Att 5 Project Determination

12/18/2015

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

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

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

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

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

What is an intervention?
Intervention includes both physical procedures by which data are gathered (e.g., venipuncture) and
manipulations of the subject or the subject's environment that are performed for research purposes.
Interaction includes communication or interpersonal contact between investigator and subject.
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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: Improving Surveillance Data Collection among Persons Not Receiving HIV Care: A Qualitative Project to Enhance the
NCHHSTP Project Number: 7091

Division: DHAP

Project Location/Country(ies):
CDC/USA

Telephone: (404) 639-2090

CDC Project Officer or CDC Co-Leads:

Jennifer Fagan and Linda Beer

Project Dates:
Start 06/01/2018
End 05/31/2020
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.
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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 Title: Improving Surveillance Data Collection among Persons Not Receiving HIV Care: A Qualitative Project to Enhance the
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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: Improving Surveillance Data Collection among Persons Not Receiving HIV Care: A Qualitative Project to Enhance th

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 Fagan, Co-Principal Investigator, DHAP/BCSB/COT
Linda Beer, Co-Principal Investigator, DHAP/BCSB/COT

2. CDC Project Officer(s) and each person’s role and responsibilities and affiliations:
Jennifer Fagan, Co-Principal Investigator, DHAP/BCSB/COT; Oversee development of the project design and protocol, facilitation of interviews,
data analysis, development of deliverables, all project management activities.
Linda Beer, Co-Principal Investigator, DHAP/BCSB/COT; Oversee development of the project design and protocol, facilitation of interviews, data
analysis, development of deliverables, all project management activities.
Shana Green, ORISE Fellow, DHAP/BCSB/COT; Development of the project design and protocol, conduct interviews, data analysis,
development of deliverables, all project management activities.
Ansley Lemons, Health Scientist, DHAP/BCSB/COT; Assist with project design, data analysis and project deliverables.
Amy Baugher, Health Scientist, DHAP/BCSB/COT; Assist with project design, data analysis and project deliverables.
Mabel Padilla, Health Scientist, DHAP/BCSB/COT; Assist with project design, data analysis and project deliverables.

3. Other CDC project members, branches, divisions, and other participating institutions, partners, and
staff:
State and local health departments are funded to conduct the Medical Monitoring Project (MMP) in their local health jurisdictions. For this project, they
will help to identify and recruit people living with HIV who are eligible to participate in a qualitative interview for this project and disseminate tokens of
appreciation to respondents.
MMP project areas are:
California; Chicago, IL; Delaware; Florida; Georgia; Houston, TX; Illinois; Indiana; Los Angeles, CA; Michigan; Mississippi; New Jersey; New York
City, NY; New York; North Carolina; Oregon; Pennsylvania; Philadelphia, PA; Puerto Rico; San Francisco, CA; Texas; Virginia; and Washington.

4. Institution(s) or other entity(ies) funding the project:
Centers for Disease Control and Prevention

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5. Project goals:

The project goal is to inform the design of the MMP questionnaire and the interpretation of the
findings from the structured interview and medical record abstraction.

6. Project objectives:
Each project objective will be used to inform the design and interpretation of findings from the Medical Monitoring Project.
The project objectives are to:
!. Evaluate existing measurements of engagement and retention in care based on how people living with HIV who are not in care describe conceptions of
engagement and retention in care to inform questionnaire design and interpretation of findings from the Medical Monitoring Project.
2. Describe barriers, and facilitators to, and motivations for, obtaining HIV care for people living with HIV who are not in care to inform the design of the MMP
questionnaire.
3. Describe implications of not receiving HIV care to inform the design of the MMP questionnaire.
4. Improve MMP recruitment methods by increasing our understanding of best approaches for locating and recruiting people living with HIV who are not in care.

7. Public health (program or research) needs to be addressed:
MMP is a national surveillance system that captures behavioral and clinical data via structured interviews and medical record abstractions among adults living with diagnosed HIV in the United States. The CDC estimates that 72.5% of persons diagnosed with HIV received care during 2014,
while fewer (56.9%) were retained in care [1]. Being without care compromises the benefits of HIV medication at the individual and population level, as receipt and retention in care are prerequisite for accessing treatment. A person living with HIV who takes HIV medication is likely to
achieve maximal and durable suppression of HIV replication leading to immune system reconstitution and prolonged survival [2-5]. People living with HIV who take HIV medications daily as prescribed can achieve and maintain an undetectable viral load and have effectively no risk of
sexually transmitting the virus to an HIV-negative partner [6-13]. Despite the benefits of HIV care engagement, it remains difficult to achieve and maintain, as even those who have received care before may continue to cycle in and out of care throughout their lifetimes [14-17].
In 2015, MMP expanded its population of inference to all adults with diagnosed HIV regardless of their care status. It is important to ensure that people who are not in care are identified and recruited, and participate in MMP. It has been difficult for MMP to recruit people who are not
engaged in care. Unweighted data from the 2015 MMP data collection cycle indicate that less than 1% of respondents (n=48) were confirmed to have not received HIV care in the 12 months prior to interview. This number is low compared to data from the CDC’s 2014 diagnosed-based HIV
care continuum that indicate that 27.5% of people diagnosed with HIV have not received care and 43.1% are not retained in care [1]. MMP staff have made concentrated efforts to locate and recruit persons presumed to be out of care in recent cycles, and information collected from
qualitative semi-structured interviews with MMP respondents who were out of care will inform future recruitment practices.
Additionally, the current MMP structured interview instrument may not adequately capture the complexities of receiving and being retained in HIV care. For example, the structured interview instrument includes a series of questions aimed at capturing barriers to linkage and engagement in
HIV care for persons living with HIV; however, interviewer observations and preliminary data collected in 2015 suggest that the questions do not align with respondents’ perceptions of barriers to HIV care. The 35-question series includes stem questions that capture high-level structural,
financial, and personal barriers [18] to linkage and engagement in care and, if applicable, probing questions that elicit details about specific barriers. Yet, more than 30% of respondents endorsed the “other specify” response option, indicating a need to revise these questions. Because
access to and utilization of care is typically determined by complex and often overlapping social, cultural, personal, economic, and biomedical influences, complementary qualitative exploratory methods are needed to adequately collect this information.
Although there have been qualitative studies on care linkage and engagement [19, 20], only a few have captured perspectives about HIV care engagement from people who are not currently engaged in care. Therefore, it is important that this perspective be captured in order to best
understand how the MMP structured interview can address the complexities of HIV care engagement for all persons living with diagnosed HIV. The findings from the proposed qualitative formative research component of MMP will improve and streamline ongoing structured surveillance
questions about HIV care and inform the interpretation of responses that are collected from MMP. This project presents a unique opportunity to link qualitative findings to comprehensive behavioral and clinical data from structured interviews and medical records, because the same people
will participate in qualitative and structured interviews. This will allow for a more in-depth understanding of potential barriers and facilitators to care. Findings will also inform strategies to increase access to care and improve health outcomes for people living with HIV, which is a national
prevention goal.

8. Population(s) or groups to be included:

This project focuses on a key population, people living with HIV who are not engaged or retained in care. This population is of great public health importance because most HIV transmissions are attributable to persons not receiving adequate HIV care.
The findings of this project will address the following public health program needs:
1. Development of surveillance questionnaire to accurately collect ongoing data about receipt of HIV care,
2. Improve methods for medical record abstraction regarding medical care utilization among people living with HIV,
3. Inform the National HIV Surveillance System measurement of HIV care,
4. Inform Data-to-Care surveillance activities,
5. Improve recruitment of people living with HIV who are not engaged or retained in care because this is a hard to reach population,

To be eligible for the Medical Monitoring Project, the following criteria must be met:
1. Person diagnosed with HIV
The 18
findings
of this project
willolder
primarily be used to inform the design and interpretation of findings from the Medical Monitoring Project for persons living with HIV who have not received care or have not been retained in care for more than 12 months. Specifically, the findings of this project
2.
years
old or
will help guide MMP’s questionnaire development, interpretation of findings, and recruitment methods. Additionally, the findings of this project can inform the methods for medical record abstraction regarding medical care utilization, help inform messages about the importance of HIV care to
patients
and inform Data
to Care
surveillance
activities.
3.
Reported
to be
living
in an
address within one of the 23 project areas in the United States
To be eligible for this project, a person living with HIV must additionally meet the following criteria:
1. Participated in the Medical Monitoring Project 2018 cycle structured interview
2. Been out of care for at least 12 months preceding their MMP structured interview, or never received HIV care
3. Speak English
4. Not be incarcerated

9. Project methods:
To achieve the project goals, we will conduct qualitative interviews with people who were eligible and participated in the 2018 Medical Monitoring Project
data collection cycle. The approach used in this project is qualitative and descriptive—the intent is to obtain deep understanding and insight through
elicitation of rich, descriptive content from interviews with respondents who freely recount their experience and perspectives. By allowing respondents to
discuss this topic in their own words, we hope to learn about how people who are not engaged in care conceptualize HIV care, perceive barriers and
facilitators to, and motivations for, obtaining HIV care, and the effect not being in care has had on their lives. Approximately 40 people living with HIV who
never received HIV care or have not received HIV care for 12 months or more will complete one-hour qualitative interviews over the phone. We will analyze
the findings from the qualitative interviews alongside data from the Medical Monitoring Project interviews and medical record abstraction. The findings will
be used to improve the Medical Monitoring Project recruitment and data collection activities and enhance interpretation of findings about people living with
HIV who are not receiving medical care.

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10. Selection, inclusion, or sampling of participants (persons or entities):
To be eligible for this project, a person living with HIV must meet the following criteria:
1. Participated in the Medical Monitoring Project 2018 cycle structured interview
2. Been out of care for 12 months or more, or never received HIV care
3. Speak English
4. Not be incarcerated
Quota sampling will be used to identify and recruit MMP project respondents for participation in this project. Quota sampling is a tailored approach that accounts for potentially relevant variations in responses. The quota sampling strategy
ensures inclusion from people who may have otherwise been underrepresented by convenience or purposive sampling. The quota sampling strategy will consider three characteristics as important for sampling strategy: race/ethnicity, length
of time without HIV care, and the region of residence at the time of the MMP interview. The combinations of these characteristics represent the profiles of people to be sampled for this project. These characteristics were chosen because
these factors have been related to HIV disparities [22] and we expect there to be some relevant variations in the experiences of people not in care who differ on these characteristics. We aim to collect data from at least five MMP respondents
for each profile described in the quota sampling strategy. Therefore, it is expected that a minimum of 40 interviews will be required. However, data collection will continue until data saturation is reached [23].

11. Incentives to be provided to participants:
Each project area will distribute tokens of appreciation equivalent to the token of appreciation
provided for participation in the Medical Monitoring Project. Tokens in each project area may differ
according to local protocols and precedents; suggested tokens are $50-$75 in cash for
participation in the qualitative interview. If local regulations prohibit cash reimbursement, equivalent
reimbursement may be offered in the form of gift certificates, or bus or subway passes.

12. Plans for data collection and analysis:
The qualitative interview will take approximately 60 minutes. The interview will be administered via phone in English by a trained interviewer (see Appendix 1c for interview guide). Qualitative interviews will be
audio-recorded. No personally identifying information will be collected. The interviewer will take detailed notes during the interview (again, notes will not contain personal identifiers). Ten percent of interview
audio-recordings will be reviewed by a CDC supervisor for quality assurance.
Interview audio-recordings will be fully transcribed verbatim together with interviewer verbal cues. Instructions will be provided for transcriptionists. Transcription documents will be stored electronically on a secure
network at the CDC. Anyone who accesses the audio-recording for transcription purposes will complete security and confidentiality training. Transcripts will also be available for the respondents who participated in each
project area.
CDC will lead the qualitative and quantitative analyses, which will be guided by the project objectives and analytic questions. Project areas will be provided access to the transcripts of respondents sampled from their
jurisdiction and may choose to analyze the data for their needs.
Interview transcripts will be analyzed using a qualitative data analysis software, NVivo 11. The software will facilitate analysis by organizing, classifying, and sorting data into categories and frequencies.

13. Confidentiality protections:
Audio-recordings and transcripts will be stored electronically and backed-up on a secure network at the CDC. Everyone who accesses the data will complete security and confidentiality training. Data will only be accessed on password-protected computers
on a secure network at the CDC. All disseminated data will be in aggregate form and will not contain any personal identifying information. Results will be disseminated via a final report from CDC to project areas. Research findings may also be
disseminated to the public at conferences or through peer-reviewed publications.
Concerns regarding maintenance of confidentiality may be raised by respondents. The interviewer will be trained to protect the confidentiality of persons participating in this project and participants will be informed of their rights for confidentiality.
All project staff will have completed security and confidentiality training and signed a statement indicating their understanding of security and confidentiality policies.
All project data will be subject to the same security and confidentiality requirements as for the HIV and AIDS Reporting System surveillance data at state/local project areas and at CDC. Data collected for this project are protected under a Federal
assurance of confidentiality.
Transcripts and audio-recordings of qualitative interviews will be stored in a password-protected database on a secure server at CDC. CDC will destroy the digital audio files 5 years after data collection ends.
CDC will not collect any personally identifying information for this project. CDC will not have access to information that would allow CDC personnel to re-link the data to respondents. However, the unique identification code assigned to respondents by the
project areas will link the interview data to the MMP interview and medical record abstraction data for analysis purposes. Contact lists that are used for standard MMP procedures will be maintained by project areas in accordance with the previously
approved MMP data storage protocol.

14. Other ethics concerns (e.g., incentives, risks, privacy, or security):
MMP respondents who take part in this project are not expected to face signficant physical, social, or psychological risks. Respondents will be asked about their experiences with obtaining medical care. It is possible that sensitive information
could be discussed by respondents in relation to barriers to seeking care, so it will be emphasized by the interviewer that respondents may decline to answer any question(s) and they can terminate the interview and their participation in this
project at any time. Concerns regarding maintenance of confidentiality may be raised by respondents. The interviewer will be trained to protect the confidentiality of persons participating in this project and will be informed of their rights for
confidentiality.
Given the potentially sensitive nature of some of the interview topics, CDC has developed and will implement an adverse event protocol in which all MMP data collectors will be trained on recruitment procedures for this project. The adverse
event protocol includes examples of possible adverse events to include issues encountered during eligibility screening, scheduling of interviews and interview data collection. The adverse event protocol also includes action steps for
emergency and urgent situations for each of the above data collection activities.
CDC will identify a list of resources and referrals to local crisis centers, healthcare providers, substance abuse providers, and mental health providers for each project area. Adverse events will be documented on the adverse event form (see
Appendix 1d). All incidents (e.g., breach of privacy or protocol), adverse events, or unanticipated problems related to human subjects will be reported to the CDC Principal Investigator as soon as possible, but no later than 48 hours after their
occurrence. The principal investigator will provide an assessment of the event or problem and suggest any proposed changes to the project protocol, project description, data security plan and/or the informed consent document.
Persons under the age of 18 years of age and persons who are incarcerated at the time of the qualitative interview will not be included in this project. Pregnant women are not specifically targeted in sampling procedures for this project, but
may be included if they meet eligibility criteria. No special procedures are required for the participation of pregnant women.

15. Projected time frame for the project:
The project will last approximately 2 years from data collection to data analysis. Data collection
for this project is expected to begin in June 2018 or later, depending on when OMB approvals
are obtained. Data collection will be completed no later than 12 months from the start of data
collection. Coding and analysis will continue 12 months after the completion of data collection.

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16. Plans for publication and dissemination of the project findings:
Results will be disseminated via a final report from CDC to project areas. Findings may also be
disseminated to the public at conferences or through peer-reviewed publications.

17. Appendices — including informed consent documents, scripts, data collection instruments, focus
group guides, fact sheets, or brochures:
Appendix 1: Protocol "Improving Surveillance Data Collection among Persons Not Receiving
HIV Care"
Appendix 1a: Recruitment script
Appendix 1b: Oral Informed Consent Document
Appendix 1c: Interview Guide
Appendix 1d: Adverse Event and Protocol Breach Report Form

18. References (to indicate need and rationale for project):
1. Centers for Disease Control and Prevention, Understanding the HIV Care Continuum. 2017. p. 1-4.
2. Andrade, H.B., et al., Highly active antiretroviral therapy for critically ill HIV patients: A systematic review and meta-analysis. PLoS One, 2017. 12(10): p. e0186968.
3. Hogg, R.S., et al., Decline in deaths from AIDS due to new antiretrovirals. Lancet, 1997. 349(9061): p. 1294.
4. Palella, F.J., Jr., et al., Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. HIV Outpatient Study Investigators. N Engl J Med, 1998. 338(13): p. 853-60.
5. Samji, H., et al., Closing the gap: increases in life expectancy among treated HIV-positive individuals in the United States and Canada. PLoS One, 2013. 8(12): p. e81355.
6. Cohen, M.S. and C.L. Gay, Treatment to prevent transmission of HIV-1. Clin Infect Dis, 2010. 50 Suppl 3: p. S85-95.
7. Marks, G., N. Crepaz, and R.S. Janssen, Estimating sexual transmission of HIV from persons aware and unaware that they are infected with the virus in the USA. Aids, 2006. 20(10): p. 1447-50.
8. Marks, G., et al., Entry and retention in medical care among HIV-diagnosed persons: a meta-analysis. Aids, 2010. 24(17): p. 2665-78.
9. Metsch, L.R., et al., HIV transmission risk behaviors among HIV-infected persons who are successfully linked to care. Clin Infect Dis, 2008. 47(4): p. 577-84.
10. Ulett, K.B., et al., The therapeutic implications of timely linkage and early retention in HIV care. AIDS Patient Care STDS, 2009. 23(1): p. 41-9.
11. Cohen, M.S., et al., Antiretroviral Therapy for the Prevention of HIV-1 Transmission. N Engl J Med, 2016. 375(9): p. 830-9.
12. Cohen, M.S., et al., Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med, 2011. 365(6): p. 493-505.
13. Rodger, A.J., et al., Sexual Activity Without Condoms and Risk of HIV Transmission in Serodifferent Couples When the HIV-Positive Partner Is Using Suppressive Antiretroviral Therapy. Jama, 2016. 316(2): p. 171-81.
14. Christopoulos, K.A., et al., "Taking a half day at a time:" patient perspectives and the HIV engagement in care continuum. AIDS Patient Care STDS, 2013. 27(4): p. 223-30.
15. Cunningham, C.O., et al., A comparison of HIV health services utilization measures in a marginalized population: self-report versus medical records. Med Care, 2007. 45(3): p. 264-8.
16. Mugavero, M.J., et al., The state of engagement in HIV care in the United States: from cascade to continuum to control. Clin Infect Dis, 2013. 57(8): p. 1164-71.
17. Rebeiro, P., et al., Retention among North American HIV-infected persons in clinical care, 2000-2008. J Acquir Immune Defic Syndr, 2013. 62(3): p. 356-62.
18. Institute of Medicine, Access to Health Care in America, M. Millman, Editor. 1993, National Academy Press: Washington, DC.
19. Remien, R.H., et al., Barriers and facilitators to engagement of vulnerable populations in HIV primary care in New York City. J Acquir Immune Defic Syndr, 2015. 69 Suppl 1: p. S16-24.
20. Liau, A., et al., Interventions to promote linkage to and utilization of HIV medical care among HIV-diagnosed persons: a qualitative systematic review, 1996-2011. AIDS Behav, 2013. 17(6): p. 1941-62.
21. Centers for Disease Control and Prevention. Medical Monitoring Project Resources. 2017; Available from: https://www.cdc.gov/hiv/statistics/systems/mmp/resources.html.
22. Centers for Disease Control and Prevention, HIV Surveillance Report, 2015. 2016. 27.
23. Guest, G., A. Bunce, and L. Johnson, How Many Interviews Are Enough?:An Experiment with Data Saturation and Variability. Field Methods, 2006. 18(1): p. 59-82.

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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

Heather M.
Bradley -S

Digitally signed by Heather
M. Bradley -S
Date: 2018.02.12 16:38:00
-05'00'

Branch Chief or Branch Science Officer

X

signed by Laura J.
Laura J. Fehrs Digitally
Fehrs -S
Date: 2018.02.15 15:02:20
-S
-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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Project Title: Improving Surveillance Data Collection among Persons Not Receiving HIV Care: A Qualitative Project to Enhance the
12/18/2015

NCHHSTP ADS/DEPUTY ADS OR ADLS REVIEW AND APPROVAL

Project Title: Improving Surveillance Data Collection among Persons Not Receiving HIV Care: A Qualitative Project to Enhance the

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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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: Improving Surveillance Data Collection among Persons Not Receiving HIV Care: A Qualitative Project to Enhance the

X

Alcia A.
Williams -S6

Digitally signed by Alcia A.
Williams -S6
Date: 2018.02.28 13:54:02
-05'00'

X

NCHHSTP ADS, Acting ADS, or Deputy ADS

NCHHSTP ADLS or Designee

Or

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