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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 because the information has not been verified recently.
Verified April 2010 by Montefiore Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Albert Einstein College of Medicine of Yeshiva University
Yale University
Information provided by:
Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT01106638
First received: April 19, 2010
Last updated: April 29, 2010
Last verified: April 2010
History of Changes
  Purpose

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 Intervention Phase
Smoking
HIV Infections
AIDS
 Behavioral: Positively Smoke Free
Behavioral: Standard care
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • Three month point-prevalence abstinence from cigarettes [ Time Frame: 3 months post-intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Three month continuous abstinence from cigarettes [ Time Frame: Three months post-intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 190
Study Start Date: November 2009
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
  • breastfeeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 of Yeshiva University
Yale University
Investigators
Principal Investigator: Jonathan Shuter, MD Montefiore Medical Center
  More Information

No publications provided by Montefiore Medical Center

Additional 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: R21 DA023362
Study First Received: April 19, 2010
Last Updated: April 29, 2010
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Smoking
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Habits

ClinicalTrials.gov processed this record on May 23, 2013