1. Implementing RTA to Identify False Positives and Immediately Refer to Care Thomas Knoble, Omar Menendez, Teri Dowling, Shelley Facente San Francisco Department of Public Health, HIV Prevention Section Kevin Delaney Division of HIV/AIDS Prevention, NCHHSTP Centers for Disease Control and Prevention

2. Study Objectives Feasibility and Cost (Can we do it & $)  Link to care, same day  Identify false positives, same day Validation (Does it work) Impact on Linkage to Care Protocols and Best Practices (What did we learn)

3. Study Structure Standard consent 100 to 150 Positive tests at intervention sites 5 sites 100 to 150 Positive tests at control sites 10 sites 18 Months, August 1 st, 2007-???? LA, additional site (200 to 300)

4. CBO, Homeless CBO, Homeless CBO, Gay Collective Methadone Clinic County Jail County Jail CBO, Asian Community 5 Sites 5 Sites

5. Test # 1 st Test Negative Reactive, 2 nd Test Non-reactive, 3rd Test NegativePositive 2 13

6. San Francisco RTA

7. 0 5 10 15 20 25 30 35 40 Minutes #1 ORAQUICK Run Time Min: 20 min. Max: 40 min. Read Window Btwn. 20-40 min. #2 STAT-PAK Run Time Min: 15 min. Max: 20 min. Read Window Btwn. 15-20 min. # 3 UNI-GOLD Run Time Min: 10 min. Max: 12 min. Read Window Btwn. 10-12 min. Run Time Read Window Run Times

8. Control Products 1 vs 3 Control Fluid Volume in Vial Unopened Shelf Life Opened Shelf Life Unopened Storage Temp Opened Storage Temp OraQuick Advance 0.2ml1 year56 days 2-8°C (35-46°F) Clearview Stat-Pak 0.25ml2 years 2-8°C (35-46°F) Uni-Gold 0.5ml1 year1 month 2-8°C (35.6-46.4°F) Xsera 1.ml2 years60 days 2-8°C (35-46°F) 2-30 ◦ C Ordering and cost are varying issues as well

9. Numbers for 3 Months August 1 st - October 31 th 2007 Intervention Control # Rapid tests run 1212 1963 # Positives 22 47 # Days referred to care 0 7.6 days (Mean) 5 did not get results # False positives 8 8 # Days for “resolution” 0 7 (Mean) Note: All RTA results matched lab results 100%

10. “…can we get the RTA? ….” after having 4 false positives in 1 month Enrique Guzman Mission Neighborhood Health Center Control Site

11. Issues Encountered Control product issues (hopefully resolved) Phlebotomy availability (ongoing; $ in process) Temperature range (ongoing/requires careful QA) Agency issues have impact on participation (ongoing communication with agencies to resolve and/or support)

12. Stories from the field…

13. Thomas’ Client 8/1/07 Case study: –Middle class, 40s, gay, Latino, some metal health issues –After disclosure of preliminary positive result, client indicated that he thought he had received a positive rapid test result in the past as well as a negative test result, but seemed confused about when he got this information. Client had trouble internalizing previous HIV information –Counselor informed the client there was no ambiguity about the results due to RTA –Client followed through with care appointment RTA helps address “false hope” of “Preliminary Positive”

14. “…before RTA it seemed premature to introduce clients to care staff….now it fits” Jason Kwong Asian Pacific and Islander Wellness Center Intervention Site

15. Omar’s Client 8/17/07 Case study; –Marginally housed, African American, 50s, Heterosexual, IDU Hx 10 years ago –Testing at wife's “request,” waiting for him –Client was in disbelief regarding reactive OraQuick. Stated repeatedly that he had not 'cheated' and had only had sexual intercourse with wife –Non-reactive Stat-Pak and Uni-Gold –Confirmatory testing was done, but client was able to leave with more information in the same day –Non-reactive Stat-Pak and Uni-Gold were comforting to client who was nervous and in a hurry to leave session, as his wife was in the waiting room RTA identified a false positive shortly after initial reactive test

16. “…I trust in rapid testing again….” Dale Gluth RTA Counselor Magnet Men’s Health Intervention Site

17. Dale and Thomas’ Client 8/18/2007 Case study: –Client actively using meth., reported significant recent risk (UAI with multiple partners) –OraQuick ‘T’ line very light, could have been missed by reader, called reactive after Dale and Thomas looked at it –Thomas felt it “looked false positive” –“Shocked” when Stat-Pak reacted strongly and quickly, within 2 minutes –Confirmed positive (EIA-RR, IFA positive) RTA removes ambiguity associated with Oral fluid testing

18. Dale’s “Two” Clients 10/25/07 Case study –Middle class, 20s, gay, white –Partner received preliminary positive at a control site the day before –Partner was in waiting room –Client asked Dale, “Why does my lover have to go back to get his result?” –Dale brought partner in to explain study to both Demand for RTA is coming……

19. Lessons Learned to Date Regular on-site QA supports good communication with intervention sites and improves quality Training is an ongoing process Start slow and build on success Clear written protocols are important

20. Recommendations Commit resources to oversee process -Training, QA, written policies Start with agencies that work well: competent, effective, good reputation Benefits to clients and counselors are great, demand is coming, start moving Call us….

21. Shelley Facente Study Data Coordinator 415-554-9136 Shelley.Facente@sfdph.org Omar Menendez Coordinator for Linkages 415-5703-7280 Omar.Menendez@sfdph.org Teri Dowling Principal Investigator 415-554-9167 Teri.Dowling@sfdph.org Thomas Knoble Intervention Site Coordinator 415-703-7279 Thomas.Knoble@sfdph.org Kevin Delaney CDC Project Officer 404-639-6142 khd8@cdc.gov Centers for Disease Control and Prevention Division of HIV/AIDS Prevention, NCHHSTP Atlanta, GA