review the system for duplicate participants and submit requests for data to the Chicago Department of Public
Health. All fields containing PII will be identified as such and this data will be removed from the datasets downloaded by CDC. All download data sets will be password
protected and stored on encrypted laptops that require a username and password to access. Collaborator accounts in REDCap will be verified every 6 months and any staff
changes will be noted at that time. All REDCap users will be prompted to change their passwords every 6 months. Study data will not be stored on the hard drive of any
partner agency computer or tablet. Computers used to access the REDCap database and study data are encrypted and password-protected. Handheld tablets used to collect
participant data in the field will be stored in a locked cabinet, in a locked office at the University of Chicago Medicine. During data collection, tablets will maintained by partner
agency study staff. When participants are directly entering data on the tablets, it will be done under the supervision of the partner agency staff.

14. Other ethics concerns (e.g., incentives, risks, privacy, or security):
University of Chicago Medicine staff engaging in human research are required to complete
research ethics training. Training includes: informed consent, data safety and monitoring, and
concerns associated with conducting research with vulnerable populations. Each staff member
is trained in proper HIPAA procedures at the time of hire. The University of Chicago Medicine
research team and partner agency data managers have completed human subjects protections
training and are HIPAA certified.
15. Projected time frame for the project:
The 12 month intervention period will be March 2018 through March 2019. Prior to beginning the intervention, data
collection will be pilot tested in each partner agency. The pilot of data collection tools and clinical data entry will be
done in November 2017. Client level data entry will occur directly in REDCap and will be completed by the client and
navigator during the study recruitment visit. Clinical data entry will occur quarterly for the duration of the study period,
March 2018 to March 2019; with clinical data entry continuing until March 2020. University of Chicago Medicine will
complete reviews of client level and clinical data every quarter and will be initiated within one month of the clinical
data entry. Interim data will be submitted to CDC bi-annually, after the completion of data entry and quality reviews.
Page 8 of 12

Project Title: Navigating Insurance Coverage Expansion (NICE): A collaboration to increase access to care for black and Hispanic
12/18/2015

16. Plans for publication and dissemination of the project findings:
Publication guidelines and agreements will be developed as well. Study results may be
disseminated through peer-reviewed journals, conference presentations, and research briefs, at
a minimum.

17. Appendices — including informed consent documents, scripts, data collection instruments, focus
group guides, fact sheets, or brochures:
Appendix 1: Informed Consent Form
Appendix 2: Participant Enrollment Form, Participant Profile and
Participant Satisfaction Survey
Appendix 3: Tracking Data Form
Appendix 4: Process Evaluation and Cost Accounting Form
Attachment A: Project Logic Model

18. References (to indicate need and rationale for project):
1 HIV Among Gay and Bisexual Men. Accessed November 8, 2015 from http://www.cdc.gov/hiv/group/msm/index.html
2 Herbst JH, Jacobs ED, Finlayson TH, McKleroy VS, Neumann MS, Crepaz N. Estimating HIV prevalence and risk behaviors of Transgender persons in the United States: a systematic review. AIDS and Behavior 2008;12:1-17.
3 Millett GA, et al. Comparisons of disparities and risks of HIV infection in black and other men who have sex with men in Canada, UK, and USA: a meta-analysis. Lancet 2012;380(9839):341-348.
4 Sullivan PS, et al. Explaining racial disparities in HIV incidence in black and white men who have sex with men in Atlanta, GA: a prospective observational cohort study. Annals of Epidemiology 2015;25(6):445-454.
5 Khan L. Transgender health at the crossroads: legal norms, insurance markets, and the threat of healthcare reform. Yale Journal of Health Policy, Law and Ethics 2011;11(2):376-418.
6 Hall G, et al. A Comparison of referred sexual partners to their community recruited counterparts in The BROTHERS Project (HPTN 061). AIDS Behav. 2015 Feb 11.
7 Motel S & Patten E. (2012). The 10 largest Hispanic origin groups: Characteristics, rankings, top Counties [Internet]. Washington, DC: Pew Research Center. Accessed December 10, 2015 from
http://www.pewhispanic.org/files/2012/06/The-10-Largest-Hispanic-Origin-Groups.pdf.
8 Grant JM, Mottet LA, Tanis J, et al. Injustice at Every Turn: A Report of the National Transgender Discrimination Survey. Washington: National Center for Transgender Equality and National Gay and Lesbian Task Force, 2011.
9 Moving Black MSM Along the HIV Care Continuum webinar. Accessed November 8, 2015 from http://www.aids.gov/pdf/bmsm-webinar-06252014.pdf.
10T urning the Tide on HIV, Division of HIV/AIDS Prevention Annual Report 2013. Accessed November 8, 2015 from http://www.cdc.gov/hiv/pdf/policies_dhap_annualreport_2013.pdf.7
11 In-Person Assistance in the Health Insurance Marketplaces, Centers for Medicare and Medicaid Services, Center for Consumer Information & Insurance Oversight, n.d., Accessed November 8, 2015 from
http://www.cms.gov/cciio/programs-and-initiatives/health-insurance-marketplaces/assistance.html.
12 OMB Memorandum M-13-17: Next Steps in the Evidence and Innovation Agenda. July 2013 from http://www.whitehouse.gov/sites/default/files/omb/memoranda/2013/m-13-17.pdf. Accessed November 5, 2015.
13 Bettinger EP, et al. The role of application assistance and information in college decisions: results from the H&R Block FAFSA experiment. The Quarterly Journal of Economics 2012; 127(3):1205-1242.
14 Chicago Department of Public Health. HIV/STI Surveillance Report 2016. Chicago, IL: City of Chicago, December 2016.
15 Matts, JP and Lachin, JM. Properties of permuted-block randomization in clinical trials. Controlled Clinical Trials 1988;9(4):327-344.
16 Farnham PG, Sansom SL, Hutchinson AB. How much should we pay for a new HIV diagnosis? A mathematical model of HIV screening in US clinical settings. Medical Decision Making 2012;32(3):459-69.
17 Gebo KA, et al. Contemporary costs of HIV healthcare in the HAART era. AIDS 2010, 24:2705-2715.
18 Horberg M and Raymond B. Financial policy issues for HIV pre-exposure prophylaxis cost and access to insurance. Am J Prev Med 2013;44(1S2):S125–S128
19 Gold M. Cost-Effectiveness in Health and Medicine. New York: University of Oxford Press; 1996.

Page 9 of 12

Project Title: Navigating Insurance Coverage Expansion (NICE): A collaboration to increase access to care for black and Hispanic
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

Yuko Mizuno S

Digitally signed by Yuko
Mizuno -S
Date: 2017.06.08 09:55:21
-04'00'

Branch Chief or Branch Science Officer

X

signed by Laura J.
Laura J. Fehrs Digitally
Fehrs -S
Date: 2017.06.20 09:59:28
-S
-04'00'

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

Page 10 of 12

Project Title: Navigating Insurance Coverage Expansion (NICE): A collaboration to increase access to care for black and Hispanic
12/18/2015

NCHHSTP ADS/DEPUTY ADS OR ADLS REVIEW AND APPROVAL
Project Title: Navigating Insurance Coverage Expansion (NICE): A collaboration to increase access to care for black and Hispanic

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: Navigating Insurance Coverage Expansion (NICE): A collaboration to increase access to care for black and Hispanic

X

Alcia A.
Williams -S6

Digitally signed by Alcia A.
Williams -S6
Date: 2017.06.23 10:28:57
-04'00'

X

NCHHSTP ADS, Acting ADS, or Deputy ADS

NCHHSTP ADLS or Designee

Or

Page 12 of 12