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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 : Unknown
Verified April 2010 by Montefiore Medical Center.
Recruitment status was:  Recruiting
First Posted : April 20, 2010
Last Update Posted : May 3, 2010
Sponsor:
Collaborators:
Albert Einstein College of Medicine, Inc.
Yale University
Information provided by:
Montefiore Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Smoking HIV Infections AIDS Behavioral: Positively Smoke Free Behavioral: Standard care Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Trial to Test the Efficacy of a Tailored Intensive Smoking Cessation Intervention in Persons With HIV (PWHs)
Study Start Date : November 2009
Estimated Primary Completion Date : March 2011
Estimated Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Intensive behavioral intervention
Eight session, behavioral intervention targeting HIV-infected smokers
Behavioral: Positively Smoke Free
An eight session, group therapy intervention targeting smokers living with HIV/AIDS
Active Comparator: Standard care
Advice to quit, smoking cessation brochure, offer of nicotine patch
Behavioral: Standard care
Advice to quit, smoking cessation brochure, and offer of nicotine patches



Primary Outcome Measures :
  1. Three month point-prevalence abstinence from cigarettes [ Time Frame: 3 months post-intervention ]

Secondary Outcome Measures :
  1. Three month continuous abstinence from cigarettes [ Time Frame: Three months post-intervention ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
  • breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01106638


Contacts
Contact: Jonathan Shuter, MD 718-920-7845 jshuter@montefiore.org
Contact: Eileen Dolce, PA 718-920-6528 edolce@montefiore.org

Locations
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Jonathan Shuter, MD    718-920-7845    jshuter@montefiore.org   
Principal Investigator: Jonathan Shuter, MD         
Sponsors and Collaborators
Montefiore Medical Center
Albert Einstein College of Medicine, Inc.
Yale University
Investigators
Principal Investigator: Jonathan Shuter, MD Montefiore Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jonathan Shuter, MD, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT01106638     History of Changes
Other Study ID Numbers: R21DA023362 ( U.S. NIH Grant/Contract )
First Posted: April 20, 2010    Key Record Dates
Last Update Posted: May 3, 2010
Last Verified: April 2010

Keywords provided by Montefiore Medical Center:
HIV
AIDS
Smoking
Tobacco
Cessation
Tobacco use in persons living with HIV/AIDS

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases