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Potential Role of Home-Use HIV Test Kits

Potential Role of Home-Use HIV Test Kits. Bernard M. Branson, M.D. A ssociate Director for Laboratory Diagnostics Division of HIV/AIDS Prevention. Persons with HIV and Awareness of HIV Status, United States - 2006. 95% Confidence Interval Number HIV infected 1,106,400 (1,056,400 – 1,156,400)

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Potential Role of Home-Use HIV Test Kits

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

  2. Persons with HIV and Awareness of HIV Status, United States - 2006 95% Confidence Interval Number HIV infected1,106,400(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 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 CategoryExtended Back-Calculation Model, 50 U.S. States & DC, 1977-2006 MSM Heterosexual IDU

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

  6. FDA-approved Rapid HIV Tests

  7. 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) 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 • 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 - 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 - Bernstein et al, National HIV Behavioral Surveillance, NYC, Arch Int Med 2008

  15. Potential Role of Home-Use Tests • Persons who might not otherwise be tested • 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 *Chicago IL, Hartford CT, New Haven CT, Oakland CA, Springfield MA - Kellerman et el, JAIDS 2002 - Heimer et al, AJPH 2007

  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. 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 Age Group (yrs) 18-24 410 57 (14) 45 (79) 25-29 303 53 (17) 37 (70) 30-39 585 171 (29) 83 (49) 40-49 367 137 (37) 41 (30) ≥ 50 102 32 (31) 11 (34) Unrecognized HIV Infection No. % HIV Prevalence No. % Total Tested Race/Ethnicity White 616 127 (21) 23 (18) Black 444 206 (46) 139 (67) Hispanic 466 80 (17) 38 (48) Multiracial 86 16 (19) 8 (50) Other 139 18 (13) 9 (50) Total 1,767 450 (25) 217 (48) MMWR June 24, 2005

  19. 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 Age Group (yrs) 18-24 410 57 (14) 45 (79) 25-29 303 53 (17) 37 (70) 30-39 585 171 (29) 83 (49) 40-49 367 137 (37) 41 (30) ≥ 50 102 32 (31) 11 (34) Unrecognized HIV Infection No. % HIV Prevalence No. % Total Tested Unaware ≠ Untested • Of those with unrecognized HIV infection: - 84% previously tested - 42% tested in the preceding year MMWR June 24, 2005

  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 • Persons who might not otherwise be tested • More frequent testing for high-risk persons • 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 partners1 • HIV-negative MSM: unprotected intercourse with partner believed to be negative was an independent risk factor for acquiring HIV2,3 • With serosorting among MSM, decline in equilibrium HIV prevalence as frequency of HIV testing increases4 1 Steward et al, AIDS Behav 2009 3 Buchbinder et al JAIDS 2005 2 Koblin et al, AIDS 2006 4 Cassels et al, AIDS 2009

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

  29. Window period: Current Assays with 15 Seroconverter Panels 1st generation EIA Flow-through RT Flow-through RT Lateral flow RT Lateral flow RT 3rd generation EIA 2nd generation EIA 3rd generation EIA RNA WB Indeterminate WB positive 10 5 25 20 15 0 Days before Western blot positive when 50% of Specimens Reactive 185 specimens from 15 seroconverters Owen et al, J. Clin. Microbiol 2008

  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 • Persons who might not otherwise be tested • More frequent testing for high-risk persons • Mutual testing with new sex partners • Repeat testing after potential “window period” • Dispense via pharmacists with counseling • 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

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