EPIDEMIOLOGY OF HIV/AIDS IN PENNSYLVANIA

1. EPIDEMIOLOGY OF HIV/AIDS IN PENNSYLVANIA *Linkage of Epidemiologic Case Surveillance of HIV to Prevention/Care Interventions: Benjamin Richard H. Muthambi, DrPH, MPH State HIV/AIDS Epidemiologist <HIV Public Health Intervention Program Support>

2. Outline for Module 1: Introductory ConceptsIntroductory Concepts on Linkage of Epidemiologic Case Surveillance of HIV to Prevention/Care Interventions • Public Health Premise/Objectives of Linkage of Epidemiologic Case Surveillance of HIV to Prevention/Care Interventions • Definition of Public Health Surveillance and Implications for Public Health Action; • A Review of Opportunities for Linkage of Case Surveillance of HIV to Prevention and Care During Public Health Surveillance of HIV. • Identification of Opportunities for Linkage of Epidemiologic Case Surveillance of HIV to Prevention/Care Interventions • Mechanisms for Linkage of Epidemiologic Case Surveillance of HIV to Prevention/Care Interventions:

3. Public Health Premise for Linkage of Epidemiologic Case Surveillance of HIV to Prevention/Care Interventions • Generic Definition of Public Health Surveillance: • The ongoing systematic collection, analysis, and interpretation of outcome-specific data(on cases of HIV disease) for use in the planning, implementation, and evaluation of public health practice; • (a surveillance system includes the functional capacity for data collection and analysis as well as the timely dissemination of these data to persons who can undertake effective prevention and control activities) Thacker and Berkelman, 1988.

4. Public Health Premise for Linkage of Epidemiologic Case Surveillance of HIV to Prevention/Care Interventions • Use of Surveillance data includes: • Use in planning of resource allocations, program development, and implementation of public health programs; • Use in evaluation of public health practice; • E.g. Evaluate implementation of Public Health Service guidelines for prevention and care of HIV patients; • Surveillance System must have functional capacity for: • Timely dissemination of these data to persons who can undertake effective prevention and control activities;

5. Public Health Surveillance of HIV:A Review of Opportunities for Linkage in a Model for Case Surveillance of HIV Flow Chart Of Case Surveillance Of HIV/AIDS A Focus on Points of Opportunity/Potential for Linkage To Prevention & Care

6. Identification of Opportunities for Linkage of Epidemiologic Case Surveillance of HIV to Prevention/Care Interventions Public Health Surveillance Chart Review First:- to identify possible missed opportunities:- at initial diagnosis and ?subsequent periodic post-test chart review & outreach for positives? • The HIV case report form for HIV case surveillance presents opportunities to assess whether the following types of linkages/referrals to care and prevention have been done by those reporting cases • Post-test return of HIV test results to positives; • Primary medical care including antiretroviral therapy, CD4 and Viral Load testing; • Partner Counseling and Referral Service(PCRS); [what about subsequent periodic post-test/post-diagnostic outreach for ongoing PCRS for positives?]; • Substance use treatment services; • Surveillance Record Linkage is possible with: • STDs; • PCRS(if under confidential protocol); • Case Management; • Public Assistance Claims; • ?Substance Use?;

7. Mechanisms for Linkage of Epidemiologic Case Surveillance of HIV to Prevention/Care Interventions • Population-level Mechanisms: • Aggregate Analyses (incl. record linkage): • Identification of patterns of needed services and missed opportunities for public health interventions; • Implementation of provider-level and population-level interventions to address needed services and missed opportunities; • Analyses of patterns of new diagnoses of HIV in the most recent 12 months; • Individual-level/Client-level Mechanisms: • Pre-test notice of possible referral to/follow-up by Public Health service included in statement of informed consent for testing; • Indirect Model/Approach: Public Health authority feedback to provider & prompt for provider follow-up/referral of patient; • Direct Model/Approach: Public Health authority directly conducts patient referral to/implementation of: • Partner Counseling & Referral (and Social Network Investigation to Study Transmission Dynamics); • Primary Medical Care/Treatment; • Adherence Case Management; • Prevention Case Management; • Substance Use Prevention and Treatment Programs; • Other support services;

9. Outline for Module 2: Issues, Approaches & Models A Roundtable Participatory Comparative Review of Linkage of Epidemiologic Case Surveillance of HIV to Prevention and Care Interventions in contrast to STIs & TB • Coordination of Public Health and Clinical Provider Actions: • Linkage of Epidemiologic Case Surveillance of HIV to Prevention/Care Interventions; • Roundtable Review: • Issues & Approaches in Linkage of Epidemiologic Case Surveillance of HIV to Prevention/Care Interventions

10. I. Linkage of Epidemiologic Case Surveillance of HIV to Prevention/Care Coordinating Public Health and Clinical Care Actions • Direct vs. Indirect Linkage to Care & Prevention: • The concept of direct linkage of HIV/AIDS surveillance to HIV/AIDS care and prevention whereby surveillance data are used by Public Health agencies (HIV/AIDS intervention program field staff) to conduct individual patient follow-up to assure linkage to prevention and care services has raised concerns about deterrence to care-seeking behavior and/or HIV testing, and may also be misperceived by some as a threat to the confidentiality of HIV/AIDS surveillance data; • HIV/AIDS “Exceptionalism”? • Inconsistency with usual linkage and continuity of public health services that is routine for many other communicable diseases such as sexually transmitted diseases, TB, etc; • This dilemma is somewhat unique to the HIV/AIDS prevention and care domain and is in stark contrast to routine public health practices;

11. II. Linkage of Epidemiologic Case Surveillance of HIV to Prevention/Care Coordinating Public Health and Clinical Care Actions • Lack of Authoritative Evidence-based Standardized Guidance/Protocols: • Public health surveillance practitioners often do not have the time or resources to review, evaluate, describe and disseminate the systems/models they develop; • The subject of models of linkage of HIV/AIDS Surveillance to Preventive and Clinical Care of HIV/AIDS cases is not of particular interest to peer-reviewed scientific journals; • Surveillance and public health program practitioners, policy makers and governmental Public Health agencies often have difficulty locating objective reviews of scientifically validated models that policy and practice on linkage of HIV/AIDS Surveillance to Preventive and Clinical Care can be based on. • Ethical Principles as a Premise of the Public Health Authority’s Mandate: • Why do public health authorities have the right to interfere with one’s liberties? • How far can they go?

12. a. Ethical Premise of Public Health Authority Mandate for “Protection of the Public Health”:Screening Programs, Surveillance, PCRS, Immunizations, etc.adapted from Bayer et al, 1986 • Ethical Principles as a Premise of the Public Health Authority’s Mandate: • Respect for persons: • Persons ought to be given a chance to determine what will or will not happen to them; and those with diminished capacity to make their own decisions should be protected by law; • The Harm Principlepermits limitations to individual’s liberty to pursue personal goals and choices when others will be harmed by those activities; • Beneficencerequires that we act on behalf of the interests and welfare of others, • These “Public Good Principles”,Respect for persons, the harm principle and beneficence form a major ethical basis for public health actions

13. Individual Needs/Rights Liberties to pursue personal choices “The Public Good” Community Interests: Beneficence Harm Principles b. Ethical Premise of Public Health Authority Mandate for “Protection of the Public Health”:Screening Programs, Surveillance, PCRS, Immunizations, etc.adapted from Bayer et al, 1986 • Justice requirements: • The benefits and burdens of particular actions are to be distributed fairly; • Discrimination should be prohibited in the distribution of burdens/benefits; • Potential Conflicts may Occur Between these Principles: • “Beneficence and harm principles” may outweigh “needs/rights/liberties of individuals not to be interfered with” in some instances/settings but never outweigh the obligation to treat persons with respect for their intrinsic worth and dignity;

14. III. Linkage of Epidemiologic Case Surveillance of HIV to Prevention/Care Coordinating Public Health and Clinical Care Actions • Bridging Disparate Approaches: • This roundtable session reviews this important area of public health practice, seeks to bridge disparate approaches through a systematic review of issues and approaches in linkage of HIV/AIDS Surveillance to Preventive and Clinical Care of HIV/AIDS cases; • Important Considerations: • Respect for others and still “protect the public health”; • Approaches which avoid deterrence to HIV testing and care-seeking behavior; • Approaches which DO NOT undermine the right to privacy and the long established tradition of confidentiality and security of HIV/AIDS surveillance data;

15. Roundtable Review of Issues, Approaches & Models:A Roundtable Participatory Comparative Review of Linkage of Epidemiologic Case Surveillance of HIV to Prevention and Care Interventions in contrast to STIs & TB • What is the Public Health Premise of Linkage of Epidemiologic Case Surveillance of HIV to Prevention/Care Interventions • Ethics, legal authority and responsibility of Public Health Agencies; • Definition of Public Health Surveillance and Implications for Public Health Action; • Why Conduct Surveillance Chart Review First before Attempting Individual/Client-level Linkage of Case Surveillance of HIV to Prevention and Care Services? • What are the Opportunities for Individual/Client-level Linkage of Epidemiologic Case Surveillance of HIV to Prevention/Care Interventions? • What are the Mechanisms for Individual/Client-level Linkage of Epidemiologic Case Surveillance of HIV to Prevention/Care Interventions? • What are the Key Issues that Require Coordination of Public Health and Clinical provider actions on Individual/Client-level Linkage of Epidemiologic Case Surveillance of HIV to Prevention/Care Interventions? • What are the Main Approaches used by Public Health Agencies to Assure Individual/Client-level Linkage of Persons Living w/HIV to Needed Prevention and Care Services? • What are the Main Approaches used by Public Health Agencies to Assure Individual/Client-level Linkage of Persons Diagnosed with STIs or TB to Needed Prevention and Care Services? • The case for Standardized Public Health Protocols for Individual/Client-level Linkage: Statewide vs. Local Approaches? • Is there a Need to Demonstrate Efficacy and Usefulness of Protocols in Use;

17. Outline for Module 3: Introduction to Applied HIV Epidemiology MethodsDesign, Conduct and Comparative Evaluation of Competing Models for Linkage of Epidemiologic Case Surveillance to Intervention Activities • Two Key Competing Approaches to Individual/Client-level Linkage of Epidemiologic Case Surveillance of HIV to Prevention/Care Interventions • Design, Conduct and Comparative Evaluation of Competing Models for Linkage of Epidemiologic Case Surveillance to Intervention Activities;

18. Local Public Heath service conducts case surveillance chart review using “standardized linkage review instrument” & identifies possible missed opportunities for linkage to needed prevention & care as per PHS prevention and care guidelines; INDIRECT MODEL/APPROACH: To address possible missed opportunities, Public Health (PH) service establishes PH practice protocol on linkage which may include providing advisory PH feedback to clinical practitioner(s) prompting patient follow-up by provider and/or provider referral to needed PH or other support services as per PHS prevention and care guidelines; DIRECT MODEL/APPROACH: To address possible missed opportunities, Public Health (PH) service establishes PH practice protocol on linkage which may include conducting direct patient follow-up to provide needed PH or other support services as per PHS prevention and care guidelines; Two Key Competing Approaches to Individual/Client-level Linkage of Epidemiologic Case Surveillance of HIV to Prevention/Care Interventions Screening or Diagnosing Practitioner use of standardized pre-test consent statement which includes notice of possible referral to/follow-up by Public Health service Referral to/ implementation of: • Partner Counseling & Referral (and Social Network Investigation of Transmission Dynamics); • Primary Medical Care/Treatment; • STI screening and treatment; or • Substance Use Prevention and Treatment Programs; • Adherence Case Management; • Prevention Case Management; • Other support services; OR

19. Design, Conduct and Comparative Evaluation of Competing Models for Linkage of Epidemiologic Case Comparative Evaluation Of DIRECT APPROACH vs INDIRECT APPROACH • Establish Common Aims & Objectives Applicable to All Participating Sites: • The purpose of the study is to: • Evaluate the effectiveness of each approach (direct or indirect approach) for using an HIV case surveillance system to link infected persons to prevention and care services; • Compare the effectiveness of a direct approach vs. an indirect approach for using an HIV case surveillance system to link infected persons to prevention and care services;

20. Design, Conduct and Comparative Evaluation of Competing Models for Linkage of Epidemiologic Case Comparative Evaluation Of DIRECT APPROACH vs INDIRECT APPROACH • 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;

21. Design, Conduct and Comparative Evaluation of Competing Models for Linkage of Epidemiologic Case Comparative Evaluation Of DIRECT APPROACH vs INDIRECT APPROACH • 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;

22. Design, Conduct and Comparative Evaluation of Competing Models for Linkage of Epidemiologic Case Comparative Evaluation Of DIRECT APPROACH vs INDIRECT APPROACH • Establish Common Methods Applicable to All Participating Sites: • This must include: • B) Selecting common study design: • e.g. Non-Randomized Community Intervention Trial;

23. Design, Conduct and Comparative Evaluation of Competing Models for Linkage of Epidemiologic Case Comparative Evaluation Of DIRECT APPROACH vs INDIRECT APPROACH • 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?

24. Design, Conduct and Comparative Evaluation of Competing Models for Linkage of Epidemiologic Case Comparative Evaluation Of DIRECT APPROACH vs INDIRECT APPROACH • 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;

25. Design, Conduct and Comparative Evaluation of Competing Models for Linkage of Epidemiologic Case Comparative Evaluation Of DIRECT APPROACH vs INDIRECT APPROACH • 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 in direct and indirect approach sites; • Implement public health intervention/practice protocols (direct or indirect) in each site synchronously (most preferable);

26. Design, Conduct and Comparative Evaluation of Competing Models for Linkage of Epidemiologic Case Comparative Evaluation Of DIRECT APPROACH vs INDIRECT APPROACH • 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 vs. median # cases with unmet need for primary medical care (CD4 or VL or Rx) in a given 12 month period); r/ship between type of linkage approach(direct vs. indirect) vs. # partners generated from each PCRS encounter; • Perform analyses of within and across site comparisons of pre- and post-intervention rates of successful linkage to respective interventions such as PCRS(analyses of covariance); • Perform analyses of within and across site comparisons of pre- and post intervention levels of outcome measures such as median # of partners elicited per PCRS encounter; incidence of risk behavior after PCRS; indicators of implementation of PHS guidelines; median CD4 cell counts; Viral Load; etc (analyses of covariance);

27. Design, Conduct and Comparative Evaluation of Competing Models for Linkage of Epidemiologic Case Comparative Evaluation Of DIRECT APPROACH vs INDIRECT APPROACH • 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;

28. Design, Conduct and Comparative Evaluation of Competing Models for Linkage of Epidemiologic Case Comparative Evaluation Of DIRECT APPROACH vs INDIRECT APPROACH • Establish Common Methods Applicable to All Participating Sites: • This must include: • F) Develop standard study protocol;

29. Design, Conduct and Comparative Evaluation of Competing Models for Linkage of Epidemiologic Case Comparative Evaluation Of DIRECT APPROACH vs INDIRECT APPROACH • Establish Common Methods Applicable to All Participating Sites: • This must include: • G) Seek Funding for Study;

30. Design, Conduct and Comparative Evaluation of Competing Models for Linkage of Epidemiologic Case Comparative Evaluation Of DIRECT APPROACH vs INDIRECT APPROACH • Establish Common Methods Applicable to All Participating Sites: • This must include: • H) Obtain IRB review, if required;

31. Design, Conduct and Comparative Evaluation of Competing Models for Linkage of Epidemiologic Case Comparative Evaluation Of DIRECT APPROACH vs INDIRECT APPROACH • Establish Common Methods Applicable to All Participating Sites: • This must include: • I) Implement Study, if funded;

32. Example of Evaluation of the Use of a Statewide Human Immunodeficiency Virus (HIV) Surveillance System to Link Infected Adolescents With Care AIDS Patient Care STDS. 2001 Mar;15(3):147-51. Linking HIV-seropositive youth with health care: evaluation of an intervention.Remafedi G • Study Purpose: The purpose of this study was to evaluate the use of a statewide human immunodeficiency virus (HIV) surveillance system to link infected adolescents with care • Study Population & Setting: Eligible participants were HIV-seropositive youths who were reported to the Department of Health from 1985 to 1998 in a state with mandatory, name-linked reporting of HIV and acquired immunodeficiency syndrome (AIDS) cases. • Study Procedures: Linkage: Standard public health disease surveillance and intervention strategies were used to link participants with HIV/AIDS case management services. • Study Procedures: Analyses: • Enrollment in case management services was assessed before and after the intervention was implemented in 1993. • Comparing pre- and post-intervention rates of linkage to case management, the proportion of participants receiving case management services increased from 33% to 51% (p = 0.058) after the intervention was implemented. • Results: Although enrollment in case management did not vary significantly with participants' demographic and transmission characteristics, people of color were less likely than Caucasians to be located and interviewed. • Conclusions: In conclusion, the system of name linked reporting of HIV/AIDS cases was used successfully to increase case management by 55% above baseline levels.

33. Design & Components of Case Surveillance System

34. BACKGROUND TO CASE SURVEILLANCE IN PREVENTION & CARE A Review of the Natural History of Disease and Levels of Prevention HIV Screening HIV|AIDS Case Surveillance • Primary Prevention: prevention of disease by altering susceptibility or reducing exposure for susceptible individuals (appropriate in the stage of susceptibility).Examples for HIV are: vaccination that prevents infection or use of condoms to prevent infection. • Secondary Prevention: early detection and treatment of disease and limit progression of disease (applied in early disease, preclinical or clinical disease). Examples: screening for HIV infection in order to initiate early interventions and such as a) prophylaxis for active TB among the dually infected; or b) early antiretroviral therapy to prevent severe immunosuppression; • Tertiary Prevention: alleviation of disability resulting from disease and attempts to restore functionality (appropriate in advanced disease or disability): Examples: Rx of advanced HIV disease manifestations, viz: Rx of severe debilitating active TB in HIV infected (AIDS).

35. = Opportunities for interventions