Revised Recommendations for HIV Screening of Adults, Adolescents, and Pregnant Women in Health Care Settings

1. Revised Recommendations forHIV Screening of Adults, Adolescents, and Pregnant Women in Health Care Settings Bernard M. Branson, M.D. Associate Director for Laboratory Diagnostics Divisions of HIV/AIDS Prevention National Center for HIV, STD, and TB Prevention Centers for Disease Control and Prevention The findings and conclusions in this presentation are those of the authors and do not necessarily represent the views of the Centers for Disease Control and Prevention

2. Presentation Outline • Epidemiologic background • The case for increased HIV testing • Current testing • Current recommendations and their effects • Considerations for revising recommendations • Adults and adolescents • Pregnant women • Summary

3. Estimated Number of AIDS Cases, Deaths, and Persons Living with AIDS,1985-2004, United States 450 90 AIDS 1993 definition implementation 400 Deaths 80 Prevalence 350 70 300 60 250 50 Prevalence (in thousands) No. of cases and deaths (in thousands) 200 40 150 30 20 100 10 50 0 0 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 Year of diagnosis or death Note. Data adjusted for reporting delays.

4. Awareness of HIV Status among Persons with HIV, United States Number HIV infected1,039,000 – 1,185,000 Number unaware of their HIV infection 252,000 - 312,000 (24%-27%) Estimated new infections 40,000 annually Glynn M, Rhodes P. 2005 HIV Prevention Conference

5. HIV/AIDS Diagnoses among Adults and Adolescents, by Transmission Category — 33 States, 2001–2004 MSM/IDU 5% Other 1% Other 3% Heterosexual 17% IDU 21% IDU 16% MSM 61% Heterosexual 76% Females (n ≈ 45,000) Males (n ≈ 112,000) MMWR, Nov 18, 2005

6. Estimated Annual Rate of HIV/AIDS Diagnoses, by Sex and Race/Ethnicity — 33 States, 2004 AI/AN M AI/AN F White M White F Black M Black F Hispanic M Hispanic F A/PI M A/PI F CDC. HIV/AIDS Surveillance Report, 2004

7. 1000 800 600 400 200 0 Estimated Number of Perinatally Acquired AIDS Cases, by Year of Diagnosis, 1985-2004 – United States PACTG 076 & USPHS ZDV Recs CDC HIV screening Recs ~95% reduction Number of cases Number of cases 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 Year of Diagnosis

8. The Case for Increased HIV Testing

9. Patients on HAART Deaths per 100 PY Mortality and HAART Use Over Time HIV Outpatient Study, CDC, 1994-2003

10. Knowledge of HIV Infection and Behavior After people become aware they are HIV-positive, the prevalence of high-risk sexual behavior is reduced substantially. Reduction in Unprotected Anal orVaginal Intercourse with HIV-neg partners: HIV-pos Aware vs. HIV-pos Unaware 68% Meta-analysis of high-risk sexual behavior in persons aware and unaware they are infected with HIV in the U.S. Marks G, et al. JAIDS. 2005;39:446

11. Awareness of Serostatus Among People with HIV and Estimates of Transmission ~25% Unaware of Infection Accounting for: ~75% Aware of Infection People Living with HIV/AIDS: ~1,050,000 New Infections Each Year: ~40,000

12. Late HIV Testing is CommonSupplement to HIV/AIDS Surveillance, 2000-2003 • 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 MMWR June 27, 2003 *16 states

13. Reasons for testing: late versus early testers Supplement to HIV/AIDS Surveillance, 2000-2003

14. Six types of HIV testing: VCT: initiated by a client Routine: initiated by HCW Diagnostic: requested by HCW as part of w/u Required: without consent (military, immigration) Blood and tissue donation For medical research Lessons from Kenya

15. Consent with six types of HIV testing: VCT: Consent implicit in seeking test; verbal Routine: Inform client, opt-out, option to decline Diagnostic: consent implicit, inform patient, opt-out, option to decline Required: Inform; no consent Blood and tissue donation: Inform; no consent For medical research: Special provisions Lessons from Kenya

16. Five principles: Provide information about HIV Must know they are being tested Opportunity to decline Must be offered their test results Access to treatment Lessons from Kenya

17. Current Testing

18. Terminology - I • Diagnostic testing: HIV testing based on clinical signs or symptoms • Screening: HIV testing for all persons in a defined population • Targeted testing: offering testing to subgroups at higher risk based on behavioral, clinical or demographic characteristics • Opt-out testing: HIV testing after notifying the patient that the test will be done; consent is inferred unless the patient declines

19. Terminology - II • Informed consent: process of communication between patient and provider through which the patient can participate in choosing whether or not to undergo HIV testing • HIV prevention counseling: interactive process to assess risk, recognize risky behaviors, and develop a plan to take steps that will reduce risks

20. Source of HIV Tests and Positive Tests • 38% - 44% of adults age 18-64 have been tested • 16-22 million persons age 18-64 tested annually in U.S. *National Health Interview Survey, 2002 **Suppl. to HIV/AIDS surveillance, 2000-2003

21. Current Recommendations and their Effects

22. Current Recommendations

23. Advancing HIV Prevention Strategies Four priorities: • Make voluntary HIV testing a routine part of medical care • Implement new models for diagnosing HIV infections outside medical settings • Prevent new infections by working with persons diagnosed with HIV and their partners • Further decrease perinatal HIV transmission MMWR April 18, 2003

24. Existing CDC RecommendationsAdults and Adolescents • Routinely recommend HIV screening in settings with high HIV prevalence (>1%)

25. Are Recommendations Having Their Intended Effect?

26. Recommendations Are Not Having Their Intended Effect in Acute Care Settings • EDs account for 10% of all ambulatory care visits

27. Rapid HIV Screening in Acute Care Settings Cook County ED, Chicago 2.3% Grady ED, Atlanta 2.7% Johns Hopkins ED, Baltimore 3.2% King-Drew Med Center ED, Los Angeles 1.3% Inpatients, Boston Medical Center 3.8% Study site New HIV+

28. Rapid HIV Screening in Medical Settings CDC, preliminary data - Dec 2005

29. Lessons Learned • Difficult to obtain written consent and provide counseling, yet still screen the large numbers of patients in acute care settings. • Sustainability will depend on streamlined systems, additional staff, or both.

30. Existing CDC RecommendationsAdults and Adolescents • Routinely recommend HIV screening in settings with high HIV prevalence (>1%) • Targeted testing based on risk assessment

31. Paradox No. 1 • We cannot rely on risk-based screening • We cannot eliminate risk-based screening

32. Criteria for Targeted Screening among STD Clinic Patients - Sex Transm Dis, 1998

33. Criteria for Targeted Screening among STD Clinic Patients - Sex Transm Dis, 1998

34. Criteria for Targeted Screening among STD Clinic Patients - Sex Transm Dis, 1998

35. Criteria for Targeted Screening among STD Clinic Patients - Sex Transm Dis, 1998

36. Existing CDC RecommendationsPregnant Women • Routine, voluntary HIV testing as a part of prenatal care, as early as possible, for all pregnant women • Simplified pretest counseling • Flexible consent process • HIV rapid testing and treatment during labor and delivery for women without prenatal testing • Re-screening in third trimester for select, high-risk women

37. Existing CDC RecommendationsAdults and Adolescents • Routinely recommend HIV screening in settings with high HIV prevalence (>1%) • Targeted testing based on risk assessment • Annual testing for sexually active MSM

38. HIV Prevalence and Proportion of Unrecognized HIV Infection Among 1,767 MSM, by Age Group and Race/Ethnicity NHBS, Baltimore, LA, Miami, NYC, San Francisco Age Group (yrs) 18-24 410 57 (14) 45 (79) 25-29 303 53 (17) 37 (70) 30-39 585 171 (29) 83 (49) 40-49 367 137 (37) 41 (30) ≥ 50 102 32 (31) 11 (34) Unrecognized HIV Infection No. % HIV Prevalence No. % Total Tested Race/Ethnicity White 616 127 (21) 23 (18) Black 444 206 (46) 139 (67) Hispanic 466 80 (17) 38 (48) Multiracial 86 16 (19) 8 (50) Other 139 18 (13) 9 (50) Total 1,767 450 (25) 217 (48) MMWR June 24, 2005

39. Paradox No. 2 • Measures put into place that were intended to protect patients from stigma and coercion may now increase stigma or discourage access to beneficial testing and services.

40. Opt-Out Consent Prenatal HIV testing for pregnant women: • RCT of 4 counseling models with opt-in consent: • 35% accepted testing • Some women felt accepting an HIV test indicated high risk behavior • Testing offered as routine, opportunity to decline • 88% accepted testing • Significantly less anxious about testing Simpson W, et al, BMJ June,1999

41. Routine Opt-Out HIV Testing Texas STD Clinics1996-2005

42. Targeted Opt-In Testing Prior to 1996 • Clients with high risk behaviors (e.g. MSM, IDU, genital ulcer disease) • Clients requesting an HIV test • Separate consent form required

43. Background: Focus Groups • Pre-test counseling identified as a deterrent to HIV testing • Many clients thought they were tested routinely and assumed they were HIV negative after their STD clinic visit • Focus group participants strongly recommended making routine HIV testing part of STD screening

44. Texas Informed Consent Law • Sec. 81.105. Informed Consent. (a) Except as otherwise provided by law, a person may not perform a test designed to identify HIV antibody without first obtaining the informed consent of the person to be tested.

45. Texas General Consent Law • Sec. 81.106. General Consent. (a) A person who has signed a general consent form for the performance of medical tests is not required to also sign a specific consent form relating to medical tests to determine HIV infection that will be performed on the person during the time in which the general consent form is in effect.

46. Evaluation Objective Evaluate major changes in the implementation of routine, opt-out HIV testing in STD clinics: • Change in eligibility, from “targeted” to “routine” • Change in consent, from • “opt-in” (separate consent solicited) to • “opt-out” (HIV test included as one of regular screening tests, unless it is refused.)

47. Methods • 6-month evaluation periods before and after implementing opt-out at 6 STD programs: Amarillo, Austin, Dallas, Fort Worth, Houston, Lubbock • Each site recorded data on: • Utilization of HIV testing, prevention counseling • Number of new HIV infections identified • Partner elicitation, counseling, and HIV testing

49. Routine Opt-Out HIV TestingTexas STD Clinics, 1996-97 Opt-In Opt-Out N (%) N (%) % change STD Visits 31,558 34,533 +9 Eligible Clients 19,184 (61) 23,686 (69) +23 Pre-test counsel 15,038 (78) 11,466 (48) -24 Tested 14,927 (78) 23,020 (97)+54 Post-test counsel 6,014 (40) 4,406 (19) -27 HIV-positive 168 (1.1) 268 (1.2) +59 Texas Department of State Health Services, 2005

50. Evaluation Summary • HIV testing increased 54% (attendance increased 9%) • HIV-positive clients identified increased 60% • Number of HIV-positive clients successfully referred to early intervention programs increased 89% • Number of new HIV-positive partners increased 200% • Demographics did not change • Risk profile did not change • HIV-negative STD clients receiving prevention counseling decreased