Carlos del Rio, MD Rollins School of Public Health of Emory University

1. HIV Testing in Medical SettingsPresentation to the IOM Committee on HIV Screening and Access to Care Carlos del Rio, MD Rollins School of Public Health of Emory University Emory Center for AIDS Research

2. 1993 and 2001 CDC Guidelines for HIV testing • Recommended routine HIV screening in settings with high HIV prevalence (>1%) • Targeted testing based on risk assessment • Routinely recommended HIV testing of those seeking treatment for STDs • Annual testing for sexually active MSM Never really implemented….

3. Rarely Followed: Why not? • Perception that: • HIV-infected patients will not be identified • Implementation is not feasible • Implementation is too expensive • Routine testing is not cost-effective

4. Motivation for Scaling Up HIV Testing • Unidentified infection: • 1,200,000 people in the US living with HIV • 280,000 undiagnosed • 56,000 new infections per year • Poor follow-up: • 25% of those testing HIV+ fail to return for results • Inadequate linkage to care: • only 2/3 of HIV-infected persons receive appropriate care • Too little, too late: • 40% learn there are HIV-infected in the year prior to AIDS • 5% learn it within the month prior to death

5. HIV Testing Initiatives • Baltimore: Routine ED HIV testing • HIV prevalence of 3.2-6.7% (Kelen Ann Emerg Med 1999) • Atlanta: Routine UCC HIV CTR • HIV prevalence of 2.6% (del Rio MMWR 2001) • Boston: Routine Inpatient HIV CTR • HIV prevalence of 6.8% (Walensky, Arch Intern Med 2002) • MA: Routine HIV CTR 4 UCC • HIV prevalence 2.0% vs. 1.4% in voluntary testing centers (Walensky MMWR 2004, Walensky AJPH 2005)

6. Updated CDC Recommendations of HIV testing September 22, 2006 • Routine voluntary testing for patients 13-64 in all healthcare settings, not based on patient risk • Exception if HIV rates are less than 0.1% • Opt-out testing • No separate consent for HIV testing • Prevention counseling not required • Repeat testing at discretion of provider, based on patient risk MMWR Rec Reports 2006 Sep 22; 55(RR-14): 1-17.

7. Missed Opportunities • Review of 4315 HIV cases in South Carolina, 2001-2005 • 41% had HIV first reported within one year of AIDS • Analysis of 1302 “late testers” • Number of healthcare visits with no HIV test: 7988 • Average 4 visits per patient • Risk-based testing visits: 1711 • No risk at visit: 6277 CDC MMWR Weekly December 1, 2006 55(47): 1269.

8. Facilitators and Barriers to HIV Testing and Linkage to Care: Inpatient and Ambulatory Care Settings

9. Primary Care Provider Training Needed • Lack of awareness of potential risks of HIV infection in patients by providers • Education on CDC guidelines and benefits of early HIV diagnosis with linkage to care • Tools for disclosing positive diagnosis and discussing risk behaviors, such as sexual practices and drug use • Technical training on rapid HIV tests • Knowledge of state laws regarding consent and counseling • Education on availability of HIV care resources in the community, e.g., Ryan White grantees Jain et al. Knowledge of the Centers for Disease Control and Prevention's 2006 routine HIV testing recommendations among New York City internal medicine residents. AIDS Patient Care STDS. 2009 Mar;23(3):167-76. Goetz et al. Evaluation of the sustainability of an intervention to increase HIV testing. J Gen Intern Med. 2009 Dec;24(12):1275-80. Mimiaga et al. Health system and personal barriers resulting in decreased utilization of HIV and STD testing services among at-risk black men who have sex with men in Massachusetts. AIDS Patient Care STDS. 2009 Oct;23(10):825-35.

10. Clinic/Care System Resource Constraints • Staffing/personnel • Reimbursement and coverage for testing • Availability and access to rapid tests • Competing priorities/general capacity issues – TIME! • Pilot projects have demonstrated feasibility but difficult to sustain without new funding sources Pinkerton et al. Cost of OraQuick oral fluid rapid HIV testing at 35 community clinics and community-based organizations in the USA. AIDS Care. 2009 Sep;21(9):1157-62. Mehta et al. Patient risks, outcomes, and costs of voluntary HIV testing at five testing sites within a medical center. Public Health Rep. 2008 Sep-Oct;123(5):608-17.

11. HIV Testing is important but not sufficient linkage to care and retention in care are key Cheever LW. Clin Infect Dis 2007; 44: 1500-2

12. Linking to Care Facilitators and Challenges • Providing newly diagnosed patients with timely appointments with HIV care providers upon diagnosis • Resources for short-term case manager/system navigators to support follow up for patients who need it • Capacity of care system to meet demand for HIV care • Complexity of patients lives, including many with serious co-morbid conditions Torian et al. Risk factors for delayed initiation of medical care after diagnosis of human immunodeficiency virus. Arch Intern Med. 2008 Jun 9;168(11):1181-7. Ulett et al. The therapeutic implications of timely linkage and early retention in HIV care. AIDS Patient Care STDS. 2009 Jan;23(1):41-9. Gardner et al. Efficacy of a brief case management intervention to link recently diagnosed HIV-infected persons to care. AIDS. 2005 Mar 4;19(4)423-31.

13. Written Consent Laws Remain a Barrier in Some States • HIV testing laws vary from state-to-state • Challenging to integrate separate written consent into work flow • Patients in states with written consent laws less likely to be tested for HIV • 6 states still require written informed consent (MA, MI, NE, NY, PA & WI).*  • Adoption of opt-in testing nationwide could yield 549,437 life years saved nationwide Ehrenkranz et al. Written informed-consent statutes and HIV testing. Am J Prev Med. 2009 Jul;37(1):57-63. April et al. Oral abstract: 1254 – The Survival Cost of Opt-In Consent for HIV Testing. IDSA Annual Meeting. Oct. 31, 2009. *WI recently introduced legislation to change its laws

14. However, even when state laws are changed, hospital practice does not • In GA the state law does not require “written informed consent” but requires that the patient consent to an HIV test. • O.C.G.A. § 31-22-9.1(a)(6) Georgia law requires that all individuals be counseled before and after being tested for HIV. • Hospital lawyers interpretation is: “In order to proof that the clinician has consented the patient a written consent is needed”

15. Opt-in vs. Opt-out Opt-in: a patient must specifically consent to an HIV-antibody test Opt-out: patients are notified that an HIV test will be included in a standard battery of tests; they may actively refuse testing

16. Opt-out testing has been critical in the virtual elimination of perinatal HIV transmission • O.C.G.A. § 31-17-4.2 "Georgia HIV Pregnancy Screening Act of 2007." Every physician and health care provider who assumes responsibility for the prenatal care of pregnant women during gestation and at delivery shall be required to test pregnant women for HIV except in cases where the woman refuses the testing.

17. HIV testing without consent in critically ill patients Halpern, JAMA 2005

18. Who will pay? • Medicaid: Coverage for HIV serology screening is optional based on state. • Medicare: On Dec 8, 2009 CMS ruled that Medicare Part B will cover HIV testing for people at risk of infection (defined as anyone who asks for the test). • But current CDC screening recommendations are for age 13-64 so would not be relevant. • Private insurance: Don’t want HIV testing (don’t want to know) • Cost of care dwarfs cost of testing. • The financial burden of expanded HIV screening will fall disproportionately on discretionary programs that fund care and will not be offset by entitlement program savings.  Testing will represent a small proportion (18%) of the total budget increase.