1. FUTURE HIV RESEARCH EFFORTS PLANNED FOR THE CLINICAL TRIALS NETWORK James L. Sorensen, Ph.D. Susan Tross, Ph.D. Raul Mandler, M.D. University of California, San Francisco and San Francisco General Hospital Presentation at American Psychological Association, San Francisco, CA August 2007

2. PREVIEW: 1.Importance of HIV/AIDS in CTN efforts 2.Mechanisms for addressing HIV/AIDS in CTN 3.Specific Studies Completed or Emerging 4.Future directions and opportunities  Data Sharing  Rapid HIV Testing  More excellent ideas!

3. 1. IMPORTANCE OF HIV/AIDS IN THE CTN Prevention and treatment of HIV are vexing problems 26 years since emergence of AIDS CTN is conducting multi-site clinical trials with emerging results that address HIV/AIDS ~27 studies in the CTN, N=8K, many topics HIV/AIDS efforts are essential in the CTN

4. Key CTN Tasks 1.Establish a clinical research enterprise to –Foster bi-directional collaboration between researchers and practitioners –Conduct multi-site clinical trials to determine the effectiveness of drug abuse treatment interventions in real-life settings 2.Transfer research results to treatment programs, clinicians, and their patients to improve the quality of drug abuse treatment 3.Utilize the CTN as a platform for research/training

5. NIDA AIDS Domestic Research Priorities (FY 07)  Racial/ethnic disparities  Improving HIV therapy  Improving HIV therapy access, utilization, adherence, and effectiveness  Spread of HIV among drug users and their networks  Role of non-injection drug use in facilitating HIV transmission  Prevention interventions among drug users in criminal justice system  Adolescent development, decision-making, impulsivity

6. More NIDA Research Priorities Intervention strategies to coordinate and improve treatment and services for HIV, drug abuse, and co-occurring conditions (e.g., HCV) Medical consequences of HIV/AIDS, drug use, comorbid conditions, and HIV treatment Enhanced testing and counseling strategies Support training of new AIDS researchers ------------------------------------------------------------- http://www.nida.nih.gov/about/organization/arp/ ARP-current.htm [PRIORITIES] http://www.nida.nih.gov/about/organization/arp/ ARP-index.htm [FUNDING OPPORTUNITIES]

7. 2. MECHANISMS TO ADDRESS HIV/AIDS IN CTN A third of the budget at NIDA All studies measure & address HIV risk behaviors HIV/AIDS Special Interest Group (SIG) Affiliated studies using the CTN “platform” Several specific AIDS studies (reviewed today)

8. 3. SPECIFIC HIV/AIDS STUDIES IN THE CTN Larry Brown Infections & Substance Abuse Bob Booth HIV & HCV Intervention in Drug Detoxification Settings Susan Tross HIV/STD Safer Sex Skills Groups for Women Don Calsyn HIV/STD Safer Sex Skills Groups for Men Lisa Metsch HIV Rapid Testing and Counseling

9. Larry Brown Infections & Substance Abuse (CTN 012) Aim: Describe HIV services in CTN Community Treatment Programs (CTPs) Scope: 269 administators of CTPs, 1723 clinicians, 48 state administrators Some results: Services related to state reqs. (.77 vs.65). HIV testing (49%) More info: JSAT, 2006

10. Bob Booth HIV & HCV Intervention in Drug Detoxification Settings (CTN 017) Aim: Efficacy of “TAU”, “counseling & Ed”, or “therapeutic alliance” intervents. Scope: 646 IDUs in residential treatment Some Results: Very high HIV risk…38% “used” used needles; 40% of women 2+ sex partners More Info: Robert.Booth@UCHSC.edu

11. Susan Tross HIV/STD Safer Sex Skills Groups for Women (CTN 019) Aim: Test efficacy of intervention Scope: 600+ women in drug treatment programs Some Results: Pending More Info: st130@columbia.edu

12. Don Calsyn HIV/STD Safer Sex Skills Groups for Men (CTN 018) Aim: Test efficacy of intervention Scope: 646 men in drug treatment programs Some Results: More sex risk in outpatient non-methadone; stimulant users show more risk More Info: Calsyn@u.washington.edu

13. Lisa Metsch HIV Rapid Testing and Counseling (CTN 032) Aim: Test efficacy of rapid test and counseling in treatment prgrams Scope: Multi-site clinical trial Status: In development More Info: Metsch@med.miami.edu

14. 4. Future Directions and Opportunities Data Sharing: http://www.ctndatashare.org/ DATASETS POSTED FOR 11 STUDIES CTN 001 – Bup/Nx vs. Clonidine in Inpatients CTN 002 – Bup/Nx vs. Clonidine in Outpatients CTN 004 – Motivational Enhancement Therapy CTN 005 --Motivational Interviewing CTN 006 -- Motivational Incentives in Drug Free Clinics CTN 007 --Motivational Incentives in Methadone Clinics CTN 008 – Baseline CTN 009 – Smoking Cessation CTN 011 – Telephone Enhancement CTN 012 – HIV & Infections CTN 016 – Patient Feedback #1 Secondary Analysis = Women’s HIV risk across studies

15. HIV RAPID TEST More about this in next paper! LM slide

16. MORE EXCELLENT IDEAS FOR THE FUTURE! Recent CTN Call for Concepts –HIV SIG had developed ~10 ideas –Consulted with NIDA—HIV Research office and CCTN –Submitted 3 among 20 from whole CTN 2 were among the 3 forwarded up the line 1 remaining was incorporated into a planning team –Studies needed Role of drug abuse treatment in HIV & related problems Impact of HIV/AIDS on drug use, other risk factors Feasibility of large-scale interventions in treatment Best-practice solutions to ethical dilemmas There are Vital Issues in Need of Attention

17. IN SUMMARY HIV/AIDS -- an essential issue in CTN –both products and processes Several mechanisms address the issues: –Budgetary Mandate -Active “SIG” –Platform Studies - HIV-Specific Studies –Secondary Analysis Future studies in planning process and needed

18. ACKNOWLEDGEMENTS Support from NIH/NIDA: P50DA09253, U10DA15915, R01DA11344, R21DA20369 Staff & Patients: San Francisco General Hospital Colleagues & Advisors:, Grant Colfax, Jennifer Hettema, Raul Mandler, Lisa Metsch Jose Szapocznik, Brad Shapiro, Betty Tai, Susan Tross,

19. MORE INFO at CTN website http://www.nida.nih.gov/CTN/Index.htm

20. THANK YOU! Contact information: James.Sorensen@ucsf.edu 415-206-3969