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Over The Counter HIV Testing Estimating The Public Health Benefit – Recommendations for Required Accuracy Freya Spielberg, MD MPH

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Presentation on theme: "Over The Counter HIV Testing Estimating The Public Health Benefit – Recommendations for Required Accuracy Freya Spielberg, MD MPH"— Presentation transcript:

1 Over The Counter HIV Testing Estimating The Public Health Benefit – Recommendations for Required Accuracy Freya Spielberg, MD MPH Freya@u.washington.edu

2 Public Health Risk vs. Benefit  Risks  False negatives – undiagnosed HIV  False positives – negative emotional reactions.  Benefits  Greater knowledge of HIV status – decreased HIV incidence  Early treatment – Decreased morbidity, mortality, negative economic and psychological consequences.

3 Weighing the Risks and Benefits  Surveys of Acceptability of OTC Testing 1,2  Experience with Home Specimen Collection 3  Self-Testing Study – Positive Perspective 4,5  Effective Sensitivity 6

4 Public Health Risk vs. Benefit If OTC results in more people overall with HIV learning their status then the benefits will likely outweigh the risks.

5 Will OTC Reach The Untested?  Two survey studies among high risk (N=460, N=354), Seattle and San Francisco -OTC preferred by 20 to 24% 1,2  OTC significantly preferred by people who had never tested. 1  In self-testing study among 240 people with HIV, 61% preferred to learn their results with OTC over clinic testing. 3,4  Home Specimen Collection (HSC) post marketing study - 49% of 1494 HIV positive users had never tested before. 5  OTC preferred 20 to 24 times more than HSC 1,2 Conclusion: It is likely that an OTC will reach a substantial number of people with HIV who have never tested before.

6 How Accurate Does an OTC Need to be for the Public Health Benefits to Outweigh the Risks?  Effective Sensitivity – The % of true positives identified in a population when testing is available: Assume performance sensitivity is 99% for staff-testing and 95% for OT C.  If staff-based rapid testing is accepted by 50% of the people with unidentified HIV,  and adding an OTC results in an additional 20% of those infected testing  then the Effective Sensitivity of the staff test would be 49.5% whereas the effective sensitivity in a population where OTC tests were also available would be 66.5%.

7 A Case for Lowering the Accuracy Bar for FDA approval of an OTC  It is unlikely that people at highest risk will have as high performance accuracy as trained staff.  In our pilot (N=240) of self testing we found 95% self-testing sensitivity 3  Requiring equivalent accuracy to lab-based tests (98%) will discourage companies from performing clinical trials.  Although the test performance sensitivity of an OTC may be somewhat lower than a staff-based test, the overall effective sensitivity of OTC testing will be comparably much higher.

8 Recommendations for Accuracy Criteria for OTC Approval  Standard Clinical Trails – Require performance sensitivity/specificity of > 95%.  Or require clinical trials that measure effective sensitivity.

9 References 1. Spielberg F, Branson B, Goldbaum G, Lockhart D, Kurth A, Celum C, Rossini A, Critchlow C, Wood R. Overcoming Barriers to HIV Testing: Preferences for New Strategies Among Clients of a Needle Exchange, an STD Clinic and Sex Venues for MSM. JAIDS 2003; 32(3):318-327. 2. Skolnik HS, Phillips KA, Binson D, Dilley JW. Deciding where and how to be tested for HIV: what matters most? J Acquir Immune Defic Syndr 2001; 27: 292–300. 3. Spielberg F, Levine RO, Weaver M. Self-testing for HIV: a new option for HIV prevention? Lancet Infect Dis. 2004 Oct;4(10):640-6. Review. 4. Spielberg F, Camp S, Ramachandra E. HIV Home Self-Testing: Can It Work? 2003 National HIV Prevention Conference, Atlanta, July 27- 30, Abstract #1007. 5. Branson B. Home sample collection tests for HIV infection. JAMA 1998; 280: 1699–701.


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