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

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ClinicalTrials.gov Identifier: NCT01106638
Recruitment Status : Completed
First Posted : April 20, 2010
Last Update Posted : April 27, 2018
Sponsor:
Collaborators:
Albert Einstein College of Medicine, Inc.
Yale University
Information provided by (Responsible Party):
Jonathan Shuter, Montefiore Medical Center

April 19, 2010
April 20, 2010
April 27, 2018
December 2009
April 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.
 
Completed
147
190
April 2011
April 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, 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 2018

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