epidemiology of hiv/aids in pennsylvania module 1 *introduction to epidemiologic methods for...

EPIDEMIOLOGY OF EPIDEMIOLOGY OF HIV/AIDS IN HIV/AIDS IN

PENNSYLVANIAPENNSYLVANIAModule 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 1Outline 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, Definitions of Primary Health Care, Primary Medical Care, & Service GapsPrimary Medical Care, & Service Gaps– 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;

– 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 Components of HRSA’s Framework for Comprehensive Needs AssessmentComprehensive 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;

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;


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;

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 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 Updates of Components of the Comprehensive Needs AssessmentNeeds 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

– Resource inventory: ?Every 1 – 2 Years?

– Profile of provider capacity and capability: ?Every 1 – 2 Years?

– Assessment of service needs among affected populations: ?Every 2 years?

– 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, Basic Concepts: Unmet Needs, Primary Health Care, Primary Medical Care, and “In 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;

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 health-related 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”.

Basic Concepts: Unmet Needs, Primary Health Care, Basic Concepts: Unmet Needs, Primary Health Care, Primary Medical Care, and “In Care”Primary Medical Care, and “In Care”

Service Gaps vs. Unmet Needs: Parts of Service Gaps vs. Unmet Needs: Parts of Comprehensive Needs AssessmentComprehensive 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 Service Gaps vs. Unmet Needs: Parts of Comprehensive Needs AssessmentComprehensive 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 DataTypes of Needs Assessment Data

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: Collaboration between Prevention & Care: Opportunities & ChallengesOpportunities & 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 Characteristics of a Comprehensive Needs AssessmentAssessment

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, 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 Importance/Rationale for Estimating Unmet Needs for Primary Health Carefor Primary Health Care

+ 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 Assessment of Unmet Need Within the Care Act Planning ProcessPlanning Process

Methodological Considerations in Estimating Unmet NeedsMethodological Considerations in Estimating Unmet Needs

Capacity: – 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 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 HIV-related 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;

Why HRSA framework focuses on PLWH/aware and not total PLWH (true HIV and AIDS prevalence):

– 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 Definitions for Calculating Unmet Needs for HIV Unmet Needs for HIV Primary Medical CarePrimary Medical Care: Outcome Measures: 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 NeededThe 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+/non-AIDS/aware) meeting primary care definition

Data SourcesData 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+/non-AIDS/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

All HIV+/aware eligible for CaseSurveillanceCohort

From Risk of Infection to Infection through Disease Progression: From Risk of Infection to Infection through Disease Progression: Order of Data Collection from Surveillance & Supplementary SourcesOrder of Data Collection from Surveillance & Supplementary Sources

(E+) HIV+

(E-) HIV+

Presence of Adverse Outcomese.g: Unmet Needs;Poor Survival; or Deceased

Absence of Adverse Outcome E.g. Met Needs;Better Survival; orAlive;

Retrospective Lookback Prospective Follow-up

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Retrospective review of

Pre-Infection to Infection stage

for “negatives”:• 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

(E+) Certain Pre-infectionExposuresPresent;

(E-) Certain Pre-infectionExposuresNot Present;

Prospective follow-up of HIV+/aware persons, service data,

intermediate disease progression and final outcomes assessed: 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

THE DYNAMIC COHORT OF THE AIDS CASE POPULATION

12 12 12 12 12 12 12 12 12 12 12 121980 1982 1984 1986 1988 1990 1992 1994 1996 1998 1999 2000

Year of Diagnosis

0

7200

14400

21600

28800

36000

43200

50400

57600

64800

72000

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December, 1994Cohort closed (truncated)

Jan 1980 Study begins

December, 1998End of all F-U (cohort censored)

48 months f-u allowed for after last diagnosis

x x

1993 revision of AIDS case definition

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x x x

AdultAIDS diagnosis (entry criterion)

Death ( x ) = outcome/ event of interest

Individual's contribution to total person-timeobserved)

The Overall Study Design for HIV/AIDS Surveillance

Survival Time, in months

Right Censoredcases, 1) end of f-u2) lost to f-u 2.1) outmigration 2.2.) death not ascertained

Not Known:max. survival time of censored cases Known: P-T contribution of censored cases to total P-T observed for cohort

N=12,804

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.

Study Design II: A Conceptual Framework of the Dynamic Cohort Study Study Design II: A Conceptual Framework of the Dynamic Cohort Study Design and Study Population in the HIV/AIDS Reporting SystemDesign and Study Population in the HIV/AIDS Reporting System

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 AIDS-defining 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;

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Study Design III: A Conceptual Framework of the Dynamic Cohort Study Study Design III: A Conceptual Framework of the Dynamic Cohort Study Design and Study Population in the HIV/AIDS Reporting SystemDesign and Study Population in the HIV/AIDS Reporting System

Setting Up the Unmet Needs FrameworkSetting Up the Unmet Needs Framework.

Population sizes 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+/non-AIDS/aware), recent time period

CDC midpoint estimate

Estimates based on

local modeling

HARS (HIV reporting

State)

HARS (HIV reporting

State)

Setting Up the Unmet Needs FrameworkSetting Up the Unmet Needs Framework.

Population sizes 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+/non-AIDS/aware), recent time period

CDC midpoint estimate

Estimates based on

local modeling

HARS (HIV reporting

State)

HARS (HIV reporting

State)

Care patterns

C. % of PLWA who received the specified primary medical care services in a 12-month period

Chart review of all PLWA

(or representative

sample)

Linked claims

databases + private care

Demonstration of VL, CD4 or ART in ASD

CD4/Viral Load Reporting in

HARS

D. % of HIV+/non-AIDS/ aware who received the specified primary medical care services in a 12-month period

AIDS progression

study

Linked claims

databases + private care

Demonstration of VL, CD4 or ART in ASD

CD4/Viral Load Reporting in

HARS

Calculating Calculating Unmet Unmet Needs Needs

Estimates Estimates w/out HIV w/out HIV Reporting Reporting

DataData

Pop Inputs

Care Inputs

Calculations

ANALYSESRESULTS FOR DEMONSTRATION ONLY

Input Value Data Source

A. Number of PLWA, recent time period (as of 12/01).

7,812 Local AIDS Reporting System. Counts for the 20 County EMA in year 2001.

B. Number of HIV+/non-AIDS/aware, recent time period (as of 12/01).

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.

E. % of PLWH who use private care only

7.7% State inpatient/discharge data from National HCUP project (1998).

Calculated results Value Calculation

F. Number of PLWA who did not receive specified primary medical care services.

2,566 = (A - C) * (1 - E)

G. Number of HIV+/non-AIDS/aware who did not receive specified primary medical care services.

4,182 = (B - D) * (1 - E)

H. Total persons not receiving specified primary medical care services ( = unmet need if all should be getting that service).

6,748 = F + G

Calculating Unmet Needs Estimates in Area w/HIV ReportingCalculating Unmet Needs Estimates in Area w/HIV Reporting

PRELIM. ANALYSESRESULTS FOR

DEMONSTRATION ONLY

Pop Inputs

Care Inputs

Calculations

Integrating the Unmet Needs Framework with Other Integrating the Unmet Needs Framework with Other Needs Assessment Analyses and ActivitiesNeeds 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;

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.

Findings of Investigations of Effect of HIV Case Management Findings of Investigations of Effect of HIV Case Management on Unmet Needs for Primary Medical Careon Unmet Needs for Primary Medical Care

EPIDEMIOLOGY OF EPIDEMIOLOGY OF HIV/AIDS IN HIV/AIDS IN

PENNSYLVANIAPENNSYLVANIAModule 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 ConceptualizationKey Steps in the Conceptualization, Design, Conduct and Outcome , Design, Conduct and Outcome Evaluation of Response Plans & Intervention ProgramsEvaluation 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 ProgramsDevelopment 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 Sources of Summary Information on Potential Risk-Factors and Outcomes in Comprehensive Unmet Needs AssessmentOutcomes in Comprehensive Unmet Needs Assessment

Integrated Epidemiologic Profile of HIV:– 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;

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.

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.

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; 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: – 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.

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.

Findings of Comprehensive Investigations of Effect of HIV Case Findings of Comprehensive Investigations of Effect of HIV Case Management as a Predictor of Unmet Needs for Primary Medical CareManagement as a Predictor of Unmet Needs for Primary Medical Care


From Risk of Infection to Infection through Disease Progression : From Risk of Infection to Infection through Disease Progression : Predictors/Determinants/Risk Factors of Unmet NeedPredictors/Determinants/Risk Factors of Unmet Need

(E+) HIV+

(E-) HIV+




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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;







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 ProgressionFrom Risk of Infection to Infection through Disease Progression : : Framework of Opportunities/Avenues for Prevention and Care ServicesFramework of Opportunities/Avenues for Prevention and Care Services

(E+) HIV+

(E-) HIV+




HIV

Dia

gno

sis

Dis

eas

e P

rogr

essi

on,

AID

S,

etc

At

Ris

k fo

r H

IV

Adv

erse

Out

com

e

HIV

Inf

ectio

n

Primary Prevention

for “negatives”: Outreach; C & T; PCRS; PCM; etc…

Prevention

for “Positives”:

HIV+/aware likely to

Transmit HIV; Outreach & risk

assessment; Ongoing PCRS; Prevention Case

Management; etc…



Primary

Prevention: Prophylaxis

for PCP, TB, etc.

Secondary Prevention: Referral & Linkage to Primary

Medical Care to prevent & monitor progression;

Rx, CD4+, VL Outreach/”Marketing” to HIV+/aware

not in care & referral to care; Adherence Case Management; Other Support Services;


From Risk of Infection to Disease Progression: From Risk of Infection to Disease Progression: Focus on Opportunities/Avenues for Care ServicesFocus on Opportunities/Avenues for Care Services

(E+) HIV+

(E-) HIV+




HIV

Dia

gno

sis

Dis

eas

e P

rogr

essi

on,

AID

S,

etc

At

Ris

k fo

r H

IV

Po

st I

nte

rven

tio

n O

utc

om

e M

easu

rem

ent

HIV

Inf

ectio

n

Primary Prevention


Primary Prevention: Prophylaxis

for PCP, TB, etc.

Secondary Prevention Interventions: Referral & Linkage to Primary

Medical Care to prevent & monitor progression: -Rx, CD4+, VL

Outreach/”Marketing” to HIV+/aware not in care & referral to care;

Adherence Case Management; Other Support Services: housing, etc

Preventionfor “Positives”:HIV+/aware likelyTo transmit; Outreach; Ongoing PCRS; Prevention Case

Management,etc



2oInterventions 2oInterventions

Pre

-In

terv

enti

on

Mea

sure

men

t






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 : From Risk of Infection to Infection through Disease Progression : Order of Data Collection from Surveillance & Supplementary SourcesOrder of Data Collection from Surveillance & Supplementary Sources

(E+) HIV+

(E-) HIV+




HIV

Dia

gno

sis

Dis

eas

e P

rogr

essi

on,

AID

S,

etc

At

Ris

k fo

r H

IV

Adv

erse

Out

com

e

HIV

Inf

ectio

n

Retrospective review of Pre-Infection to Infection stagefor “negatives”:• 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



Prospective follow-up of HIV+/aware persons, service data,

intermediate disease progression and final outcomes assessed: PLWH (HIV+/aware) followed through time, service data, intermediate and

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 : From Risk of Infection to Infection through Disease Progression : Comprehensive Evaluation of Outcomes through Surveillance & Supplementary Sources

(E+) HIV+

(E-) HIV+




HIV

Dia

gno

sis

Dis

eas

e P

rogr

essi

on,

AID

S,

etc

At

Ris

k fo

r H

IV

Adv

erse

Out

com

e

HIV

Inf

ectio

n



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;









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;




Outline for Module 3: Outline for Module 3: Introduction to Applied HIV Epidemiology Collaboration MechanismsIntroduction to Applied HIV Epidemiology Collaboration Mechanisms

Addressing Unmet Needs at the Agency Level through Commissioned & Mentored In-Service 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 MechanismsIntroduction to Applied HIV Epidemiology Collaboration Mechanisms

Addressing Unmet Needs at the Agency Level through Commissioned & Mentored In-Service Learning Projects

Applied HIV Epidemiology Collaboration Mechanisms for Local or Applied HIV Epidemiology Collaboration Mechanisms for Local or Community-Based Research: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: From Risk of Infection to Disease Progression: Focus on Opportunities/Avenues for Care ServicesFocus on Opportunities/Avenues for Care Services

(E+) HIV+

(E-) HIV+




HIV

Dia

gno

sis

Dis

eas

e P

rogr

essi

on,

AID

S,

etc

At

Ris

k fo

r H

IV

Pos

t In

terv

entio

n O

utco

me

Mea

sure

men

t

HIV

Inf

ectio

n

Primary Prevention


Primary Prevention: Prophylaxis

for PCP, TB, etc.

Secondary Prevention Interventions: Referral & Linkage to Primary

Medical Care to prevent & monitor progression: -Rx, CD4+, VL

Outreach/”Marketing” to HIV+/aware not in care & referral to care;

Adherence Case Management; Other Support Services: housing, etc

Preventionfor “Positives”:HIV+/aware likelyTo transmit; Outreach; Ongoing PCRS; Prevention Case

Management,etc



2oInterventions 2oInterventions

Pre

-Int

erve

ntio

n M

easu

rem

ent

Design, Conduct Implementation and Evaluation of Response Plans to Design, Conduct Implementation and Evaluation of Response Plans to Unmet Needs Assessment for Primary Medical CareUnmet Needs Assessment for Primary Medical Care

Establish Common Aims & Objectives (preferably, Applicable to All Establish Common Aims & Objectives (preferably, Applicable to All Participating Sites):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;

Establish Common Methods Applicable to All Participating Sites: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;



A) Selecting potential study sites:– a site may be a local health Department or individual facilities;



B) Selecting common study design: – e.g. Non-Randomized Community Intervention Trial;



C) Determine standard predictor and outcome variables to be measured; – What variables can we consider measuring?



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;



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);


Establish Common Methods Applicable to All Participating Establish Common Methods Applicable to All Participating Sites: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 pre- and 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);



E) Define common approach for interpreting results and for translating findings into public health action to improve services;



F) Develop standard study protocol;



G) Seek Funding for Study;



H) Obtain IRB review, if required;



I) Implement Study, if funded; (how & who?);


epidemiology of hiv/aids in pennsylvania module 1 *introduction to epidemiologic methods for...

Documents

assessment of unmet

needs assessment activities

unmet needs methods

unmet needs estimates

hiv primary medical

prevention care

service area

services provider profiles