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RNA Testing VS. Rapid Testing


           Is it worth the wait?

   An Insight Into MSM Testing Preferences


                Joshua D. O’Neal
          Matthew R. Golden, MD, MPH
           Joanne D. Stekler, MD, MPH
University of Washington Department of Medicine
      Public Health-Seattle & King County
Background


                OraQuick
   2003            Neg       Real Time
Pooled RNA     but EIA Pos    Testing
 for MSM        & Frozen       Study
                 OQ Pos
Background




                        Specimen
                        Collection


Time

        Window Period
Background


             HIV
           Testing
HIV Testing          HIV
 Consent          Counseling
Background
Methods
Methods
          Eligibility

HIV Neg MSM or Transgender

Seeking HIV Testing

Not Tested in Last 3 Months

Read & Speak English
Methods




         OraQuick                                  Determine™*
                                        UniGold
 Oral Fluids & Fingerstick                        Ab + Ag Combo

* Not Available for sale in the US
Methods




ELISA & RNA
Methods
Rapid   • Testing Information
          Provided
Tests
                           •    Method Preference
                           •    Test Trust
           Survey          •    ONE Test
                           •    Consent
                           •    Counseling

                                   Rapid
                                    Test
                                  Results
Results
           Test                 N = 902

Concordant Rapid                30 (3.3%)
Positive Tests

Discordant Rapid Tests          4 (0.4%)
Among HIV Pos

Rapid Neg / EIA Pos             1 (0.1%)

Acute (EIA Neg / NAAT Pos)      5 (0.6%)
Total HIV Pos                   40 (4.4%)
HIV Testing:
      Trust VS. Specimen Collection Method
           5
                                                     OQ_OralFluids
                                                     OQ_FingerStick
           4                                         UNIGOLD
                                                     DETERMINE*
                                                     ELISA
   Trust




           3                                         RNA

                                                     = STD Clinic
                                                       (N=267)
           2
                                                     = Gay City
                                                       (N=223)
           1
               1         2           3   4       5
                    Specimen Collection Method
* Not Available for sale in the US
If you could get only one HIV test
       today, which test would you get?
                                           Gay City
                                            N= 56           OQ Oral Fluids

                                               9%      4%   OQ Finger Stick

                                                      7%    UNIGOLD
                                     44%
                                                            DETERMINE™*
                                                      24%
                                                            ELISA
                                             11%
                                                            RNA


                                                                         14%
* Not Available for sale in the US
Should your doctor have to get your consent
       to test you for HIV Infection?




                                    N = 329



                                    N = 223
Which pre-test counseling option
      would you prefer?
Summary
• MSM prefer less invasive specimen collection methods

• MSM trust lab based testing more than rapid HIV testing

• RNA testing was the most preferred single test

• MSM would like a provider to obtain consent for HIV testing

• MSM want pre-test counseling available with HIV testing
Limitations
• Testing information provided throughout testing session
  varied by location/counselor

• Survey conducted after testing

• Not all study participants surveyed (HIV+, time restrictions)

• Representativeness: Population already seeking testing

• 4th generation test not FDA approved
Discussion
• Important to provide the most preferred types of testing

• Consider integrating RNA testing into rapid testing programs

• Once FDA approved, 4th generation rapid testing may
  become a more preferable testing option

• Caution in separating both consent and counseling from HIV
  testing
Acknowledgments
    NIH R01 MH-86360
    Study Participants
    Alere: Providing Determine™* Test Kits
    Public Health-Seattle & King County HIV/STD Program
    Gay City Health Project
    UW Primary Infection Clinic
    Bernard Branson
    Heather D. Baldwin



* Not Available for sale in the US

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RNA Testing VS. Rapid Testing

  • 1. RNA Testing VS. Rapid Testing Is it worth the wait? An Insight Into MSM Testing Preferences Joshua D. O’Neal Matthew R. Golden, MD, MPH Joanne D. Stekler, MD, MPH University of Washington Department of Medicine Public Health-Seattle & King County
  • 2. Background OraQuick 2003 Neg Real Time Pooled RNA but EIA Pos Testing for MSM & Frozen Study OQ Pos
  • 3. Background Specimen Collection Time Window Period
  • 4. Background HIV Testing HIV Testing HIV Consent Counseling
  • 7. Methods Eligibility HIV Neg MSM or Transgender Seeking HIV Testing Not Tested in Last 3 Months Read & Speak English
  • 8. Methods OraQuick Determine™* UniGold Oral Fluids & Fingerstick Ab + Ag Combo * Not Available for sale in the US
  • 10. Methods Rapid • Testing Information Provided Tests • Method Preference • Test Trust Survey • ONE Test • Consent • Counseling Rapid Test Results
  • 11. Results Test N = 902 Concordant Rapid 30 (3.3%) Positive Tests Discordant Rapid Tests 4 (0.4%) Among HIV Pos Rapid Neg / EIA Pos 1 (0.1%) Acute (EIA Neg / NAAT Pos) 5 (0.6%) Total HIV Pos 40 (4.4%)
  • 12. HIV Testing: Trust VS. Specimen Collection Method 5 OQ_OralFluids OQ_FingerStick 4 UNIGOLD DETERMINE* ELISA Trust 3 RNA = STD Clinic (N=267) 2 = Gay City (N=223) 1 1 2 3 4 5 Specimen Collection Method * Not Available for sale in the US
  • 13. If you could get only one HIV test today, which test would you get? Gay City N= 56 OQ Oral Fluids 9% 4% OQ Finger Stick 7% UNIGOLD 44% DETERMINE™* 24% ELISA 11% RNA 14% * Not Available for sale in the US
  • 14. Should your doctor have to get your consent to test you for HIV Infection? N = 329 N = 223
  • 15. Which pre-test counseling option would you prefer?
  • 16. Summary • MSM prefer less invasive specimen collection methods • MSM trust lab based testing more than rapid HIV testing • RNA testing was the most preferred single test • MSM would like a provider to obtain consent for HIV testing • MSM want pre-test counseling available with HIV testing
  • 17. Limitations • Testing information provided throughout testing session varied by location/counselor • Survey conducted after testing • Not all study participants surveyed (HIV+, time restrictions) • Representativeness: Population already seeking testing • 4th generation test not FDA approved
  • 18. Discussion • Important to provide the most preferred types of testing • Consider integrating RNA testing into rapid testing programs • Once FDA approved, 4th generation rapid testing may become a more preferable testing option • Caution in separating both consent and counseling from HIV testing
  • 19. Acknowledgments NIH R01 MH-86360 Study Participants Alere: Providing Determine™* Test Kits Public Health-Seattle & King County HIV/STD Program Gay City Health Project UW Primary Infection Clinic Bernard Branson Heather D. Baldwin * Not Available for sale in the US