1. Implementing screening for acute HIV infection in STD clinics already using rapid HIV antibody testing, New York City, 2007 Kathleen D. Gallagher, MPH 1 Pragna Patel, MD MPH 2, Alexis Kowalski, MPH 1, Ellen Klinger, MPH 1, Kathy Gombel 3, Tim Sullivan 3, Monica Parker 3, PhD, Susan Blank, MD MPH 1,2 1 New York City Department of Health & Mental Hygiene (NYC DOHMH) 2 Centers for Disease Control & Prevention (CDC) 3 New York State Department of Health (NYS DOH)

2. Acute HIV Infection (AHI) Highly infectious and often symptoms not recognized Not detectable by routine antibody tests, requires direct detection of HIV virus Important to diagnose as it poses high impact opportunity to interrupt the spread of disease Screening all STD clinic-based testers could have large impact on decreasing new HIV infections

3. HIV Virus HIV Antibody 11 0 102030 40 5060708090100 22 Acute HIV Infection 3-4 week mark when oral swab and WB can start to detect HIV Period when AHI test can detect HIV Exposed and infected with HIV 28 # of Days Number of days needed for HIV detection – virus & antibody

4. New York City Dept. of Health STD Clinics 10 clinics - 136,109 visits in 2006 All patients offered HIV antibody testing Confirmatory blood routinely collected for all testers; discarded if rapid test negative Individual tests for HIV virus available on a case-by-case basis as part of routine care

5. Project Objective Develop system to screen and identify AHI: Acceptable to patients Clinically useful Operationally feasible

6. Methods National CDC-sponsored feasibility study Convenience sample at 3 of our STD clinics Eligibility Requirements: Confidential HIV antibody tester >18 yrs of age Signed research consent Routinely collected whole blood specimens tested for HIV RNA via nucleic acid amplification testing (NAAT) at Wadsworth Lab

7. AHI screening enrollment NYC STD clinics, June-October 2007 **Enrollment hours changed Enrolled JuneJulyAugustSept.Oct.** Ft. Greene N = 1015 71%56%48%41%21% Chelsea N = 745 42%29%37%31%19% Morrisania N = 1895 88%89%82%86%85% Total N = 3655 69%56%55%52%39%

8. Antibody & NAAT results for AHI Enrollees *Data: June 4, 2007 – October 31, 2007

9. Descriptive Epi Difference between those who accepted AHI and those who refused AHI were examined: Gender Race/ethnicity Sexual risk factor Age group Significant p<0.001

10. Operational Issues Shipping requirements limited enrollment hours Consenting process added additional time to clinic visit NAAT results take 5-7 days to return and introduced the need for participants to retrieve results

11. Summary Due to the limitations of HIV antibody testing we are missing acutely infected individuals Pooled HIV NAAT is an economical way to screen rapid antibody negative specimens for HIV virus Additional consent form posed a barrier in NYC With opt-in testing more worried well than truly high risk patients accepted additional HIV NAAT

12. Why continue HIV NAAT? Routinizing pooled HIV NAAT screening as part of standard consent would allow testing of all high risk individuals Identified 4 cases of acute HIV out of 3621 pooled rapid HIV negative samples (0.11%) NYC DOHMH clinics performed 53,169 HIV antibody tests in 2006 Adding HIV NAAT could help us identify ~50 acutely infected individuals each year

13. Lessons Learned Simplify consent process Decrease test turn around time - time between testing and receiving results Reduce the labor intensity of specimen processing

14. Next Steps Work to incorporate new language into current NYS HIV consent form to allow for routine HIV NAAT Streamline specimen packaging for local pick- up and testing Collaborate with local Public Health Lab (PHL) to create infrastructure for HIV NAAT Develop electronic mechanisms for data exchange with local PHL

15. Acknowledgements Pragna Patel, MD MPH NYC DOHMH Chelsea, Ft. Greene, Chelsea clinic staff Public Health Laboratory Alexis Kowalski (Project Coordinator) NYS DOH Wadsworth Center Tim Sullivan Kathy Gombel

16. Contact Information Kathleen Gallagher kgallagh@health.nyc.gov (212) 788-6614