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A Trial of Positively Smoke Free Group Therapy for HIV-infected Smokers

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ClinicalTrials.gov Identifier: NCT02072772
Recruitment Status : Completed
First Posted : February 27, 2014
Last Update Posted : April 27, 2018
Sponsor:
Collaborator:
Georgetown University
Information provided by (Responsible Party):
Jonathan Shuter, Montefiore Medical Center

Tracking Information
First Submitted Date  ICMJE February 25, 2014
First Posted Date  ICMJE February 27, 2014
Last Update Posted Date April 27, 2018
Actual Study Start Date  ICMJE May 2014
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2014)
6 month abstinence from cigarettes [ Time Frame: 6 months ]
Biochemically-confirmed 7-day point-prevalence abstinence from cigarettes at the 6-month timepoint
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02072772 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2014)
Cost per incremental quit [ Time Frame: 6 months ]
Estimated cost per incremental quit
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial of Positively Smoke Free Group Therapy for HIV-infected Smokers
Official Title  ICMJE A Trial of Positively Smoke Free Group Therapy for HIV-infected Smokers
Brief Summary The purpose of this study is to determine whether Positively Smoke Free group therapy is more effective at promoting cessation than standard care.
Detailed Description

There are 1.1 million persons living with HIV (PLWH) in the US, 60% of them smoke cigarettes, and 75% of these are interested in quitting. Almost none are currently accessing smoking cessation interventions designed to meet their specific needs and concerns.

Cigarette smoking is responsible for 24% of deaths among PLWH, and 30% of non-AIDS defining malignancies. It is driving the alarming rise in cardiac events and lung cancers in this highly vulnerable population. The lack of access to proven, effective, culturally appropriate tobacco cessation services represents a health disparity of the first order. The psychosocial profile of the PLWH-smoker community, characterized by high rates of psychiatric comorbidity, drug and alcohol use, and low levels of social support, suggests that achieving high cessation rates will be a great challenge.

Positively Smoke Free (PSF) is an intensive, multisession, group cessation program specifically developed for PLWH smokers. A pilot study of PSF yielded promising results. This proposal aims (1) to perform a definitive efficacy study of PSF by comparing 6-month biochemically confirmed abstinence rates in subjects randomized to PSF vs. standard care in a cohort of 450 PLWH smokers, (2) to determine the sociobehavioural moderators and mediators associated with successful cessation, and (3) to complete a careful cost analysis of PSF in order to estimate the incremental cost per quit associated program participation.

If PSF is proven to be effective it will establish a new treatment option for PLWH smokers. Determination of moderators and mediators of program success will provide insight into the mode of action of the intervention and will help guide the development of additional treatment strategies in the future. Finally, the cost analyses will provide critical information about the feasibility of program dissemination and implementation.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Tobacco Use in Persons Living With HIV
Intervention  ICMJE
  • Behavioral: Positively Smoke Free group treatment
    See Arm Description
  • Behavioral: Standard Care
    See Arm Description
Study Arms  ICMJE
  • Experimental: Positively Smoke Free group treatment

    Eight 90 minute group sessions (6-8 HIV-infected smokers per group) led by a pair of trained group leaders: a "professional" with psychology or social work training and a "peer" HIV-infected ex-smoker with tobacco treatment training.

    All subjects will be offered a 3 month supply of nicotine patches

    Intervention: Behavioral: Positively Smoke Free group treatment
  • Active Comparator: Standard care
    Brief (<5 minutes) advice to quit Offer of nicotine patches Self-help brochure
    Intervention: Behavioral: Standard Care
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 25, 2018)
449
Original Estimated Enrollment  ICMJE
 (submitted: February 26, 2014)
450
Actual Study Completion Date  ICMJE March 2018
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • HIV-infection
  • Receives care at Montefiore Medical Center or Georgetown University
  • Motivated to quit
  • Willing to attend eight 90 minute group sessions

Exclusion Criteria:

  • Pregnancy or breastfeeding
  • Contraindication to nicotine patch use
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02072772
Other Study ID Numbers  ICMJE 1R01DA036445-01( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jonathan Shuter, Montefiore Medical Center
Study Sponsor  ICMJE Montefiore Medical Center
Collaborators  ICMJE Georgetown University
Investigators  ICMJE
Principal Investigator: Jonathan Shuter, MD Montefiore Medical Center/Albert Einstein College of Medicine
PRS Account Montefiore Medical Center
Verification Date April 2018

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