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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
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!
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
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
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
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]
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)
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
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
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: [email protected]
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: [email protected]
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: [email protected]
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: [email protected]
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
HIV RAPID TEST
• More about this in
next paper!
LM slide
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
IN SUMMARY
• HIV/AIDS -- an essential issue in CTN
– both products and processes
• Several mechanisms address the issues:
– Budgetary Mandate
– Platform Studies
– Secondary Analysis
-Active “SIG”
- HIV-Specific Studies
• Future studies in planning process and needed
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,
MORE INFO
at CTN website
• http://www.nida.nih.gov/CTN/Index.htm
THANK YOU!
Contact information:
[email protected]
415-206-3969