1. To Test or Not To Test August 25, 2011 Paul McGaha, D.O., M.P.H. Regional Medical Director Texas Department of State Health Services Tyler, TX

2. DISCLOSURE STATEMENT Conflict of Interest I have no real or perceived vested interests that relate to this presentation nor do I have any relationships with pharmaceutical companies, biomedical device manufacturers, and/or other corporations whose products or services are related to pertinent therapeutic areas

3. DISCLOSURE STATEMENT Commercial support There is no commercial company support for this CNE activity Non-Endorsement of Products The Center for Health Training approval status refers only to continuing nursing education activities and does not imply that there is a real or implied endorsement of any product, service, or company referred to in this activity nor of any company subsidizing costs related to the activity Off-Label Product Use This CNE activity does not include any unannounced information about off-label use of a product for a purpose other than that for which it was approved by the Food and Drug Administration (FDA)

4. LEARNING OBJECTIVES At the conclusion of this training, participants will be able to… Describe the impact of HIV in East Texas Discuss the 2006 CDC Revised Recommendations for HIV Testing Recognize the benefits of implementing routine opt-out testing Explain the ethical issues related to routine HIV testing in medical settings

5. Make HIV Testing Routine in Your Practice

6. HIV/AIDS in the USA An estimated 1,039,000 to 1,185,000 persons are living with HIV/AIDS 56,300 new HIV infections annually 73% among males 45% among African Americans 34% among individuals ages 13-29

7. Since the first cases were diagnosed 30 years ago - Over 576,000 Americans have lost their lives to AIDS More than 56,000 people in the US become infected with HIV each year There are more than 1.1 million Americans living with HIV – 1 in 5 (21%) are unaware of their infection Almost half of all Americans know someone living with HIV

8. Only compose 12% of US population

9. 9 Texas’ Major Infectious Disease Challenges: HIV/AIDS Between 2002 - 2008, the number of living HIV/AIDS cases in Texas rose ~6% a year During the same period, new HIV diagnoses stayed stable at ~4,500 per year, and deaths at ~1,200 year In 2008, the rate among blacks was 4 - 5 times higher than the rates in whites and Hispanics –Blacks also had the highest number and rate of newly diagnosed infections

10. 10 Newly Diagnosed HIV Cases, Deaths, & Persons Living with HIV (Texas, 1980-2008) New HIV Cases Deaths among HIV Cases Living with HIV

12. Newly-diagnosed HIV Case Rates by Race/Ethnicity: Texas, 1999-2009

13. 13 Newly-diagnosed HIV Cases*: Texas, 1999-2008 * AIDS cases were diagnosed with AIDS within 1 month of HIV diagnosis

14. Percent of Total HIV Diagnoses that were Late Diagnoses* by Race/Ethnicity and Sex, Texas 2009 *AIDS diagnosis occurred within 1 month of HIV diagnosis

15. 48% 11% 36% 5% Newly-diagnosed HIV Cases by Race/Ethnicity: Texas, 2008 43% 29% 26% 2% White Hispanic Other/Unknown Black Texas Population n=24,383,647 New HIV Cases n=4,293 15

16. Smith County HIV/AIDS Trends – 2010 ▪ 309 persons living with HIV/AIDS in Smith County through 12-31-10 ▪ 20 New cases of HIV were reported in Smith County in 2010 ▪ 4 New cases of AIDS were reported in Smith County in 2010 Gender Males (13) Females (7) Race African American (14) White (4) Hispanic (1) Unknown (1)

17. Gregg County HIV/AIDS Trends – 2010 ▪ 330 persons living with HIV/AIDS in Gregg County through 12-31-10 ▪ 25 New cases of HIV were reported in Gregg County in 2010 ▪ 6 New cases of AIDS were reported in Gregg County in 2010 Gender Males (14) Females (11) Race African American (17) White (5) Hispanic (2) Unknown (1)

18. Smith County – New HIV Cases by Race & Sex 2010 (n = 20)

19. Gregg County – New HIV Cases by Race & Sex 2010 (n = 25)

20. Smith County – Newly Reportable HIV Cases 2003 - 2010

21. Gregg County – Newly Reportable HIV Cases 2003 - 2010

22. “Late” HIV Testing is Common Among 4,127 persons with AIDS*, 45% were first diagnosed HIV-positive within 12 months of AIDS diagnosis (“late testers”) Late testers, compared to those tested early (>5 yrs before AIDS diagnosis) were more likely to be: Younger (18 -29 yrs) Heterosexual Less educated African American or Hispanic *16 states

23. The Problem Every 9 ½ minutes someone in the U.S. is infected with HIV More than 20% of those living with HIV do not know it Late diagnosis contributes to: –Poor outcomes, decreased productivity, and early death –Increased health care costs –More transmission of HIV

24. Late HIV diagnosis contributes to: Poor outcomes, decreased productivity, and early death; Increased health care costs; and More transmission of HIV

26. http://www.cdc.gov/mmwr/preview/mmwrhtml/ss5506a1.htm?s_cid=ss5506a1_e

27. The Facts Persons who do not know they are infected with HIV may be responsible for more than half of new transmissions Most of those unaware of their infection visit a health care facility but are not tested for HIV

28. Effect of Awareness on Transmission ~25% Unaware of Infection ~75% Aware of Infection People with HIV/AIDS: 1,039,000-1,185,000 New Sexual Infections Each Year: ~32,000 Accounts for ~54% of New Infections ~46% of New Infections Marks, et al AIDS 2006;20:1447-50

29. The Facts 1 out of 3 HIV infected Texans are diagnosed with AIDS within one year of their HIV diagnosis.

30. The Facts Hospitals, community clinics, and doctor’s offices account for more than half of all HIV diagnoses in Texans.

31. The Facts Routine HIV testing in multiple major emergency departments has identified new HIV infections that would have normally been missed.

32. The Solution Implement routine HIV testing in all health care settings per the 2006 CDC Recommendations MMWR 2006; 55 (RR14); 1-17 Establishing early care for HIV positive patients results in better survival gains than chemotherapy (non-small cell lung cancer), adjuvant chemotherapy (breast cancer), acute myocardial infarction, and bone marrow transplant. Walensky et al. JID, 2006

34. Objectives of the 2006 Revised Recommendations Increase HIV screening in health-care / medical settings. Foster earlier detection of HIV infection Identify and counsel persons with unrecognized HIV infection and link them to services Further reduce perinatal HIV transmission

35. CDC Revised Recommendations for Adults and Adolescents Routine, voluntary HIV screening for all persons 13 - 64 in health care settings, not based on risk. Repeat HIV screening of persons with known risk at least annually. Opt-out HIV screening with the opportunity to ask questions and the option to decline. Include HIV consent with general consent for care; separate signed informed consent not recommended. Prevention counseling in conjunction with HIV screening in health care settings is not required.

36. CDC Revised Recommendations for Adults and Adolescents Intended for all health care settings : Inpatient services Emergency Departments Urgent care clinics STD clinics TB clinics Public health clinics Community clinics Substance abuse treatment centers Correctional health facilities Primary care settings

37. Definitions Informed Consent – A process of communication between a patient and a provider through which the informed patient can either choose or decline to test. Opt-in – Patients are provided pre-HIV test education then must specifically consent, either orally or in writing, to an HIV test. Opt-out – Performing an HIV test after notifying a patient that the test is done routinely unless the patient declines. Assent is inferred unless the patient declines.

38. Revised Recommendations Adults and Adolescents Include HIV consent with general consent for care with “opt out” option - A separate signed informed consent should not be required Prevention counseling in conjunction with HIV screening in health care settings should not be required Arrange access to care, prevention, and support services for patients with positive HIV test results

39. Results in the US The $111 million effort provided funding for health departments in 25 of the nation’s hardest-hit areas –CDC-supported health departments were able to offer 2.8 million HIV tests in just three years As a result of the Expanded Testing Initiative, more than 18,000 Americans living with HIV learned their HIV status for the first timeExpanded Testing Initiative –Approximately three-quarters of the individuals who were newly diagnosed were successfully linked to HIV care, of those for whom follow up data were available Each HIV infection averted saves an estimated $367,000 in lifetime medical costs (2009 dollars) http://www.whitehouse.gov/blog/2011/06/27/national-hiv-testing-day-2011-0

40. Results in Texas Opt-out HIV testing in STD clinics 1999 Opt-out HIV testing pregnant women 1997

41. Criteria that Justify Routine Screening 1.Serious health disorder that can be detected before symptoms develop 2.Treatment is more beneficial when begun before symptoms develop 3.Reliable, inexpensive, acceptable screening test 4.Costs of screening are reasonable in relation to anticipated benefits 5.Treatment must be accessible Principles and Practice of Screening for Disease -WHO Public Health Paper, 1968

42. Benefits of Routine Testing Identify new HIV cases earlier Early diagnosis and treatment leads to: –better prognosis, –greater response to therapy, –reduced viral load, –lower transmission of HIV by reducing the number of persons unaware of their HIV status and unknowingly transmitting the virus to partners, –slower clinical progression, and –reduced mortality

43. What’s the Point? Reduce the number of new HIV infections Reduce health disparities Increase access to and use of HIV care and treatment

44. Strategies to Overcome Barriers: To facilitate routine HIV testing Conduct patient flow analysis to identify best process for your setting. Institute routine testing in Standing Delegation Orders. Integrate a reminder notification in EMR system. Post reminder messages at points of care directed at providers and staff.

45. Strategies to Overcome Barriers CONSENT Texas law does not require separate consent form for routine HIV testing.* General consent for care includes HIV testing. Documented verbal consent is sufficient. Pretest counseling is NOT required. * Texas Health and Safety Code, Chapter 81 – Communicable Diseaseswww.statutes.legis.state.tx.us/Docs/HS/htm/HS.81.htm

46. Strategies to Overcome Barriers DELIVERING RESULTS Providing HIV/AIDS diagnosis is no different than delivering a diagnosis of cancer or any other chronic disease. Back et al. Arch Intern Med. 2007. Public health disease intervention specialists (DIS) are available to provide results, linkage to care and other services for all newly reported HIV+ cases.

47. Strategies to Overcome Barriers FOLLOW-UP CARE Local and regional health authorities follow up on all newly reported HIV+ cases to ensure linkage to treatment, prevention counseling, and partner services. Treatment funding is available for eligible persons who test positive.** ** Texas HIV Medication Programwww.dshs.state.tx.us/hivstd/meds

48. The Test Texas HIV Coalition is dedicated to encouraging the implementation of routine opt-out HIV testing in medical settings. http://testtexashiv.org/

49. Hospital Community Benefit Report If HIV screening is conducted as part of community outreach, it may be eligible to be included in a hospital's community benefit report to the Internal Revenue Service. For more information, consult with the person in your hospital who is responsible for community benefit reporting

50. The ethical dilemma – To test or not to test? What determines the ethical standards we follow? What do we base our ethical standards on? How do these standards get applied to specific situations, specifically to routine HIV testing?

51. Three common principles in bioethics Respect for persons (autonomy) entails respecting the decisions of autonomous persons and protecting persons who lack decision-making capacity and therefore are not autonomous –also imposes an obligation to treat persons with respect by maintaining confidences and keeping promises Beneficence imposes a positive obligation to act in the best interests of patients –often is understood to require that the risks of research/treatment be minimized and that the risks be acceptable in light of the potential benefits Justice requires that people be treated fairly –often understood to require that benefits and burdens be distributed fairly within society http://hivinsite.ucsf.edu/InSite?page=kb-08-01-05#S2X

52. Other approaches of ethical standards Utilitarian: Provides the most good or does the least harm, produces the greatest balance of good over harm for all Common good: Life in community is a good in itself and our actions should contribute to that life –Interlocking relationships of society are the basis of ethical reason and that respect and compassion for all others-especially the vulnerable-are requirements for such reasoning Virtue: Dispositions that enable us to act according to the highest potential of our character and on behalf of values like honesty, courage, compassion, generosity, tolerance, etc

53. Not everyone agrees on… A standard behavior The same set of human and civil rights What is a ‘good’ and what is a ‘harm’ How to answer “What is ethical?” Population health vs individual health Mandatory testing? Costs of testing Mandatory treatment?

54. American Medical Association Opinion 2.23 – HIV Testing Physicians’ duties to promote patients’ welfare and to improve the public’s health are fostered by routinely testing their adult patients for HIV Physicians must balance these obligations with their concurrent duties to their individual patients’ best interest by the guidelines that follow:

55. AMA Guidelines Support routine universal routine universal opt-out HIV screening  to protect patients, avoid injury to third parties, and promote public health (beneficience) Recommend/encourage patients to be screened  the ethical tenets of respect for autonomy and informed consent require that physicians continue to seek patients’ informed consent  It is justifiable to test patients without prior consent only in limited cases where the harms to individual autonomy are offset by significant benefits to known third parties. Such exceptions including testing for the protection of occupationally exposed health care professionals or patients. Ensure HIV positive patients receive appropriate follow-up care and counseling (justice) Comply with applicable disease reporting laws

56. Summary There is an urgent need to increase the proportion of persons who are aware of their HIV-infection status. Many patients with HIV visit health care providers but their infection goes undetected. People tend to decrease their risk behaviors when they find out they are infected with HIV. HIV meets the criteria for screening, is cost effective, and successful treatment is available.

57. “Learning one's positive serostatus is the first step for newly diagnosed HIV patients to get linked to care and treated early in the disease process with the potential to have a nearly normal lifespan.” — C. Everett Koop, Former Surgeon General of the United States