1. Over The Counter HIV Testing A Technology Whose Time has Come Freya Spielberg, MD MPH Freya@u.washington.edu

2. My Background  Assistant Professor of Family Medicine, University of Washington  Researcher in Center For AIDS and STDs  15 Years Research Experience in Alternative HIV Counseling and Testing Strategies  Test development  Acceptability  Effectiveness  Cost  First study of self-testing for HIV (n=240)

3. Need  >1 Million currently infected with HIV  40,000 new HIV infections in the US every year (CDC, 2004)  >250,000 of those infected unaware of their status (25-33% of all positives ) (CDC, 2003;CDC, 2001)  30% of positives, 40% negatives don’t return for standard antibody test results  Knowledge of HIV infection decreases behavior that can result in HIV transmission (Liddicoat et al., 2004)

4. Why an OTC Rapid Test  Preferable - Studies have shown self-testing is preferable to people at risk who have never tested (Spielberg JAIDS 2003)  Better Access - Self-testing is 25 times more acceptable than home specimen collection, so access to acceptable testing would be substantially improved (Spielberg JAIDS 2003)  Overcoming stigma - People with stigma who avoid clinics may be more likely to test.  Likely safe - Post-Marketing studies of home specimen collection showed that the vast majority of people with positive test results accepted referrals or were already in care. (Branson JAMA 1998) No studies have shown increased risk of suicide with HIV testing.

5. Questions to be Answered  Can people perform the test accurately?  Will people understand the meaning of their test results? (preliminary, need for confirmation)  Will people who positive results follow up for counseling, confirmation, and medical care.  What type of education/counseling will be necessary to ensure accuracy, safety and follow up for confirmatory testing.  Pre-test counseling – Brochure vs. Computer  Post-test counseling – 24 hour telephone counseling  How much will people be willing to pay?

6. Preliminary Study of Self-Testing  Study of 240 people with HIV  Tests performed with written instructions  Difficulties observed, revisions to instructions made for 7 waves of n=20  Accuracy evaluated with final instructions N=100  Preferences assessed N=240  Willingness to pay assessed N=240

7. Accuracy of Self-Tests (N=100) Compared to Staff Finger-StickOral Fluid False Negative* 5 6 True Positive 8485 Invalid**119 * HAART increases false negative rates ** Invalids due to inability to get FS specimen or not putting device into diluent.

8. Preferences (N=240) PreferencesHomeClinic Location61% 37% Privacy73% 6% Convenience76% 10% Comfortable70% 10% Safety48% 21% Accuracy22% 43%

9. Willingness to Pay For Self-Test: CostFinger-stickOral Fluid $587%89% $1085%87% $1570%69% $2037%43% $3013%19%

10. Clinical Trial Considerations  Recruit from populations where marketing is planned (drugstores, internet, high-risk outreach venues).  How sensitive does an OTC test need to be for the benefit to outweigh the risk?  Benefit - Number of HIV positive people learning their status who would not have tested without an OTC test  Risk – If lower sensitivity, number positive people who would have tested at a clinic but instead used an OTC test

11. Clinical Trial Considerations  With sensitivity > 80 % the benefits of an OTC HIV test would outweigh the risks if for every one first-time tester who tested positive using an OTC < 5 people with HIV switched from clinic-based testing to OTC.  Conservatively assuming that >25% (HSC 49%, Branson, JAMA 1998 ) of the testers will be first-time testers, there will likely be a ratio of 1 new tester : < 4-5 switchers.  In the least favorable circumstances OTC sensitivity was 94% so it is likely that the benefits will outweigh the risks for an OTC rapid HIV test.

12. Clinical Trial Considerations  Post Marketing Studies - Conduct post- marketing studies to determine actual uptake among those who have never tested vs. switchers, safety, post-test behaviors and follow up for care.  Integrate into existing CDC National Behavioral Surveillance  Conduct a follow up assessment of a subset of customers

13. Summary  Concerns about the risks of self-testing remain unproven.  The benefits of an over-the-counter HIV test very likely outweigh the risks.  FDA should move forward quickly to encourage clinical trials for an OTC rapid HIV test.  Short of a vaccine, a widely accessible inexpensive OTC HIV test is the only intervention currently available that could feasibly change the course of the epidemic.  Fast-track the approval - There is no time to waste.