To Test or Not To Test

1. To Test or Not To Test John Jordan, MD, MPH Medical Director DSHS HSR 6/5 South

2. DISCLOSURE STATEMENTConflict 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 Jefferson Co 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. Since the first cases were diagnosed 30 years ago - • Over 575,000 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 • Almost half of all Americans know someone living with HIV

7. Texas HIV/AIDS Trends - 2009 • 66,126 persons were living with HIV/AIDS in Texas through 12-31-09. • 4,355 new HIV cases were reported in Texas in 2009. Gender 78% Male (3,379) 22% Female (976) Race: 44% African American (1,893) 30% Hispanic (1,322) 24% White (1,066) 1% Other (47) 1 % Unknown (27)

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

9. 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

10. Jefferson County HIV/AIDS Trends - 2009 799 persons living with HIV/AIDS in Jefferson County through 12-31-09. 71 new HIV cases were reported in Jefferson County in 2009. Gender 58% Male (41) 42% Female (30) Race: 75% African American (53) 17% White (12) 7% Hispanic (5) 1% Unknown (1)

11. Jefferson CountyNew HIV Cases by Race & Sex2009 – (n=71)

12. Jefferson County Newly Reported HIV Cases 2002 – 2009 12

13. Jefferson County – New HIV Cases by City of Residence – 2009 (n=71) • Beaumont 53 new HIV cases in 2009 31 Males 22 Females • Port Arthur 15 new HIV cases in 2009 8 Males 7 Females • Other Jefferson Co Cases 3 new HIV cases in 2009 2 Males 1 Female

14. 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 and; • More transmission of HIV

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

16. 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

17. Source of HIV Tests & Positive Tests * National Health Interview Survey, 2006 ** Supplement to HIV/AIDS Surveillance, 2000-2003

18. The Solutions/Results • 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

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20. 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

21. Revised RecommendationsAdults and Adolescents • Routine, voluntary HIV screening for all persons 13-64 in health care settings, not based on risk. (Opt-out HIV screening with the opportunity to ask questions and the option to decline testing) • Repeat HIV testing of persons with know risk at least annually

22. Revised RecommendationsAdults and Adolescents • When acute retroviral infection is a possibility, use an RNA test in conjunction with an HIV antibody test • Settings with low or unknown prevalence: • Initiate screening • If yield from screening is less than 1 per 1000, continued screening is not warranted

23. Revised RecommendationsAdults and Adolescents • Include HIV consent with general consent for care. A separate signed informed consent should notbe 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

24. Consent for HIV Testing • Texas Health & Safety Code Sections 81.105 & 81.106 do not require a separate consent form for HIV. • Client must sign general consent for medical treatment. • Verbal consent for HIV testing must be documented and constitutes informed consent.

25. Opt-out HIV testing in STD clinics 1999 Opt-out HIV testing pregnant women 1997 Will this work in Texas?

26. 81.105. Informed Consent • Except as otherwise provided by law, a person may not perform a test designed to identify HIV or its antigen or antibody without first obtaining the informed consent of the person to be tested. • Consent need not be written if there is documentation in the medical record that the test has been explained and the consent has been obtained.

27. Consent • 81.106. General Consent(a) A person who has signed a general consent form for the performance of medical tests or procedures is not required to also sign or be presented with a specific consent form relating to medical tests or procedures to determine HIV infection, antibodies to HIV, or infection with any other probable causative agent of AIDS that will be performed on the person during the time in which the general consent form is in effect.

28. § 81.109  COUNSELING REQUIRED FOR POSITIVE TEST RESULTS A positive test result may not be revealed to the person tested without giving them the immediate opportunity for individual, face-to-face post-test counseling about: • the meaning of the test result;                  • the possible need for additional testing; • measures to prevent the transmission of HIV; • the availability of appropriate health care services, including mental health care, and appropriate social and support services in the geographic area of the person's residence • the benefits of partner notification; • the availability of partner notification programs.  

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

30. 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, • slower clinical progression, and • reduced mortality.

31. Benefits of Routine Testing • Prevention of new cases of HIV • Reduce the number of persons unaware of their HIV status who knowingly transmit the virus to their partners and contacts. • Increase the number of persons who know their HIV status • Too few persons are being tested for HIV in Texas. • 1 in 3 HIV infected Texans are diagnosed with AIDS within one year of their HIV diagnosis.

32. Benefit of Early Diagnosis - Patient Late diagnosis has a higher risk of clinical events and death; More likely to have a poorer response when HAART is begun [1]; Initiating therapy at higher CD4 counts has better prognosis [2]; & Cost of treating late diagnosis patients is more than 2 times higher [3]. Skowron G, Street J, Obee E. J Acquir Immune Defic Syndr. 2001; 28: 313-9. 2. Klein D, Hurley L, Merrill D, et al. JAIDS. 2003; 32(3): 143-52. 3. Krentz HB, Auld MC, Gill MJ. HIV Med. 2004; 5: 93-8.

33. Missed Opportunities for HIV Diagnosis A CDC report examined HIV/AIDS case reporting before the 2006 guidelines were developed & looked at healthcare visits that occurred during 1997 to 2005 in S Carolina: During 2001 to 2005 a total of 4,315 case of HIV infection were reported in S Carolina; 1,784 (42%) developed AIDS within 1 year of HIV test; 1,302 (73%) made 7,988 previous health-care visits(median 4 per patient) but were not tested for HIV; 6,303 (79%) were visits to emergency departments; & Diagnosis codes for 6,277 (79%) of prior visitswould not have prompted an HIV test. MMWR December 1, 2006 33

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

35. 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?

36. 5 sources of ethical standards • Utilitarian • Rights • Fairness or justice • Common good • virtue

37. Utilitarian Approach • The ethical act is one that provides the most good or does the least harm, or • Produces the greatest balance of good over harm for all. • Deals with consequences and tries to increase the good done or reduce the harm done.

38. Rights Approach • The act that best protects and respects the moral rights of those affected. • Begins with the belief that humans have a dignity based on their human nature per se or on their ability to choose freely what they do with their lives. • The right to make one’s own choices.

39. Fairness or Justice Approach • All equals should be treated equally. • Equal access to treatment and care.

40. Common Good Approach • Life in community is a good in itself • 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. • Common conditions that are important to the welfare of everyone, e.g., laws, health care, etc.

41. Virtue Approach • Ethical actions should be consistent with certain ideal virtues that provide the full development of our humanity. • Dispositions and habits 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.

42. Not everyone agrees on… • A standard behavior • The same set of human and civil rights • What is a ‘good’ and what is a ‘harm’ • The different approaches may not answer “What is ethical?” in the same way

43. Making Ethical Decisions • Need to explore the ethical aspects of a decision • Need to weigh the considerations that should impact the choice of a course of action.

44. HIV and AIDS • Have had an enormous impact on health care provision • Has forced medical community to openly address the needs of populations who have historically been marginalized in our society (gay men and IV drug users)

45. Response to HIV/AIDS • Federal level – rapid approval of medicines by the FDA • State and city health departments – organize culturally sensitive, anonymous HIV counseling and testing centers • Individual level – physicians confront their own biases to provide ongoing care for a new and possibly transmissible epidemic.

46. AMA 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:

47. AMA Guidelines • Support routine universal routine universal opt-out HIV screening. • Recommend/encourage patients to be screened. • Ensure HIV positive patients receive appropriate follow-up care and counseling. • Comply with applicable disease reporting laws.