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A Trial to Test the Efficacy of a Tailored Intensive Smoking Cessation Intervention in Persons With HIV (PWHs)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2010 by Montefiore Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01106638
First Posted: April 20, 2010
Last Update Posted: May 3, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Albert Einstein College of Medicine, Inc.
Yale University
Information provided by:
Montefiore Medical Center
April 19, 2010
April 20, 2010
May 3, 2010
November 2009
March 2011   (Final data collection date for primary outcome measure)
Three month point-prevalence abstinence from cigarettes [ Time Frame: 3 months post-intervention ]
Same as current
Complete list of historical versions of study NCT01106638 on ClinicalTrials.gov Archive Site
Three month continuous abstinence from cigarettes [ Time Frame: Three months post-intervention ]
Same as current
Not Provided
Not Provided
 
A Trial to Test the Efficacy of a Tailored Intensive Smoking Cessation Intervention in Persons With HIV (PWHs)
A Trial to Test the Efficacy of a Tailored Intensive Smoking Cessation Intervention in Persons With HIV (PWHs)
The purpose of this study is to determine whether an intensive, eight session behavioral intervention is superior to standard care in achieving abstinence from cigarettes in smokers living with HIV/AIDS.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Smoking
  • HIV Infections
  • AIDS
  • Behavioral: Positively Smoke Free
    An eight session, group therapy intervention targeting smokers living with HIV/AIDS
  • Behavioral: Standard care
    Advice to quit, smoking cessation brochure, and offer of nicotine patches
  • Experimental: Intensive behavioral intervention
    Eight session, behavioral intervention targeting HIV-infected smokers
    Intervention: Behavioral: Positively Smoke Free
  • Active Comparator: Standard care
    Advice to quit, smoking cessation brochure, offer of nicotine patch
    Intervention: Behavioral: Standard care
Moadel AB, Bernstein SL, Mermelstein RJ, Arnsten JH, Dolce EH, Shuter J. A randomized controlled trial of a tailored group smoking cessation intervention for HIV-infected smokers. J Acquir Immune Defic Syndr. 2012 Oct 1;61(2):208-15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
190
May 2011
March 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV-infection
  • current cigarette smoker
  • high motivation to quit

Exclusion Criteria:

  • Pregnancy
  • breastfeeding
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01106638
R21DA023362( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
Jonathan Shuter, MD, Montefiore Medical Center
Montefiore Medical Center
  • Albert Einstein College of Medicine, Inc.
  • Yale University
Principal Investigator: Jonathan Shuter, MD Montefiore Medical Center
Montefiore Medical Center
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP