Research determination

12/18/2015

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

This form should be used to request NCHHSTP/OD/ADS or ADLS office review and approval on behalf of
CDC of a new, continued, or amended project for those projects for which NCHHSTP staff/employees,
branches, divisions, and center/OD/ADS or ADLS office are responsible.
Any NCHHSTP activity that meets the definition of a project (see the following section) and represents
one of the four project categories must be approved by the respective NCHHSTP branch and division and
by the NCHHSTP/OD/ADS or ADLS office. Approval by the NCHHSTP ADS or ADLS office
([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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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

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Project Title: Medical Monitoring Project (MMP)
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: Medical Monitoring Project (MMP)
NCHHSTP Project Number:

Division: Division of HIV/AIDS Prevention

Project Location/Country(ies):
23 state and local health departments (see #3)

Telephone: (404) 639-4678

CDC Project Officer or CDC Co-Leads:

R. Luke Shouse, MD

Project Dates:
Start 06/01/2018
End 05/31/2021
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: Medical Monitoring Project (MMP)
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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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Project Title: Medical Monitoring Project (MMP)
12/18/2015

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: Medical Monitoring Project (MMP)
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: Medical Monitoring Project (MMP)

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:
R. Luke Shouse

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

Jason Craw, Margaret Nyaku, and Sandra Stockwell. All project officers provide support to the
individual project areas, develop and revise data collection instruments and project protocols,
and provide input on project methods and operations.

3. Other CDC project members, branches, divisions, and other participating institutions, partners, and
staff:
State and local health departments are funded to conduct MMP in their local health jurisdictions:
• 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.
Data Coordinating Center
• CDC awarded a contract in 2008 to maintain a Data Coordinating Center, which was operational as of January 2009. The Data Coordinating Center (DCC) is a system with
a secure file data server where MMP data are transmitted and stored confidentially. The DCC also processes data for quality assurance, creates and transfers cumulative and
final datasets to CDC and to MMP sites, provides technical assistance to sites, provides formal training sessions for sites and communicates and reports to CDC.

4. Institution(s) or other entity(ies) funding the project:
Centers for Disease Control and Prevention, National Institutes of Health, Health Resources and
Services Administration

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Project Title: Medical Monitoring Project (MMP)
12/18/2015

5. Project goals:

The Medical Monitoring Project (MMP) is a supplemental surveillance project conducted by local
and state health departments. MMP’s goal is to facilitate understanding of health-related
behaviors, experiences, and needs of people diagnosed with HIV infection across the U.S. and
in specific jurisdictions. The project goals have not changed since 2015 PD approval.

6. Project objectives:
The objectives of the project are, among persons diagnosed with HIV, to: 1) provide locally and
nationally representative estimates of risk behaviors and clinical outcomes; 2) describe
health-related behaviors; 3) determine accessibility and use of prevention, care, and support
services; 4) increase knowledge of the care and treatment provided; and 5) examine variations
of factors by respondent characteristics. The objectives of the project have not changed since
2015 PD approval.

7. Public health (program or research) needs to be addressed:
The National HIV Surveillance System (NHSS) collects a core set of information in all U.S. states on persons with a diagnosis of HIV infection or AIDS, persons who are living with HIV infection or AIDS, and persons who have died from HIV infection or AIDS. Historically,
supplemental surveillance projects have provided complementary information about the clinical outcomes of HIV infection and the behaviors of HIV-infected persons with respect to seeking medical care, access to and utilization of health care services, and ongoing risk
behaviors. For example, the Adult/Adolescent Spectrum of Disease (ASD) and the Supplement to HIV/AIDS Surveillance (SHAS) projects provided these kinds of data. However, data are needed on a national basis to understand the provision and impact of treatments
for HIV, health care utilization, ongoing HIV risk behaviors, care seeking behaviors, quality of life for persons with HIV infection, and acceptance of and adherence to prescribed antiretroviral therapy (ART). In recent years a growing body of scientific evidence has
demonstrated that early initiation of HIV treatment and long-term adherence leads to better health outcomes and that ART therapy dramatically reduces the probability of HIV transmission. Together, this evidence has prompted increasing public health emphasis on
treatment as prevention via early linkage to and retention in HIV care (1-4). By collecting data from a probability sample of all HIV diagnosed persons drawn from NHSS, MMP provides data that identifies barriers to and monitors progress towards one of the National
HIV/AIDS Strategy’s strategic areas of national focus: increasing access to care. These data are especially important as a means of evaluation for new prevention initiatives (e.g., High-Impact HIV Prevention), which call for a focus on provision of prevention services to
persons living with HIV infection.
This project links NHSS and MMP, thereby improving the quality and usefulness of both systems. For example, NHSS case surveillance data may be used to supplement incomplete MMP data. Analyses may be performed to assess the quality of MMP and NHSS data by
comparison of related variables. Additionally, creation of a permanent linkage between NHSS and MMP increases the usefulness of MMP data by allowing prospective monitoring of the HIV care utilization, treatment, and mortality of MMP participants.
As a supplemental surveillance system designed to generate nationally representative estimates of clinical outcomes and HIV-related behaviors among persons living with HIV, MMP has enabled health departments to estimate resource needs for treatment and services
for HIV-infected persons in their jurisdictions and guide local prevention planning, (i.e., Community Planning Groups and local planning councils) in determining local allocation of CDC and Ryan White CARE Act funds). Aggregate data from the project has demonstrated
how access to care is affecting the health of HIV-infected persons. Additionally, because MMP estimates reflect the characteristics of all HIV-diagnosed persons, they provide important information for resource allocation and/or programmatic decision-making.

8. Population(s) or groups to be included:
The population to be studied for MMP is HIV-infected adults (18 years of age or older) whose
HIV diagnosis was reported to NHSS from any MMP project area, who were alive on the date of
sampling, and whose last reported address in NHSS was within the project area of sampling.
For each project area, the population to be studied is HIV-infected adults whose HIV diagnosis
was reported to eHARS in the project area, who were alive on the date of sampling, and whose
last reported address in NHSS was within the project area of sampling.
9. Project methods:
The annual MMP sample is drawn from all HIV-diagnosed adults reported to NHSS. Sampled patients will continue to be recruited to participate in either in-person or
telephone interviews, and persons who have received medical care for HIV will have their medical records abstracted. The mode of interview administration will be
chosen according to participant preference and/or to optimize the efficiency of project area operations. Data from interviews provide information on the current
behaviors that may facilitate HIV transmission and conditions or circumstances that facilitate or impede receipt of HIV medical care and adherence to antiretroviral
therapy; patients’ seeking of, access to, and use of HIV-related prevention services; utilization of HIV-related medical services; and adherence to antiretroviral
medication regimens. The questionnaire has not changed since 2015 PD approval (Appendix A). Data from medical record abstraction provide information on
insurance status, clinical conditions that result from HIV-infected persons’ disease or the medications they take, as well as the HIV care and support services they
receive and the quality of these services. Medical record abstraction data elements have not changed since 2015 PD approval (Appendix B). The design allows for
national and state or local estimates of certain characteristics and behaviors that will be generalizable to HIV-diagnosed adults in the U.S.

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Project Title: Medical Monitoring Project (MMP)
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10. Selection, inclusion, or sampling of participants (persons or entities):
Since 2015, MMP's population of inference has been all HIV-diagnosed adults reported to NHSS. MMP employs a 2-stage sample design that
results in annual cross-sectional probability samples of HIV-diagnosed adults in the United States. During the first stage of sampling, geographic
primary sampling units (PSUs) were selected using probability proportional to size (PPS) sampling based on AIDS prevalence at the end of
2002. Twenty PSUs were sampled originally but, due to lack of funding, 3 PSUs were randomly dropped and 17 PSUs have comprised the first
stage sample since 2009. During the second stage of sampling, participants are randomly sampled directly from NHSS. Persons eligible for
sampling are: adults (>18 years old) who meet the HIV case definition (5), have been reported to the NHSS and reside in one of the PSUs (which
include 23 participating project areas: Puerto Rico, 16 sampled states, and 6 separately funded cities within the sampled states).

11. Incentives to be provided to participants:

Participants will be reimbursed approximately $50-75 (this amount may differ by project area) in
cash for participation in the interview. If local regulations prohibit cash reimbursement,
equivalent reimbursement may be offered in the form of personal gifts, gift certificates, or bus or
subway tokens.

12. Plans for data collection and analysis:
MMP’s data collection continues to have two primary components: an interview and medical record abstraction (Appendices A and B). The interview and abstraction data consist of the information collected from selected patients, obtained through conducting interviews and abstracting
medical records. Demographic and HIV-related laboratory information associated with sampled participants will continue to be extracted from CDC's existing HIV case surveillance database, NHSS. Data extracted from NHSS (previously called the minimum dataset or MDS) consist of very
basic demographic and clinical data, and are used to assess non-response bias (Appendix C) . These datasets also contain the NHSS coded identifier. This link to NHSS data allows MMP and NHSS data to be combined at CDC for proper weighting of MMP data and other analytic
purposes such as monitoring of ongoing care and treatment of MMP respondents through CD4+ T-lymphocyte counts and viral load test results reported prospectively to NHSS. The interview, abstraction, and NHSS data will be used to create analytic data files, which will be analyzed at the
project area and national levels to describe the populations of HIV-diagnosed persons and to address project-related questions.
Recruitment
MMP will continue to use direct recruitment of sampled persons by MMP project area staff as well as recruitment through medical care providers. Most often, MMP project area staff contact and recruit sampled persons, including all who are not receiving HIV medical care and those who
cannot be reached through a health care provider. Making contact with individuals based on information reported to HIV case surveillance at their diagnosis can be problematic, as the contact information in NHSS may be out-of-date, especially for those who have had no medical care after
diagnosis or who have discontinued care. Therefore, MMP project area staff will continue to search for contact information for persons sampled in other databases used routinely for public health work. Such databases include health department surveillance and intervention databases for
other diseases such as tuberculosis or sexually transmitted diseases, electronic medical record systems to which health departments have access, as well as the Social Security Death Index.
Project area staff will log the time, date, method, and outcome of recruitment attempts locally, but this informatioin is not transmitted to CDC. Project area and facility staff will continue to use the same model recruitment letters and telephone, text, and email scripts as in previous cycles (see
Appendices D1, D2, D3, and D4).
Sampled persons may be interviewed wherever they currently reside, as long as they are confirmed to have been living in an MMP project area on the date of sampling. Interviewing residents of other jurisdictions is conditional on local law and policy, and will take place in a manner
specified by a written, project-specific agreement with the HIV surveillance unit at the health department in the jurisdiction of current residence. Allowing MMP project area staff to recruit sampled persons from other MMP project areas or non-participating areas to which the sampled
persons have moved is expected to increase response rates if there are no local legal or policy barriers that prevent this activity. The Council of State and Territorial Epidemiologists (CSTE), working with its constituency and CDC staff, has coordinated the development of a template for
inter-agency agreements regarding cross-jurisdictional recruitment for MMP (see Appendix E). The agreements specify whether and how cross-jurisdictional recruitment of MMP participants will be done. CDC Project Officers maintain copies of these agreements.

13. Confidentiality protections:

Interview
Since 2013, persons who are ill or who cannot complete the interview in English or in Spanish are offered the choice to complete as much of the standard interview as they are able. Persons who cannot complete the interview in English or Spanish are administered the standard
questionnaire by a certified and trained interpreter when interpretation resources are available. Interviews will continue to be conducted in person and over the telephone.

MMP data are subject to the same security and confidentiality requirements as those implemented for HIV/AIDS surveillance data at state and local project areas, as well as at CDC. These requirements include adherence to CDC guidelines for the security and confidentiality of project area
Through English and Spanish interviews with sampled, consenting HIV-diagnosed adults, MMP interviewers will continue to collect: information to confirm eligibility to participate, and to characterize demographics, HIV testing, linkage to care, and facilitators of engagement in care,
eHARS data as well as security protection standards for contacting participants and conducting interviews. Specifically, MMP interviewers, abstractors, and data managers will undergo the same security and confidentiality training as that required for health department staff who conduct
experiences of and perceptions about stigma and discrimination, adherence to antiretroviral therapy, sexual behavior, drug and alcohol use, unmet needs for services, experiences with depression and anxiety, access to HIV prevention services, gynecological and reproductive history,
HIV/AIDS surveillance. While conducting MMP activities, protocols are strictly followed at the project area and national level to ensure the integrity, confidentiality, and security of all MMP data.
health conditions, and receipt of preventive therapy (Appendix A). The interview continues to be an average 45-minutes in length.
The contractor that will manage data for the proposed project through the Data Coordinating Center, ICF International, is required by the terms of the contract to adhere to the Guidelines for HIV/AIDS Surveillance – Security and Confidentiality. In addition, all software developed by ICF
Medical Record Abstraction (MRA)
International adheres to CDC Confidentiality and Security Guidelines.
Since 2013, a web-based application developed by Cerner Corporation and called Discovere™ is used to collect MRA data in order to maximize efficiency. The observation period for MRA is the 24 months prior to patient interview if the sampled patient was interviewed. Medical records
are abstracted for persons who are interviewed.
HIV and AIDS case surveillance data are collected according to the Assurance of Confidentiality under Sections 306 and 308(d) of the Public Health Service Act (42 U.S.C. Sections 242k and 242m(d), see Appendix F). Information collected in the surveillance system that would permit
identification of any individual or establishment is collected with a guarantee that it will be held in strict confidence, will be used only for purposes stated in the assurance, and will not otherwise be disclosed or released without the consent of the individual or the establishment in accordance
Information to be collected through abstraction of sampled individuals’ medical records continues to include: demographics and insurance status; the prevalence and incidence of AIDS-defining opportunistic illnesses and co-morbidities related to HIV disease; the receipt of prophylactic and
with Section 306 and 308(d) of the Public Health Service Act. Because data collected for the MMP constitutes enhanced surveillance activity, these data are reported to and maintained by CDC in the same manner as are current HIV and AIDS surveillance data and accordingly are covered
antiretroviral medications; and whether patients are receiving screening and treatment according to U.S. Public Health Service guidelines (Appendix B).
by the existing Assurance of Confidentiality.
Procedures for approaching facilities to obtain medical records for abstraction will remain the same as in prior MMP data collection cycles. Most MMP jurisdictions have authority to access medical records for HIV surveillance purposes. All persons for whom project areas request medical
MMP data collection is anonymous (neither names nor social security numbers are collected). Previously collected date of birth will continue to be extracted from NHSS for the proposed project. Date of birth has been shown to be a predictor of non-response for MMP, and is used to adjust
records will have given informed consent that their medical records would be abstracted by MMP staff (see Appendix H1), and this can be provided to the facility if the project area does not have surveillance authority or if the HIV facility does not recognize the project area’s surveillance
for non-response bias. Although MMP interview and abstraction data records do not contain specific participant identifiers (e.g., name, address, social security number), they are linkable to local eHARS data, which do contain participant identifiers, only through the eHARS STATENO
authority. In some cases, project areas may ask participants to sign a medical record release so they can access the medical records under the patient’s legal right to release his/her medical records to whomever he/she chooses.
variable, which cannot be combined with any data elements to produce information that would be considered to be potentially identifying or sensitive. Lists of eHARS numbers linking MMP data to specific identifiers (e.g., patient name) at the project area are kept under lock and key, and
destroyed when they are no longer needed or no later than 24 months after the end of each data collection cycle; access to them is strictly limited. To facilitate ongoing data analysis, a link between eHARS numbers and MMP IDs is maintained by CDC and the local jurisdiction according to
Data extracted from NHSS
the security standards for HIV/AIDS surveillance data.
Data extracted from the National HIV Surveillance System (NHSS) is used to adjust for bias resulting from non-participation. The 2015 datasets contained 82 data elements. The proposed 2018 datasets contains 81 data elements. The net change is a 1-element reduction. Forty-three
data elements that were not found to be useful for making adjustments to account for non-participation bias, or are no longer collected by NHSS, were dropped from the 2018 dataset. Forty-two data elements were added to the 2018 dataset. These additions were necessary due to
Paper forms, only used in cases of electronic data collection equipment failure, are filed by the unique ID and date of interview and stored under lock and key; information collected on paper is entered into the appropriate data system at the project area and the paper forms will be destroyed
changes in the data structure of NHSS and the availability of more detailed information for non-response analysis. The variables retained in, deleted from, and added to the 2018 datasets are listed in Appendix C.
6-12 months after the data collection cycle has ended. If signed informed consent forms for MMP are required, these are securely stored separately from the participant responses, preferably at the central eHARS office of the project area, under the same security procedures as those for
eHARS surveillance forms. Contact attempt data collected locally by the project areas but not sent to CDC will be destroyed no later than 24 months after the end of each data collection cycle.

14. Other ethics concerns (e.g., incentives, risks, privacy, or security):

The QDS™ software used to collect the interview data and Discovere™, the web-based electronic medical record abstraction application, support encryption of response data and password-protection of interviews and abstractions so that unauthorized users are unable to view, export, or
modify collected data. Discovere™ has undergone certification and accreditation by CDC. The security of the system meets all Federal Information Systems Management Act (FISMA), OMB, HHS, and CDC IT Security requirements which ensure the confidentiality, integrity, and availability
of data on federal information systems.

Project area staff may inadvertently contact a person who was previously unaware of his/her HIV status (not a common occurance among persons whose diagnoses have been reported to surveillance). If this occurs, staff are prepared to immediately perform the following:
The interview data warehouse and abstraction database for each project area, as well as lists linking STATENO with the MMP participant ID, are stored on the area’s HIV/AIDS surveillance data drive, which is located on a secure server with limited access. Frequent backup of the interview
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services.
MMP
will benefit
communities
by project
helpingarea.
HIV prevention and care planners more appropriately allocate state and local HIV prevention resources and federal, state, and local HIV care services.
The DCCunder
contractor
staff
and
final datasets
from
thepregnant
interviewwomen
data received
project
areasifand
record
data received
fromdisabilities
Cerner, and
theseindatasets
to CDC
and toany
MMP
sites.alive
TheatDCC
usesofthe
secure data
transferprovide
algorithm,
FIPS
Persons
the age
of create
18 are cumulative
not included
in MMP.
Prisoners
and
may be from
included
in MMP
theythe
aremedical
sampled
from abstraction
NHSS. Persons
with mental
maytransfers
be included
the sample;
however,
person
the time
interview
who cannot
informed
140-2 (Federal
Information
Processing
Standards
Publication).
The data transfer
methodology
is compliant
with the
guidelines set forth in OMB memorandum M-0404 (E-Authentication Guidance for Federal Agencies) as well as with OMB, HHS, and CDC Certification and Accreditation
consent
will be excluded
from
participation
in the project.
All participants
will be afforded
the same
human rights
protections.
Guidelines outlined in NIST SP 800-37 (Guide for the Security Certification and Accreditation of Federal Information Systems). In addition to the technical requirements listed above, data management processes are in compliance with Data Security and Confidentiality Guidelines for HIV,
Viral
Hepatitis,
Sexually
Transmitted
Disease,
and
Tuberculosis
Programs.
All project areas have procedures for dealing with adverse events and protocol breaches that meet the requirements of their governing institutions and/or IRBs, which include procedures for reporting. Project areas will report all serious adverse events to CDC within 24 hours of occurrence.
All adverse events and protocol breaches, regardless of severity, will be reported to CDC within two weeks. Detailed guidance on reporting of and development of procedures to address adverse events is given in Appendices G1 and G2.
Lists linking STATENO with the MMP participants’ IDs are sent directly to the project areas by CDC via the Secure Access Management System (SAMS), which is the standard protocol for transmission of NHSS data, and will be securely stored with limited access.

15. Projected time frame for the project:
June 1, 2018 – May 31, 2021

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Project Title: Medical Monitoring Project (MMP)
12/18/2015

16. Plans for publication and dissemination of the project findings:
Data from MMP improve surveillance activities, contribute to prevention programs and treatment services, provide information about unmet needs for HIV prevention and care services, and increase
knowledge about medical care for persons with HIV. Results also guide national surveillance efforts, particularly through the use of both self-reported and medical record information, by increasing our
understanding of conditions and relationships that are difficult to assess using only interview data or only medical record abstraction.
Most of the results are are useful at the local level; other results are more meaningful after the data from all project areas have been aggregated. Each project area has responsibility for the release of local
estimates. CDC has primary responsibility for aggregated estimates from the project areas and disseminates this information. These data are distributed to the providers, researchers, policymakers, and
other interested persons through presentations at local, national, and international conferences, publications in peer-reviewed journals, and presentations at forums such as continuing medical education
courses and seminars. Furthermore, CDC regularly publishes surveillance reports based on the data collected annually.
Patients and community members are informed of MMP findings through multiple conduits. National data estimates are released on the CDC’s MMP Web site and through national publications and
presentations at conferences. Similarly, local data results are reported to the community through multiple conduits, such as local publications, epidemiologic profiles, and presentations to local AIDS service
organizations and community planning groups and at conferences and workshops.

17. Appendices — including informed consent documents, scripts, data collection instruments, focus
group guides, fact sheets, or brochures:
Appendix
Document
A Att A_MMP 2018 Questionnaire
B Att_B_MMP MRA Data Structure 2018
C Att_C_MMP NHSS Dataset Elements
D1 Att_D1_MMP Model Recruitment Letter
D2 Att_D2_MMP Recruitment Script Project Staff
D3 Att_D3_MMP Recruitment Script Facility
D4 Att_D4_MMP Recruitment Script Text E-mail
E Att_E_MMP Cross-Jurisdictional Agreement
F Att_F_Assurance of Confidentiality
G1 Att_G1_Adverse Events and Protocol Breach Guidance
G2 Att_G2_Model Adverse Events and Protocol Breach Report Form
H1 Att_H1_MMP Model Consent Form 2018
H2 Att_H2_MMP Model Consent Form 2015 2018 Comparison
I Att_I_MMP list of changes
Informed consent for the interview must be obtained according to the MMP Protocol and as required by state and local IRBs for participating project areas. A model consent form that can be modified for local area use is included in Appendix H1. Modifications from the previously approved
consent have been made to decrease the reading comprehension level, ensure incarcerated persons understand that participation will not affect their parole and clarify whom participants should contact for different concerns. A comparison of the 2018 consent form with the previously
approved consent form is provided in Attachment H2. Non-substantive changes were made to the protocol to to decrease the reading comprehension level and clarify whom participants should contact for different concerns.
Informed consent may be obtained by any of the following methods:
• The participant reads and signs the informed consent form.
• The interviewer reads the form to the participant and asks the participant to sign the form.
• The interviewer reads the form to the participant or the participant reads the form and the interviewer indicates on the form that the participant provided oral consent.
For interviews conducted over the telephone, project areas will read the consent form to the participant and obtain oral consent. Where oral consent is not allowed, project areas will obtain signed consent from the participant via mail prior to the interview.
Participants will be advised, when consent is obtained for the interview, that information from their medical records also will be collected and analyzed along with their answers to the interview questions. Participants will also be advised that a small number of interviews and medical record
reviews will be observed by supervisors to provide feedback to MMP staff on their work.

18. References (to indicate need and rationale for project):

Project areas should follow their own regulations regarding any consent forms or confidentiality agreements, including those necessary for a translator. Project areas will modify the templates of the consent forms to fulfill the requirements of their IRB, if applicable. These consent forms will
also be modified to be used by hearing and visually impaired participants. All project areas must maintain a secure file of informed consent forms to document that informed consent was obtained for each participant. These secure files will be available upon request.

1 Bertolli, J., et al. (2013). "Missed Connections: HIV-Infected People Never in Care." Public Health Rep. 128: 117-128.
2 Buskin, S. E., et al. (2011). "HIV infected individuals presumed to not be receiving HIV medical care: a surveillance program evaluation for investigations and
referrals in Seattle, Washington State, USA." jHASE-Journal of HIV/AIDS Surveillance & Epidemiology 3(1): 3.
3 Dombrowski JC, Fleming M, Simoni J, Hughes JP, Golden MR. (2013). Surveillance-based outreach to promote HIV care engagement and antiretroviral use:
results from the pilot phase of a health department intervention [X-244]. 2013 Conference on Retroviruses and Opportunistic Infections, Atlanta.
4 Sweeney P, Gardner L, Buchacz K, Garland PM, Mugavero MJ, Bosshart JT, Shouse RL, Bertolli J (2013). Shifting the paradigm: Using HIV surveillance data
as a foundation for improving HIV care and preventing HIV infection. Milbank Q 91(3):558-603.
5 Centers for Disease Control and Prevention. Revised surveillance case definition for HIV infection--United States, 2014. MMWR Recomm Rep. Apr 11 2014;63
(RR-03):1-10.

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Project Title: Medical Monitoring Project (MMP)
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

Heather M.
Bradley -S

Digitally signed by Heather
M. Bradley -S
Date: 2017.06.08 09:42:43
-04'00'

Branch Chief or Branch Science Officer

X

signed by Laura J.
Laura J. Fehrs Digitally
Fehrs -S
Date: 2017.06.12 16:00:29
-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: Medical Monitoring Project (MMP)
12/18/2015

NCHHSTP ADS/DEPUTY ADS OR ADLS REVIEW AND APPROVAL
Project Title: Medical Monitoring Project (MMP)

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: Medical Monitoring Project (MMP)

X

Alcia A.
Williams -S6

Digitally signed by Alcia A.
Williams -S6
Date: 2017.06.15 11:21:35
-04'00'

X

NCHHSTP ADS, Acting ADS, or Deputy ADS

NCHHSTP ADLS or Designee

Or

Page 12 of 12