Notes

Outline

Changes in HIV Testing Practices and  Counseling Recommendations

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

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

Slide 4

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

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%

Rapid HIV Screening in Medical Settings

Rapid HIV Testing in Non-Clinical Settings

HIV Screening with OraQuick in MIRIAD  Mother 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%

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

Performance of OraQuick:  Known HIV+

Performance of OraQuick:  Prospective Testing

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

Postmarketing Surveillance:  2004-2005

Postmarketing Surveillance:  2004-2005

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

Postmarketing Surveillance: Home Sample Collection HIV Testing User characteristics, May 1996 – September 1997

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

Postmarketing Surveillance: Home Sample Collection HIV Testing 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

HIV Testing, Persons Age 18-64, 2002 (Excluding Blood Donation)

HIV Testing, Persons Age 18-64, 2002 Source of Most Recent Test

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

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

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

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%