Transcript Document

EPIDEMIOLOGY OF
HIV/AIDS IN PENNSYLVANIA
Module 1
*Introduction to Epidemiologic Methods for Assessment of Unmet Needs
for HIV-related Primary Medical Care
Benjamin Richard H. Muthambi, DrPH, MPH
State HIV/AIDS Epidemiologist
<HIV Public Health Intervention Program Support>
Outline for Module 1

Components of HRSA’s Framework of Comprehensive Needs
Assessment
– The Quandary of Definitions of Unmet Needs
– Types of Needs Assessment Data
Definitions of Primary Health Care,
Primary Medical Care, & Service Gaps
–
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Collaboration between Prevention & Care: Opportunities & Challenges
Characteristics of a Comprehensive Needs Assessment
Importance of/Rationale for Estimating Unmet Needs for
Primary Health Care
Assessment of Unmet Need Within the Care Act Planning
Processes;
Methodological Considerations in Estimating Unmet Needs;
Methods: HRSA-Defined Framework for Measuring Unmet
Need;
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Introduction
Definitions for Calculating Unmet Needs for HIV Primary Medical Care
The Unmet Needs Framework
Data Sources
Setting Up the Unmet Needs Framework
Population Input Examples
Care Input Example
Calculating Unmet Needs Estimates
Costs
Integrating the Unmet Needs Framework with Other Needs Assessment
Activities
Components of HRSA’s Framework for
Comprehensive Needs Assessment

Integrated Epidemiologic Profile of HIV;

Assessment of service needs among affected populations;

Resource inventory;

Profile of provider capacity and capability;

Assessment of unmet need and service gaps;

Annual Updates;
Components of HRSA’s Framework for
Comprehensive Needs Assessment

Integrated Epidemiologic Profile of HIV:
– Describes the current status of the epidemic in the service area: of greater
relevance to care, the Epidemiologic profile specifically describes the
prevalence of HIV and AIDS overall and among defined subpopulations;
Components of HRSA’s Framework for
Comprehensive Needs Assessment

Resource inventory:
– Describes organizations and individuals providing services across the full
spectrum of HIV services accessible to PLWH in the service area, regardless
of funding source. www.stophiv.pitt.edu

Profile of provider capacity and capability:
– Identifies the extent to which services identified in the resource
inventory are accessible, available, and appropriate for PLWH,
including specific subpopulations;
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Describe Capacity: how much of which services a provider can deliver ;
Describe Capability: the degree to which a provider is actually
accessible and has the needed expertise to provide services ;
Assessment of barriers to PLWH receiving services is an important
aspect of this component (i.e., the profile should inquire from PLWH
directly or service providers the barriers faced in accessing services);
Provider profiles may also explore client perceptions of service quality
and appropriateness: assessment of client satisfaction is a complex
effort that should be undertaken thoroughly in the planning body's quality
improvement process.
Components of HRSA’s Framework for
Comprehensive Needs Assessment

Assessment of service needs among affected populations:
– Includes barriers that prevent PLWH from receiving needed services;
– Information must be collected from multiple sources, among them PLWH
and other community members, the health department, Medicaid agency,
community-based providers and, where applicable, grantees of other CARE
Act titles. Information must be obtained from and about HIV-positive
individuals who know their status and are not in care.

Assessment of unmet need and service gaps:
– This should include an assessment of the unmet need for PLWH who know
their HIV status but are not “in care” (unmet needs) and an assessment of
service gaps for all PLWH—both in and out of care (service gaps);
– This assessment should bring together the quantitative and qualitative data
on service needs, resources, and barriers to help set priorities and allocate
resources;
Updates of Components of the Comprehensive
Needs Assessment

Annual Updates: of Comprehensive Needs Assessment:
– The comprehensive needs assessment need to be updated regularly
– Certain aspects need to be updated annually;
– Other aspects at least every 2 years;

Timing of Updates of Each Component:
–
Integrated Epidemiologic Profile of HIV:
 Minor updates: Twice Yearly
 Major update: Every 2 years
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Resource inventory: ?Every 1 – 2 Years?
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Profile of provider capacity and capability: ?Every 1 – 2 Years?
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Assessment of service needs among affected populations: ?Every 2 years?
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Assessment of unmet need and service gaps:
 Annual Update;
 Comprehensive update: Every 2 years (reconciling unmet needs and service
gaps)
Basic Concepts: Unmet Needs, Primary Health
Care, Primary Medical Care, and “In Care”

HRSA/HAB defines unmet need as the need for HIV-related health services by
individuals with HIV who are aware of their HIV status, but are not receiving
regular primary health care;
–
Primary health care includes:
 *Primary Medical Care: Medical evaluation and clinical care that is consistent with
Public Health Service guidelines, including CD4 cell monitoring, viral load testing,
antiretroviral therapy, prophylaxis and treatment of opportunistic infections,
malignancies, and other related conditions;
 ^Other Primary Health Care:
– Oral health care
– Outpatient mental health care
– Outpatient substance abuse treatment
– Nutritional services, and
– Specialty medical care referrals.
– The focus of assessment of unmet need is on need for HIV-related primary
health care, more specifically Primary Medical Care;
Basic Concepts: Unmet Needs, Primary Health
Care, Primary Medical Care, and “In Care”

The needs of individuals for other HIV-related services such as counseling
and testing or case management is recognized;
–
Non-Medical Supportive Services: other services that facilitate a) access to/contribute
to PLWH accessing primary medical care and b) remaining/retention in primary medical
care;
– By HRSA definition, the assessment of needs for these “non-primary health care”
support services is referred to as assessment of service gaps (see next page);

"In care”
–
means receiving primary medical care for HIV disease that is consistent with U.S.
Public Health Service Treatment Guidelines. Persons who are accessing other healthrelated services and/or support services but are not receiving primary medical care are
not considered to be "in care“. Hence, such persons are considered to “have unmet
needs for primary medical care”.
Service Gaps vs. Unmet Needs: Parts of
Comprehensive Needs Assessment

Service gaps: all service needs not currently being met for all PLWH except for
the need for primary health care for individuals who know their status but are
not in care;
–
includes additional need for primary health care for those already receiving primary medical
care ("in care");
– also includes the need for supportive services for individuals not receiving primary medical
care ("not in care").

The needs assessment will help the planning body set service priorities and
advise the grantee about how best to meet those priorities:
–
Hence, your needs assessment will need to address not only the unmet need for primary
health care but also other service needs—referred to as service gaps to distinguish them
from unmet needs;
Service Gaps vs. Unmet Needs: Parts of
Comprehensive Needs Assessment

Service gaps may occur because no services are currently available or
because available services are either not appropriate for or not accessible to
the target population. For example:
–
A service area that includes Latino PLWH with limited English proficiency but lacks
Spanish-English bilingual case managers may have a service gap for bilingual case
management services;
– A rural service area that has a high incidence of injection drug use but lacks substance
abuse services may have a lack of residential treatment facilities;

Assessing unmet needs should be part of a coordinated overall
comprehensive needs assessment process conducted in each jurisdiction:
–
Requires finding and determining the needs and service gaps of PLWH who are not
receiving primary health care (Such individuals are likely to be members of traditionally
underserved populations and may be among those with the greatest need for and
dependence on CARE Act services);
Types of Needs Assessment Data
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Secondary source data:
– Existing information that is primarily documented for a different
purpose and obtained/abstracted and used secondarily for
Epidemiologic purposes; viz. HIV Surveillance data; or
Primary source data:
– Information collected by the grantee, planning body, or applicant
through such methods as surveys, interviews, and focus groups;
Secondary and primary source data can be:
– Quantitative: numerical information, such as epidemiologic data,
and/or
– Qualitative: descriptive or narrative information, such as focus group
input.
Collaboration between Prevention & Care:
Opportunities & Challenges

Some components of Comprehensive Needs Assessment may be an
Avenue for Collaboration between Prevention and Care Planning:
–
Preparation and presentation of an epidemiologic profile:
 Data on AIDS cases, HIV cases, and co-morbidities are of similar importance in
both prevention and care planning.
 These data are typically compiled by the same State or local health department,
which may find it more efficient to compile them once a year for both users
 Mutual accomodation is needed as data needs are not identical.
– Preparation of a resource inventory:
 A resource inventory that catalogues available prevention and care services—
including a description of services provided, clients served, and funding levels
and sources—is needed by both prevention and care planners;
 Sharing of mailing lists can be the beginning of collaboration on such an
inventory.
 A joint provider survey can be conducted to obtain data needed by either or both
groups, with shared data analysis responsibility.
 The CARE Act planning body analyzes information needed only for care planning;
the prevention group analyzes data needed only for prevention planning
Characteristics of a Comprehensive Needs
Assessment

Collective experience indicates that a sound needs assessment—a
needs assessment that provides the information needed for priority
setting, planning, and the design of service systems to address service
gaps and unmet needs—typically has the following characteristics:
– It is comprehensive, looking at a broad range of service categories,
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populations, and geographic areas.
It is broadly participatory, including input from population groups affected
by the local epidemic—including individuals who know their HIV status but
are not in care—and collaborates (where feasible) with other HIV/AIDS
planning efforts.
It includes both quantitative and qualitative information.
It develops and follows a process that results in community
acceptance of the outcome.
It is designed with specific "end uses and users" in mind.
It includes year-round efforts to identify and assess the service needs of
individuals who know their HIV status but are not receiving primary health
care.
Importance/Rationale for Estimating Unmet Needs
for Primary Health Care
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+ 75% of HIV-infected Americans know their HIV status, ~ 650,000 (CDC)
+ 33% of the 650,000 who know their status (233,000) are not receiving HIV-related primary
health care (I.e. they have HRSA-defined unmet needs);
Analysis in PA shows that HIV continues to disproportionately affect historically underserved
populations;
Some people living with HIV (PLWH) populations are disproportionately less likely than others
to be receiving primary health care (HRSA);
HRSA guidelines call for getting more PLWH into primary care, particularly those who are
disproportionately affected;
Care Act Amendment of 2000 requirements include:
– An assessment of the unmet needs of PLWH “who know their HIV status and are not
receiving HIV-related services”,
 Particularly those from “disproportionately affected and historically underserved
populations.”
Care Act resources are to be kept “focused on early intervention and care delivery rather than
expansion into prevention areas such as outreach to persons who do not know their HIV status;
Targeting the needs of the “disproportionately affected and historically underserved populations”
requires assessment of unmet need.
Understanding the magnitude and determinants of unmet needs will enable public health
program planners and implementing partners to craft strategies to address service barriers,
deliver primary health care and also avail other support services that enable those in need to
obtain and maintain primary care.
Assessment of Unmet Need Within the Care Act
Planning Process
Methodological Considerations in Estimating Unmet Needs

Capacity:
–
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Methodologically complicated process; requires capacity to collect needed data,
integrate and use data from multiple data sources, combine quantitative and
qualitative data, and translate information into understandable form for use in planning
and priority setting;
Data Limitations:
–
Availability and access limitations in relation to need for HIV reporting data; Limitations
of surveillance data/databases; Lack of agreed-upon key questions and "core
variables; Cross-title issues regarding data collection and data sharing; Lack of
access to data from non-CARE Act sources/providers including other Federal
agencies; need for client-level databases; Non-generalizable data; matching data from
different databases; Confidentiality concerns;

Use of Multiple Data Sets:
 Resource Limitations:
–
Financial and personnel resources; Limitations of surveys addressing unmet need;
Burden of developing methodologies;
Intro to HRSA-Defined Framework for Measuring Unmet Need

HRSA-recommended framework to estimate the number of individuals in service
area who are aware of their HIV status (PLWH/aware) but not receiving HIVrelated primary medical care;
–
Primary medical care is roughly equivalent to "medical evaluation and clinical care" in
the HRSA definition of primary health care;

Goal is to calculate how many PLWH/aware individuals in a particular area are
"in" and "out" of primary medical care;
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Why HRSA framework focuses on PLWH/aware and not total PLWH (true HIV
and AIDS prevalence):
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A diagnosis of HIV must be made before receiving HIV primary medical care;
– The CARE Act legislation requires grantees to focus on individuals who are aware of
their status;

Framework differentiates PLWH/aware into 2 main subsets:
–
PLWA(HIV+/AIDS)/aware
– PLWH (HIV+/non-AIDS)/aware
Definitions for Calculating Unmet Needs for HIV
Primary Medical Care: Outcome Measures

Unmet need for HIV primary medical care:
– No evidence of any of the following three components of HIV primary
medical care during a specified 12-month time frame:
 Viral Load (VL) Testing,
 CD4 Count, or
 Provision of Anti-Retroviral Therapy (ART).

Met need for HIV primary medical care:
– Demonstration of any one or more of the three measures during the
specified 12-month time frame.
The Unmet Needs Framework: Data Needed

2 Primary Inputs for Unmet Needs Calculation
=> Care Input / Population Input

Population Size Data Needed:
# diagnosed with HIV in service area during time period
=> PLWH (AIDS AND NON-AIDS)
=> (A) # PLWA & (B) # PLWH HIV+/non-AIDS/aware)

Care Patterns Data Needed:
# receiving primary care from any provider
=> % PLWH (AIDS AND NON-AIDS) meeting primary care definition
=> (A) % PLWA meeting primary care definition & (B) % PLWH HIV+/nonAIDS/aware) meeting primary care definition
Data Sources

Number of People Living with AIDS (PLWA): <= AIDS Surveillance [State
HIV/AIDS Reporting System (HARS)]

Number of People Diagnosed and Living with HIV/non-AIDS (HIV+/nonAIDS/aware): <= HIV Surveillance [State HIV/AIDS Reporting System (HARS)]

Percent or number of PLWH/aware (AIDS and non-AIDS) meeting primary
medical care definition:
–
–
Surveillance data:
Linked utilization data:
 Linking billing or service information in various client-level databases, with the
use of adequate measures to protect confidentiality (use of a non-identifying
unique identifier or soundex code, e.g.
– Combining data from CARE Act (ideally Titles I-IV), Medicaid, and
Veterans Administration (VA) will cover the largest sources of HIV primary
medical care.
– Adjust for care received privately;
– Special studies data:
 AIDS Spectrum of Disease (ASD)
 Supplemental HIV/AIDS Survey (SHAS),
 Other approaches
From Risk of Infection to Infection through Disease Progression:
Order of Data Collection from Surveillance & Supplementary Sources
Retrospective Lookback
Prospective Follow-up
Presence of
Adverse Outcomes
e.g: Unmet Needs;
Poor Survival; or
Deceased
(E+) Certain
(E+) HIV+
Pre-infection All
Exposures
HIV+/aware
Present;
eligible
for
(E-) Certain Case
Pre-infection Surveillance
Cohort
Exposures
(E-) HIV+
Not Present;
Retrospective review of
Pre-Infection to Infection stage
for “negatives”:
•
Absence of
Adverse Outcome
E.g. Met Needs;
Better Survival; or
Alive;
Prospective follow-up of HIV+/aware persons, service data,
intermediate disease progression and final outcomes assessed:

Past exposures ascertained through
lookback review of medical charts at •
time of entry into cohort (i.e. reported
diagnoses of HIV/AIDS meeting CDC
•
surveillance case definition); past
exposures/ risk info may be
supplemented through linkage studies
with STD surveillance, case reports
•
from confidential C&T, etc
Subjects followed through time, service data, intermediate and final
outcomes assessed:
“In Care” service indicator data collected in surveillance and other
linkable service provider datasets; viz. Treatment, Adherence Case
Management, etc.
Intermediate outcomes/end-points are used to monitor disease
progression with ongoing reports of laboratory test results of CD4, Viral
Load (and Antiretroviral treatment) as indicators of disease progression or
access/delivery of services;
Potential outcome of death is ascertained through regular matching with
the death registry
Study Design II: A Conceptual Framework of the Dynamic Cohort Study
Design and Study Population in the HIV/AIDS Reporting System

Study subjects
enter the cohort
study at diagnosis
(which may be at
different calendar
time points
=~dynamic cohort)
and are followed up
through death,

The Study cohort
on this slide was
derived from the
Pennsylvania AIDS
surveillance
database and
included all 12,804
adult AIDS cases
diagnosed in PA
before January
1995,

The cohort was
followed up
through December
31, 1998, allowing
for at least 48
months after the
last diagnosis.
THE DYNAMIC COHORT OF THE AIDS CASE POPULATION
The Overall Study Design for HIV/AIDS Surveillance
1993 revision of
AIDS case definition
N=12,804
72000
64800
57600
Number of Cases
x
x
x
50400
x
43200
36000
Right
Censored
cases,
x
x
x
x
28800
Not Known:
max. survival time
of censored cases
Known:
P-T contribution
of censored cases
to total P-T
observed for
cohort
x
x
21600
x
14400
x
7200
x
x
1) end of f-u
2) lost to f-u
2.1) outmigration
2.2.) death not
ascertained
x
x
0
12
1982
12
1984
12
1986
12
1988
Jan 1980
Study begins
12
1992
12
1994
Year of Diagnosis
Adult
AIDS diagnosis
(entry criterion)
}
Individual's
contribution
to total
person-time
observed)
12
1990
Death ( x )
= outcome/
event of interest
Survival Time, in months
12
1996
}
12
1980
December, 1994
Cohort closed
(truncated)
12
12
12
1998
1999
2000
December, 1998
End of all F-U
(cohort censored)
48 months f-u
allowed for after last
diagnosis
Study Design III: A Conceptual Framework of the Dynamic Cohort Study
Design and Study Population in the HIV/AIDS Reporting System

Death
Another Perspective:
 The study subjects enter
the cohort study at
diagnosis through case
report by physician,
laboratory and ICD-9/lab
data audits of provider
reporting;
 Follow-up data on
disease progression is
monitored through
ongoing reporting of lab
test results and AIDSdefining illnesses
derived from physician
reports and matches
with facility diagnostic
codes in discharge
summaries and other
data sources;
 Cases are followed up
through death which is
ascertained through
matches with the death
registry;
.
Setting Up the Unmet Needs Framework
Jurisdiction
1
Jurisdiction
2
Jurisdiction
3
Jurisdiction 4
A. Number of persons
living with AIDS (PLWA),
recent time period
HARS
HARS
HARS
HARS
B. Number of persons
living with HIV (HIV+/nonAIDS/aware), recent time
period
CDC
midpoint
estimate
Estimates
based on
local
modeling
HARS
(HIV reporting
State)
HARS
(HIV reporting
State)
Population sizes
.
Setting Up the Unmet Needs Framework
Jurisdiction
1
Jurisdiction
2
Jurisdiction
3
Jurisdiction 4
A. Number of persons
living with AIDS (PLWA),
recent time period
HARS
HARS
HARS
HARS
B. Number of persons
living with HIV (HIV+/nonAIDS/aware), recent time
period
CDC
midpoint
estimate
Estimates
based on
local
modeling
HARS
(HIV reporting
State)
HARS
(HIV reporting
State)
Population sizes
Care patterns
C. % of PLWA who
received the specified
primary medical care
services in a 12-month
period
D. % of HIV+/non-AIDS/
aware who received the
specified primary medical
care services in a 12month period
Chart review
Linked
of all PLWA
Demonstration CD4/Viral Load
claims
(or
of VL, CD4 or
Reporting in
databases +
representative
ART in ASD
HARS
private care
sample)
AIDS
progression
study
Linked
Demonstration CD4/Viral Load
claims
of VL, CD4 or
Reporting in
databases +
ART in ASD
HARS
private care
Input
Pop Inputs
Value
A. Number of PLWA, recent
time period (as of 12/01).
B. Number of HIV+/nonAIDS/aware, recent time period
(as of 12/01).
Care Inputs
Calculations
Data Source
7,812
Local AIDS Reporting
System. Counts for the 20
County EMA in year 2001.
7,550
CDC Estimates, midpoint,
for 20- county EMA in year
2001.
Care patterns
C. # of PLWA who received the
specified primary medical care
services in 12-month period.
5,032
Linked client data (based on
date of birth, race, & gender)
from Medicaid, VA, and
CARE Act databases for
year 2001.
D. # of HIV+/non-AIDS/aware
who received the specified
primary medical care services
in 12-month period.
3,019
Same as above.
7.7%
State inpatient/discharge
data from National HCUP
project (1998).
E. % of PLWH who use private
care only
Calculated results
F. Number of PLWA who did
not receive specified primary
medical care services.
G. Number of HIV+/nonAIDS/aware who did not
receive specified primary
medical care services.
H. Total persons not receiving
specified primary medical care
services ( = unmet need if all
should be getting that service).
Value
Calculation
2,566
= (A - C) * (1 - E)
4,182
= (B - D) * (1 - E)
6,748
=F+G
Calculating
Unmet
Needs
Estimates
w/out HIV
Reporting
Data
ANALYSES
RESULTS FOR
DEMONSTRATION
ONLY
Input
Pop Inputs
Value
A. Number of PLWA, recent
time period (as of 12/01).
B. Number of HIV+/nonAIDS/aware, recent time period
(as of 12/01).
Care Inputs
Calculations
Data Source
7,812
Local AIDS Reporting
System. Counts for the 20
County EMA in year 2001.
7,550
CDC Estimates, midpoint,
for 20- county EMA in year
2001.
Care patterns
C. # of PLWA who received the
specified primary medical care
services in 12-month period.
5,032
Linked client data (based on
date of birth, race, & gender)
from Medicaid, VA, and
CARE Act databases for
year 2001.
D. # of HIV+/non-AIDS/aware
who received the specified
primary medical care services
in 12-month period.
3,019
Same as above.
7.7%
State inpatient/discharge
data from National HCUP
project (1998).
E. % of PLWH who use private
care only
Calculated results
F. Number of PLWA who did
not receive specified primary
medical care services.
G. Number of HIV+/nonAIDS/aware who did not
receive specified primary
medical care services.
H. Total persons not receiving
specified primary medical care
services ( = unmet need if all
should be getting that service).
Value
Calculation
2,566
= (A - C) * (1 - E)
4,182
= (B - D) * (1 - E)
6,748
=F+G
Calculating
Unmet
Needs
Estimates
w/out HIV
Reporting
Data
ANALYSES
RESULTS FOR
DEMONSTRATION
ONLY
Input
Pop Inputs
Value
A. Number of PLWA, recent
time period (as of 12/01).
B. Number of HIV+/nonAIDS/aware, recent time period
(as of 12/01).
Care Inputs
Calculations
Data Source
7,812
Local AIDS Reporting
System. Counts for the 20
County EMA in year 2001.
7,550
CDC Estimates, midpoint,
for 20- county EMA in year
2001.
Care patterns
C. # of PLWA who received the
specified primary medical care
services in 12-month period.
5,032
Linked client data (based on
date of birth, race, & gender)
from Medicaid, VA, and
CARE Act databases for
year 2001.
D. # of HIV+/non-AIDS/aware
who received the specified
primary medical care services
in 12-month period.
3,019
Same as above.
7.7%
State inpatient/discharge
data from National HCUP
project (1998).
E. % of PLWH who use private
care only
Calculated results
F. Number of PLWA who did
not receive specified primary
medical care services.
G. Number of HIV+/nonAIDS/aware who did not
receive specified primary
medical care services.
H. Total persons not receiving
specified primary medical care
services ( = unmet need if all
should be getting that service).
Value
Calculation
2,566
= (A - C) * (1 - E)
4,182
= (B - D) * (1 - E)
6,748
=F+G
Calculating
Unmet
Needs
Estimates
w/out HIV
Reporting
Data
ANALYSES
RESULTS FOR
DEMONSTRATION
ONLY
Calculating Unmet Needs Estimates in Area w/HIV Reporting
PRELIM. ANALYSES
RESULTS FOR
DEMONSTRATION ONLY
Pop Inputs
Care Inputs
Calculations
Calculating Unmet Needs Estimates in Area w/HIV Reporting
PRELIM. ANALYSES
RESULTS FOR
DEMONSTRATION ONLY
Pop Inputs
Care Inputs
Calculations
Calculating Unmet Needs Estimates in Area w/HIV Reporting
PRELIM. ANALYSES
RESULTS FOR
DEMONSTRATION ONLY
Pop Inputs
Care Inputs
Calculations
Integrating the Unmet Needs Framework with Other
Needs Assessment Analyses and Activities

Further analyses needed in addition to calculating how many PLWH
who know their status are not receiving HIV-related primary medical
care:
– Describe who these people are and where they are.
 The planning body can consider what can be done in the State or locality to
improve primary care access.

Data needed to estimate the number of PLWH who not receiving
primary medical care generally also allow sub-analyses:
– By characteristics of people with unmet needs in terms of gender,
race/ethnicity, and other important sociodemographic characteristics;
– Some population and care data can also be analyzed for smaller
geographic areas, such as counties, regions, or Public Health Service
Areas, allowing for better targeting of resources and activities;
– To assess the relationship between service gaps and unmet needs,
correlation analyses of the relationship between unmet needs and
ecological variables such as levels of service gaps may also identify larger
contextual forces that may be associated with aggregate measures of
indicators of unmet need;
Findings of Investigations of Effect of HIV Case Management
on Unmet Needs for Primary Medical Care
Adapted from Katz MH et al. Ann Intern Med. 2001 Oct 16;135(8 Pt 1):557-65.

RESULTS: At baseline, 56.5% of the sample studied had contact with a case
manager in the previous 6 months.
 In multiple logistic regression analyses that adjusted for potential confounders,
contact with a case manager at baseline was associated with decreased
unmet need for income assistance (odds ratio [OR], 0.57 [95% CI, 0.36 to
0.91]), health insurance (OR, 0.54 [CI, 0.33 to 0.89]), home health care (OR,
0.29 [CI, 0.15 to 0.56]), and emotional counseling (OR, 0.62 [CI, 0.41 to 0.94])
at follow-up.
 Contact with case managers was not significantly associated with
utilization of ambulatory care (OR, 0.77 [CI, 0.57 to 1.04]), hospitalization (OR,
1.13 [CI, 0.84 to 1.54]), or emergency department visits (OR, 1.30 [CI, 0.97 to
1.73]) but was associated with higher utilization of two-drug (OR, 1.58 [CI,
1.23 to 2.03]) and three-drug (OR, 1.34 [CI, 1.00 to 1.80]) antiretroviral
regimens and of treatment with protease inhibitors or non-nucleoside
reverse transcriptase inhibitors (OR, 1.29 [CI, 1.02 to 1.64]) at follow-up.

CONCLUSIONS: Case management appears to be associated with
fewer unmet needs and higher use of HIV medications in patients
receiving HIV treatment.
EPIDEMIOLOGY OF
HIV/AIDS IN PENNSYLVANIA
Module 2
*Epidemiology Methods: Conceptualization, Design, Conduct and
Outcome Evaluation of Response Plans & Intervention Programs (to
address unmet needs)
Benjamin Richard H. Muthambi, DrPH, MPH
State HIV/AIDS Epidemiologist
<HIV Public Health Intervention Program Support>
Key Steps in the Conceptualization, Design, Conduct and Outcome
Evaluation of Response Plans & Intervention Programs

Review Sources of Summary Information on Potential Risk-Factors and
Outcomes in Comprehensive Unmet Needs Assessment

Conceptualize Response Plans & Intervention Programs to Address Unmet
Needs; (incorporating other components of the comprehensive assessment
of unmet needs);

Design Response Plans & Intervention Programs/Practice Protocols to
Address Unmet Needs

Conduct/Implement Response Plans & Intervention Program/Practice
Protocols to Address Unmet Needs;

Outcome Evaluation of Response Plans & Intervention Program/Practice
Protocols to Address Unmet Needs;
Development and Evaluation of Response Plans & Intervention Programs


Review the comprehensive needs assessment and identify data-driven findings and
recommended public health actions as a basis for a series of program plans to address each
recommendation;
Prioritize risk factors based on findings of relative importance of risk factors identified in
multivariate analyses of comprehensive unmet need data: a key factor in such prioritization is
the projected potential for preventing unmet needs (based on the concept of “attributable risk”,
“prevented fraction” is the proportion of unmet needs that would be prevented by eliminating or
reducing a given risk factor or determinant);
Sources of Summary Information on Potential Risk-Factors and
Outcomes in Comprehensive Unmet Needs Assessment

Integrated Epidemiologic Profile of HIV:
–

Assessment of service needs among affected populations:
–
–

Identifies the extent to which services identified in the resource inventory are accessible, available, and
appropriate for PLWH, including specific subpopulations;

Describe Capacity: how much of which services a provider can deliver ;

Describe Capability: the degree to which a provider is actually accessible and has the needed expertise to
provide services ;

Assessment of barriers to PLWH receiving services is an important aspect of this component (i.e., the
profile should inquire from PLWH directly or service providers the barriers faced in accessing services);

Provider profiles may also explore client perceptions of service quality and appropriateness: assessment of
client satisfaction is a complex effort that should be undertaken thoroughly in the planning body's quality
improvement process.
Assessment of unmet need and service gaps:
–
–
–

Describes organizations and individuals providing services across the full spectrum of HIV services accessible
to PLWH in the service area, regardless of funding source.
Profile of provider capacity and capability:
–

Includes barriers that prevent PLWH from receiving needed services;
Information must be collected from multiple sources, among them PLWH and other community members, the
health department, Medicaid agency, community-based providers and, where applicable, grantees of other CARE
Act titles. Information must be obtained from and about HIV-positive individuals who know their status and are
not in care.
Resource inventory:
–

Describes the current status of the epidemic in the service area: of greater relevance to care, specifically
describe the prevalence (burden of disease) of HIV and AIDS overall and among defined subpopulations;
This should include an assessment of the unmet need for PLWH who know their HIV status but are not in care
and an assessment of service gaps for all PLWH—both in and out of care;
This assessment should bring together the quantitative and qualitative data on service needs, resources, and
barriers to help set priorities and allocate resources;
Gap analyses are used to correlate services, morbidity, unmet needs, etc
Annual Updates: Certain components of the needs assessment should be expanded and/or updated, depending
on trends and special issues facing the State, EMA, or other service area.
Findings of Comprehensive Investigations of Effect of HIV Case
Management as a Predictor of Unmet Needs for Primary Medical Care
Adapted from Katz MH et al. Ann Intern Med. 2001 Oct 16;135(8 Pt 1):557-65.

RESULTS: At baseline, 56.5% of the sample studied had contact with a case
manager in the previous 6 months.
 In multiple logistic regression analyses that adjusted for potential confounders,
contact with a case manager at baseline was associated with decreased
unmet need for income assistance (odds ratio [OR], 0.57 [95% CI, 0.36 to
0.91]), health insurance (OR, 0.54 [CI, 0.33 to 0.89]), home health care (OR,
0.29 [CI, 0.15 to 0.56]), and emotional counseling (OR, 0.62 [CI, 0.41 to 0.94])
at follow-up.
 Contact with case managers was not significantly associated with
utilization of ambulatory care (OR, 0.77 [CI, 0.57 to 1.04]), hospitalization (OR,
1.13 [CI, 0.84 to 1.54]), or emergency department visits (OR, 1.30 [CI, 0.97 to
1.73]) but was associated with higher utilization of two-drug (OR, 1.58 [CI,
1.23 to 2.03]) and three-drug (OR, 1.34 [CI, 1.00 to 1.80]) antiretroviral
regimens and of treatment with protease inhibitors or non-nucleoside
reverse transcriptase inhibitors (OR, 1.29 [CI, 1.02 to 1.64]) at follow-up.

CONCLUSIONS: Case management appears to be associated with
fewer unmet needs and higher use of HIV medications in patients
receiving HIV treatment.
From Risk of Infection to Infection through Disease Progression :
Predictors/Determinants/Risk Factors of Unmet Need
Retrospective Lookback
Prospective Follow-up
Presence of
Adverse Outcomes
e.g: Unmet Needs;
Poor Survival; or
Deceased
(E+) Certain
(E+) HIV+
Pre-infection
All
Exposures
HIV+/aware
Present;
eligible
for
Case
(E-) Certain
Surveillance
Pre-infection Cohort
Exposures
(E-) HIV+
Not Present;
Predictors/Determinants/Risk Factors of
Unmet Need:





Demographic, Socioeconomic & other
factors;
Referral & Linkage to Primary Medical Care
to prevent & monitor progression;

“In Care Indicators”: Rx, CD4+, VL
Outreach/”Marketing” of care to
HIV+/aware not in care & referral to care;
Adherence Case Management;
Other Support Services;
Absence of
Adverse Outcome
E.g. Met Needs;
Better Survival; or
Alive;

Prioritize risk factors based on findings of relative
importance of risk factors identified in multivariate
analyses of comprehensive unmet need data: a key factor
in such prioritization is the projected potential for
preventing unmet needs (based on the concept of
“attributable risk”, “prevented fraction” is the proportion
of unmet needs that would be prevented by eliminating or
reducing a given risk factor or determinant);
Development and Evaluation of Response Plans & Intervention Programs




Review the comprehensive needs assessment and identify data-driven findings and
recommended public health actions as a basis for a series of program plans to address each
recommendation;
Prioritize risk factors based on findings of relative importance of risk factors identified in
multivariate analyses of comprehensive unmet need data: a key factor in such prioritization is
the projected potential for preventing unmet needs (based on the concept of “attributable risk”,
“prevented fraction” is the proportion of unmet needs that would be prevented by eliminating or
reducing a given risk factor or determinant);
Conceptualize response programs to be used to target and decrease the identified
influential/key risk factors of unmet need in affected communities;
Develop and/or implement response program protocols targeting the identified key risk factors
or indicators of unmet need in affected communities and systematically embed measurement
and documentation of relevant outcome indicators during program implementation;
From Risk of Infection to Infection through Disease Progression :
Framework of Opportunities/Avenues for Prevention and Care Services
Retrospective Lookback
Prospective Follow-up
Presence of
Adverse Outcomes
e.g: Unmet Needs;
Poor Survival; or
Deceased
(E+) Certain
(E+) HIV+
Pre-infection
All
Exposures
HIV+/aware
Present;
eligible
for
Case
(E-) Certain
Surveillance
Pre-infection Cohort
Exposures
(E-) HIV+
Not Present;
Primary Prevention
for “negatives”:

Outreach;

C & T;

PCRS;

PCM; etc…
Absence of
Adverse Outcome
E.g. Met Needs;
Better Survival; or
Alive;
Secondary Prevention:
Prevention
Primary

Referral & Linkage to Primary
for “Positives”:
Prevention:
Medical Care to prevent & monitor
HIV+/aware likely to  Prophylaxis
progression;
for PCP, TB,
Transmit HIV;
 Rx, CD4+, VL

Outreach & risk  etc.

Outreach/”Marketing” to HIV+/aware
assessment;
not in care & referral to care;

Ongoing PCRS;

Adherence Case Management;

Prevention Case

Other Support Services;
Management; etc…
From Risk of Infection to Disease Progression:
Focus on Opportunities/Avenues for Care Services
Retrospective Lookback
Prospective Follow-up
Presence of
Adverse Outcomes
e.g: Unmet Needs;
Poor Survival; or
Deceased
(E+) Certain
(E+) HIV+
Pre-infection
All
Exposures
HIV+/aware
Present;
eligible
for
Case
(E-) Certain
Surveillance
Pre-infection Cohort
Exposures
(E-) HIV+
Not Present;
Primary
Prevention
for “negatives”:

Outreach;

C & T;

PCRS;

PCM; etc…
2oInterventions

2oInterventions
Absence of
Adverse Outcome
E.g. Met Needs;
Better Survival; or
Alive;
Secondary Prevention Interventions:
Prevention
Primary

Referral & Linkage to Primary
for “Positives”:
Prevention:
Medical Care to prevent &
HIV+/aware likely  Prophylaxis
monitor progression: -Rx, CD4+, VL
for PCP, TB,
To transmit;

Outreach/”Marketing” to

etc.

Outreach;
HIV+/aware not in care & referral

Ongoing PCRS;
to care;

Prevention Case

Adherence Case Management;
Management,etc

Other Support Services: housing,
Development and Evaluation of Response Plans & Intervention Programs





Review the comprehensive needs assessment and identify data-driven findings and
recommended public health actions as a basis for a series of program plans to address each
recommendation;
Prioritize risk factors based on findings of relative importance of risk factors identified in
multivariate analyses of comprehensive unmet need data: a key factor in such prioritization is
the projected potential for preventing unmet needs (based on the concept of “attributable risk”,
“prevented fraction” is the proportion of unmet needs that would be prevented by eliminating or
reducing a given risk factor or determinant);
Conceptualize response programs to be used to target and decrease the identified
influential/key risk factors of unmet need in affected communities;
Develop and/or implement response program protocols targeting the identified key risk factors
or indicators of unmet need in affected communities and systematically embed measurement
and documentation of relevant outcome indicators during program implementation;
To determine the impact/outcomes of response programs, conduct outcome evaluations
in progressive stages; and repeat service gap analyses :
–
–
–

Assess the reduction in risk factors targeted by response programs, e.g. targeting a risk
factor/determinant/predictor variable of unmet needs such as “lack of case management”
through redirecting adherence case management resources and outreach to/linkage of those
with unmet need may increase intermediate outcomes such as the number of persons under
adherence case management;
Assess changes in outcomes in unmet needs such as retention in primary medical care and
adherence to medications;
Evaluate the relationship between changes in unmet needs, levels of bio-markers of health status
and long-term outcomes such as survival in which response programs are implemented;
Assess change by comparing pre- and post- intervention levels of outcome measures
and service gaps;
From Risk of Infection to Infection through Disease Progression :
Order of Data Collection from Surveillance & Supplementary Sources
Retrospective Lookback
Prospective Follow-up
Presence of
Adverse Outcomes
e.g: Unmet Needs;
Poor Survival; or
Deceased
(E+) Certain
(E+) HIV+
Pre-infection
All
Exposures
HIV+/aware
Present;
eligible
for
Absence of
Case
(E-) Certain
Adverse Outcome
Surveillance
Pre-infection Cohort
E.g. Met Needs;
Exposures
Better Survival; or
(E-) HIV+
Not Present;
Alive;
Retrospective review of
Prospective follow-up of HIV+/aware persons, service data,
Pre-Infection to Infection stage
intermediate disease progression and final outcomes assessed:
for “negatives”:

PLWH (HIV+/aware) followed through time, service data, intermediate and
•
Past exposures ascertained through look
back review of medical charts at time of •
entry into cohort (i.e. reported diagnoses
of HIV/AIDS meeting CDC surveillance
case definition); past exposures/ risk info
•
may be supplemented through linkage
studies with STD surveillance, case
reports from confidential C&T, etc
•
final outcomes assessed:
“In Care” service indicator data collected in surveillance and other
linkable service provider datasets; e.g. Treatment, Adherence Case
Management, etc.
Intermediate outcomes/end-points/indicators of “being in care” for
monitoring disease progression: ongoing reports of laboratory test results
of CD4, Viral Load (and Antiretroviral treatment) as indicators of disease
progression or access/delivery of services;
Potential outcome of death is ascertained through regular death matching
From Risk of Infection to Infection through Disease Progression :
Comprehensive Evaluation of Outcomes through Surveillance & Supplementary Sources
Retrospective Lookback
Prospective Follow-up
Presence of
Adverse Outcomes
e.g: Unmet Needs;
Poor Survival; or
Deceased
(E+) Certain
(E+) HIV+
Pre-infection
All
Exposures
HIV+/aware
Present;
eligible
for
Absence of
Case
(E-) Certain
Adverse Outcome
Surveillance
Pre-infection Cohort
E.g. Met Needs;
Exposures
Better Survival; or
(E-) HIV+
Not Present;
Alive;
Prospective follow-up of HIV+/aware persons, service data, intermediate disease progression
and final
outcomes assessed:


To determine the impact/outcomes of response programs, conduct comprehensive outcome evaluations in
progressive stages; and repeat service gap analyses :
–
Assess change/likelihood of reduction in risk factors targeted by response programs, e.g. targeting a risk
factor/determinant/predictor variable of unmet needs such as “lack of case management” through redirecting
adherence case management resources and outreach to/linkage of those with unmet need may increase
intermediate outcomes such as the number of persons under adherence case management;
–
Assess changes in outcomes in unmet needs such as retention in primary medical care and adherence to
medications;
–
Evaluate the relationship between changes in unmet needs, levels of bio-markers of health status and long-term
outcomes such as survival in which response programs are implemented;
Assess change by comparing pre- and post- intervention levels of outcome measures and service gaps;
Development and Evaluation of Response Plans & Intervention Programs






Review the comprehensive needs assessment and identify data-driven findings and
recommended public health actions as a basis for a series of program plans to address each
recommendation;
Prioritize risk factors based on findings of relative importance of risk factors identified in
multivariate analyses of comprehensive unmet need data: a key factor in such prioritization is
the projected potential for preventing unmet needs (based on the concept of “attributable risk”,
“prevented fraction” is the proportion of unmet needs that would be prevented by eliminating or
reducing a given risk factor or determinant);
Conceptualize response programs to be used to target and decrease the identified
influential/key risk factors of unmet need in affected communities;
Develop and/or implement response program protocols targeting the identified key risk factors
or indicators of unmet need in affected communities and systematically embed measurement
and documentation of relevant outcome indicators during program implementation;
To determine the impact/outcomes of response programs, conduct outcome evaluations in
progressive stages; and repeat service gap analyses :
– Assess change/likelihood of reduction in risk factors targeted by response programs, e.g.
targeting a risk factor/determinant/predictor variable of unmet needs such as “lack of case
management” through redirecting adherence case management resources and outreach
to/linkage of those with unmet need may increase intermediate outcomes such as the
number of persons under adherence case management;
– Assess changes in outcomes in unmet needs such as retention in primary medical care
and adherence to medications;
– Evaluate the relationship between changes in unmet needs, levels of bio-markers of health
status and long-term outcomes such as survival in which response programs are
implemented;
Assess change by comparing pre- and post- intervention levels of outcome measures and
service gaps;
Outline for Module 3:
Introduction to Applied HIV Epidemiology Collaboration Mechanisms
Addressing Unmet Needs at the Agency Level through Commissioned & Mentored InService Learning Projects

Logistical Considerations for Design, Conduct and Comparative Evaluation
of Competing Models for Linkage of Epidemiologic Case Surveillance to
Intervention Activities;
Introduction to Applied HIV Epidemiology Collaboration Mechanisms
Addressing Unmet Needs at the Agency Level through Commissioned & Mentored InService Learning Projects

Applied HIV Epidemiology Collaboration Mechanisms for Local or
Community-Based Research:
– Commissioned Projects;
– Commissioned Mentored In-Service Learning Projects
– What are the aspects of the project which may require technical support?
From Risk of Infection to Disease Progression:
Focus on Opportunities/Avenues for Care Services
Retrospective Lookback
Prospective Follow-up
Presence of
Adverse Outcomes
e.g: Unmet Needs;
Poor Survival; or
Deceased
(E+) Certain
(E+) HIV+
Pre-infection
All
Exposures
HIV+/aware
Present;
eligible
for
Case
(E-) Certain
Surveillance
Pre-infection Cohort
Exposures
(E-) HIV+
Not Present;
Primary
Prevention
for “negatives”:

Outreach;

C & T;

PCRS;

PCM; etc…
2oInterventions

2oInterventions
Absence of
Adverse Outcome
E.g. Met Needs;
Better Survival; or
Alive;
Secondary Prevention Interventions:
Prevention
Primary

Referral & Linkage to Primary
for “Positives”:
Prevention:
Medical Care to prevent &
HIV+/aware likely  Prophylaxis
monitor progression: -Rx, CD4+, VL
for PCP, TB,
To transmit;

Outreach/”Marketing” to

etc.

Outreach;
HIV+/aware not in care & referral

Ongoing PCRS;
to care;

Prevention Case

Adherence Case Management;
Management,etc

Other Support Services: housing,
Design, Conduct Implementation and Evaluation of Response Plans to
Unmet Needs Assessment for Primary Medical Care

Establish Common Aims & Objectives (preferably, Applicable to All
Participating Sites):
–
The purpose of the study is to:
 To develop and implement and evaluate response plans to unmet needs assessment
for primary medical care;
Design, Conduct Implementation and Evaluation of Response Plans to
Unmet Needs Assessment for Primary Medical Care

Establish Common Methods Applicable to All Participating Sites:
– This must include:




Selecting potential study sites;
Selecting common study design;
Determine standard predictor and outcome variables to be measured;
Establishing comparable study procedures;
– Measurement Procedures:
– Intervention Procedures:
– Analyses Procedures:





Defining common approaches for interpreting, sharing and publishing
results and for translating findings into public health action to improve
services;
Develop standard study protocol;
Seek Funding for Study;
Obtain IRB review, if required;
Implement Study, if funded;
Design, Conduct Implementation and Evaluation of Response Plans to
Unmet Needs Assessment for Primary Medical Care

Establish Common Methods Applicable to All Participating Sites:
– This must include:
 A) Selecting potential study sites:
– a site may be a local health Department or individual facilities;
Design, Conduct Implementation and Evaluation of Response Plans to
Unmet Needs Assessment for Primary Medical Care

Establish Common Methods Applicable to All Participating Sites:
– This must include:
 B) Selecting common study design:
– e.g. Non-Randomized Community Intervention Trial;
Design, Conduct Implementation and Evaluation of Response Plans to
Unmet Needs Assessment for Primary Medical Care

Establish Common Methods Applicable to All Participating Sites:
– This must include:
 C) Determine standard predictor and outcome variables to be measured;
– What variables can we consider measuring?
Design, Conduct Implementation and Evaluation of Response Plans to
Unmet Needs Assessment for Primary Medical Care

Establish Common Methods Applicable to All Participating Sites:
–
This must include:
 D) Establish comparable study procedures;
– a) Measurement Procedures:
• Define pre- and post-intervention measures of predictor and outcome
variables [e.g. no of contacts generated from each index HIV+ individual per
PCRS encounter; eligibility criteria for each intervention type; success of
linkage to prevention, care or support services (e.g. linkage to PCRS or case
management); CD4; VL; etc].
• Measure pre-intervention levels of predictor and outcome variables;
• Measure post-intervention levels of predictor and outcome variables;
Design, Conduct Implementation and Evaluation of Response Plans to
Unmet Needs Assessment for Primary Medical Care

Establish Common Methods Applicable to All Participating Sites:
– This must include:
 D) Establish comparable study procedures;
– b) Intervention Procedures:
• Develop public health intervention/practice protocols to be implemented
across sites;
• Implement public health intervention/practice protocols in each site
synchronously (most preferable);
Design, Conduct Implementation and Evaluation of Response Plans to
Unmet Needs Assessment for Primary Medical Care

Establish Common Methods Applicable to All Participating
Sites:
– This must include:
 D) Establish comparable study procedures;
– c) Analyses Procedures:
• Define relationships to be analyzed: e.g. r/ship of # successful
linkages to case management or county of residence vs. median #
cases with unmet need for primary medical care (CD4 or VL or Rx)
in a given 12 month period);
• Perform analyses of within and across-site comparisons of
pre- and post-intervention rates of successful linkage to
respective interventions such as case management (analyses of
covariance);
• Perform analyses of within and across site comparisons of preand post intervention levels of outcome measures such as
unmet needs; indicators of implementation of PHS guidelines;
median CD4 cell counts; Viral Load; etc (analyses of covariance);
Design, Conduct Implementation and Evaluation of Response Plans to
Unmet Needs Assessment for Primary Medical Care

Establish Common Methods Applicable to All Participating Sites:
–
This must include:
 E) Define common approach for interpreting results and for translating findings into
public health action to improve services;
Design, Conduct Implementation and Evaluation of Response Plans to
Unmet Needs Assessment for Primary Medical Care

Establish Common Methods Applicable to All Participating Sites:
– This must include:
 F) Develop standard study protocol;
Design, Conduct Implementation and Evaluation of Response Plans to
Unmet Needs Assessment for Primary Medical Care

Establish Common Methods Applicable to All Participating Sites:
– This must include:
 G) Seek Funding for Study;
Design, Conduct Implementation and Evaluation of Response Plans to
Unmet Needs Assessment for Primary Medical Care

Establish Common Methods Applicable to All Participating Sites:
– This must include:
 H) Obtain IRB review, if required;
Design, Conduct Implementation and Evaluation of Response Plans to
Unmet Needs Assessment for Primary Medical Care

Establish Common Methods Applicable to All Participating Sites:
– This must include:

I) Implement Study, if funded; (how & who?);