1. Universal HIV Testing Closing the Gap Peter A. Leone, MD Associate Professor of Medicine University of North Carolina Medical Director, NC HIV/STD Prevention and Care, NCDHHS

2. Awareness of HIV Status among Persons with HIV, United States Number Infected Number unaware of their HIV infection Estimated new infections annually 1,039,000-1,185,000 252,000-312,000 (24%-27%) 40,000 Glynn M, Rhodes P. 2005 HIV Prevention Conference

3. Source of HIV tests and Positive Tests 38-44% of adults 18-64 yrs. have been tested 16-22 million aged 18-64 yrs. tested/yr in U.S. HIV Tests HIV+ Tests Private MD/HMO 44% 17% Hospital/ED/Outpt. 22% 27% Public clinics 9% 21% HIV C&T 5% 9% Correctional facility 0.6% 5% STD clinics 0.1% 6% Drug treatment 0.7% 2% National Health Interview Survey,2002; Suppl; to HIV/AIDS surveillance,2000-2003

4. Former CDC Recommendations Adults and Adolescents Routinely recommend HIV screening in settings with high HIV prevalence (>1%) Targeted testing based on risk assessment Routinely recommend HIV Testing for all persons seeking treatment for STDs Annual testing for sexually active MSM

5. Criteria for Targeted screening among 12,038 STD Clinic patients % of % of HIV Patients Patients Prev tested identified tested Risk factors in 10% 39% 7.5% patients or partners Sex Transm Dis, 1998

6. Criteria for Targeted screening among 12,038 STD Clinic patients % of % of HIV Patients Patients Prev tested identified tested Risk factors in 10% 39% 7.5% patients or partners Risk factors and all 40% 79% 3.8% Patients > 30 yrs Sex Transm Dis, 1998

7. Criteria for Targeted screening among 12,038 STD Clinic patients % of % of HIV Patients Patients Prev tested identified tested Risk factors in 10% 39% 7.5% patients or partners Risk factors and all 40% 79% 3.8% Patients > 30 yrs All patients 100% 100% 1.9% Sex Transm Dis, 1998

8. Texas: Targeted Opt-In Testing Prior to 1996 Clients with high risk behaviors ( e.g. MSM, IDU,GUD) Clients requesting an HIV test Separate consent form required

9. Texas Focus Groups Pre-test counseling identified as a deterrent to HIV testing Many thought they were tested and assumed they were HIV negative after their STI clinic evaluation Focus group participants strongly recommended making HIV testing routinely part of STI screening

10. Texas Law Sec. 81.105 requires informed consent Sec.81.106 clarifies that general consent is sufficient and specific consent form for HIV testing is not required

11. Routine Opt-Out Testing Phased Implementation 1996-1997 All clients tested unless: Client known HIV + Recently tested (30-90 days) Client declined test General consent for all STD service (includes HIV testing)

12. Reasons for Changing to Opt-out ~50% of HIV+ not tested in some STD clinics Only ~50% of clients accepted opt-in HIV testing Routine opt-out testing historical norm for other STD screening Opportunity for early diagnosis of HIV and screen high risk clients

13. Results opt-in opt-out N(%) N(%) %change STD visits 31,558 34,533 +9 Eligible 19,184(61) 23,686(69) +23 Pre-test 15,038(78) 11,466(48) -24 Tested 14,927(78) 23,020(97) +54 Post-test 6,014(40) 4,406(19) -27 HIV+ 168(1.1) 268(1.2) +59 Eligible STD Clients Tested 2003-2005 93-96%

14. New CDC Recommendations for Screening for HIV infection: In all health care settings, screening for HIV infection should be routinely performed for all patients age 13-64 Providers should initiate screening unless the prevalence of undiagnosed HIV infection in the patients they serve has been documented to be <0.1%. All patients initiating treatment for TB should be routinely screened for HIV infection All patients seeking treatment for STDs, including all patients attending STD clinics, should be routinely screened for HIV during each visit for a new complaint, regardless of whether the patient is known or suspected to have specific behavioral risks for HIV infection.

15. CDC Recommendations Diagnostic testing is performing an HIV test based on the presence of clinical signs or symptoms. Screening is performing an HIV test for all persons in a defined population. Targeted testing is performing HIV screening on subgroups of persons at higher risk Opt-out screening is performance of an HIV test after notifying the patient that the test will be done; consent is inferred unless the patient declines.

16. New CDC Recommendations In health care settings: · HIV screening is recommended in all health care settings, after notifying the patient that testing will be done unless the patient declines (opt-out screening) · Persons at high risk for HIV infection should be screened for HIV at least annually · Separate written consent for HIV testing is not required. General consent for medical care is sufficient to encompass consent for HIV testing · Prevention counseling need not be conducted in conjunction with HIV testing

17. Communicating Test Results The central goal of HIV screening in health care settings is to maximize the number of persons who are aware of their HIV infection and receive care and prevention services. Definitive mechanisms should be established to inform patients of their test results. Negative test results may be conveyed without direct personal contact between the patient and provider. Persons known to be at high risk for HIV infection should also be advised of the need for periodic retesting, and offered or referred for prevention counseling.

18. Changes to NC Administrative Code Providers and Laboratories to report HIV/AIDS from 7 days to 24 hrs Remove the strict requirement for pretest counseling HIV testing can be a part of a panel of tests without a standalone written consent just for HIV testing as long as the consent for testing specifies that HIV testing is included.

19. CHAPTER 41 – HEALTH: EPIDEMIOLOGY SUBCHAPTER 41A – COMMUNICABLE DISEASE CONTROL SECTION.0200 - CONTROL MEASURES FOR COMMUNICABLE DISEASES 10A NCAC 41A.0202 Testing for HIV may be offered as a part of routine laboratory testing panels where a single consent for all laboratory tests is obtained so long as the patient is notified that they are being tested for HIV and given the opportunity to refuse testing.

20. NC Recommendations for HIV Testing Opt-out HIV screening for prenatal and STD visits Pretest counseling not required Post-test counseling required only for positives HIV tests at first prenatal visit and 3 rd trimester HIV test at L&D for all women for whom HIV status is unknown and in infant if test not obtained from mother

21. Indirect (but compelling) Evidence for Effect in Averting Vertical Transmission In 1 st 2 years, 5 acute cases were pregnant women –4% of all HIV cases at Prenatal/OB testing sites –~30% of all female acute cases All pregnant, acutely HIV infected women received urgent counseling and ART. 5/5 infants have been delivered uninfected. During this same period, 3 of the 6 infants born HIV infected in NC were born to mothers who were tested and found to be HIV antibody negative early in pregnancy.

22. Highlights Every pregnant woman shall be given HIV pre-test counseling, as described in 1510A NCAC 1941A.0202(10), by her attending physician as early in the pregnancy as possible at her first prenatal visit and either in the third trimester or at labor and delivery. At the time this counseling is provided, and after informed consent is obtained, the attending physician shall test the pregnant woman for HIV infection, unless the pregnant woman refuses the HIV test. (15)Testing for HIV may be offered as a part of routine laboratory testing panels where a single consent for all laboratory tests is obtained so long as the patient is notified that they are being tested for HIV and given the opportunity to refuse testing.

23. Further Modification to “Routinize” HIV testing in Medical Care Setings "Testing for HIV may be offered as a part of routine laboratory testing panels where a single consent for all laboratory tests is obtained" "Testing for HIV may be offered as part of routine laboratory testing panels using a general consent which is obtained from the patient for treatment and routine laboratory testing,so long as the patient is notified that they are being tested for HIV and given the opportunity to refuse testing."

24. General Consent Form I hereby voluntarily consent to medical and/or dental examinations, treatments and procedures including HIV testing, laboratory tests and x-rays which are deemed necessary in the opinion of my physician and health care providers selected by my physician. I understand that no guarantees or warranties have been made to me concerning the results of the examinations, treatments or procedures. My signature acknowledges that I have been given the opportunity to ask questions about this consent form. I refuse HIV testing ________________________

25. Incorporating AHI Screening in STD clinics: 1.Screen all STD clients for HIV Ab and AHI 2.If offering rapid HIV then offer Rapid Test “Plus” -Rapid HIV tests can be offered with symptom screen Problem: Which symptoms (fever?) What time period (2-4 wks)? What duration ( 3 days)? Symptoms at best will detect 40% - Targeted screening Risk based ( i.e. MSM, anal/vaginal sex in past 2 weeks,etc ) Site based ( prevalence 0.5% or type STD,CTS, etc.) 3. Bottom line- rapid testing and AHI screening are not mutually exclusive -Need for further research to define symptom screen and develop predictive models for AHI screening

26. Incorporating AHI Screening : 1.Screen all STD clients for HIV Ab and AHI 2.If offering rapid HIV then offer Rapid Test “Plus” -Rapid HIV tests can be offered with symptom screen Problem: Which symptoms (fever?) What time period (2-4 wks)? What duration ( 3 days)? Symptoms at best will detect 40% - Targeted screening Risk based ( i.e. MSM, anal/vaginal sex in past 2 weeks,etc ) Site based ( prevalence 0.5% or type STD,CTS, etc.) 3. Bottom line- rapid testing and AHI screening are not mutually exclusive -Need for further research to define symptom screen and develop predictive models for AHI screening

27. Goals Universal testing of HIV for individuals 14-64 years of age Opt-out HIV testing in STD and Prenatal settings Disconnect pre- and post-test counseling from HIV testing itself Add second HIV test in pregnancy and mandate HIV testing for pregnant women at L&D with unknown HIV status