FUTURE HIV RESEARCH EFFORTS PLANNED FOR THE CLINICAL TRIALS NETWORK

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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

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PREVIEW

• Importance of HIV/AIDS in CTN efforts
• Mechanisms for addressing HIV/AIDS in CTN
• Specific Studies Completed or Emerging
• Future directions and opportunities
• Data Sharing
• Rapid HIV Testing
• More excellent ideas!

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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, N8K, many topics
• HIV/AIDS efforts are essential in the CTN

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Key CTN Tasks

• 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
• Transfer research results to treatment programs,
  clinicians, and their patients to improve the
  quality of drug abuse treatment
• Utilize the CTN as a platform for
  research/training

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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

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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

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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)

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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
•  

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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

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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 risk38 used used
  needles 40 of women 2 sex partners
• More Info Robert.Booth_at_UCHSC.edu

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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_at_columbia.edu

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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_at_u.washington.edu

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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_at_med.miami.edu

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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 Womens HIV risk across
  studies

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HIV RAPID TEST

• More about this in next paper!

LM slide
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MORE EXCELLENT IDEAS FOR THE FUTURE!

• Recent CTN Call for Concepts
• HIV SIG had developed 10 ideas
• Consulted with NIDAHIV 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

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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

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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,
  

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MORE INFOat CTN website

• http//www.nida.nih.gov/CTN/Index.htm

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THANK YOU!

• Contact information
• James.Sorensen_at_ucsf.edu
• 415-206-3969