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Routine HIV Testing, State Law, and Testing Technology

Routine HIV Testing, State Law, and Testing Technology

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Routine HIV Testing, State Law, and Testing Technology

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  1. Routine HIV Testing, State Law, and Testing Technology MATEC Midwest AIDS Training and Education Center

  2. Disclosure As stated in the No Conflict of Interest policy maintained by Health Care Education and Training, Shelly Ebbert agrees to present the following information fairly and without bias. Funding for this program was provided through the Region V Training Project of Health Care Education and Training.

  3. Midwest AIDS Training and Education Center • Ryan White CARE Act-funded training agency • Mission: To enhance the capacity of clinicians to provide quality health care services for people living with HIV/AIDS in Illinois, Indiana, Iowa, Michigan,. Minnesota, Missouri, and Wisconsin

  4. Summary of Presentation Snapshot of Epidemiology Approaches to Testing Protocol for Testing Under New Law Rapid Test Technology The Imperative for Routine HIV Testing

  5. Epidemiology Nationwide: • CDC estimates approx. 56,000 persons are newly infected with HIV each year • 21% of people who are HIV+ do not know their status • 32% diagnosed with HIV in 2007 were late diagnoses, occurring shortly before they developed AIDS • The number of adults age 18-64 who were ever tested for HIV increased to 11.4 million in 2006-2009; but an estimated 55% of adults have never been tested

  6. Epidemiology CDC Statement on Testing: • Early HIV testing reduces the spread of disease, extends life expectancy, and reduces costs. • Every new HIV infection that is prevented saves approximately $367,000 in lifetime medical costs Source: Morbidity and Mortality Weekly Report, Centers for Disease Control and Prevention (www.cdc.gov/mmwr) Early Release / Vol. 59 November 30, 2010

  7. Epidemiology Illinois: Total living AIDS cases = 17,882 Total living HIV cases = 14,953 Chicago = 65% PLWA, and 69% PLWHIV New cases (statewide) in 2008 - 2009 approx. 2,000 per year (42% AIDS in 2008) Source: IDPH HIV/AIDS Section, Surveillance Program December 2009

  8. Epidemiology Health Disparities and HIV • People of Color are disproportionately affected • 51% living cases in African American Community as compared to 33% White • 15% living cases in Hispanic Community • Disparities due to Social Determinants of Health • Class • Race • Education • Access to health care

  9. Epidemiology Populations at Increased Risk • Youth and young adults age 13-29 account for 19% PLWHIV in Illinois • MSM behavior most common mode of transmission • 63% MSM • IDU decreasing but still significant source of transmission • Among males: 63% PLWHIV contracted through MSM • Among females: 43% PLWHIV contracted through Heterosexual Contact (38% undetermined) Source: IDPH HIV/AIDS Section, Surveillance Program December 2009

  10. Approaches to HIV Testing • Diagnostic • Test patients who present with symptoms • Shortcoming: • Misses asymptomatic patients • Lack of knowledge about symptoms of HIV • Targeted • Behavioral based-target those most at risk • Shortcomings: • Patient may not perceive themselves to be at risk • Patient does not disclose at-risk behavior

  11. Approaches to HIV Testing • Universal Screening • Test universally in all clinical settings regardless of risk factors • Impact: normalizes test, reduces stigma of being tested

  12. What makes Routine Screening for HIV a good idea? • 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

  13. Illinois Law Prior to July 2008 ‘Opt-In’ approach to testing Testing is offered, patient must give written, informed consent before the test occurs Pre and post test counseling required including discussion of risk factors Patients had right to be tested anonymously

  14. Illinois Law After July 2008 ‘Opt-Out’ approach to testing Testing is offered, patient must give consent before the test occurs; can be verbal as long as it is documented Provides guidance for pre- and post- test information Patients has right to be tested anonymously Increases penalty for unauthorized release of test result

  15. Illinois Law Related to HIV Testing The AIDS Confidentiality Act (ACA): Patients must receive pretest information: • Procedures to be followed • Purpose of test and meaning of results • Testing is voluntary and results are confidential • The right to anonymous testing if preferred • Availability of referrals for more info/counseling • Allows patient to ask questions / decline testing

  16. Illinois Law Related to HIV Test Results Requires providers to provide post test information: • Give test results in person whenever possible • Provide referrals for follow-up counseling • Provide referrals to appropriate medical care

  17. Reasons Law Changed Why routine testing? • Lack of knowledge about HIV+ correlates to increased spread of disease • Those who are aware of their HIV+ are more likely to alter their behavior to prevent spread of the disease (prevention to positives) • Lack of knowledge of HIV status means patient not receiving care • Medical treatment lowers viral load which may correspond to reduced rate of transmission (care = prevention)

  18. Implications for CDC Recommendations and Changes to State Law Increased testing in Emergency Departments Increase routine testing in other medical settings Decrease in stigma associated with taking test Link clinical care with prevention efforts Increase linkages to care for newly diagnosed Targeted interventions will continue to take place and follow pre and post test guidelines in locations that receive funding from state Departments of Health for Counseling Testing and Referral (CTR)

  19. Rapid HIV Tests

  20. Role for Rapid HIV Tests Increase receipt of test results Increase identification of HIV-infected pregnant women so they can receive effective prophylaxis Increase feasibility of testing in acute-care settings with same-day results Increase number of venues where testing can be offered to high-risk persons

  21. Uni-Gold Recombigen Clearview Complete HIV 1/2 Multispot HIV-1/HIV-2 Reveal G3 Clearview HIV ½ Stat Pak OraQuick Advance 21

  22. FDA-approved Rapid HIV Tests(2008)

  23. Test Technology Clearview Stat Pack OraQuick

  24. CLIA Waivers for Rapid Tests The Clinical Laboratory Improvement Amendments of 1988 (CLIA) establish quality standards for laboratory testing to ensure the accuracy, reliability, and timeliness of patient test results. CLIA requires that any facility examining human specimens for diagnosis, prevention, treatment of a disease or for assessment of health must register with the federal Centers for Medicare & Medicaid Services (CMS) and obtain CLIA certification.

  25. Clearview by FAST: TWO EASY STEPS WITH A REACTIVE RESULT IN AS LITTLE AS 15 MINUTES Reliable: built-in control ensures accuracy FLEXIBLE: USE WITH MULTIPLE SPECIMEN TYPES - WHOLE BLOOD (FINGER STICK OR VENIPUNCTURE), SERUM OR PLASMA “CLEARLY BETTER” 99.7% sensitive and 99.9% specific for all sample types

  26. OraQuick by RAPIDPROVIDES RESULTS IN 20 MINUTES FLEXIBLEAPPROVED FOR ORAL FLUID, PLASMA, FINGER STICK OR VENIPUNCTURE WHOLE BLOOD SPECIMENS. IDEAL FOR BOTH CLINICAL AND NON-CLINICAL SETTINGS. ACCURATEGREATER THAN 99% AGREEMENT WITH CONFIRMATORY WESTERN BLOT.1 SIMPLECLIA-WAIVED FOR ORAL FLUID, FINGER STICK AND VENIPUNCTURE WHOLE BLOOD AND OFFERS THE ABILITY TO TEST IN NON-TRADITIONAL TESTING ENVIRONMENTS, SUCH AS OUTREACH PROGRAMS AND MOBILE TESTING CLINICS.

  27. Detects p24 antigen and HIV antibody - Time to result: 29 minutes - 100 results/hour - FDA-approved June 22, 2010 Abbott Architect 4th Generation Combo Ag/Ab Assay

  28. INSTI by bioLytical Laboratories, Inc FDA approved for rapid testing November 29, 2010 Whole blood, serum, or plasma Detects HIV 1 & 2 Results immediately

  29. Preliminary Positive All HIV rapid tests that are “reactive” or “positive” must be confirmed positive. A Western Blot must be run on a specimen to confirm HIV. CDC and others are discussing confirmatory algorithms – no changes yet.

  30. Considerations Regarding Rapid HIV Tests Increased cost Personnel requirements Quality assurance requirements Interface with lab information systems

  31. Evolution of HIV Testing • Antibody Tests detect HIV antibodies an within 90 days after initial infection (1st generation tests – EIA) • Each progressive “generation” of tests can detect the presence of HIV a bit sooner in the disease process • 4th generation tests detect antibodies AND antigen

  32. Window Period and HIV Infection 0 10 20 30 40 50 60 70 80 90 100 HIV RNA (plasma) HIV Antibody HIV p24 Ag p24 Ag EIA - 1st gen 2nd gen 3rd gen 16 22 11 Acute HIV Infection

  33. Clinical Syndrome of Acute HIV • - Kahn et al, NEJM 1998 • - Weintrob et al, Arch Int Med 2003 • 40-90% develop symptoms of Acute HIV • 50%-90% with symptoms seek medical care • Of those diagnosed with Acute HIV, 50% of patients seen at least 3 times before diagnosis

  34. Role of Acute/Early HIV Infection Xiradou AIDS 2004: Acute = 11% of new infections 35% from casual partners; 6% from steady partners Yorke JAIDS 2004: Transmissions in symptomatic stage dominate in established epidemics Brenner JID 2007: Recent infection accounted for half of onward transmissions in Quebec Pinkerton AIDS 2007: 8.6% of new infections from Acute 48.5% from nonacute, serostatus unaware 42.9% from nonacute, serostatus aware

  35. 5 4 3 2 AIDS Acute Infection 3 wks Asymptomatic Infection HIV Progression Risk of Sexual Transmission of HIV Risk of Transmission Reflects Genital Viral Burden 1/30- 1/200 HIV RNA in Semen (Log10 copies/ml) 1/100- 1/1000 1/500 - 1/2000 1/1000 - 1/10,000 Cohen, Pilcher, UNC Center for AIDS Research

  36. Bottom Line for Routine HIV Testing • Find new cases early • Link new positives to medical care to reduce viral load and delay disease progression • Provide risk reduction information • Reduce/eliminate new infections • Test partners

  37. Why would a patient decline testing? • Patient doesn’t feel “at risk” (51.6%) • Patient is scared of potential result (19.1%) • Patient doesn’t want to know status (14.2%) • Patient may be enrolled in a clinical trial • HIV Vaccine clinical trial participants are advised to not seek testing outside of the trial setting • Why? VISP! Burns et al (2004). Factors that may increase HIV testing uptake in those who decline to test. Sexually Transmitted Infec, 80:249

  38. Vaccine Induced Seropositivity • Volunteer’s body may produce antibodies to HIV, if reacting to vaccine • Most standard HIV tests look for antibodies • Important to distinguish between testing for antibodies vs. testing for actual virus • “Antibody positive” = volunteer is producing antibodies against HIV due to vaccine response • “Antibody positive”= volunteer is NOT actually HIV infected

  39. For More Information on the Vaccine Trials Referrals to the Vaccine Trial/ Project WISH: UIC College of Medicine 312-413-5897 Presentations and other information: James Carey, MPH, CHES • Training Specialist, MATEC • Community Educator, Project WISH and HIV Vaccine Trials Network (HVTN) • 312-996-3160 • jcarey4@uic.edu

  40. For materials, training, and technical assistance about HIV Routine Testing SHELLY EBBERT, M.P.H. Regional Program Specialist MATEC sebbert@uic.edu 312/996-0180