1. HIV Testing: The Road Less Travelled Peter A. Leone, MD Professor of Medicine University of North Carolina Medical Director NC HIV/STD Prevention and Care NCDHHS

2. State Statutes consistent with CDC HIV Testing Guidelines

3. Hurdles or Pitfalls to Expanded HIV testing State law requiring counseling and proof of informed consent Institutional Policies Lack of knowledge regarding state law and local institutional policies Time and logistical constraints Provider apathy Hanssens C CID 2007:45 (Suppl 4).

4. Hurdles or Pitfalls to Expanded HIV testing Misunderstanding of HIV testing windows by clients and provider Costs of tests and billing Stigma of risk factors and diagnosis but not the test Concerns regarding linkage to care and availability of ADAP Inadequate counseling before or after test Criminalization of HIV Hanssens C CID 2007:45 (Suppl 4).

5. Communicable Disease Surveillance Unit Changes to NC Administrative Code Nov. 1, 2007 Opt-out HIV screening in medical settings and for prenatal and STD visits Opt-out HIV screening in medical settings and for prenatal and STD visits Pretest counseling not required Pretest counseling not required Post-test counseling required only for positives Post-test counseling required only for positives HIV tests at first prenatal visit and 3 rd trimester HIV tests at first prenatal visit and 3 rd trimester Mandatory HIV test at L&D for all women for whom HIV status is unknown and in infant if test not obtained from mother Mandatory HIV test at L&D for all women for whom HIV status is unknown and in infant if test not obtained from mother

6. Communicable Disease Surveillance Unit HIV Tests North Carolina DHHS Laboratory

7. Communicable Disease Surveillance Unit North Carolina HIV Disease Reports

8. Communicable Disease Surveillance Unit North Carolina Opt-out testing Only one major medical center with change in testing requirements Only one major medical center with change in testing requirements - risk management is barrier - risk management is barrier Emergency Departments: Although waiving of separate written informed consent at UNC, continue with limited testing in ED Emergency Departments: Although waiving of separate written informed consent at UNC, continue with limited testing in ED - cost of test - cost of test - commitment of emergency department - commitment of emergency department limited staffing limited staffing - not understanding targeted testing - not understanding targeted testing STD Clinics STD Clinics

9. ED Barriers Concern for follow-up Confidentiality in ED Newly Dx HIV patients require linkage to medical care, support from social work during transition Timely linkage comprehensive HIV outpatient services Cost of the test and charge to patients Staff view of stigma associated with testing and of offering “prevention services “ unrelated to reason for visit Arbelaez C, et al. 2009

10. HIV(+) Patients, June 2008-May 2009 The average age = 41 years CD4 count (average): 231 - Acute HIV Infection Diagnosis: 445 - New Diagnoses: 207 - Previous Diagnoses: 221 Viral load (average): 977,724 - Acute HIV Infection Diagnosis: >10,000,000 - New Diagnoses: 309,744 - Previous Diagnoses: 409,487 Positivity Rate = 2.51% New Dx Positivity Rate = 1.15%

11. HIV & STD Testing, June 2008-May 2009 Patients Tested Also Tested for HIV*, % (n) All STDs26999.56% (258) Syphilis111718.35% (205) Gonorrhea18646.65% (124) Chlamydia18666.59% (123) HSV4121.95% (9) * Based 667 HIV tests performed, excluding organ transplant patients

12. ED HIV testing should remain targeted until a feasible and resource-efficient system that preserves linkage to care is in place for testing all patients for HIV infection We should develop clear message on testing guidelines rather than test all with recommendations based on HIV prevalence Link HIV testing to performance standards

13. Slide 13 HIV tests by clinic 86.5% % 78.4%

14. Slide 14 * “traditional” HIV risk factor: Same sex partner, sex with bisexual male, sex for drugs/money, Sex with IVDU, sex with HIV+ partner, paid for sex % with at least one “traditional” risk factor* WAKEDURHAM

15. Slide 15 NC Delay to Testing  Over one-quarter of patients reported delayed seeking an HIV test for over 4 years.  Patients who reported HIV infection in more recent calendar years had a shorter duration of testing delay. Self-reported HIV testing delay in North Carolina S Napravnik APH 2009

17. Barriers to initiation of testing: Patients The lack of perceived vulnerability to HIV acquisition could be broadly divided into three themes: 1. people who did not recognize their behavior as risky 2. people who viewed their behavior as very low risk 3. people who felt like exposure to HIV was unlikely, regardless of behavior Few identified benefits of seeking an HIV test Would accept testing if offered by provider S.I. McCoy, et al. 2009

18. Barriers to initiation of testing: Access to Health Care Most participants accepted testing when it was offered; suggesting that routine screening may increase the numbers of people tested and de- stigmatize the testing process. For expanded HIV testing programs to have impact, people living with unrecognized HIV infection must have contact with the healthcare system. In the Southeast, HIV infection is often a disease of the rural and poor, new strategies to improve health care access will be a necessary precursor for any increased screening to reach the groups most in need.

19. NC DOC Opt-In HIV Testing at Each Intake Prison 15% Rosen et al AJPH 2009

20. NC DOC Opt-Out HIV Testing From 11/1/08 to 6/1/09, under Opt-Out testing: 16,867 inmates (87.5% men) entered DOC 15,258 were HIV tested with 1.3% found to be HIV-positive. 91.1% of the men were tested with 1.2% HIV+ 86% of the women were tested with 1.9% HIV+ Median CD4 cell count of all was 381/uL. Wohl, et al CROI 2010

21. Slide 21 CONCLUSION  Increased awareness of the importance of HIV testing among high risk populations and their providers is essential  Find the intersection – many without primary care providers and without insurance  Opt-out testing can increase testing  Systems of care that reduce time from infection to care initiation need to be a priority.  A large proportion of patients who suspect that they have been infected with HIV delay testing for several years.

22. Slide 22 Fiebig Classification Fiebig et al, AIDS. 2003;17:1871- 9.

23. Lack of Recognition of AHI Patients This lack of awareness was in three primary domains: 1.the signs and symptoms of an acute retroviral syndrome, 2. the different HIV testing technologies available 3. the heightened infectiousness during AHI, when an HIV antibody test is likely to be negative. Clinicians 1.Lack of recognition of Acute Retroviral Syndrome 2.Lack of understanding of window 3.Lack of understanding how to make diagnosis Remien RH, et al. AIDS Behav (2009) 13:1046–1053

24. PCR Testing of Pooled Sera to Identify Acute HIV Infection (seronegative, PCR positive) Source: ISSTDR, 2007 25% in the Chelsea STD clinic

25. Detection of Acute HIV Infection Decrease transmission Earlier treatment with HAART Earlier linkage to care Most useful in high risk setting i.e. STD clinic

26. Targeted Screening for AHI A combination of five indicators 1.Testing site 2.Sexual preference, 3.Sex with a person with HIV infection 4.County HIV incidence 5.Race Identified 92% of recent infections while testing 50% of the population. Conclusion: AHI can be identified accurately using targeted testing Miller, Leone et.al 2009

27. What’s Needed Detect HIV Ab response Identify and distinguish AHI and Recent Infection from established HIV infection Quantify ( Qualitative vs. Quantitative) HIV viral load POC

28. Challenges Opt-out testing can increase HIV testing Risk management still a barriers Focus on targeted testing in ED Educate at risk patients and clinicians on HIV tests differences and signs/symtpoms of AHI The test is less of a stigma than the diagnosis