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pdfPrint Date: 8/17/23
Title:
Medical Monitoring Project
Project Id:
0900f3eb821eb56a
Accession #:
NCHHSTP-COT-8/4/23-d7f20
Project Contact:
Linda Beer
Organization:
NCHHSTP/DHP/BCSB/COT
Status:
Pending Regulatory Clearance
Intended Use:
Project Determination
Estimated Start Date:
06/01/2024
Estimated Completion Date:
05/31/2027
CDC/ATSDR HRPO/IRB Protocol #:
OMB #0920-0740
OMB Control #:
Determinations
Determination
Justification
HSC:
Does NOT Require HRPO
Review
Not Research - Public Health Surveillance
PRA:
PRA Applies
Completed
Entered By & Role
8/17/23
Dodson_Janella R. (jhd7) CIO HSC
8/17/23
Bonds_Constance (akj8) CTR OMB/PRA Coordinator
45 CFR 46.102(l)(2)
Description & Funding
Description
Priority:
Standard
Date Needed:
08/29/2023
Determination Start Date:
08/17/23
Description:
This request is to add an active, ongoing non-research, surveillance system with a current Project Determination into STARS for the
first time. The Medical Monitoring Project (MMP) is an annual surveillance system that conducts behavioral interviews and medical
record abstraction with a representative sample of persons with diagnosed HIV (MMP; OMB # 0920-0740, exp. 5/31/2024). MMP
has a two-stage sampling design in which, during the first stage, 16 states#including 6 separately funded jurisdictions within those
states#and Puerto Rico were sampled from all U.S. states, the District of Columbia, and Puerto Rico. During the second stage,
annual simple random samples of persons with diagnosed HIV aged 18 years and older are drawn for each participating state
/territory from the National HIV Surveillance System. Data collection instruments are developed by CDC staff and data are collected
by state and local health departments. Participants may complete the 40-minute interview by telephone or in person. MMP has
previously received a Project Determination, but it has not been entered into STARS. This survey does not involve human subjects
research because it is a surveillance activity. It will require OMB approval; an OMB PRA ICR has been submitted to the DHP PRA
Coordinator for review.
IMS/CIO/Epi-Aid/Lab-Aid/Chemical Exposure
Submission:
No
IMS Activation Name:
Not selected
Primary Priority of the Project:
Not selected
Secondary Priority(s) of the Project:
Not selected
Task Force Associated with the Response:
Not selected
CIO Emergency Response Name:
Not selected
Epi-Aid Name:
Not selected
Lab-Aid Name:
Not selected
Assessment of Chemical Exposure Name:
Not selected
Goals/Purpose
MMP#s goals are to facilitate understanding of health-related behaviors, experiences, and needs of people with diagnosed HIV
across the U.S. and in specific jurisdictions.
Objective:
The objectives of the project are, among persons with diagnosed 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.
Does your project measure health disparities among Yes
populations/groups experiencing social, economic,
geographic, and/or environmental disadvantages?:
Does your project investigate underlying
contributors to health inequities among populations
/groups experiencing social, economic, geographic,
and/or environmental disadvantages?:
Yes
Does your project propose, implement, or evaluate
an action to move towards eliminating health
inequities?:
No
Activities or Tasks:
New Collection of Information, Data, or Biospecimens
Target Populations to be Included/Represented:
Other - Adults with diagnosed HIV
Tags/Keywords:
HIV ; Antiretroviral Therapy, Highly Active ; Healthcare Disparities ; Social Determinants of Health ; Men who have sex with men
(MSM)
CDC's Role:
Activity originated and designed by CDC staff, or conducted at the specific request of CDC, or CDC staff will approve study design
and data collection as a condition of any funding provided
Method Categories:
Individual Interview (Quantitative); Record Review; Survey
Methods:
Detailed information on MMP#s methods can be found in the attached Project Description. Since 2015, MMP's population of
inference has been all adults with diagnosed HIV reported to the National HIV Surveillance System (NHSS), a census of U.S.
persons with diagnosed HIV. MMP employs a 2-stage sample design that results in annual cross-sectional probability samples of
adults with diagnosed HIV 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. Seventeen PSUs have
comprised the first stage sample since 2009. During the second stage of sampling, participants are annually sampled directly from
NHSS. Persons eligible for sampling are: adults (>18 years old) who meet the HIV case definition, 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). MMP data are weighted based on probabilities of selection, adjusted for nonresponse
using information on all sampled persons from NHSS (Appendix C), and post-stratified to NHSS population totals by age, sex, and
race/ethnicity. The design allows for national and state or local estimates of characteristics and behaviors that will be generalizable
to adults with diagnosed HIV in the U.S. and participating jurisdictions. Sampled patients will continue to be recruited to participate
in either telephone or in-person interviews, and persons who have received medical care for HIV will have their medical records
abstracted. Most often, MMP project area staff contact and recruit sampled persons, although in some cases HIV care facilities may
assist in recruitment. 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. Sampled
persons will be offered $50 in cash or equivalent (such as a gift card) as a token of appreciation for participation. Informed consent
will be obtained from all participants; the consent form can be found in Appendix H.
MMP#s data collection continues to have two primary components: an interview and medical record abstraction. 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
(Appendix A). The interview averages 40-minutes in length and is completed over the telephone or in-person according to the
sampled person#s preference. 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
Collection of Info, Data or Biospecimen:
Expected Use of Findings/Results and their impact:
Could Individuals potentially be identified based on
Information Collected?
and the quality of these services (Appendix B). MMP interview and medical record abstraction data are collected via a web-based
data collection tool called Voxco, which has undergone Security Assessment and Authorization (SA&A) by CDC and 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. 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 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. MMP and interview and
medical record data do not contain any personally identifiable information. Previously collected date of birth will continue to be
extracted from NHSS. Date of birth has been found in certain cycles to be a predictor of non-response for MMP and is sometimes
used to adjust for non-response bias.
With its national scope and unique design, MMP allows CDC to monitor national progress toward ensuring high quality care for all
people with diagnosed HIV. Specifically, at the national level, MMP data are used for tracking national trends in HIV-related
morbidity and service access and utilization, for focusing and prioritizing national initiatives to improve the provision of treatment and
prevention resources, and for benchmarking and evaluating progress toward national prevention and treatment initiatives. CDC is
responsible for issuing policies and recommendations for HIV-related medical and prevention services, and MMP provides an
evidence base for these activities, as well as a means to monitor the uptake and impact of the guidelines. At the local health
jurisdiction level, MMP data are used for HIV prevention program planning purposes, including the development of local
epidemiologic profiles and responding to data requests from the Health Resources and Services Administration (HRSA) and other
agencies that manage resources for HIV prevention, care, and treatment. MMP provides information to evaluate local care and
prevention services for persons receiving HIV medical care. This information is used to improve local care and prevention services
for people with diagnosed HIV in these jurisdictions. Many of the results from MMP 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.
No
Funding
Funding Type
Funding Title
Funding #
Original Budget Yr
# Years Award
Budget Amount
CDC Cooperative Agreement
Medical Monitoring Project (MMP)
CDC-RFA-PS20-2005
2020
5
705000.00
HSC Review
HSC Review
Regulation and Policy
Do you anticipate this project will need IRB review
by the CDC IRB, NIOSH IRB, or through reliance on
an external IRB?
No
Estimated number of study participants
Population - Children
Protocol Page #:
Population - Minors
Protocol Page #:
Population - Prisoners
Protocol Page #:
Population - Pregnant Women
Protocol Page #:
Population - Emancipated Minors
Protocol Page #:
Suggested level of risk to subjects
Do you anticipate this project will be exempt
research or non-exempt research
Requested consent process waviers
Informed consent for adults
No Selection
Children capable of providing assent
No Selection
Parental permission
No Selection
Alteration of authorization under HIPPA Privacy
Rule
No Selection
Requested Waivers of Documentation of Informed Consent
Informed consent for adults
No Selection
Children capable of providing assent
No Selection
Parental permission
No Selection
Consent process shown in an understandable language
Reading level has been estimated
No Selection
Comprehension tool is provided
No Selection
Short form is provided
No Selection
Translation planned or performed
No Selection
Certified translation / translator
No Selection
Translation and back-translation to/from target
language(s)
No Selection
Other method
No Selection
Clinical Trial
Involves human participants
No Selection
Assigned to an intervention
No Selection
Evaluate the effect of the intervention
No Selection
Evaluation of a health related biomedical or
behavioral outcome
No Selection
Registerable clinical trial
No Selection
Other Considerations
Exception is requested to PHS informing those
bested about HIV serostatus
No Selection
Human genetic testing is planned now or in the
future
No Selection
Involves long-term storage of identfiable biological
specimens
No Selection
Involves a drug, biologic, or device
No Selection
Conducted under an Investigational New Drug
exemption or Investigational Device Exemption
No Selection
Institutions & Staff
Institutions
Institutions yet to be added .....
Staff
Staff Member
SIQT
Exp. Date
Angela
Blackwell
11/30
/2025
Catherine
Espinosa
07/10
/2026
Jason Craw
Staff Role
Email
Phone
Organization
Project
Officer
ifa1@cdc.
gov
4044984354
CLINICAL OUTCOMES TEAM
Project
Officer
xwn7@cdc.
gov
5738643223
CLINICAL OUTCOMES TEAM
07/25
/2026
Project
Officer
emf4@cdc.
gov
4046396395
CLINICAL OUTCOMES TEAM
JEN FENG LU
07/27
/2026
Statistician
ogj7@cdc.
gov
4102598474
BEHAVIORAL AND CLINICAL
SURVEILLANCE BRANCH
Jennifer Fagan
07/07
/2026
Project
Officer
chx5@cdc.
gov
4046398396
CLINICAL OUTCOMES TEAM
Jennifer
Taussig
07/14
/2026
Project
Officer
jft0@cdc.
gov
4047183323
CLINICAL OUTCOMES TEAM
John Weiser
08/08
/2026
Project
Officer
eqn9@cdc.
gov
4046398405
CLINICAL OUTCOMES TEAM
Linda Beer
07/28
/2026
Project
Officer
gur0@cdc.
gov
4046395268
CLINICAL OUTCOMES TEAM
Mabel Padilla
03/28
/2026
Project
Officer
ymj0@cdc.
gov
4046398013
CLINICAL OUTCOMES TEAM
Project
rax6@cdc.
404718-
Mohua Basu
06/04
CITI Biomedical
Exp. Date
08/14/2023
CITI Social &
Behavioral Exp. Date
08/16/2026
11/09/2025
05/17/2025
06/08/2025
CITI Good Clinical
Practice Exp. Date
CLINICAL OUTCOMES TEAM
/2024
Officer
gov
8365
Priya Nair
07/25
/2026
Statistician
qro2@cdc.
gov
4046176533
INACTIVE
Rodel
Desamu
Thorpe
07/10
/2026
09/28/2021
Project
Officer
ksz2@cdc.
gov
4047181397
CLINICAL OUTCOMES TEAM
Ruth Gierke
08/09
/2026
09/08/2023
Project
Officer
ihg3@cdc.
gov
4047186580
CLINICAL OUTCOMES TEAM
Sahithi Kalari
07/26
/2026
Statistician
qvh3@cdc.
gov
4044984841
BEHAVIORAL AND CLINICAL
SURVEILLANCE BRANCH
Sandra
Stockwell
12/10
/2024
11/27/2021
11/26/2021
Project
Officer
ihg7@cdc.
gov
4047188521
CLINICAL OUTCOMES TEAM
Sharoda
Dasgupta
07/24
/2026
09/06/2021
09/06/2021
Project
Officer
ibz8@cdc.
gov
4046395191
CLINICAL OUTCOMES TEAM
Stacy Crim
07/12
/2026
01/08/2022
Project
Officer
dex2@cdc.
gov
4046392257
CLINICAL OUTCOMES TEAM
Taylor Robbins
08/04
/2026
Project
Officer
kyx4@cdc.
gov
4046390016
CLINICAL OUTCOMES TEAM
Timothy
Mcmanus
07/19
/2026
Project
Officer
tsm9@cdc.
gov
4047188146
CLINICAL OUTCOMES TEAM
Xin Yuan
07/25
/2026
Statistician
lqk7@cdc.
gov
--
BEHAVIORAL AND CLINICAL
SURVEILLANCE BRANCH
Yi Jian
07/30
/2026
Statistician
szt4@cdc.
gov
2055162518
BEHAVIORAL AND CLINICAL
SURVEILLANCE BRANCH
Yishiow Kuo
07/28
/2026
Statistician
utm5@cdc.
gov
4177710924
BEHAVIORAL AND CLINICAL
SURVEILLANCE BRANCH
12/09/2021
Yunfeng
(Tracy) Tie
06/27
/2026
Project
Officer
hzu3@cdc.
gov
4047185781
CLINICAL OUTCOMES TEAM
Data
DMP
Proposed Data Collection Start Date:
6/1/24
Proposed Data Collection End Date:
5/31/27
Proposed Public Access Level:
Non-Public
Non-Public Details:
Reason For Not Releasing Data:
Other - Surveillance data collected under an Assurance of Confidentiality
Public Access Justification:
N/A
How Access Will Be Provided for Data:
Data will be available upon request from CDC and contingent on meeting the requirements of the Data Security and Confidentiality
Guidelines for HIV, Viral Hepatitis, Sexually Transmitted Disease, and Tuberculosis Programs.
Plans for Archival and Long Term Preservation:
All MMP data are received for processing by ICF#s Data Coordinating Center (DCC), a contractor who performs data management
activities and weighting for MMP. Interview and medical record abstraction data for MMP are collected via the Voxco platform, which
sits behind CDC#s Secure Access Management System (SAMS). CDC, DCC, and MMP health department staff are granted access
to specific MMP activities within SAMS based on their role in the project. DCC fully complies with all federal IT security standards,
and MMP and has an Authorization to Operate (ATO) which authorizes DCC operation until 7/1/2024. Physical site visits to the
contractor#s facility are conducted annually by MMP staff and the Contracting Officer#s Representative for the DCC contact. Data
transmitted to CDC are sent monthly by DCC via their secure DCC Data Portal, which sits behind CDC SAMS. All data deliverables
are double encrypted and require recipient-specific PGP keys to decrypt and download the data files. Once downloaded, all MMP
data are saved to restricted access data drives with user access managed using CDC#s Multi-User Share Tool (MUST). To access
MMP datasets, a user must complete annual data security and confidentiality training, complete and sign all required paperwork,
request access to the specific restricted data drives, and be granted access by the team#s data steward. At least twice per year, the
team#s data steward reviews the complete list of all persons with access to MMP data drives and revokes access for any persons
who have departed the team, whose time duration for access has expired, or those who have not completed annual data security
and confidentiality training. CDC MMP data management staff are the only staff with the ability to create and modify final MMP
datasets and accompanying documentation such as data dictionaries, labels, formats, and format statements. All other MMP staff
have read-only access to final MMP datasets and documentation. Files that contain data from the National HIV Surveillance System
(NHSS) are archived or destroyed within 12 months of the end of the data collection cycle. MMP staff document all NHSS data files
that are archived or destroyed and share this information with the Division of HIV Prevention#s HIV Surveillance Branch at least two
times per year. All NHSS and MMP data files at DCC are purged from the Data Portal and from SAS servers within 24 months of
the end of the data collection cycle. Data destruction documentation listing all purged data files is shared with MMP staff on an
annual basis.
Spatiality
Country
State/Province
United States
North Carolina
United States
New York
United States
New Jersey
United States
Mississippi
United States
Michigan
United States
Indiana
United States
Illinois
United States
Georgia
United States
Florida
United States
Delaware
United States
California
Puerto Rico
United States
Washington
United States
Virginia
United States
Texas
United States
Pennsylvania
United States
Oregon
Dataset
County/Region
Dataset
Title
Dataset
Description
Data Publisher
/Owner
Public Access
Level
Public Access
Justification
External
Access URL
Download
URL
Type of Data
Released
Collection
Start Date
Collection End
Date
Dataset yet to be added...
Supporting Info
Current
CDC Staff
Member and
Role
Date Added
Description
Supporting Info Type
Supporting Info
Current
Beer_Linda
(gur0)
Project Contact
08/07/2023
MMP project description
Protocol
Medical Monitoring Project Project Description .docx
Current
Beer_Linda
(gur0)
Project Contact
08/07/2023
App G.1 Adverse Events and
Protocol Breach Guidance
Other-Adverse Events and
Protocol Breach Guidance
App G.1 Adverse Events and Protocol Breach Guidance.
docx
Current
Beer_Linda
(gur0)
Project Contact
08/07/2023
App B MMP MRA Data Structure
2024
Other-MRA Data Structure
App B MMP MRA Data Structure 2024.docx
Current
Beer_Linda
(gur0)
Project Contact
08/07/2023
App H MMP Model Consent
Other-MMP Model Consent
App H MMP Model Consent.doc
Current
Beer_Linda
(gur0)
Project Contact
08/07/2023
App A MMP 2024 Questionnaire
Data Collection Form
App A MMP 2024 Questionnaire.pdf
Current
Beer_Linda
(gur0)
Project Contact
08/07/2023
App G.2 Model Adverse Events
and Protocol Breach Report Form
Other-Model Adverse Events and
Protocol Breach Report Form
App G.2 Model Adverse Events and Protocol Breach
Report Form.docx
Current
Beer_Linda
(gur0)
Project Contact
08/07/2023
App D.1 MMP Model Recruitment
Letter
Other-MMP Model Recruitment
Letter
App D.1 MMP Model Recruitment Letter.docx
App C MMP NHSS Dataset
Other-MMP NHSS Dataset
Current
Beer_Linda
(gur0)
08/07/2023
App C MMP NHSS Dataset Elements.docx
Project Contact
Elements
Elements
Current
Beer_Linda
(gur0)
Project Contact
08/07/2023
App I Agreement To Abide by
Restrictions
Other-Agreement To Abide by
Restrictions
App I Agreement To Abide by Restrictions.docx
Current
Beer_Linda
(gur0)
Project Contact
08/07/2023
App D.3 MMP Recruitment Script
Facility
Other-MMP Recruitment Script
Facility
App D.3 MMP Recruitment Script Facility.docx
Current
Beer_Linda
(gur0)
Project Contact
08/07/2023
App D.2 MMP Recruitment Script
Project Staff
Other-MMP Recruitment Script
Project Staff
App D.2 MMP Recruitment Script Project Staff.doc
Current
Beer_Linda
(gur0)
Project Contact
08/07/2023
App E MMP Cross-Jurisdictional
Agreement
Other-MMP Cross-Jurisdictional
Agreement
App E MMP Cross-Jurisdictional Agreement.docx
Current
Beer_Linda
(gur0)
Project Contact
08/07/2023
App D.4 MMP Recruitment Script
Text E-mail
Other-MMP Recruitment Script
Text E-mail
App D.4 MMP Recruitment Script Text E-mail.docx
Current
Beer_Linda
(gur0)
Project Contact
08/07/2023
App F Assurance of Confidentiality
Other-Assurance of Confidentiality
App F Assurance of Confidentiality.docx
File Type | application/pdf |
File Modified | 0000-00-00 |
File Created | 2023-08-17 |