1. Potential Role of Home-Use HIV Test Kits Bernard M. Branson, M.D. A ssociate Director for Laboratory Diagnostics Division of HIV/AIDS Prevention

2. 95% Confidence Interval Number HIV infected 1,106,400 (1,056,400 – 1,156,400) Number unaware of their HIV infection 232,700 (21%) (221,200 – 244,200) Estimated new infections 56,300 (48,200 – 64,500) annually Persons with HIV and Awareness of HIV Status, United States - 2006 Campsmith M et al, MMWR October 2008 Hall I, et al JAMA August 2008

3. Estimated Rates of new HIV Infections by Race/ethnicity 50 U.S. States & DC, 2006 Total Male: 34.3 per 100,000 Total female: 11.9 per 100,000

4. Estimated Number of New HIV Infections by Transmission Category Extended Back-Calculation Model, 50 U.S. States & DC, 1977-2006 MSM Heterosexual IDU

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

6. FDA-approved Rapid HIV Tests Sensitivity (95% C.I.) Specificity (95% C.I.) Oral fluid OraQuick Advance Whole blood OraQuick Advance UniGold Recombigen Clearview Stat-Pak Clearview Complete 99.3 (98.4 - 99.7) 99.6 (98.5-99.9) 100 (99.5 – 100) 99.7 (98.9 – 100) 99.7 (98.9 – 100) 99.8 (99.6-99.9) 100 (99.7 – 100) 99.7 (99.0 – 100) 99.9 (98.6 – 100) Serum/plasma Reveal G3 Multispot 99.8 (99.2 – 100) 100 (99.9 – 100) 99.1 (98.8 – 99.4) 99.9 (99.8 – 100)

7. Postmarketing Surveillance: 2004-2005 No. of Tests HIV Seropositivity Median % (range) Estimated Specificity Median % (range) PPV Median % (range) RT whole blood135,7240.8 (0.1-2.6)99.98 (99.7-100)99.2 (66.7-100) RT oral fluid26,0661.0 (0-4.0)99.89 (99.4-100)90.0 (50.0-100) Project-specific median (range) for confirmed HIV seropositivity, specificity and positive predictive value of OraQuick (347 testing sites, 14 project areas) Wesolowski et al, AIDS 2006

8. Developments Since March 2006 BPAC

9. Rapid Test Utilization by Health Departments In 2008:  2,093,339 rapid HIV tests (estimated)  52% of all HIV tests conducted  87% of all HIV tests in community-based sites Clients increasingly familiar with rapid HIV tests

10. Counseling with Testing 2006 CDC Recommendations for health-care:  Provide written or oral pre-test information; emphasis on post-test counseling for persons who test HIV+ USPSTF 2008 Review:  Moderate to high-intensity behavioral counseling is effective in reducing STI incidence in high-risk populations.  Little evidence suggests that single-session interventions or interventions lasting less than 30 minutes were effective in reducing STIs. - CDC, MMWR 2006 -Lin et al, Annals Internal Medicine 2008

11. Potential Role of Home-Use Tests 1. Persons who might not otherwise be tested

12. Decrease in Anonymous vs Confidential HIV Tests, Florida, 2002 - 2008 10% 1.2% - Florida Dept of Health, HIV Counseling and Testing Annual Report, 2008

13. Men with Male Sex Partner in Past Year: Disclosure to Health-Care Provider DisclosedDid Not DiscloseOdds Ratio Total277 (61%)175 (39%) Age <28111 (52%)101 (48%)1 (Reference) ≥28 166 (69%) 74 (31%)2.04 Education College grad 161 (74%) 58 (27%)6.94 Some college 67 (56%) 53 (44%)3.16 HS graduate 39 (50%) 2.50 Less than HS 10 (29%) 25 (71%)1 (Reference) - Bernstein et al, National HIV Behavioral Surveillance, NYC, Arch Int Med 2008

14. Men with Male Sex Partner in Past Year: Disclosure to Health-Care Provider DisclosedDid Not DiscloseOdds Ratio Race/ethnicity White134 (81%)31 (19%)1 (Reference) Black38 (40%)56 (60%)0.16 Hispanic65 (52%) 61 (48%)0.25 Sexual Preference Heterosexual 0 5 (100%) Homosexual274 (78%) 77 (22%) Bisexual 0 86 (100%) - Bernstein et al, National HIV Behavioral Surveillance, NYC, Arch Int Med 2008

15. Potential Role of Home-Use Tests 1. Persons who might not otherwise be tested 2. More frequent testing for high-risk persons CDC Recommendation: Persons with known risk factors for HIV infection should be tested at least annually.

16. HIV Testing Among IDU HIV Testing Survey, 1998-1999  90% previously tested 5 cities, 1998 – 2002 *  93% previously tested  69% tested within previous year - Kellerman et el, JAIDS 2002 - Heimer et al, AJPH 2007 *Chicago IL, Hartford CT, New Haven CT, Oakland CA, Springfield MA

17. HIV Testing Among MSM Young MSM study, 1998-2000  88% previously tested, 54% in previous year National HIV Behavioral Surveillance 2003-2005:  92% previously tested, 77% in previous year 57,131 MSM visits to STD clinics, Denver, DC, San Francisco, Seattle  94% previously tested  Median inter-test interval 243 days - MacKellar et al, Sex Transm Diseases 2006 - CDC, MMWR Surveillance Summaries 2006 -Helms et al, JAIDS 2009

18. Total Tested HIV Prevalence No. % Unrecognized HIV Infection No. % Age Group (yrs) 18-24410 57(14)45(79) 25-29303 53(17)37(70) 30-39585171(29)83(49) 40-49367137(37)41(30) ≥ 50102 32(31)11(34) Race/Ethnicity White616127(21)23(18) Black444206(46)139(67) Hispanic466 80(17)38(48) Multiracial 86 16(19) 8(50) Other139 18(13) 9(50) Total1,767450(25)217(48) HIV Prevalence and Proportion of Unrecognized HIV Infection Among 1,767 MSM, by Age Group and Race/Ethnicity NHBS, Baltimore, LA, Miami, NYC, San Francisco MMWR June 24, 2005

19. Total Tested HIV Prevalence No. % Unrecognized HIV Infection No. % Age Group (yrs) 18-24410 57(14)45(79) 25-29303 53(17)37(70) 30-39585171(29)83(49) 40-49367137(37)41(30) ≥ 50102 32(31)11(34) HIV Prevalence and Proportion of Unrecognized HIV Infection Among 1,767 MSM, by Age Group and Race/Ethnicity NHBS, Baltimore, LA, Miami, NYC, San Francisco MMWR June 24, 2005  Of those with unrecognized HIV infection: - 84% previously tested - 42% tested in the preceding year Unaware ≠ Untested

20. Parameters Determining Potential Utility of Home-Use Tests for Public Health Characteristics/demographics of likely users Ability of users to obtain accurate results Users understanding of instructional materials, including limitations (e.g., window period before antibody development; importance of confirmation) Mechanisms for obtaining follow-up testing and care Benefits and adverse consequences from receiving a positive test result Cost of the test

21. Likely Users Are Difficult to Predict HIV Testing Survey, 1995-1996:  19% would choose a home kit for their next HIV test Home Collection HIV Test Kit Approved July 1996 HIV Testing Survey, 1998-1999:  54% had heard of home test kits  1% had used home test kit

22. CDC Qualitative Research, 2004 10 focus groups:  8 with MSM, 2 with high-risk heterosexual women  Miami, New Orleans, New York City, San Francisco, Washington, DC  Participants 18-50 years of age Conducted shortly after CLIA waiver but before widespread use of rapid HIV tests by health departments  First CLIA waiver approved January 31,2003  Oral fluid rapid test received CLIA waiver June 25, 2004

23. Focus Groups: Major Themes Might encourage some persons to get tested Testing with partner might allow unprotected sex, especially in long-term relationships Seeing it used in clinics and doctor’s office would lend credibility about accuracy More likely to use if recommended by their doctor Would not consider positive result definitive or replacement for seeing a doctor

24. Focus Groups: Major Themes Most reacted negatively to asking a new acquaintance to test before casual sex, but geographical differences Understanding (and concern) about window period Essential: Some means of getting access to counseling or support must be provided for persons who test positive Expect test to cost $10 to $30

25. Potential Role of Home-Use Tests 1. Persons who might not otherwise be tested 2. More frequent testing for high-risk persons 3. Mutual testing with sex partners

26. HIV Testing with Prospective Partners 2006 CDC Recommendation:  Health-care providers should encourage patients and their prospective sex partners to be tested before initiating a new sexual relationship. “Serosorting” among MSM:  Practice of preferentially choosing sex partners, or deciding not to use condoms with selected partners, based on their disclosed, concordant HIV status

27. “Serosorting”: Mixed Evidence Increasing practice among MSM HIV-infected MSM: decrease in proportion of unprotected sex acts with uninfected partners 1 HIV-negative MSM: unprotected intercourse with partner believed to be negative was an independent risk factor for acquiring HIV 2,3 With serosorting among MSM, decline in equilibrium HIV prevalence as frequency of HIV testing increases 4 1 Steward et al, AIDS Behav 2009 2 Koblin et al, AIDS 2006 3 Buchbinder et al JAIDS 2005 4 Cassels et al, AIDS 2009

28. Potential Role of Home-Use Tests 1. Persons who might not otherwise be tested 2. More frequent testing for high-risk persons 3. Mutual testing with new sex partners 4. Repeat testing after potential “window period”

29. WB positive RNA 3 rd generation EIA 2 nd generation EIA Flow-through RT 1 st generation EIA Lateral flow RT Days before Western blot positive when 50% of Specimens Reactive WB Indeterminate 0 510 152025 Window period: Current Assays with 15 Seroconverter Panels 185 specimens from 15 seroconverters Owen et al, J. Clin. Microbiol 2008 Flow-through RT Lateral flow RT

30. Undetected “Window Period” Infections in High-Risk Populations Rapid test negative, detectable RNA:  0.3% of 14,005 frequently tested MSM in Seattle STD clinic; represent 20% of all HIV infections detected  0.08% of 21,222 STD clinic patients in New York City; represent 9% of all HIV infections detected - Stekler et al, Clin Infect Dis 2009 - Shepard et al, MMWR in press

31. Potential Role of Home-Use Tests 1. Persons who might not otherwise be tested 2. More frequent testing for high-risk persons 3. Mutual testing with new sex partners 4. Repeat testing after potential “window period” 5. Dispense via pharmacists with counseling 6. Provide to HIV-infected persons for use when notifying partners (analogy: expedited partner therapy for chlamydia)

32. Additional Considerations 2-test combination would be preferable to increase predictive value of positive test result Engagement in ongoing care and prevention is ultimate goal for persons who test positive