1. Rapid Testing and Counseling Research within the CTN Lisa Metsch, Ph.D. James L Sorensen, Ph.D. Grant Colfax, M.D. Jose Szapocznik, Ph.D. Susan Tross, Ph.D. Raul Mandler, M.D.

2. Other Collaborators Dan Feaster, Debbie Orr, Tiffany Kyle, Lauren Gooden, Florida Node Dan Feaster, Debbie Orr, Tiffany Kyle, Lauren Gooden, Florida Node Tim Matheson, California and Arizona Node Tim Matheson, California and Arizona Node Louise Haynes, South Carolina Node Louise Haynes, South Carolina Node Paul McLaughlin, New England Node Paul McLaughlin, New England Node Janet Levy, JJ Pan and Paul Wakim, NIDA Janet Levy, JJ Pan and Paul Wakim, NIDA Carl Pieper, Dan Blazer, Maureen Cunningham, Craig McClendon and Curtis Campbell, DCRI Carl Pieper, Dan Blazer, Maureen Cunningham, Craig McClendon and Curtis Campbell, DCRI Carol Wenck and Karen Nesmith, EMMES Carol Wenck and Karen Nesmith, EMMES Bernard Branson, CDC, Technical Consultant Bernard Branson, CDC, Technical Consultant

3. HIV Rapid Test FDA approved FDA approved Only requires blood from a finger stick or oral fluid from a swab Only requires blood from a finger stick or oral fluid from a swab Results in 20 minutes Results in 20 minutes Does not require laboratory facilities and can be done by drug counselors Does not require laboratory facilities and can be done by drug counselors Positive results require confirmatory testing Positive results require confirmatory testing

4. Late HIV Testing is Common Supplement to HIV/AIDS Surveillance, 2000-2003 Among 4,127 persons with HIV/AIDS*, 45% were diagnosed AIDS within 12 months after finding out HIV positive status (“late testers”) Among 4,127 persons with HIV/AIDS*, 45% were diagnosed AIDS within 12 months after finding out HIV positive status (“late testers”) Late testers, compared to those tested early (>5 yrs before AIDS diagnosis) were more likely to be: Late testers, compared to those tested early (>5 yrs before AIDS diagnosis) were more likely to be: –Younger (18-29 yrs) –Heterosexual –Less educated –African American or Hispanic MMWR June 27, 2003*16 states

5. Benefits of Widespread HIV Screening Decreases spread of HIV: An HIV diagnosis is associated with reduction in high risk sexual and injection behaviors Decreases spread of HIV: An HIV diagnosis is associated with reduction in high risk sexual and injection behaviors Improves survival: Linkage to care and treatment Improves survival: Linkage to care and treatment May reduce the stigma that is associated with testing based on risk May reduce the stigma that is associated with testing based on risk

6. Offering HIV Testing in Outpatient Health Care Settings CDC now recommends offering routine HIV testing to persons regardless of risk factors: CDC now recommends offering routine HIV testing to persons regardless of risk factors: –Emergency Departments –Sexually Transmitted Diseases (STD) Clinics –Labor and Delivery –Correctional Facilities –Offices of Primary Care Physicians –Substance Abuse Treatment Clinics –

7. The Case for Drug Treatment…. Fewer than 1/3 of U.S drug treatment programs offer HIV testing and counseling* Fewer than 1/3 of U.S drug treatment programs offer HIV testing and counseling* Less than ½ of CTN CTPs made HIV testing available either in the CTP, through referral or outsourced ** Less than ½ of CTN CTPs made HIV testing available either in the CTP, through referral or outsourced ** CTN provides an ideal setting to introduce routine, on-site rapid HIV testing and counseling CTN provides an ideal setting to introduce routine, on-site rapid HIV testing and counseling * SAMSHA, 2004 **Brown et al. JSAT, 2006; Pollack et al., 2006

8. Need for Scientific Studies CDC and new guidelines are moving away from HIV counseling at the time of testing CDC and new guidelines are moving away from HIV counseling at the time of testing Scientific study is needed to evaluate the effectiveness of offering HIV rapid testing + counseling in drug treatment programs Scientific study is needed to evaluate the effectiveness of offering HIV rapid testing + counseling in drug treatment programs –Effect on getting people tested –Effect on sexual risk behaviors

9. David Holtgrave: Costs and Consequences of the New CDC Testing Guidelines (June, 2007; www.plosmedicine. org) www.plosmedicine Article questions costs and consequences of new CDC guidelines regarding routine HIV testing without risk reduction counseling (compared with a more targeted counseling and testing strategy) Article questions costs and consequences of new CDC guidelines regarding routine HIV testing without risk reduction counseling (compared with a more targeted counseling and testing strategy) Uses scenario and cost-effectiveness analysis Uses scenario and cost-effectiveness analysis Concludes that abandoning counseling would have real public health consequences in terms of HIV infections that could have been averted Concludes that abandoning counseling would have real public health consequences in terms of HIV infections that could have been averted

10. David Holtgrave: Costs and Consequences of the New CDC Testing Guidelines (June, 2007; www.plosmedicine. org) www.plosmedicine Editor’s note says that Holtgrave article Editor’s note says that Holtgrave article “has a major limitation in that it tried to predict what might happen in the future – it did not study the actual impact of the two different types of testing on a group of people.” “has a major limitation in that it tried to predict what might happen in the future – it did not study the actual impact of the two different types of testing on a group of people.”

11. Research Questions Among persons who attend substance abuse treatment and report being HIV negative or not knowing their status… (1) What is the more effective testing strategy to ensure they get HIV tested and receive their results? (2) What is the more effective testing strategy to decrease their risk behaviors?

12. Three Testing Strategies to be evaluated in 3 arm RCT Offer on-site HIV rapid testing (via oral fluid) with brief participant-tailored prevention counseling Offer on-site HIV rapid testing (via oral fluid) with brief participant-tailored prevention counseling Offer on-site HIV rapid testing (via oral fluid) with information only Offer on-site HIV rapid testing (via oral fluid) with information only Offer referral for HIV testing in the community Offer referral for HIV testing in the community

13. CTN 0032 PROTOCOL DEVELOPMENT HIV Rapid Testing and Counseling Protocol Concept approved by CTN, then by Dr. Volkow in November, 2006 Protocol Concept approved by CTN, then by Dr. Volkow in November, 2006 Protocol Development is in progress Protocol Development is in progress Informal surveys of CTPs, February – May, 2007 Informal surveys of CTPs, February – May, 2007 –Amount of testing? On site? How recent? Protocol was reviewed by DSMB in July, 2007 Protocol was reviewed by DSMB in July, 2007 Revisions expected to be made in August/September, 2007 Revisions expected to be made in August/September, 2007

14. Interest in Health Services Research Ancillary Studies Feasibility of implementing HIV rapid testing and counseling in drug tx Feasibility of implementing HIV rapid testing and counseling in drug tx Acceptability by drug counselors of conducting HIV rapid testing in drug tx Acceptability by drug counselors of conducting HIV rapid testing in drug tx Durability of providing HIV rapid testing and counseling after CTN study is completed. Durability of providing HIV rapid testing and counseling after CTN study is completed.

15. IN SUMMARY Significant changes in HIV testing and counseling Significant changes in HIV testing and counseling –Technology, Policy, and Ethical Challenges Study of HIV Rapid Testing and Counseling being planned Study of HIV Rapid Testing and Counseling being planned Need information (need research) Need information (need research) –Impact on drug use, other risk factors –Feasibility of large-scale testing in treatment programs –Best-practice solutions to ethical quandries These are Vital Issues in need of attention These are Vital Issues in need of attention

16. We welcome your questions and suggestions Lisa Metsch, Ph.D. Lmetsch@med.miami.edu