1. Opt-Out HIV Testing in the Denver STD Clinic Kees Rietmeijer, MD, PhD Denver Public Health Department American Society for Microbiology 107 th General Meeting Toronto, Canada May 22, 2007

3. “Many HIV-infected persons do not get tested until late in their infection, and many persons who are tested do not return to learn their test results” “The development of new tests for HIV creates prospects for expanding HIV testing to identify and treat HIV-infected persons earlier”

4. “Stable HIV-associated morbidity and mortality, concerns about possible increases in HIV incidence, and the recent availability of a simple, rapid HIV test combined with strong prevention collaborations among communities heavily affected by HIV, support the need to reassess and refocus some of CDC’s HIV prevention activities”

5. “An emphasis on greater access to testing and on providing prevention and care services for persons infected with HIV can reduce new infections and lead to reductions in HIV-associated morbidity and mortality”

6. Objectives To describe trends in HIV testing uptake and newly diagnosed HIV infections following the introduction of rapid testing and the implementation of opt-out consent at the Denver STD clinic To describe the “linkage to care” program To briefly discuss advantages and potential disadvantages of rapid/opt-out testing

7. Denver Metro Health Clinic Largest STD clinic and HIV testing facility in Rocky Mountain region Provides: – confidential HIV testing at the STD clinic – confidential and anonymous testing at the HIV counseling and testing site integrated in the clinic In 2006: – ~16,000 visits – 11,300 HIV tests – 119 HIV diagnoses: ~50% of new HIV infections in the Denver Metro area; ~30% in Colorado.

8. HIV Testing at Denver STD Clinic Before November 2003 General consent for all procedures and testing, except HIV testing, obtained at registration HIV testing offered by clinician during the clinic visit, based on risk assessment Blood drawn for syphilis and HIV (if accepted) testing during the clinic visit HIV test used: standard EIA

11. HIV Testing at Denver STD Clinic November 1, 2003: Rapid HIV testing (OraQuick) offered as optional alternative to standard EIA – After 6 weeks, >95% of clients in CTS preferred the rapid HIV test – Adoption in STD clinic significantly slower due to increased length of visit May, 2004: Change in testing logistics July 1, 2004: Standard testing discontinued

12. HIV Testing at Denver STD Clinic Change in Testing Logistics To avoid adding another 20 minutes to the visit, prior to clinic encounter: – Draw RPR blood before clinician sees patient – Offer HIV testing routinely – Obtain additional consent – Use RPR blood draw to collect extra tube for rapid HIV test

13. Rapid Testing Trends 9/01/03 – 9/31/04 Number of Tests Performed Rapid testing only. Change in clinic logistics Start rapid testing

14. Impacts of Rapid Testing Denver Metro Health Clinic Percentage of patients who received their positive test results: Before: After: 66%100%

16. Evaluation HIV testing acceptance and HIV test positivity was evaluated for 4 time periods: – Period 1: The year before introduction of rapid testing December 2002 – November 2003 – Period 2: The 6 months following introduction or rapid testing, before logistical adjustment in the clinic and discontinuation of the standard test December 2003 – May 2004 – Period 3: The 10 months following logistical adjustment, but before introduction of the electronic medical record and opt-out testing June 2004 – March 2005 – Period 4: The 6 months following opt-out testing April 2005 – September 2005

17. Inclusion/Exclusion Criteria New problem visits RPR performed Previously known HIV+ excluded

18. HIV Testing Acceptance Period 1: Before introduction of rapid testing Period 2: Following Period 1, before logistical adjustments Period 3: Following Period 2, before opt-out consent Period 4: After Introduction of opt-out %

19. HIV Positivity Period 1: Before introduction of rapid testing Period 2: Following Period 1, before logistical adjustments Period 3: Following Period 2, before opt-out consent Period 4: After Introduction of opt-out %

21. HIV Testing Acceptance %

22. HIV Positivity %

23. New HIV Infections and Initial Versus Subsequent NIR Status Year# HIV+ NIR Initial Subsequent* 200339 3 (7.6%)3 (7.6%) 200448 6 (12.5%)5 (10.4%) 20055511(20.0%)6 (10.9%) 2006**13 3 (23.1%)2 (15.3%) *After interview with DIS or PCM **Through March 16, 2006

24. Opt-Out Analysis During the first 3 months of 2006 – 800/4,000 (20%) opted out Of those opting out: – 18% were HIV tested after further counseling – 39% were recently tested – 10% were follow-up visits – 3% were known to be HIV+ – 30% were not tested for unknown reasons

25. Opt-Out Analysis Those opting out for unknown reasons: – 50% were low-risk MSW – 9% were low-risk women – 13% were MSM Not known to the clinic to be HIV+ – 2% left before being seen/tested

26. Rapid Test False Positives Assume: – 10,000 rapid tests – Test specificity: 99.7% – True positivity: 1% This will result in: – 130 positives – 30/130 are false positives: 23%

27. False Positives: The Flipside Of 28 UniGold/OraQuick discrepant results – 27 were deemed false positive by viral load – 1 was an acute infection Viral load 750,000 Western Blot indeterminate (p24+)

28. What About Counseling? Concern: – Traditional (2-visit) testing provides the opportunity for 2-session (pre- and post-test) counseling – In a multi-site, randomized, controlled study (Project Respect), 2-session counseling (1 week apart) was associated with a 30% reduction of sexually transmitted infections at 6 months and 20% at 3 months* *Kamb et al. JAMA 1998;280:1161-7

29. What about Counseling? Rapid testing provides pre- and post-test counseling at the same visit Is this as effective as when the sessions are separated by a week?

30. What About Counseling? Project Respect-2*: – STI at12 months: 19.1% in the rapid group 17.1% in the standard group Difference (~10%) not statistically significant – STI incidence higher among: Men (RR 1.34; 95% CI 1.06-1.70) MSM (RR 1.86; 95% CI 0.92 – 3.76) No STI at baseline (RR 1.21; 95% CI 0.99 – 1.48) *Metcalf et al. Sex Transm Dis 2005;32:130-8

31. Conclusions Enhancing HIV testing uptake at the Denver STD clinic appeared to be principally a matter of logistics and convenience: – Rapid HIV Testing – Change in clinic logistics to avoid lengthier visits – Offer HIV testing on a routine basis rather than as part of risk assessment

32. Conclusions Issues that appear not to influence testing uptake: – Stigma STD clinic is already a stigmatized environment – Testing acceptance Most patients expect HIV testing to be part of the STD clinic testing protocol Acceptance among clinicians may play a larger role – Specific HIV consent Opt-out testing only marginally improved testing acceptance rates, especially among non-MSM

33. Concerns Coercion Inadvertent testing due to mislabeling of blood specimens PEMS (Prevention Evaluation Measurement System) Effects on prevention counseling by clinicians – Of particular concern in STD clinics where most are at higher risk for non-HIV STD’s and where prevention counseling is most effective in reducing incident/recurrent STD’s How to optimally link to care and prevention services Cost issues

34. Solutions? De-link counseling from HIV testing – STD clinicians should be trained to develop client-centered skills, not as a an add-on counseling within the encounter, but rather as a way of communicating with the client

35. Solutions? Develop innovative prevention strategies – Prevention case management (PCM) and PCM- ”light” (long-term follow-up with known positives) – Prevention for known HIV-infected individuals visiting STD clinics – ongoing PCRS? – Prevention counseling in HIV care settings

36. STD/HIV Prevention Training Centers www.stdhivpreventiontraining.org

37. Acknowledgements Christie Mettenbrink Brandy Mitchell Dean McEwen Lesley Brooks