Study Protocol

Medical Monitoring Project
2011 Protocol

Clinical Outcomes Team
Behavioral and Clinical Surveillance Branch
Division of HIV/AIDS Prevention
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention
Centers for Disease Control and Prevention
September 2010

Table of Contents
List of Appendices……………………………………………………………………….
Abbreviations, Acronyms, and Definitions…………………………………………….
I. Introduction…………………………………………………………………………….
A. Background……………………………………………………………………….
B. Purpose and Scope……………………………………………………………...
C. Collaborating Agencies and Stakeholders……………………………………
D. Initiation, Duration, and Project Period………………………………………..
II. Methods……………………………………………………………………………….
A. Population of Inference………………………………………………………….
B. Population Definition Period (PDP)…………………………………………….
C. Eligibility Criteria…………………………………………………………………
1. State and Local Health Departments………………………………………..
2. Facilities…………………………………………………………………………
3. Patients………………………………………………………………………….
D. Sampling Methods……………………………………………………………….
1. First-Stage Sampling…………………………………………………………..
2. Second-Stage Sampling………………………………………………………
a. Constructing the sampling frame of facilities………………………………
b. Facility Sampling Frame Activities for the 2009-2013 Cycle……………
i. Updating the Facility Sampling Frame……………………………………
ii. Reconstructing the Facility Sampling Frame……………………………
iii. Creating a matrix of EPLs from each data source……………………..
iv. Selecting the best EPL for each facility………………………………….
c. Small facilities: adjusting EPLs to a minimum value or linking to other
facilities for sampling purposes…………………………………………….
d. Selecting the sample of facilities……………………………………………
e. Facility recruitment for participation in MMP………………………………
3. Third-Stage Sampling…………………………………………………………
I. List Based Sampling…………………………………………………………..
a. Constructing the patient sampling frame………………………………….
i. Obtaining lists of PDP patients from each participating facility………...
ii. Creating a file of PDP patient lists………………………………………..
iii. Comparing the selected best EPLs with PDP patient loads…………..
b. Selecting the patient sample………………………………………………..
c. Patient recruitment for participation in MMP………………………………
II. Real Time Sampling………………………………………………………….
a. Constructing the patient sampling frame………………………………….
b. Selecting the patient sample using RTS…………………………………..
c. Patient recruitment for participation in MMP using Real Time Sampling
III. Project area patient sample sizes……………………………………..
E. Data Collection…………………………………………………………………...
1. Personal Interview……………………………………………………………..
a. Interview instruments/applications………………………………………….
i. Local questions………………………………………………………………
b. Interviewees…………………………………………………………………..
i. Short Questionnaire……………………………………
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ii. Special populations………………………………………………………...
c. Interviews using an interpreter………………………………………………
d. Interview locations……………………………………………………………
e. Concluding the interview…………………………………………………….
f. Reimbursement………………………………………………………………..

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g. Interviewer training…………………………………………………………...
h. Interview quality control and assurance……………………………………
i. Interviews conducted in other MMP project area jurisdictions……………
2. Medical Record Abstraction…………………………………………………..
a. Medical record abstraction training…………………………………………
b. Medical record abstraction quality control and assurance……………….
3. Minimal Data……………………………………………………………………
III. Data Management and Analysis…………………………………………………..
A. Data Management……………………………………………………………….
1. Tracking data…………………………………………………………………...
2. Personal interview data……………………………………………………….
3. Medical record abstraction data……………………………………………...
4. Minimal data……………………………………………………………………
5. Analytic data……………………………………………………………………
B. Data Analysis…………………………………………………………………….
IV. Security and Confidentiality of MMP Data…………………………………….
V. Human Subjects Considerations………………………………………………….
A. Non-Research Determination…………………………………………………..
B. Anticipated Risks and Benefits…………………………………………………
C. Vulnerable Populations………………………………………………………….
D. Adverse Events…………………………………………………………………..
E. Informed Consent………………………………………………………………..
VI. Data Dissemination………………………………………………………………..
A. Notifying Providers, Patients and the Community of Findings……………...
VII. References…………………………………………………………………………

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List of Appendices
Appendix A

First Stage Project Area Sampling

Appendix B.1

Guidance for Updating the MMP Facility Sampling Frame (FSF)
2009-2013
Medical Monitoring Project Guidance for Reconstructing the Facility
Sampling Frame 2014-2018
Facility Eligibility Determination Algorithm
Response Sheet for Verification of HIV Facility Eligibility and
Estimated Patient Load (for New Facilities)
Response Sheet for Verification of HIV Facility Eligibility and
Estimated Patient Load (for Facilities in the previous Facility
Sampling Frame)

Appendix B.2
Appendix B.3
Appendix B.4
Appendix B.5

Appendix C

Project Area Identification Numbers and Abbreviations

Appendix D

Second Stage Facility Sampling

Appendix E

Third Stage Patient Sampling

Appendix F

Patient Sample Sizes by Project Area

Appendix G.1
Appendix G.2
Appendix G.3
Appendix G.4

2011 Interview Questionnaire
2011 Spanish Interview Questionnaire
2011 Short Interview Questionnaire
2011 Spanish Short Interview Questionnaire

Appendix G.5

Interviewer Material Checklist

Appendix H.1
Appendix H.2

Statement of Informed Consent (English)
Statement of Informed Consent (Spanish)

Appendix I
Appendix J

Interviewer Evaluation Form
Interjurisdiction Flow Chart

Appendix K.1
Appendix K.2

Appendix L

2011 Medical Record Abstraction Module―Medical History Form
2011 Medical Record Abstraction Module―Surveillance Period
Summary Form
2011 Medical Record Abstraction Module―Surveillance Period
Visit Form
2011 Medical Record Abstraction Module―Surveillance Period
Inpatient Form
MMP Minimum Data Set Fields

Appendix M

NCHHSTP Non-research Determination

Appendix K.3
Appendix K.4

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Abbreviations, Acronyms, and Definitions
2011 data
collection
cycle

The period of time during which MMP interview and medical record
abstraction data will be collected for the 2011 patient sample. This period
of time is from May 1, 2011 through April 30, 2012.

Abstraction Software program for collecting MMP medical record data on laptop
application computers developed by CDC utilizing Visual Basic.net and a Microsoft
database engine.
ASD

Adult/Adolescent Spectrum of HIV Disease

CAPI

Computer Assisted Personal Interview – A method of administering
interviews in person using a personal computer, typically either a laptop or
tablet personal computer.

Computed
variables

Computed variables have values that are the result of arithmetical or
logical manipulations performed using values from other, pre-existing
variables.

DCC
Portal

The Data Coordinating Center portal allows field staff to securely
exchange data with CDC that are considered sensitive or critical in nature.

Design
effect

Design effect is the increase in statistical variance that is introduced by
using a multi-stage complex sampling design to obtain patient or other
samples. Mathematically, design effect is the variance obtained using a
complex sampling design divided by the variance that would have been
obtained from a simple random sample of the same size. A design effect
of 2 means that the variance obtained using a complex sampling design
was twice as large as the variance that would have been obtained from a
simple random sample of the same size.

EPL

Estimated Patient Load - The estimated number of eligible patients in care
for HIV at a facility during the population definition period (PDP). These
estimates are obtained prior to the end of the PDP from various data
sources, including the HIV/AIDS Reporting System (HARS) or the
electronic HIV/AIDS Reporting System (eHARS), laboratory reports of
HIV-related tests, and facility contacts, and are used to select eligible
facilities for MMP participation.

Facility

For MMP, a facility is defined as any clinic, health care institution, private
or group physician practice that shares common medical records or a
medical record system. Thus, a facility is defined in terms of medical
record storage, not in terms of a physical location (address) or the names
of individual practitioners. For example, if the 5 physicians who comprise a
group practice keep their patients’ charts in a single medical record
system, that group practice would be considered a single facility for MMP.
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If, however, each of those 5 physicians stored his/her patients’ charts in a
different medical record system from those of the other 4 physicians, then
each physician would be defined as a unique MMP facility. Note that
facilities must meet additional eligibility requirements for participation in
MMP.
HAPI

Handheld Assisted Personal Interview – A method of administering
interviews in person using a hand-held personal computer.

HARS

HIV/AIDS Reporting System

eHARS

Electronic HIV/AIDS Reporting System

HIV medical For identifying facilities that are eligible for MMP, HIV medical care is
care
defined as conducting CD4 or HIV viral load testing and/or providing
prescriptions for antiretroviral medications in the context of treating and
managing a patient’s HIV disease on an outpatient basis. Thus, facilities
providing HIV care could include outpatient facilities such as hospitalaffiliated clinics, free-standing clinics or private physician offices; and
Veterans Administration facilities. Note that although inpatient facilities,
prisons and jails, federal military and penitentiary facilities, and emergency
departments may provide HIV care, these types of facilities are not
considered eligible for the 2011 data collection cycle.
IRB

Institutional Review Board

MHF

Medical History Form

MMP

Medical Monitoring Project

MRA

Medical Record Abstraction

MDS

Minimum Data Set – Basic core surveillance information obtained for all
sampled patients. This information will be obtained from HARS. These
data are referred to as minimal data.

PDP

Population Definition Period – For a given year or cycle of data collection,
a predetermined period of time which defines the population of inference.
The PDP for the 2011 data collection cycle is the 4 month period from
January 1 – April 30, 2011.

PDP PL

Population Definition Period Patient Load - The actual count of individual
HIV-infected patients seen at a facility during the PDP (i.e., the total PDP
patient load derived from a facility’s patient list or lists). These counts will
differ from the EPLs used to construct the facility sampling frame, because
the latter only estimate the PDP PL.

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PPS

Probability Proportional to Size – A method of sampling in which the
probability of selection for each unit on the sampling frame is proportional
to some measure of size. For the 2011 MMP data collection cycle, the
measure of size for first stage sampling of project areas was the number
of reported living AIDS cases as of December 2002. For second stage
sampling of HIV care facilities, it is the best estimate of the number of
eligible HIV-infected patients who received care at each facility during the
PDP (i.e., the best EPL obtainable). Thus, in the second stage of
sampling, facilities with more eligible HIV patients have higher selection
probabilities than facilities with fewer patients.

Provider

A provider is an individual health practitioner (physician, nurse, etc.) within
a facility (see Facility definition).

PSU

Primary Sampling Unit – The element, or entity, that is sampled in the first
stage of sampling. For MMP the 50 U.S. states, plus the District of
Columbia and Puerto Rico, were the 52 primary sampling units.

QDS

Questionnaire Development System - Software (NOVA Research
Company, Bethesda, Maryland) used to develop the MMP interview
questionnaire applications deployed on laptop and hand-held personal
computers (see CAPI and HAPI definitions).

Sampling
frame

In probability sampling, the probability of selection of any element or unit,
such as a patient, in the population must be known. In order for selection
probabilities to be known, a list of population elements is developed from
which the sample can be selected. Such a list is called a sampling frame
and has the property that every element in the population has a known
chance of being selected for the sample. For multistage sampling, a
separate sampling frame is developed for each stage of sample selection.
Each of the sampling frames after the first selection stage does not list all
elements in the entire population, however; each subsequent frame only
includes the population of elements within a sampled unit from the prior
stage of selection. In MMP, patient sampling frames within a project area
will not list all eligible HIV infected persons in care in the project area but
only those in care at the sampled participating facilities. Because the
probability of selection for each facility from which patient lists are
obtained is known, the overall probability of selection for each patient
selected during the final patient sampling stage can be determined.

SDN

Secure Data Network – The SDN allows field staff and public health
partners to securely exchange data with CDC that are considered
sensitive or critical in nature. The SDN will be used for any confidential
communication directly from the project areas to CDC.

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SHAS

Supplement to HIV/AIDS Surveillance

SHDC

Survey of HIV Disease and Care

SHDC-Plus Survey of HIV Disease and Care Plus
Short
Questionnaire

Abbreviated form of the questionnaire conducted only under limited
circumstances, such as when a patient is too ill or otherwise unable
to complete the longer standard interview, or when translation is
required.

SPIF

Surveillance Period Inpatient Form

SPSF

Surveillance Period Summary Form

SPVF

Surveillance Period Visit Form

Standard
Unabridged form of the questionnaire
Questionnaire
Surveillance The 12 months prior to patient interview, if the sampled patient was
Period
interviewed, or the 12 month period prior to the date of first attempt to
contact the sampled patient, if an interview is not obtained (e.g., the
participant refused to participate, is known to have died, or is lost to
follow-up).

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I. Introduction
A. Background
HIV/AIDS surveillance programs in all U.S. states collect a core set of information
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.
The Adult/Adolescent Spectrum of HIV Disease (ASD) project was implemented
in 1990 as a supplemental surveillance system to collect information on the treatment
and clinical outcomes of HIV-infected persons who were in care.1 ASD, a facility-based,
observational medical record abstraction project, involved the abstraction of medical
records of more than 60,000 people receiving HIV care in 11 U.S. cities. ASD data have
been used to examine trends in the incidence of AIDS-defining opportunistic illnesses,
to determine whether eligible patients were receiving prophylactic and antiretroviral
medications, and to provide information for treatment and prevention guidelines.2-6
The need for data on HIV-infected persons’ risk behaviors and health care
seeking behaviors led to the implementation of the Supplement to HIV/AIDS
Surveillance (SHAS) project in 1990. SHAS surveyed persons in 19 areas who were
newly reported as having HIV infection or AIDS; these persons were asked about HIV
testing, care seeking, access to health care and related services, and ongoing risk
behaviors.7 Analyses examining reasons for late HIV testing, quality of life, drug use,
and sexual behaviors have contributed to local planning and the tracking of behavioral
trends among persons with HIV infection in care.7-15
During the past decade, ASD and SHAS have provided much-needed
information that has been used to understand the HIV epidemic. However, in recent
years, several factors have progressively limited the usefulness of these surveillance
projects. First, early in the epidemic, HIV/AIDS cases were concentrated in large urban
areas, primarily on the East and West coasts. Currently, a much larger number of cities
and states are heavily affected by the HIV/AIDS epidemic, limiting the usefulness of
data collected from the geographic areas in the ASD and SHAS projects. Second, the
lack of linked medical record and interview data in these projects limited the ability to
estimate key indicators, such as the quality of HIV-related ambulatory care and the
severity of need for HIV-related care and services. Third, the generalizability of results
from ASD and SHAS to the rest of the adult HIV-infected community was limited
because these projects did not use probability sampling methods.
To address some of these concerns, the Survey of HIV Disease and Care
(SHDC) was piloted in several areas during 1999. SHDC was a cross-sectional,
population-based medical-record abstraction project in which 2-stage sampling was
used to obtain probability samples of HIV-infected patients in care in the U.S.16 In
SHDC-Plus, a modification of SHDC conducted in 3 areas during 2003–2004, a subset
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of persons whose medical records had been abstracted were interviewed. Both projects
were conducted in limited geographic areas. The Medical Monitoring Project (MMP)
grew out of experience with ASD, SHAS, SHDC and SHDC-Plus and incorporates some
of their features, but unlike these earlier projects it is designed to provide nationally
representative, population-based surveillance data. Furthermore, MMP’s design
addresses the limitations described above.
B. Purpose and Scope
The primary objectives of MMP are to obtain data from a national probability
sample of HIV-infected persons who received care in the United States to:
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describe the clinical and virologic status of these persons
describe the prevalence of co-morbidities related to HIV disease
describe HIV care and support services received and the quality of such
services determine prevalence of ongoing risk behaviors and access to, and
use of, prevention services among persons living with HIV
identify met and unmet needs for HIV care and prevention services to inform
prevention and care planning groups, health care providers, and other
stakeholders

The primary purpose of this protocol is to provide a consistent method for U.S.
state and local health departments to use in collecting data on behaviors and clinical
outcomes from a probability sample of adults who received care for HIV infection or
AIDS in their jurisdictions. The method involves the selection of patients who received
care during a predefined time period by means of a 3-stage sampling design, in-person
interviews of eligible patients, and abstraction of their HIV-related medical records.
Collection of data from interviews with HIV-infected patients will provide
information on the current behaviors that may facilitate HIV transmission; patients’
seeking of, access to, and use of HIV-related prevention services; utilization of HIVrelated medical services; and adherence to medication regimens. Through abstraction
of medical records and interviews with eligible persons, MMP will provide information on
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. Ultimately, this surveillance project will describe met and unmet needs for HIV
care and prevention services, information that can be used to evaluate these services
and to direct future resources for HIV-infected persons.
The design will allow for national and state or local estimates of certain
characteristics and behaviors that will be generalizable to adults in care for HIV infection
in the United States. In order to make estimates that are truly representative, it will be
necessary to obtain very high enrollment and participation rates of sampled facilities
and patients. State and local HIV/AIDS surveillance programs, which have been
operating for more than 20 years, have a history of collaboration with the medical
providers and patients in their jurisdictions on projects involving both interview and
medical record abstraction. Surveillance programs will need to build on these
collaborations to ensure the high participation rates required for this project.
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C. Collaborating Agencies and Stakeholders
MMP is conducted through cooperative agreements between CDC’s Division of
HIV/AIDS Prevention–Surveillance and Epidemiology and the following state and local
health departments:
California Department of Health Services
Chicago Department of Public Health
County of Los Angeles Department of Health Services
Delaware Division of Public Health
Florida Department of Health
Georgia Department of Human Resources
Houston Department of Health and Human Services
Illinois Department of Public Health
Indiana State Department of Health
Michigan Department of Community Health
Mississippi State Department of Health
New Jersey Department of Health and Senior Services
New York State Department of Health
New York City Department of Health & Mental Hygiene
North Carolina Department of Health and Human Services
Oregon Department of Human Services
Philadelphia Department of Public Health
Pennsylvania Department of Health
Puerto Rico Department of Health
San Francisco Department of Public Health
Texas Department of Health
Virginia Department of Health
Washington State Department of Health
In addition to CDC, stakeholders for this project include other agencies and
groups such as:
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State and local health departments
National Institutes of Health (NIH)
Health Resources and Services Administration (HRSA)
National Association of AIDS Education and Training Centers (AETCs)
National Alliance of State and Territorial AIDS Directors (NASTAD)
American Academy of HIV Medicine (AAHIVM)
Communities Advocating Emergency AIDS Relief (CAEAR)
Association of Nurses in AIDS Care (ANAC)
Council of State and Territorial Epidemiologists (CSTE)
HIV Medicine Association (HIVMA)
National Association of People with AIDS (NAPWA)
National Alliance of State and Territorial AIDS Directors (NASTAD)
National Minority AIDS Council (NMAC)
HIV prevention planning groups
Ryan White planning councils and consortia
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Providers of HIV medical care and prevention services
HIV-infected persons

CDC established relationships with other federal stakeholders during the
conception and development of MMP. Communications with these federal partners will
continue for the duration of this project. CDC will maintain communication with state and
local health departments through e-mails, conference calls, site visits, and meetings
with Principal Investigators, Project Coordinators and other project staff.
Participating health departments should ensure the involvement of local
stakeholders in MMP, including affected communities and providers of HIV care.
Community input may be sought from established groups that represent HIV-affected
communities (such as community planning groups and other potential consumers of the
surveillance data) or if already established groups cannot provide appropriate input,
from a group of community representatives convened to consult with the health
department about this project. Provider input may be obtained by presenting – at local
medical society meetings or through newsletters for local providers or other networks –
the project, its aims, and its effect on the providers selected to participate.
Many state and local health departments have established relationships with
local community planning groups and Ryan White planning groups. These groups
should be made aware of the purpose and status of MMP, and the data it may provide
to support local HIV planning activities.
At the national level, CDC has convened community and provider advisory
boards for MMP, which include one community representative and one provider
representative from each of the 23 project areas. These boards also include members
of national organizations (e.g., National Association of People With AIDS, National
Minority AIDS Council, HIV Medical Association, American Academy of HIV Medicine,
and others). These boards provide input on the data collection instruments, operational
considerations, barriers to participation, the usefulness of collected data, and optimal
methods for data dissemination. The community members and providers who serve on
the national boards are the designated contact persons at the local level and serve as a
resource to patients or providers who are approached about participating but who wish
input from a peer before deciding whether to do so.
CDC has contracted with ICF Macro to provide data management support. The
scope of the work for the contract as it pertains to MMP consists of Macro
independently, and not as an agent of the Government, furnishing all necessary
personnel, facilities, supplies, and equipment to establish and implement a Data
Coordinating Center as an integral part of MMP to achieve each of the following
objectives:
1. Receiving data from the 23 MMP project areas (CDC designated project
areas)
2. Processing data for quality assurance
3. Creating and transferring cumulative and final data sets to CDC and to project
areas
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4. Providing ad-hoc technical assistance to MMP project areas
5. Providing formal training sessions for MMP project areas
6. Communication and reporting to CDC

D. Initiation, Duration, and Project Period
MMP was initially funded for 4 years (mid-2004 through mid-2008). A cost
extension was approved to extend funding through mid-2009 and the project was
funded for an additional 5 years (mid-2009 through mid-2013). Thirteen project areas
were funded to pilot data collection during year 1: Delaware, Florida, Houston (Texas),
Illinois, Los Angeles (California), Maryland, Michigan, New Jersey, New York City (New
York), Philadelphia (Pennsylvania), South Carolina, Texas, and Washington. Twentysix project areas were funded for data collection in years 2 through 5. Year 2 project
activities, including preparation for data collection, began in all project areas in June
2005. Because of delays in the Office of Management and Budget Office clearance
process and the time needed to complete project activities, the decision was made to
skip data collection for the 2006 cycle (data collected on patients in care in 2006) and
begin the first full year of data collection in year 4 (patients in care in 2007). Sampling
and data collection also took place in year 5 (patients in care in 2008) and will take
place in years 6 through 10. Data collection for the 2011 cycle will begin January 1,
2011 and will terminate April 30, 2012. Twenty-three project areas are funded for the
2011 cycle.

II. Methods
A. Population of Inference
For each MMP data collection cycle, the national population of inference is HIVinfected adults (18 years of age or older) who received care from known providers of
outpatient HIV medical care in the United States during the population definition period
(PDP). For each project area, the population of inference is HIV-infected adults who
received care from known providers of outpatient HIV medical care operating within the
project area during the PDP.
B. Population Definition Period (PDP)
The PDP is a predefined time period during which HIV-infected patients must
have received care at sampled facilities to be eligible to be selected to participate in
MMP. For the MMP 2011 data collection cycle, the PDP is uniform across all project
areas and extends from January 1 through April 30, 2011.
C. Eligibility Criteria
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1. State and Local Health Departments
The goal of MMP is to obtain a national probability sample of HIV-infected adults
receiving care from known providers of outpatient HIV medical care in the United
States; therefore, all 50 states plus the District of Columbia and Puerto Rico were
eligible to participate. Six areas separately funded for other surveillance activities
(Chicago, Houston, Los Angeles, New York City, Philadelphia, and San Francisco) were
included as part of their respective states for first-stage sampling. Therefore, the entities
eligible for first-stage sampling were the 50 states plus the District of Columbia and
Puerto Rico. Fifty states, the District of Columbia, Puerto Rico, and the 6 cities above
were eligible to receive MMP funding.
2. Facilities
In each selected project area, any outpatient facility that provided HIV medical
care during the time period(s) used to construct the facility sampling frame (FSF) (i.e.,
during the time periods for which records were available from each data source) is
considered eligible for MMP. For the purposes of MMP FSF construction, providing HIV
care is operationally defined as conducting CD4 or HIV viral load testing or providing
prescriptions for antiretroviral medications in the context of treating and managing a
patient’s HIV disease. Thus, facilities providing HIV care could include outpatient
facilities such as hospital-affiliated clinics, free-standing clinics or private physician
offices. In addition, for MMP a facility is defined as any clinic, health care facility, group
or private physician practice, or grouping of such entities that share medical records or
a medical records system (in this protocol, this will be referred to as the “MMP facility
definition”).
Facilities that are known not to provide medical care, such as HIV counseling and
testing sites, should be excluded from selection for MMP (i.e., excluded from the FSF).
In addition, if all medical providers at a facility obtain CD4 T-lymphocyte counts and HIV
viral loads only for referral purposes or if they only provide antiretroviral refill
prescriptions – but do not play a more active role in managing their patients’ HIV
infection – then that facility should also be excluded from MMP selection. Other
facilities that should be excluded from each project area’s FSF are facilities that provide
exclusively inpatient care, including hospices; emergency departments; facilities located
outside the funded project area; facilities that have closed; federal, state and local
correctional and work-release facilities; tribal facilities; and health facilities located on
military installations. Facilities that have provided HIV care only to patients under the
age of 18 should also be excluded from the FSF. Some facilities providing HIV care for
patients under the age of 18 also do so for those 18 years and older; these facilities are
eligible to be included on the FSF as well. Veterans Administration (VA) facilities in
every project area are eligible for participation and must be included on the FSF.
Inpatient facilities are excluded from MMP eligibility because in these facilities the
medical care provided to HIV-infected patients often may not be HIV-related. In
addition, acute care providers in inpatient hospital facilities, such as medical residents,
are not known providers of regular HIV medical care and as such may not be able to
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participate in patient contact and recruitment if required by a project area or selected
facility. Emergency departments are excluded from MMP for similar reasons. Although
a hospice may in some instances provide some short-term HIV medical care, these
facilities also are not considered to be known providers of regular HIV medical care. A
separate list of excluded inpatient and other ineligible facilities should be kept by each
project area.
3. Patients
At each eligible facility, all patients who meet the following conditions are eligible
for inclusion:
1. Diagnosed with HIV, with or without AIDS at any time prior to the end of the PDP
2. At least 18 years of age at the beginning of the PDP
3. Received medical care (defined as any visit to a known provider of HIV medical
care for medical care or prescription of medications, including refill
authorizations) during the PDP
HIV-infected patients who received all of their care solely from emergency
departments or inpatient facilities will be excluded from MMP, given that these facilities
are excluded from the FSF. Note that exclusion of these patients is based on eliminating
certain types of facilities from the FSF; HIV-infected patients who received care at an
eligible facility but who also have visited an emergency department or inpatient facility
will be eligible for selection to participate in MMP. Information on patient visits to
emergency departments or inpatient facilities will be obtained during interviews, or may
be documented in medical records.

D. Sampling Methods
MMP uses a 3-stage sampling design resulting in annual cross-sectional
probability samples of adults receiving outpatient care for HIV infection in the U.S.
During the first stage of sampling, which was conducted during early 2004, 20
geographic primary sampling units (PSUs) were selected using probability proportional
to size (PPS) sampling based on AIDS prevalence at the end of 2002. For the second
stage of sampling, the areas will use their 2011 facility sampling frame for the
2011 cycle. During the third stage of sampling, patients will be selected with equal
probability sampling methods from all eligible patients seen during the PDP at selected
participating facilities. More detail about each of these stages of sampling is provided in
the following sections.
1. First-Stage Sampling
For the first stage of sampling, geographically stratified random sampling was
used in which selection probabilities were proportional to a known measure of size.
Because the goal of MMP is to obtain a series of national probability samples of adults
7

in care for HIV infection in the United States, all 50 states plus the District of Columbia
and Puerto Rico were eligible for selection. Although 6 cities (Chicago, Houston, Los
Angeles, New York City, Philadelphia, and San Francisco) were qualified to receive
separate funding for MMP, these separately funded cities were included with their
respective states for the purposes of first stage sampling. Therefore, the first-stage
sampling frame consisted of 52 PSUs: the 50 states plus the District of Columbia and
Puerto Rico.
First stage sampling for MMP was conducted in early 2004. During this stage of
selection, systematic PPS sampling was used in which the measure of size for each
PSU was the estimated total number of persons living with AIDS, as reported to the
national HIV/AIDS Reporting System (HARS) at the end of 2002. Note that although
the target population for MMP is all persons diagnosed with HIV in care in the US, since
at the time there was no data system that collected information on HIV infected persons
in care, the best available proxy (indirect) measure of PSU size, i.e., the estimated
number of persons living with AIDS, was used during this stage of sampling. Using an
indirect measure of size at any given sampling stage does not affect the validity of the
statistical estimates derived from the overall sample. Because the first stage of MMP
sampling was conducted using probabilities proportional to the measure of the number
of persons living with AIDS associated with each PSU, it is estimated that this first-stage
sample included more than 80% of the persons living with AIDS in the U.S. during 2002.
On the basis of available funding, 20 PSUs were selected during the first stage of
sampling. All 20 state and 6 local (for the separately funded cities within the states)
health departments in areas selected for the first stage sample agreed to participate in
MMP, resulting in 26 project areas. For the current data collection cycle, 23 project
areas were funded. See Appendix A for more information regarding first stage selection.

2. Second-Stage Sampling

a. Constructing the sampling frame of facilities
The Facility Sampling Frame (FSF) is a comprehensive list of all facilities
providing HIV medical care within the local project area’s jurisdiction. HIV medical care
is defined as the treatment and management of HIV disease, and includes monitoring
CD4 and HIV viral load tests and/or the prescription of antiretroviral medications. To be
eligible for MMP the facility must be a provider of HIV medical care and share a
common medical record system. Project areas must also obtain from each eligible
MMP facility an Estimated Patient Load (EPL) – an estimate of the number of HIVinfected adult patients served for a pre-determined 4 month time period. The EPL is
integral to the facility sample selection process. A high-quality EPL is one based on a
data run or other objective information source. The FSF serves as the frame from which
the MMP facility sample is selected. Because facilities are sampled PPS, an accurate
estimate of the number of HIV-infected adult patients in care at each facility during the
PDP (i.e., the EPL) must be included on the frame for each facility. The initial FSF was
developed by all project areas prior to the first cycle of MMP data collection.
8

For the purposes of FSF construction and updates, HIV medical care is
operationally defined as conducting CD4 or HIV viral load testing and/or providing
prescriptions for antiretroviral medications in the context of treating and managing a
patient’s HIV disease. Thus, facilities providing HIV care could include outpatient
facilities such as hospital-affiliated clinics, free-standing clinics or private physician
offices.
Facilities that are known not to provide HIV-related medical care, such as
counseling and testing sites, should be excluded from the FSF. Other facilities that
should be excluded from each project area’s FSF are facilities that provide exclusively
inpatient care, including hospices; emergency departments; facilities located outside the
funded project area; facilities that have closed; federal, state and local correctional and
work-release facilities; tribal facilities; and health facilities located on military
installations. Facilities that provided HIV care only to patients under the age of 18 also
should be excluded from the FSF. A separate list of excluded inpatient and other
ineligible facilities should be kept by each project area.

b. Facility Sampling Frame Activities for the 2009-2013 Cycle
All MMP project areas started the 2009-2013 funding period with an updated FSF
that was reconstructed from the original FSF used in the previous 5-year cycle. The
reconstructed FSF will be used through the entire 5-year funding period, with an
updating every two years in which project area staff note which facilities opened, closed,
merged, or experienced changes in the EPLs. For detailed information on activities that
are used to reconstruct or update the FSF, please see below and Appendices B.1
through B.5.

i. Updating the Facility Sampling Frame
In each funded project area, the previously constructed FSF for that project area will be
updated every two years to reflect the most recent information available regarding all
eligible outpatient facilities known to provide HIV care to adults within the project area’s
jurisdiction. The objectives of an FSF update are to prepare an accurate, complete, and
up-to-date list of facilities eligible for MMP from which a representative sample of
facilities can be drawn. As a starting point in conducting an update of the FSF, project
area staff should review their existing FSF. These facilities, having previously met the
criteria for MMP eligibility, are likely to remain eligible for the upcoming MMP cycle.
For the 2011 and 2013 MMP data collection cycles, the period of time since the FSF
was updated will be greater than one year. During this period of time, new HIV careproviding facilities may have begun operations within the jurisdiction of the project
areas. CDC recommends that the MMP project area staff meet with HIV core
surveillance staff by June 30 of the year before the data collection cycle begins to
identify new facilities that are providing HIV care, as well as obtain information about
previously eligible facilities whose status has changed (e.g., closed, HIV provider left,
9

etc). MMP staff should take advantage of this meeting with HIV core surveillance staff to
obtain contact information for these new facilities and any other information that might
be useful to obtain an EPL. To ensure the completeness of the updated FSF, project
areas should use two other sources of information (facility visits log and medical record
abstractions) to identify potentially eligible facilities.

A new sample of facilities will be drawn from the updated FSF for the 2011 and
2013 data collection cycles. In order to prepare for the 2011 FSF, project areas should
update and correct their FSF throughout the 2010 cycle.
ii. Reconstructing the Facility Sampling Frame
In each funded project area, the previously constructed FSF for that project area
will be reconstructed every five years. For the 2011 data collection cycle, the 2011
updated FSF will be used. As such, the following information is presented for reference
only. The list of eligible facilities included all eligible facilities within a project area’s
jurisdiction that would potentially provide HIV care to HIV-infected patients during the
2009 PDP. In order to reconstruct the FSF, project areas first should review all records
entered into eHARS since the first HARS extract was performed to develop the previous
FSF. Project areas should also choose the two to three most useful data sources, aside
from eHARS, used to identify facilities for the first FSF (i.e., the data sources that
provided the most facilities not also found in eHARS), and obtain records that were
entered for each source subsequent to the previous data extract. Information obtained
from MMP interview or medical record abstraction data from previous cycles also should
be used to identify facilities not on the previous FSF.
Once the records from each of these data sources have been obtained, they
should be cleaned and standardized using methods developed for the initial FSF.
These facilities then should be combined into one list, and this list compared to those
that were considered eligible for the previous FSF and those that were considered
ineligible. Any facilities not on either list are considered newly identified for the data
collection cycle. These newly identified facilities should be contacted to determine
whether they are eligible for MMP participation; in addition, previously identified eligible
and ineligible facilities also should be contacted to confirm their eligibility status for the
data collection cycle. Although correctional facilities such as prisons and jails are not
eligible for selection, they should be included on the list of facilities sent to CDC with an
indication in the comments field that they are correctional facilities. See Appendices B.1
through B.3 for additional information.
The FSF will be reconstructed again for the 2014-2018 funding period during the
2013 cycle.
iii. Creating a matrix of EPLs from each data source
10

For the 2011 data collection cycle, the 2011facility sampling frame will be used.
The EPL is an estimate of the actual number of eligible patients that will be seen at a
facility during the PDP for a given data collection cycle. In the original construction of
the FSF, for each data source from which EPLs could be derived, a 1 year EPL for each
facility was determined. Project areas also obtained 1 year EPLs directly from the
facilities, either from a data run or other record-based source or as a less precise
estimate, at the time facilities first were contacted to determine MMP eligibility. One
year EPLs were obtained because it was thought this might be the most feasible time
period for EPL determinations by facilities. A matrix, or table, of EPLs from each data
source was constructed for all eligible facilities using templates provided by CDC, and
this matrix was used to create the FSF used to select facilities for the previous data
collection cycles. During this step, the quality of the different EPLs obtained across the
various data sources should have been evaluated in order to determine, for each
facility, which EPL was the most accurate to use for facility sampling.
For the 2011 FSF, the matrix of 4 month EPLs for all large facilities and a sample
of medium sized facilities was created from facility contacts where facility staff provided
information either from a data run or other record-based source.. For all other facilities,
project areas will use the most recent data available from existing data sources to
accurately reflect the patient load for the January 1 through April 30, 2011 PDP.
iv. Selecting the best EPL for each facility
For the 2011 data collection cycle, the 2011 facility sampling frame will be used.
A high quality EPL is one that accurately represents the true count of HIV-infected
individuals who receive care at a given facility within the PDP for a given data collection
cycle. The process of determining, from among the various data sources available for a
given facility, which EPL to use in the final FSF is somewhat subjective. This
determination is made based on the purpose of the data source, as well as the
completeness and comprehensiveness of the data source with regard to the HIV care
variable collected in the data base. For example, a complete source of laboratory
reports is one which includes all CD4 and HIV viral load values; a comprehensive
source of laboratory reports is one that includes all reportable CD4 and HIV viral load
tests ordered by all eligible facilities in the project area.
MMP staff members in each project area should have periodic discussions with
their CDC Project Officer regarding the data sources used to identify newly eligible
facilities and update the matrix of EPLs, and the information used to determine the
quality of the EPLs from each of those sources. See Appendices B.1 through B.5 for
more information regarding reconstructing and updating the FSF.
The complete FSF were due to CDC by November 30, 2010 so that facility
samples could be drawn by December 31, 2010.

c. Small facilities: adjusting EPLs to a minimum value or linking to other
facilities for sampling purposes
11

Please note, for the 2011 data collection cycle, the 2011 facility sampling frame
will be used. For MMP, it is desirable that the overall probability of selection for each
sampled patient be uniform, because this uniformity will result in greater statistical
efficiency (i.e., confidence limits for estimates derived from MMP data will be
minimized). Small facilities (i.e., facilities with very low EPLs) are technically
problematic when multistage probability sampling is conducted and uniformity of the
overall patient selection probabilities is desired, because the overall selection probability
for a given participant is the product of that patient’s selection probability across all
three sampling stages. Small facilities will be identified prior to facility sampling in order
to adjust the second stage selection probability for these facilities by performing facility
linkage prior to facility sampling to achieve combined EPLs for the linked facilities that
meet or exceed a minimum value.
Facilities designated as small are linked to one or more other facilities so that the
small facility is selected for the sample only if the facilities to which it is linked also are
selected. The desired minimum EPL across each project area ranges between 40 and
80, and will depend in part on the distribution of EPLs across the entire FSF for that
project area. Minimum values of 40 to 80 have been determined to be optimal for
selecting the facility sample across project areas.
In project areas of large geographic size, or with variations in facility attributes by
region, this linkage can be performed within pre-specified regions to facilitate efficient
use of project area resources during data collection, as well as to ensure facilities from
every region are selected. Facility linkage will be performed by CDC staff, in conjunction
with project area MMP staff, prior to selecting the facility sample.
d. Selecting the sample of facilities
For the 2011 data collection cycle, the 2011facility sample will be used. Each
project area will send its final, updated matrix of EPLs (including the designated best
EPL for each facility) to CDC through the DCC. Any small facility linkage will be
performed by CDC staff in conjunction with project area staff, and included as a
separate sheet in the workbook containing the matrix of EPLs. All files sent to CDC
should be stripped of identifying information for each facility; facilities will be identified
only by unique numeric facility identification (ID) number, which will be assigned by the
project area. Facility ID numbers for all project areas will be made unique by adding a 4digit project area code (see Appendix C) in front of the assigned 4-digit facility ID
number.
CDC staff will select the PPS sample of facilities. In most project areas, 25 to 50
facilities will be sampled for the 2011 and 2012 MMP data collection cycles. However,
the overall requirements of the sampling design, as well as the number and size
distribution of facilities within a given project area, will determine the number of facilities
that will be selected from each stratum. See Appendix D for more information regarding
second stage facility selection.
e. Facility recruitment for participation in MMP
12

Once the sample of facilities has been selected, project area staff will contact
each sampled facility to inform the appropriate contact person(s) that the facility has
been selected to participate in MMP. Facilities that are selected in 2011 will be
recruited for participation in the 2011 and 2012 data collection cycles. At this time,
issues related to how the facility can develop a list or obtain an accurate and reliable
count of HIV-infected adults who receive care at the facility during the 2011 PDP, and
when this list can be provided to project area staff, should be discussed. Discussions
regarding data collection activities for patients selected from the facility should also be
initiated at the time the facility is contacted.
Facility recruitment should occur prior to the PDP (January 1 – April 30, 2011) so
that patient lists can be obtained as soon as possible following the PDP end date.
The goal of MMP is to obtain participation from all sampled facilities. The
generalizability of a probability sample depends on an acceptable overall response rate.
Therefore, high overall response rates should be obtained at both the project area and
the national level. The overall response rate is dependent on the facility response rate;
therefore, facility response rates should be as high as possible. See the sections on
third stage sampling for more information regarding the overall response rate.
It is expected that sustained effort will be necessary from project area staff in
order to successfully recruit each sampled facility to participate in MMP. Every funded
project area should have a strategy, based on their experience conducting MMP and
similar projects and discussions among all funded project areas, for contacting and
recruiting sampled facilities. Experience from previous surveillance projects suggests
that reluctant or otherwise difficult-to-enroll facilities are most likely to respond favorably
if contacted by the medical director of the health department or HIV program.
Alternatively, the local MMP Provider Advisory Board (PAB) member might be helpful
for recruiting facilities that are initially reluctant to participate. Because a high facility
response rate is critical to the success of MMP, each project area should develop a
strategy for facility recruitment that will maximize facility participation.
Even if a facility is not willing to participate, the facility is retained as part of the
facility sample for a given project area. No substitutions will be made for facilities that
refuse to participate in MMP. A facility that refuses to participate is refusing
participation for all of its patients; these patients, and similar patients, will have a
lesser opportunity or no opportunity at all, to be represented by MMP. If a facility
refuses to participate in 2011, they will still be eligible for participation in the 2012 data
collection cycle, since the same facility sample will be used for 2011 and 2012.
3.

Third-Stage Sampling

At each participating facility, eligible patients will be sampled for inclusion in
MMP. Patients will be sampled either using List Based Sampling (i.e. from lists of
patients seen at each facility during the 2011 PDP) or through Real Time Sampling
(RTS). The selection of the patient sample will be done in a manner that will result in an
equal probability of selection method sample at the patient level. This means that
13

patients will be sampled from each facility with a third-stage sampling probability which,
when multiplied by the second-stage selection probability, results in the same overall
selection probability for every patient selected in the project area.

I. List Based Sampling
a. Constructing the patient sampling frame
A list of HIV-infected adults who received medical care during the 2011 PDP
should be requested from all sampled facilities. Templates for collecting and recording
this information will be provided to project areas by CDC. The patient lists should
include each patient only once (i.e., patients seen for care in the PDP should not be
included an additional time if they had another visit to the facility later in the PDP).
Methods for constructing patient lists may vary by facility. Strategies could include using
lists of patients whose classifications according to the International Classification of
Diseases (ICD-9 or ICD-10) for procedures, tests or prescriptions during the PDP are
related to HIV. This should not be the only method used by a facility to identify eligible
patients, however, because for third stage sampling all HIV-infected adult patients
presenting for any type of care at that facility are eligible for inclusion.
i. Obtaining lists of PDP patients from each participating facility
Patients will be eligible for selection only at their first reported visit to the facility
during the PDP in order to ensure that multiple visits to the same facility do not lead to
multiple opportunities for selection. Note that the operational definition for this
component of patient eligibility (receipt of any care at the facility during the PDP) is
different from that which is used to operationalize facility eligibility (CD4 or HIV viral load
testing or prescription of antiretroviral therapy). Care is defined as any visit to the
facility for medical care or prescription of medications, including refill authorizations and
vaccinations. It is important that the list contain only patients who received care at the
facility; facilities should exclude patients who made appointments but did not keep them.
The list of eligible patients will be collected from every participating facility after
the end of the PDP (April 30, 2011). Lists should be obtained from each facility as soon
as they are available; patient sampling cannot be conducted until patient lists are
received from every participating facility within a project area. Patient lists are due to
CDC by June 30, 2011, and patient samples should be drawn by July 31, 2011.

ii. Creating a file of PDP patient lists
As patient lists are received from participating facilities, each project area will
create a file containing these lists or estimates. A template for this purpose will be
provided by the DCC. Project areas should request patient lists that contain unique
identification information or, at minimum, codes for individual patients within each
participating facility. The patient information provided by each facility should include
14

unique identifying information which will enable the facility to fully identify each patient
that is selected for MMP participation.
If feasible, the project area should review the information received from each
facility to ensure no patient appears on a given facility’s list more than once. Since
information used to identify patients will differ across facilities, the lists should not be
unduplicated across any of the facilities; instead, adjustments will be made to the
statistical weights used in data analysis to account for multiple patient visits to different
facilities during the PDP.
iii. Comparing the selected best EPLs with PDP patient loads
For each facility, the actual count of unique patients seen during the entire PDP
(the PDP patient load, which is derived from a facility’s patient list or lists) will differ from
the selected best EPL used to construct the FSF. The extent to which this EPL for each
selected facility differs from the PDP patient load should be reviewed by the project
areas, in conjunction with the CDC Project Officer, as patient lists and estimated PDP
PLs are received during facility recruitment.
b. Selecting the patient sample
Once a project area has obtained PDP patient lists from all participating facilities
where list based sampling will be used, a copy of this file should be made in preparation
for transmitting the patient lists to the DCC. The copied file should then be stripped of
patient identifiers used by the facilities. If estimated PDP PLs have been obtained, lists
of individual patients should be generated from these estimates. Patients on every
patient list will be identified only by a 12-digit participant ID number that will be assigned
by the project area. This unique identifier will be associated with each patient
throughout a data collection cycle in MMP and should appear on all data collection
forms and in all databases. Participant ID numbers will be formed using 4-digit numbers
that are assigned consecutively to patients on each facility’s patient list. The first 8
digits of the participant ID will be the full ID of the state/city and facility from which the
patient was sampled. The edited, copied file should be encrypted and sent to the DCC
via the data portal.
For each project area using list based sampling, patient sampling will be
conducted shortly after the end of the PDP (April 30, 2011), as soon as the patient lists
have been received from all participating facilities (all patient lists should be sent to
CDC by June 30, 2011). The file containing lists of HIV-infected patients seen during
the PDP at all participating facilities will be used to select the patient sample. The
selected participant ID numbers will be returned to the project area via the SDN after
patient sampling has been completed; this set of participant IDs will comprise the entire
patient sample for the project area. See Appendix E for more information regarding
third stage patient selection using list based sampling.
c. Patient recruitment for participation in MMP using List Based Sampling

15

Persons selected during third-stage patient sampling may be offered enrollment
through two general recruitment processes: MMP project area staff-contact enrollment
or facility-referred enrollment. The recruitment strategy will vary according to facility
preference, and state or local project area Institutional Review Board (IRB)
requirements.
For MMP staff-contact enrollment, facilities will provide project area MMP staff
with contact information for patients selected for recruitment. After obtaining patient
contact information, the MMP staff will contact selected patients to describe the project
and offer enrollment. Telephone scripts will be used by all project areas to ensure a
standardized recruitment approach within project areas. Patients who are eligible for
enrollment and agree to participate will be scheduled for an interview at a location that
is convenient for the patient and meets the need for patient privacy or will be
interviewed over the phone.
Patients recruited through facility-referred enrollment initially will be contacted by
staff of the facility from which they were sampled. This may be done by telephone, in
person, through chart insert and/or letter mailed from the facility. If by telephone or in
person, the facility staff will describe the project briefly and ask permission to provide
contact information to MMP staff so that enrollment can be completed, or the facility
staff will ask the patient to contact the MMP staff. If recruitment takes place via chart
insert or letter, the documents will describe the project briefly and will provide contact
information to enable the participant to reach MMP staff.
All patients selected for the sample should be recruited for enrollment in MMP.
Patients are considered eligible if they receive care in a project area jurisdiction even if
they are a resident of another jurisdiction.

II. Real Time Sampling
a. Constructing the patient sampling frame
HIV infected persons receiving care at certain care facilities selected for
participation in MMP may be recruited for participation in MMP using RTS methods.
RTS is a variation of time-space sampling in which persons are recruited for
participation at pre-specifed intervals during pre-selected time blocks at pre-selected
locations. For MMP, RTS activities will take place during the PDP of any given cycle
(i.e. January 1st to April 30th). The project area and CDC will determine the most
appropriate facilities in which to conduct RTS. Factors considered include: size of
patient population, number of patients sampled for MMP, clinic patient flow, entry
point(s) for patient check in, prior MMP patient contact and participation rates, and
cooperation of facility staff. The project area will collect detailed information from
facilities chosen so that a patient selection algorithm can be developed. This
information will be determined by CDC and will include information such as: schedule of
facility operations during the RTS period, number and description of patient check in
entry point(s), predicted clinic patient volume by day and time, and facility contact
persons for RTS implementation. This information will be used to develop a sample of
16

office-period units where offices are nested within facilities and periods are nested
within days. CDC will then develop a patient sampling algorithm that will be used by
MMP staff at the facility to produce a sample of patients selected from the first-stage
sampling units (office-period units).
b. Selecting the patient sample
MMP staff, in consultation with CDC,will work with facility staff to identify eligible
patients, and will use existing protocols used for on-site recruiting in list-based
samplingto ensure that patient confidentiality will be maintained during the selection
process. Recruitment and data collection after RTS patient selection will follow
established MMP protocols. See Appendix E for more information regarding third stage
patient selection using real time sampling.

c. Patient recruitment for participation in MMP using Real TimeSampling
Persons selected during third-stage patient sampling using RTS will be enrolled
by MMP project area staff-contact.
For MMP staff-contact enrollment, the MMP staff will contact selected patients to
describe the project and offer enrollment. Patients who are eligible for enrollment and
agree to participate will be scheduled for an interview after their medical appointment or
at a later date at a location that is convenient for the patient and meets the need for
patient privacy. Telephone interviews will also be an option for interviews scheduled at a
later date.
All recruitment and data collection after RTS patient selection will follow established
MMP protocols.
All patients selected for the sample should be recruited for enrollment in MMP.
Patients are considered eligible if they receive care in a project area jurisdiction even if
they are a resident of another jurisdiction.
III. Project area patient sample sizes
MMP staff in all project areas will interview patients and abstract medical records
during the 2011 data collection cycle. MMP patient sample sizes in the project areas
range from 100 to 800 during 2011 (Appendix F).
Because MMP is primarily a descriptive project, power calculations, which are
used in sample size determinations for studies that test specific hypotheses, were not
performed. Instead, the level of precision (i.e., the estimated 95% confidence interval
half-width) was the criterion for determining sample sizes in individual project areas.
Ninety-five percent (95%) confidence interval half-widths were calculated for a variety of
sample sizes and design effects.

17

95% Confidence Interval half-widths for total population estimates for various
sample sizes and design effects

N
100
200
300
400
500
600
700
800
900
1000
1200

CI half-width
design effect = 1
9.80%
6.93%
5.66%
4.90%
4.38%
4.00%
3.70%
3.46%
3.27%
3.10%
2.83%

CI half-width
Design effect = 2
13.86%
9.80%
8.00%
6.93%
6.20%
5.66%
5.24%
4.90%
4.62%
4.38%
4.00%

CI half-width
design effect = 3
16.97%
12.00%
9.80%
8.49%
7.59%
6.93%
6.42%
6.00%
5.66%
5.37%
4.90%

CI half-width
design effect = 4
19.60%
13.86%
11.32%
9.80%
8.77%
8.00%
7.41%
6.93%
6.53%
6.20%
5.66%

CI half-width
design effect = 5
21.91%
15.50%
12.65%
10.96%
9.80%
8.95%
8.28%
7.75%
7.30%
6.93%
6.33%

It was determined that 400 is the minimum sample size for a state to obtain total
population estimates with an acceptable level of precision (assuming a moderate design
effect, or increase in variance of estimates due to using a multistage sampling design).
This sample size was assigned to most of the states with the lowest AIDS prevalence.
Sample sizes for states with moderate to high AIDS prevalence were determined based
on the distribution of cases among the 20 sampled states and the 6 separately funded
cities in those states, in order to achieve a national sample size of approximately
10,000. These project area sample sizes will allow national estimates at an acceptable
level of precision (assuming a moderate design effect) for subpopulations as small as
5% of the total population of interest.
E. Data Collection
For the 2011 data collection cycle, all project areas will conduct interviews for all
participating sampled patients. Each project area also will perform medical record
abstractions, and will collect minimal data elements on each sampled patient.
1. Personal Interview
The MMP interview is a face-to-face or telephone structured interview
administered to sampled patients who consent. Interviews for the 2011 data collection
cycle should begin as soon as the project area receives their patient sample or no later
than July 1, 2011, and should be completed by April 30, 2011. All interview data should
be sent to the DCC according to DCC submission schedules.
a. Interview instruments/applications
There are two instruments used to collect interview data for MMP: the Standard
Questionnaire and Short Questionnaire. The Standard Interview takes approximately 45
minutes to complete and is available in English (Appendix G.1) and in Spanish
(Appendix G.2). The Short Questionnaire is an abridged version of the Standard
18

Questionnaire and takes approximately 20 minutes to complete. The Short
Questionnaire is available in English (Appendix G.3) and Spanish (Appendix G.4).
The 2011 Standard Questionnaire consists of 10 modules to be administered in
all project areas: Preliminary Information; Demographics; Access to Health Care; HIV
Treatment and Adherence; Sexual Behavior; Drug and Alcohol Use; Prevention
Activities; Anxiety and Depression; Health Conditions and Preventive Therapy; and
Gynecological and Reproductive History. An optional module, Acculturation Scale, is
also available.
It is always preferable that the interview be completed during a single encounter.
However, follow-up time may be scheduled to complete an interview if it cannot be
completed during a single encounter. In the latter instance, the interviewer should
attempt to complete the interview as soon as possible after the encounter in which the
interview is initiated.
Electronic versions of all questionnaires will be provided by CDC for
administration by means of a handheld-assisted personal interview (HAPI) , utilizing a
device such as a personal digital assistant (PDA), or computer-assisted personal
interview (CAPI) via a laptop computer. HAPI and CAPI interview applications were
developed using Questionnaire Development System (QDS) software (NOVA Research
Company, Bethesda, Maryland). Paper versions of the questionnaires will also be
provided for administration of the interview in the event that a devices malfunction and
HAPI or CAPI cannot be conducted. A complete checklist of all interview-related
materials and equipment is provided in Appendix G.5.
i. Local questions
Project areas may choose to develop questions for local use. These questions are not
part of the CDC MMP. However, because the addition of local questions can have an
impact on MMP, CDC strongly recommends the following guidelines:
•
•

•
•
•

The administration time for local questions should not exceed 10 minutes.
If local questions pertain to subject matters that are sensitive or have potential
legal implications (e.g. childhood or sexual abuse, suicide), the project area
must ensure that interviewers are properly trained to deal with adverse events
and are knowledgeable about and able to offer appropriate referrals.
Local questions must be administered after all other interview questions are
completed, at the conclusion of the MMP interview.
A courtesy copy of all local questions in use by a project area should be
provided to the CDC Project Officer.
Local questions and data from local questions that are presented at scientific
meetings, shared with colleagues for scientific input, used for publication in
abstracts or journals, or disseminated in any other format should include a
disclaimer indicating that such questions were developed by the respective
state/local health department and are not part of the CDC MMP.

19

•

Obtaining approval for the use of local questions (e.g. IRB approval or any
other type of required approval, as applicable) is the sole responsibility of the
project area.

b. Interviewees
i. Short Questionnaire
Unless circumstances preclude it, the Standard Questionnaire should be
administered. Patients who are too ill to complete the Standard Questionnaire, but are
able to complete an abridged version, may be administered the Short Questionnaire.
All respondents administered the Standard or Short Questionnaire must provide
appropriate consent prior to interview participation, in compliance with all state and
local, and when necessary, facility-specific IRB guidance. See Appendices H.1 and H.2
for English and a Spanish translation of the “MMP Statement of Informed Consent” as
example informed consent forms that could be used for this purpose.
Non-English, non-Spanish speaking patients requiring a translator should be
administered the Short Questionnaire through the translator or interpreter (see section
ii, subheading c entitled “Interviews using an interpreter”. Project areas should follow
their state or local IRB guidance regarding any consent forms or confidentiality
agreements necessary for circumstances in which a translator or interpreter is required.
ii. Special populations
When interviewing a patient with hearing impairment, a sign language interpreter
may be required. These instances should be treated as all other interpreted interviews
(see below). Administration of the MMP interview questionnaire does not pose any
special risk to pregnant women. While prisons are no longer included in the sample
frame, the eligibility of incarcerated persons recruited at an eligible facility, yet residing
in jail or prison, will be determined by the project areas according to local regulations
and requirements.
c. Interviews using an interpreter
Persons considered to be acceptable interpreters for the MMP interview will vary
by project area. Health departments may already have standards in place and some
state or local IRBs may have specific requirements for interpreters. At a minimum, the
interpreter must sign a confidentiality agreement in accordance with project area
requirements.
All project areas should create standards for translated interviews and adhere to
them throughout the data collection cycle. Reference material may be found at the
Office of Civil Rights, Title VI. Additional information about Title VI and Limited English
Proficiency or LEP guidance may be found on the Department of Health and Human
Services website at http://www.hhs.gov/ocr/civilrights/resources/specialtopics/lep/ .
20

Project areas should anticipate what non-English, non-Spanish languages they
are likely to encounter, and what resources and arrangements they may need to make
to secure an effective interpreter.
Below are some general guidelines for identifying appropriate translators/interpreters:
•
•
•
•

The interpreter needs to be proficient in both English and the other language.
The interpreter should be culturally competent and demonstrate that he or
she is capable of accurately conveying information in both languages.
The interpreter should be provided orientation and training that includes
interpretation/interviewing skills, ethical considerations, and confidentiality
considerations.
Family members or friends of the patient must not be used as interpreters for
MMP.

d. Interview locations
Interviews may be conducted in a variety of settings, including medical facilities;
in the patient’s home; in a hospital; at another, mutually agreed-upon location where
security and confidentiality can be guaranteed.
e. Concluding the interview
Interviews will always be administered in a setting where the respondent’s
privacy and confidentiality is assured. At the end of the interview, participants will
receive prevention materials and referrals to local prevention and care services; they
will also be given the opportunity to ask the MMP staff questions about prevention
methods. At the conclusion of the interview, participants will be reimbursed for their
time.
f. Reimbursement
Participants will be reimbursed approximately $40 (this amount may differ by
project area) either in cash or a cash equivalent, for their 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.
g. Interviewer training
CDC will provide participating state and local health departments with a manual
containing detailed instructions on conducting MMP interviews. CDC will convene
meetings in which lessons learned throughout the interview process are discussed by
staff from all project areas.
h. Interview quality control and assurance
Automated edit checks will be built into the QDS software applications used to
conduct MMP interviews in order to assure high quality data are collected. For
additional quality assurance purposes, a minimum of 5% of interviews will be observed
21

by the project coordinator or other supervisory staff to ensure data quality and
completeness. Periodic review of interviews also will ensure that interviewers use the
same techniques in administering the questionnaire. Appendix I contains the MMP
Interviewer Evaluation Form that may be used by project areas for this purpose.

i. Interviews conducted in other MMP project area jurisdictions
Sampled patients that have moved out of the jurisdiction of the project area from
which they were sampled may be interviewed if circumstances allow. If the patient is
still receiving care in the original project area’s jurisdiction, it may be possible to
interview the patient at their next appointment. If the patient has moved and is no
longer receiving care in the original jurisdiction, then the following guidelines apply:
•
•

If the patient has moved to an area that is not conducting MMP, the patient
will not be interviewed, but the patient’s medical records may be abstracted if
the project area’s surveillance authority allows them to do so.
If the patient has moved to an area that is conducting MMP, the original
project area may contact the new project area to determine whether an
interview can be conducted by the new project area’s MMP staff. It is up to
the Principal Investigators of both areas to agree upon a protocol for
recruiting the patient and obtaining informed consent. Procedures for patient
contact, recruitment and interview must meet the IRB requirements of the
new jurisdiction (to which the patient has moved and where the patient will be
interviewed). For certain project areas, IRB restrictions from the original
jurisdiction also may apply.

If the second condition is met, staff from the new project area should interview
the patient and should submit the patient's data to ICF Macro through the DCC portal
using the original project area's MMP Participant ID. CDC will store the data record for
this participant in the appropriate data set (that of the original project area). Information
in the DCC portal must be updated to reflect that that patient has been interviewed. An
email should be sent to the DCC notifying them that there is an interview that belongs to
another project area that has been submitted with your data. A descriptive flow chart for
this process is in Appendix J. Regardless of whether an interview is administered, the
original project area should collect minimal data and medical record abstraction data for
this patient to the extent allowed by their surveillance authority.
2. Medical Record Abstraction
Patients who consent to participate in MMP will be interviewed first, and then
their medical records will be abstracted after the interview is completed. Trained staff
will abstract clinical data from medical charts using an electronic medical record
abstraction application provided by CDC. Medical record abstractions for the 2011 data
collection cycle should begin as soon as the project area receives the patient sample
and conducts the first interview, or no later than July 1, 2011, and should be completed
by April 30, 2011. All medical record abstraction data should be sent to ICF Macro.
22

The electronic medical record abstraction application consists of 4 modules,
representing 4 data collection forms: Medical History Form; Surveillance Period Visit
Form; Surveillance Period Summary Form; and Surveillance Period Inpatient Form.
Information abstracted will reflect the patient’s clinical condition and experience before
and during the surveillance period. The information will be primarily related to the
diagnosis of opportunistic illnesses and other HIV-related conditions, provision of
preventive care, prescription of antiretroviral medications, laboratory results, and health
services utilization. If a patient cannot be located for recruitment, the patient’s medical
record will be abstracted without interview, if allowed under local surveillance authority.
In addition, if MMP is considered to be research by the local IRB in the project areaand
a patient is known to have died before recruitment, a waiver of consent can be obtained
for medical record abstraction [HIPAA Privacy Rule 45 CFR 164.512(i)(1)(iii), which can
be found at
www.dhhstgov/ocr/privacy/hipaa/understanding/special/research/research.pdf],according
to the project areas' discretion (i.e., local IRB requirements)
MMP will capture clinical data from facilities providing primary HIV care during
the surveillance period (SP). For patients participating in the interview, the SP is the
twelve months prior to the interview date. For sampled non-participants, the SP is the
twelve months prior to the first attempt to recruit the patient for interview. Medical
record abstraction for non-participants who are not known to be deceased will only
occur in project areas where abstraction can be performed without consent from the
patient. However, as previously mentioned, the medical records of deceased patients
may be abstracted after obtaining a waiver of consent in those project areas where
MMP is considered research by the local IRB. The SP for deceased patients is the
twelve months prior to the date of death.
Whenever possible, medical record information should be obtained from all
facilities where a participant has received medical care for HIV infection during the SP.
Sources of information about where patients received care during the SP are as follows:
•
•

Interviews – facilities at which the participant reported receiving care during
the MMP interview are recorded on the interview facility visits log
Medical records – during abstraction, references to medical care received at
other facilities (e.g., hospital admissions, medical referrals, transfers) found in
the medical record are recorded on the Surveillance Period Summary Form.

When it is not possible to conduct abstraction at all facilities that provided HIV
care to a participant during the surveillance period, the following priority (in decreasing
order) should be followed for abstractions:
• the facility where the participant was sampled
• the facility reported by the participant as being the primary provider of his/her
medical care for HIV
• facilities where the participant received inpatient care during the surveillance
period.

23

Information about the patient’s medical history, and all information on care
provided during the SP will be abstracted using the following modules in the electronic
medical record abstraction application:
•

•

A single Medical History Form (MHF), covering the period from the date of
first medical care after HIV diagnosis to the date prior to the surveillance
period start date, will be completed for every facility at which medical record
abstraction is performed (see Appendix K.1).
A Surveillance Period Summary Form (SPSF) will be completed once for
each facility at which abstraction was performed. Information collected in the
SPSF captures selected events, including those that are not likely to recur in
the SP (e.g., Pap smear, pneumovax, pregnancy) and thus are not
appropriate for inclusion on the SPVF (see Appendix K.2).

•

A Surveillance Period Visit Form (SPVF) will be completed on each eligible
outpatient visit the patient made to a given facility during the SP (see
Appendix K.3).

•

A Surveillance Period Inpatient Form (SPIF), will be completed for each
inpatient stay during the SP (see Appendix K.4).

The personal identifying information used in recruiting and contacting patients will
not be transmitted outside the project area; medical record abstraction form data
received by the CDC will be identified only through the use of the Participant ID, the
Facility ID, the form type, and (for Surveillance Period Visit Forms) the visit date.
Project areas will track abstractions of each patient’s records using the DCC
tracking system, which will be used to make sure all identified eligible facilities at which
the patient had at least one health care visit (which was HIV-related or at one of the
eligible facilities listed above) during the surveillance period have been recorded and
abstractions have been completed at all assigned facilities.
a. Medical record abstraction training
CDC will provide training on conducting MMP medical record abstractions and on
use of the medical record abstraction application and ICF Macro will provide training on
data transfer. Detailed written instructions and guidance will be provided in an
abstraction manual given to abstractors, as well as through the Call Center – a
mechanism for abstractors to request help with specific abstraction or data
management issues and receive technical assistance through the DCC. CDC will
convene meetings in which lessons learned throughout the abstraction process are
discussed by staff from all project areas.
b. Medical record abstraction quality control and assurance
MMP abstraction modules must be checked for completeness by project area
supervisory staff prior to transfer to ICF Macro. For additional quality assurance
purposes, a minimum of 5% of medical records will be re-abstracted by a second,
24

independent reviewer. The two abstractions will then be examined for discrepancies
and compared for completeness. The medical records selected for re-abstraction will
be from multiple facilities, representing the work of all abstractors, over varying
periods of time.
3. Minimal Data
It is important to obtain information on every patient who was selected to
participate in MMP in order to provide basic descriptive information regarding the
population of inference. In addition, this information can be used to assess potential
non-participation bias for the data collected through interview and medical record
abstraction.
Ideally, interview and medical record abstraction data will be collected on each
patient. If the patient refuses to participate in the interview, in project areas that have
the surveillance authority to abstract the medical records of selected patients without
their consent, medical record abstraction should be completed for these patients, in
addition to those who are not interviewed because they cannot be located. In project
areas where there is a more narrow definition of surveillance and medical record
abstraction cannot be completed without patient consent (or the provider denies MMP
staff access to the medical records), minimal data will be collected. Regardless of level
of participation, minimum data should be collected on all sampled patients, including
those persons for whom interview and medical record abstraction data is obtained. The
minimum data set will contain the same fields as the HARS case report form, and
therefore these data can be collected in all project areas under their HIV/AIDS
surveillance authority. In order to appropriately assess non-participation bias, these
data should ideally be collected from a single source within each project area; this
source should be HARS/eHARS. A form displaying the data fields in the minimum data
set is provided in Appendix L. If the data cannot be collected via HARS/eHARS, MMP
project area staff will ask the facility to complete the MDS form (Appendix L). .
CDC will provide project areas with a SAS program that should be used to
extract MDS data from eHARS and an Excel workbook with all Participant IDs for all
sampled patients. All project areas will need to identify and add the HARS/eHARS ID
number (stateno) for each sampled patient. The SAS program will read the CDC
supplied Excel workbook which includes the statenos and will generate the minimum
data set in two formats - an Excel workbook and a SAS file. Two copies of each of
these files are generated by the SAS program: one copy will include the patient’s
stateno and should remain at the project area only; it should not be sent to ICF Macro.
The other copy of the SAS and Excel minimum data set files will exclude the statenos
and should be transmitted to ICF Macro using a secure data network.

III. Data Management and Analysis
Four types of data will be collected for MMP: tracking data, interview and
abstraction data, and minimal data for the minimum data set. The tracking data consist
of information collected in order to select and recruit facilities and patients for
25

participation in MMP, and will be used to inform project staff regarding progress and to
create statistical weights for data analysis. The interview data and abstraction data
consist of the information about selected patients obtained through conducting
interviews and abstracting medical records. The minimum data set consists of very
basic demographic and clinical data, and will be collected for all selected patients in
order to obtain data on everyone sampled. These minimal data will be extracted from a
single source (eHARS). The tracking, interview, abstraction, and minimum data set
data will be used by ICF Macro to create analytic data files, which will be used by the
CDC and the project areas to describe the populations of HIV-infected patients
receiving medical care and address project-related questions. All data management
and transfer for the 2011 cycle are within the scope of the Data Coordinating Center
contract with ICF Macro. All data analysis for MMP will be conducted by CDC and/or
project areas.
The purpose of the Data Coordinating Center (DCC), managed by ICF Macro, is
to implement a data management system (DMS) to provide MMP project areas with a
secure web based data portal system through which project areas can submit data to
CDC, revise submitted data sets, and receive final data from CDC. The system also
allows the project areas and CDC staff to track critical respondent and medical record
abstraction (MRA) activities. The DCC data portal is equipped with an access control
system that supports different levels of access so that the project areas can see only
their own data, and unauthorized use can be prevented. The three main features of the
DMS are the data portal, which enables data to be uploaded and downloaded, the
tracking component, and the reporting component. Each of these features has a
specific function:
•

•

The data portal provides project areas with a secure web-based mechanism
by which they can submit interview data, data changes, and MRA data. The
data portal also allows project areas and CDC to track the status of data
submissions, provide transfer of data error reports between the DCC and
project areas, and enable project areas and CDC to download the most
recent data sets. In addition, the data portal provides access to the
respondent tracking component. The respondent tracking component of the
data management system assists project areas in managing contacts with
sampled facilities, interview assignments, respondent dispositions, and MRA
assignments.
Finally, the DCC data portal provides the project areas and CDC with
management-level reports that include information on data collection status at
each project area such as number of completes, number of refusals, number
lost to follow-up, number ineligible for participation. Reports will be available
by project area and in aggregate.

Data management procedures performed by the DCC have been implemented using
standard data processing and analysis tools such as SQL and SAS that will process all
incoming data, generate error reports, incorporate data changes, and produce the
necessary management reports required by CDC. The system also incorporates a
secure web-based interface that allows CDC and project area staff to easily submit
data, track project area activities, retrieve data sets and reports.
26

A. Data Management
1. Tracking data
Various elements of tracking information will be collected during the following
phases of MMP conduct: project area sampling, facility sampling, facility recruitment,
patient sampling, patient recruitment, interview, medical record abstraction, and
acquiring minimal data. Examples of tracking data include EPLs for all facilities
determined to provide HIV care in the project area, facilities selected to participate in
MMP, PDP PLs at participating facilities, and interview status for sampled patients who
agree to participate.
This data tracking system, which is part of the DCC data portal, is accessed only
by a limited number of users at each project area and at CDC, using a secure digital
identification system. Information that identifies patients, such as name or patient
medical record number, is not sent to CDC or to ICF International.
Tracking data is collected and stored by each project area using a system
developed by ICF Macro via the DCC data portal. In addition to delivering the tracking
system, Macro is also responsible for providing any technical assistance to project
areas on how to use the tracking system.

2. Personal interview data
Interview data will be collected with either HAPI or CAPI, using an MMP interview
application which has been developed by CDC using the QDS software. In rare
instances, interview data may be collected using paper forms, such as in the event of
device failure. In these cases, the data will be entered using a hand-held or laptop
computer as soon as is feasible.
Interview data will be stored in, and uploaded from, the electronic devices as two
QDS data files with the extension .QAD [the standard questionnaire (including
completion module) and local questions (if applicable). Upload procedures have been
demonstrated via CD and described in written documentation, which have been
provided to each project area. Multiple interview records may be contained in each
.QAD file. The .QAD files will correspond to two types of information which are
collected and stored during the interview: core data, (all questionnaire modules except
the local questions) and the local question data. The local question .QAD files will be
kept only at the project area for local use – this local question data file will not be sent to
CDC or ICF Macro.
The filenames of the interview .QAD files will be automatically generated by the
QDS software, and will include the project area abbreviation, whether the data were
collected via HAPI or CAPI, the data collection cycle, type of data, and the date and
time the .QAD file was created. In order to uniquely identify each file, each file name
27

also will include the identification number of the electronic device with which the data
were collected as specified below.
The project area abbreviations for state and local project areas are provided in
Appendix C. The device code is a three digit code unique to the device (such as 073)
used to collect the data. The date part of the file name will be the eight digit date when
the file was created (e.g., 02152006 for February 15, 2006), and the time part will be the
hour, minute and second the file was created (e.g., 172347 for 5:23:47 pm).
The uploaded .QAD data files will be saved onto a secure network computer
drive, which will serve as the physical storage location of all interview and abstraction
data files for the project area. The file folder structure used on this drive will be based
on guidelines provided by CDC. Interview data will be uploaded from the electronic
devices on a daily basis, or as soon as is feasible for staff who must travel long
distances to collect the data.
In instances where the project area is using contract or regional surveillance staff
to collect MMP data in certain locations, the project area will ensure that a secure data
system with data encryption software is available at the contract or regional site.
Interview data collected by contract or regional staff will be encrypted and transmitted to
the central project area location on a periodic basis, using protocols to verify recordspecific transmission and receipt. These data then will be stored on a secure drive as
described above. Project area staff must back up and store the .QAD files on a periodic
basis.
Once the data are transferred to the secure drive, project area staff will perform
quality assessment reviews of each data record, including checks for duplicate records,
incomplete records, and inappropriate data values, using software applications and/or
programs supplied by CDC. The applications will allow staff to review each record
visually and export the data to an external file that can be accessed using standard data
management and analysis software such as MS Access and SAS. Any data revisions
identified will be documented and transmitted to ICF Macro via the DCC data portal.
Copies of recently uploaded interview .QAD files will be sent to the DCC data
portal on a periodic basis via a secure network using encryption software that has been
provided to project areas (or using other approved encryption software). No facility or
patient identifiers, other than MMP-specific IDs, will be transmitted to CDC or ICF
Macro, and no data from local questions will be sent to CDC or ICF Macro.
Once the data files are received by the DCC, additional quality assessment
programs will be implemented that will compare tracking and interview information and
produce reports specifying any discrepancies found. These reports will be provided to
the project area, and after project area review any corrections to be made to the data
will be entered on the interview data change list. The updated cumulative change lists
will be entered in the DCC data portal, documented, and the updates will be made to
the data. The change lists may also be used by the project area to update the interim
interview data files maintained locally. For information on the standard naming
28

conventions for interview data, please refer to the Medical Monitoring Project Data
Management Manual.

3. Medical record abstraction data
Medical record abstraction data will be collected with using laptop computers,
using an application which has been developed by CDC using the Net software. In rare
instances, abstraction data may be collected using paper forms, such as in the event of
device failure. In these cases, the data will be entered using a laptop computer as soon
as is feasible.
Data from the electronic medical record abstraction tool will be exported in a
standardized format and structure, encrypted, and then uploaded to the DCC portal.
Once at the DCC portal, the data will be decrypted, cleaned, and processed according
to CDC guidelines. As part of this processing, the medical record abstraction data will
be linked to patient interview data. The processed data will be provided to CDC and to
the project areas in a timely manner following the close of data collection.
The uploaded data files will be saved onto a secure network computer drive,
which will serve as the physical storage location of all interview and abstraction data
files for the project area. The file folder structure used on this drive will be based on
guidelines provided by CDC. Abstraction data will be uploaded from the electronic
devices on a daily basis, or as soon as is feasible for staff who must travel long
distances to collect the data.
In instances where the project area is using contract or regional surveillance staff
to collect MMP data in certain locations, the project area will ensure that a secure data
system with data encryption software is available at the contract or regional site.
Abstraction data collected by contract or regional staff will be encrypted and transmitted
to the central project area location on a periodic basis, using protocols to verify recordspecific transmission and receipt. These data then will be stored on a secure drive as
described above. Project area staff must back up and store the files on a periodic
basis.
Once the data are transferred to the secure drive, project area staff will perform
quality assessment reviews of each data record, including checks for duplicate records,
incomplete records, and inappropriate data values, using software applications and/or
programs supplied by CDC. The applications will allow staff to review each record
visually and export the data to an external file that can be accessed using standard data
management and analysis software such as MS Access and SAS. Any data revisions
identified during this initial project area review will be documented and transmitted to
CDC or ICF Macro on an abstraction data change list, using a template provided by
CDC for this purpose.
Copies of recently uploaded abstraction files will be uploaded to the DCC data
portal on a periodic basis via the secure network using encryption software that has
been provided to project areas (or using other approved encryption software). No
29

facility or patient identifiers, other than MMP-specific IDs, will be transmitted to CDC or
ICF Macro, and no data from local questions will be sent to CDC or ICF Macro.
Once the data files are received, additional quality assessment programs will be
implemented that will compare tracking and abstraction information and produce reports
specifying any discrepancies found. These reports will be provided to the project area,
and after project area review any corrections to be made to the data will be entered on
the abstraction data change list. The updated cumulative change lists will be sent to
CDC or ICF Macro, documented, and the updates will be made to the data stored at
CDC. The change lists may also be used by the project area to update the interim
abstraction data files maintained locally. For information on the standard naming
conventions for interview data, please refer to the Medical Monitoring Project Data
Management Manual.
4. Minimal data
The goal of MMP is to collect interview and medical record abstraction data on all
sampled patients. For sampled patients who refuse to be interviewed or whom project
staff are not able to locate, project areas should collect minimal data. This minimal data
will be obtained for all sampled patients (see Appendix L).
Minimal data include basic demographic information, such as sex and age, and a
very limited number of clinical fields (first CD4 count and viral load). Minimal data will
preferably be extracted from the project area HARS/eHARS using SAS programs
provided by CDC. In situations where the Minimal data cannot be extracted from
HARS/eHARS, the data may also be collected directly from the facilities. As the
minimum data set information is collected, copies of the data files without statenos and
with the _CDC_ included in the file names will be sent to CDC via the SDN. The file
names for these data will use naming conventions similar to those for the interview data:
AreaAbbreviation_cycle year_MDS_CDC_mmddyyyy.xls (Excel workbook)
AreaAbbreviation_cycle year_MDS_CDC_mmddyyyy.sas7bdat (SAS data file)
Minimal Data for the 2011 data collection cycle should be completed and sent to
ICF Macro by the end of the data collection period.
5. Analytic data
The interview, medical record abstraction, and minimal data will be linked by ICF
Macro using the MMP Participant ID. A SAS analytic file containing each project area’s
data also will be created by the DCC. The appropriate SAS analytic file will be sent to
each project area via the DCC data portal after the data collection cycle has ended. The
SAS analytic data files for all MMP project areas will be used to create MMP national
analytic files. The project area files as well as the national files will contain both ‘raw’
and computed variables. ‘Raw’ variables values represent the direct untransformed
responses to items on the interview questionnaire and abstraction forms. Computed
30

variables values are the result of calculations performed on ‘raw’ and/or other computed
variables.

B. Data Analysis
Project areas will have the primary responsibility for analysis and use of data at
the state and local levels, and for developing reports based on individual and/or
combined project area data. CDC will be responsible for analysis of these data at the
national level, as well as for developing annual reports based on data collected across
all project areas.
The MMP project area and national data will be analyzed using the sample
survey procedures contained in the SAS version 9.1.3 (or higher) software package
(SAS Institute, Inc., Cary, NC) and using SUDAAN software (Research Triangle
Institute, Research Triangle Park, NC). These or similar software packages must be
used for MMP data analysis in order to produce valid population estimates from the
MMP data.

IV. Security and Confidentiality of MMP Data
MMP data will be 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 HARS data. Specifically, MMP interviewers, abstractors,
and data managers will undergo the same security and confidentiality training as that
required for health department staff who conduct HIV/AIDS surveillance. While
conducting MMP, protocols will be strictly followed at the project area and national level
to ensure the integrity, confidentiality, and security of all MMP data.
Security and confidentiality of 2011 cycle data is within the scope of the ICF
Macro Data Coordinating Center Contract. Macro will adhere to the Guidelines for
HIV/AIDS Surveillance – Security and Confidentiality. In addition, all software
developed by Macro for MMP (Phase III) will adhere to CDC Confidentiality and Security
Guidelines.
HIV and AIDS case surveillance data are currently 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)). 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 with Section 306 and
308(d) of the Public Health Service Act. Because data collected for the MMP constitutes
31

enhanced surveillance activity, these data will be reported to and maintained by CDC in
the same manner as are current HIV and AIDS surveillance data, and accordingly are
covered by the existing Assurance of Confidentiality.
MMP interview and abstraction data records will not contain specific participant
identifiers (e.g., name, address, social security number) and are linkable to HARS only
through the HARS surveillance numbers. No specific identifiers will be included on the
data collection instruments. Paper forms, when used, will be filed by the unique ID and
date of interview and stored under lock and key; information collected on paper will be
entered into the appropriate data system at the project area and the paper forms will be
destroyed 6-12 months after the data collection cycle has ended. Lists of HARS
numbers linking MMP data to specific identifiers (e.g., the facility or patient name) will
be kept under lock and key, and destroyed once they are no longer needed; access to
them will be strictly limited. If signed informed consent forms for MMP are required,
these will be securely stored separately from the data collection instruments, preferably
at the central eHARS office of the project area, under the same security procedures as
those for eHARS surveillance forms.
The QDS software that will be used to collect the interview data supports the
ability to encrypt response data and password-protect interviews and abstractions so
that unauthorized users are unable to view, export, or modify collected data.
Security of the data files while on the electronic data collection devices is
enhanced by the use of individual passwords, which are known only to the user and to
data managers at the project area and CDC.
The interview data warehouse for each project area will be 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 and abstraction records will be performed by
the project area using protocols developed by CDC. Project areas upload data on a
monthly basis to the DCC data portal. The DCC has 1 month from receipt of project
area data to upload a cumulative project area specific data set to the data portal.
Project areas will be able to download data from the data portal on a monthly basis.
The DCC will also post project area specific reports on the data portal which can only be
accessed by the CDC and the project area.
V. Human Subjects Considerations
A. Non-research Determination
The National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention
(NCHHSTP), CDC, has determined that MMP is not research and that it is a routine
disease surveillance activity, with data being used for disease control program or policy
purposes (Appendix M). Because NCHHSTP has determined that MMP is not research,
it is not subject to human subjects regulations, including federal institutional review
board (IRB) review and approval. All federal, state, and local MMP staff must adhere to
the ethical principles and standards by respecting and protecting the privacy,
confidentiality, and autonomy of participants to the maximum extent possible.
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MMP project areas should follow state and/or local procedures to determine
whether the MMP protocol is subject to state and/or local human subject regulations.
The need for state/local IRB review, and the IRB approval and renewal dates if
applicable, must be kept on file in every project area. Copies of this documentation
should be provided to CDC on an annual basis.
IRB approval of MMP also may need to be obtained at the facility level. In these
instances, the project area’s Principal Investigator should identify an appropriate
provider to present the protocol to the facility IRB, if necessary, and assist the provider
by preparing required documentation and attend the IRB presentation to address any
concerns that may arise. The IRB approval and renewal dates for each facility must be
kept on file in every project area. A template for this purpose will be provided by CDC.
B. Anticipated Risks and Benefits
Participation in MMP presents no more risks to patients than those that might
occur outside the context of surveillance. Non-surveillance contexts include participation
in individual or group HIV prevention activities and interactions with HIV prevention and
health care providers in public or clinical settings.
Participating patients may benefit from participating in MMP by better recognizing
their own risks for transmitting HIV or other sexually transmitted infections, talking with
trained staff about how to reduce those risks, learning more about local HIV prevention
efforts, and obtaining prevention materials and referrals for health care, social, and
prevention services. MMP participation will benefit communities by helping HIV
prevention and care planners more appropriately allocate state and local HIV prevention
resources and federal, state, and local HIV care services.
C. Vulnerable Populations
Persons under the age of 18 will not be included in MMP. Pregnant women may
be included in MMP if they are sampled from a participating facility. Persons with mental
disabilities may be included in the patient sample; however, any person alive at the time
of interview who cannot provide informed consent will be excluded from participation in
the project. All participants will be afforded the same human rights protections.
D. Adverse Events
No serious adverse events are anticipated as a result of this project. Potential
adverse experiences are expected to be rare and limited to emotional distress resulting
from concerns about patient confidentiality. Although unlikely, it also is possible that
participants may experience anxiety or emotional distress when responding to interview
questions on sensitive topics such as health status or sexuality.
Potential adverse experiences are most likely to be identified during initial contact
with potential participants or during the consent and interview process. Patients will first
be contacted in person or by telephone; the wording of the contact scripts will be
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developed by MMP staff in local project areas and will use language that includes
assurance of confidentiality. Local informed consent forms will incorporate the language
used in the standard informed consent form approved by CDC and, as appropriate, the
local IRB, which also includes assurance of confidentiality and the person to contact if
an adverse event occurs.
Interviews will be conducted by local public health personnel trained to respond
appropriately to concerns about the security and confidentiality of the information
collected. Project interviewers also will be trained in interview techniques for sensitive
topics. Project interviewers or the adverse-event contact (depending on the
interviewer’s training and expertise) will be able to refer patients to psychiatric care or a
social service agency if necessary. The local MMP Principal Investigator and the
patient’s health care provider will supervise all referral activities performed by project
staff.
Project areas should develop procedures for dealing with adverse events that
meet the requirements of their governing institutions and/or IRBs, which should include
procedures for reporting adverse events. Project areas should report all serious
adverse events to CDC within 24 hours of occurrence. All adverse events, regardless
of severity, should be reported to CDC within two weeks.
E. Informed Consent
Informed consent for the interview must be obtained according to the federal
Assurance of Confidentiality requirements and as required by state and local IRBs for
participating project areas. 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.
Participants should be advised, when consent is obtained for interview, that
information from their medical records also will be collected and analyzed along with
their answers to the interview questions. In many project areas, state legal surveillance
authority will allow surveillance staff to collect medical record information even if the
patient declines to participate in the MMP interview, and in those instances medical
records should be abstracted. In project areas where this is not possible, only minimal
data will be obtained for those patients for whom neither interview nor medical record
abstraction data were collected.
Patients who are too ill to complete the Standard Questionnaire, but are able and
willing to complete an abridged version, may be administered the Short Questionnaire.
Likewise, patients requiring a translator should complete the Short Questionnaire
through the translator. Informed consent should be obtained from the participant in both
cases. The Statement of Informed Consent (Model Consent Form) are two examples of
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consent forms, one in English and one in Spanish that can be modified for local area
use (Appendices H.1 and H.2, respectively). Project areas should follow their own
regulations regarding any consent forms or confidentiality agreements necessary for a
translator.
Project areas should modify the templates of the consent forms to fulfill the
requirements of their IRB. These consent forms should 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.
VI. Data Dissemination
A. Notifying Providers, Patients and the Community of Findings
Data from MMP are expected to improve surveillance activities, contribute to
prevention programs and treatment services, provide information about unmet needs in
HIV care, and increase knowledge about medical care for persons with HIV. Results are
also expected to guide national surveillance efforts, particularly in the use of both selfreport and medical abstraction information by increasing our understanding of
conditions that were difficult to assess by using only interview data or only medical
record abstraction. Because MMP is a surveillance system that represents HIV-infected
persons in the United States, it will be imperative to notify the project areas and
stakeholders of the findings of this project as soon as they are available.
Most of the results are expected to be useful at the local level; other results will
be more meaningful after the data from all project areas have been aggregated. Each
project area will have responsibility for the release of local data. CDC will have primary
responsibility for the release of data aggregated from the project areas and will provide
this information. These data will be 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
will regularly publish surveillance reports based on the data collected annually.
Patients and community members will be informed of MMP findings through
multiple conduits. National data results will be released on the CDC’s MMP Web site
and through national publications and presentations at conferences. Similarly, local data
results will be reported to the community through multiple channels, such as local
publications, epidemiologic profiles, and presentations to local AIDS service
organizations and community planning groups and at conferences and workshops.
All project areas are encouraged to provide a copy of all MMP data releases
(abstracts, publications, fact sheets, etc.) prior to the date of data release.

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