Research Determination

Print 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