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Changes in HIV Testing Practices and Counseling Recommendations

Changes in HIV Testing Practices and Counseling Recommendations. FDA Blood Products Advisory Committee Meeting November 3, 2005. Bernard M. Branson, M.D. Associate Director for Laboratory Diagnostics Divisions of HIV/AIDS Prevention National Center for HIV, STD, and TB Prevention

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Changes in HIV Testing Practices and Counseling Recommendations

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  1. Changes inHIV Testing Practicesand Counseling Recommendations FDA Blood Products Advisory Committee Meeting November 3, 2005 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

  2. Outline • Role of rapid HIV tests in the HHS “Advancing HIV Prevention” Initiative • Postmarketing surveillance: rapid HIV tests and home sample collection HIV tests • CDC’s planned revisions of counseling recommendations • Anticipated value of an OTC vs CLIA-waived test • Validating HIV tests for home use

  3. Advancing HIV Prevention Four priority strategies: • 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

  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 Estimated number of 40,000 new infections annually Glynn et al 2005 HIV Prevention Conference

  5. Role for Rapid HIV Tests • Increase receipt of test results: • In 2000, 31% did not return for results of HIV-positive conventional tests at publicly funded sites • 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 • Increase identification of HIV-infected pregnant women so they can receive effective prophylaxis

  6. 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, Los Angeles 1.3% CDC HIV testing sites: 1.1% Study site New HIV+

  7. Rapid HIV Screening in Medical Settings CDC, preliminary data - Sept 2005

  8. Rapid HIV Testing in Non-Clinical Settings CDC, preliminary data - Sept 2005

  9. HIV Screening with OraQuick in MIRIADMother Infant Rapid Intervention At Delivery Testing of pregnant women in labor for whom no HIV test results are available; 12 hospitals in 5 cities: Atlanta, Chicago, Miami, New Orleans, New York 7680 women screened • 54 (0.7%) new HIV infections identified • 6 false positive OraQuick tests, no false negatives • 15 false-positive EIAs: 7 p24 only, 8 WB negative Specificity: OraQuick 99.92%; EIA 99.80% Positive predictive value: OraQuick 90%; EIA 76% Bulterys et al, JAMA July 2004

  10. Performance of OraQuick Rapid HIV Test 4 studies comparing OraQuick with whole blood and oral fluid to EIA/Western blot: • Known HIV+ persons – Los Angeles • Prospective testing, HIV testing clinic and STD clinics – Los Angeles, Phoenix • Pregnant women – 5 MIRIAD cities • Outreach settings – Minneapolis

  11. Performance of OraQuick: Known HIV+ Sensitivity

  12. Performance of OraQuick: Prospective Testing Combined study population: 327 HIV-positive by reference tests 12,010 HIV-negative by reference tests

  13. Postmarketing Surveillance: 2003 • 20,585 rapid whole blood HIV tests • 392 (1.9%) confirmed HIV-positive • 21 (5.4%) reactive OraQuick had negative or indeterminate confirmatory test results • 10 resolved as true positive on follow-up • 4 resolved as false-positive on follow-up • 7 with unsuccessful follow-up

  14. Postmarketing Surveillance: 2004-2005 Project-specific median (range) for confirmed HIV seropositivity, specificity and positive predictive value of OraQuick (347 testing sites, 14 project areas) CDC, preliminary data - Oct 2005

  15. Postmarketing Surveillance: 2004-2005 Project-specific median (range) of clients who received test results (347 testing sites in 14 project areas) CDC, preliminary data - Oct 2005

  16. Postmarketing Surveillance: 2004-2005 • Quality assurance outcomes, 154 sites, 7 project areas January 1, 2005 to June 30, 2005 • 35,188 persons tested • 4 (0.01%) invalid test results • 1,086 controls run • median 2.7% (range 0.5% - 9.7%) of all tests • 2 controls reported as “invalid” • 2 sites each reported testing clients on one day when temperature was out of range • 1 site reported one day when tests kits were stored outside recommended temperature range CDC, preliminary data - Oct 2005

  17. User characteristics, May 1996 – September 1997 Postmarketing Surveillance: Home Sample Collection HIV Testing Data available for 76,373 (59%) of 165,194 users -JAMA 1998

  18. Postmarketing Surveillance: Home Sample Collection HIV Testing • 58% of all users and 49% of users who tested HIV positive had never been tested before. • HIV prevalence: • 0.8% among those with no previous test • 0.7% among those with previous negative test -JAMA 1998

  19. Postmarketing Surveillance: Home Sample Collection HIV Testing Analysis of counselors “call log” and telephone results • HIV-positive users: • 23% had a source of follow-up care • 65% accepted referrals for care • 12% were already receiving antiretroviral therapy • Psychological distress: • 7% expressed shock at unexpected positive result • 5% hung up immediately, without counseling • HIV-negative users: • 82% received recorded message only • 29% called more than once • 12% elected to speak with a counselor -JAMA 1998

  20. HIV Testing, Persons Age 18-64, 2002 (Excluding Blood Donation) NHIS: National Health Interview Survey BRFSS: Behavioral Risk Factor Surveillance System - MMWR December 3, 2004

  21. HIV Testing, Persons Age 18-64, 2002 Source of Most Recent Test National Health Interview Survey - MMWR December 3, 2004

  22. Changes in Testing and Counseling Recommendations • Routine HIV screening in health care settings in high prevalence communities or facilities • Opt-out consent for pregnant women, with written or verbal notification that testing will be done • Written or verbal information about HIV • Prevention counseling in conjunction with HIV testing not required in health care settings • Retesting at least annually for persons at high risk • Ensure linkage to care for persons who test positive

  23. Rationale for Proposed Changes • High levels of knowledge about HIV, availability of effective treatment, experience with HIV testing • Many HIV-infected persons access health care but are not tested for HIV until symptomatic • Inconclusive evidence about prevention benefits from typical counseling for persons who test negative • Substantial reductions in high-risk sexual behavior among persons aware of HIV infection • 68% reduction in unprotected intercourse with partners not known to be HIV-positive • Prevention counseling encouraged for high risk persons but does not have to occur in context of HIV testing

  24. Potential Value of OTC vs CLIA-Waived Test • Persons unwilling to be tested in other settings • Persons who retest frequently • Knowledge of partner’s status as a prevention intervention • Local requirements for laboratories beyond CLIA requirements that impede HIV testing

  25. Potential Validation Studies • Observed self-testing at high risk venues • Counselor provides client with “OTC” device • Observes specimen collection and testing • Documents client reaction to test result • Verifies client interpretation of test result • Select 2 to 3 settings serving clients with different characteristics • Minimum 500 clients in setting with HIV prevalence of 3% to 5%

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