1. Combined Rapid and HIV RNA Testing in a Public STD Clinic: San Francisco, 2003-2006 Jeffrey D. Klausner, Susan Philip, Katherine Ahrens, Giuliano Nieri, Robert P. Kohn, Brian Louie, Ernest Wong, Sally Liska

2. Session: Strategies for Targeted Screening for Acute HIV Infection Objectives: To describe how to combine POC Strategy #1 with Lab Strategy #4 (testing for Acute HIV Infection). To present results from combined HIV Rapid and RNA testing done at San Franciscos STD clinic (City Clinic) between November 2003 and December 2006.

4. Background STD clinic patients are at increased risk for HIV infection, but may not return to receive conventional testing results. Persons with acute HIV infection {HIV antibody negative but detectable HIV ribonucleic acid (RNA)} are at increased risk of transmitting HIV because of high viral loads and unknown infection status.

5. Background Advances in HIV testing technology have made available: 1.Rapid, point of care HIV Ab screening 2.Sensitive testing methods for HIV RNA; allowing for identification and counseling of patients with acute infection.

6. Methods All patients at risk of HIV infection are offered confidential HIV testing (POC or Lab-based). Select high-risk patients (or high likelihood of loss to follow up) are tested onsite (with Oraquick Advance HIV-1/2) Target group identified as: –unprotected anal sex, –unprotected vaginal sex with HIV+ or unknown partner with risk factors, –concurrent STD

7. Methods Persons who are rapid test negative have blood drawn for HIV RNA. Testing is performed using Versant HIV-1 RNA 3.0 assay (Bayer Corp.) at the Public Health Laboratory. A one-stage pooling of 10 serum specimens is used, with results available within 10 days.

8. Rapid Test at clinic. Draw Blood. (by bDNA)

9. Methods Positive HIV RNA tests are confirmed by follow-up antibody testing or viral load testing. We calculated the sensitivity and binomial exact 95% confidence limits of the rapid HIV test.

10. Results Figure 1. Diagram of Rapid HIV Test Results, San Francisco City Clinic, November 2003–December 2006, N=1092

11. Results Among the 1000 persons with rapid antibody negative tests that were tested for RNA, 11 (1.1%) were RNA positive (figure 1). Of RNA positives, 91% (10/11) were confirmed. HIV rapid testing had a sensitivity of 89.1% (95% CI 82.7 - 95.5%) in terms of detecting HIV infection.

12. Results All patients (100%), who received their positive RNA result, were counseled and referred into care. Persons with newly identified HIV infection were more likely to be a gay/bisexual man and to have an STD diagnosis (genital, rectal or pharyngeal) at the time of their HIV test than were HIV-negative persons.

13. Results Table 1. Rapid Testers Demographics and STD Infections at Time of HIV Testing, San Francisco City Clinic, Nov. 2003–Dec. 2006, N=1081

14. Results Figure 2. Proportion of HIV Infections Detected by Each Test Type Using a Rapid Antibody & RNA Testing Algorithm, San Francisco City Clinic, Nov. 2003–Dec, 2006, N=92 HIV RNA screening increased HIV case detection by 12% (92/82). RNA+ 12% 88% Rapid Ab+

15. Summary 1.Acute HIV infection screening can be incorporated successfully with rapid antibody testing with nearly all (99%) patients agreeing to additional RNA testing and blood draw. 2.The combination of rapid HIV antibody testing and HIV RNA screening assured that most infected patients learned their test results immediately and helped identify an additional 12% of those with HIV infection. 3.Patients with acute HIV infection were identified and counseled while highly infectious, thereby potentially averting transmission to their partners.

16. Implications Wider use of combined rapid antibody testing (Strategy #1) and RNA screening (Strategy #4), particularly for high risk individuals (e.g. STD clinic settings), could contribute to the reduction of HIV incidence and thus transmission.

17. Acknowledgements San Francisco Dept. of Public Health STD Prevention & Control Andrew Reynolds PH Laboratory Brian Louie This project was supported in part by the University of California Universitywide AIDS Research Program Grant CH05-SMCHC-612.