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

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

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.

Condition or disease Intervention/treatment Phase
Tobacco Use in Persons Living With HIV Behavioral: Positively Smoke Free group treatment Behavioral: Standard Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 449 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Trial of Positively Smoke Free Group Therapy for HIV-infected Smokers
Actual Study Start Date : May 2014
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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

Behavioral: Positively Smoke Free group treatment
See Arm Description

Active Comparator: Standard care
Brief (<5 minutes) advice to quit Offer of nicotine patches Self-help brochure
Behavioral: Standard Care
See Arm Description

Primary Outcome Measures :
  1. 6 month abstinence from cigarettes [ Time Frame: 6 months ]
    Biochemically-confirmed 7-day point-prevalence abstinence from cigarettes at the 6-month timepoint

Secondary Outcome Measures :
  1. Cost per incremental quit [ Time Frame: 6 months ]
    Estimated cost per incremental quit

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

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 identifier (NCT number): NCT02072772

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United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10804
Sponsors and Collaborators
Montefiore Medical Center
Georgetown University
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Principal Investigator: Jonathan Shuter, MD Montefiore Medical Center/Albert Einstein College of Medicine

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Responsible Party: Jonathan Shuter, Prof. Infectious Diseases, Montefiore Medical Center Identifier: NCT02072772     History of Changes
Other Study ID Numbers: 1R01DA036445-01 ( U.S. NIH Grant/Contract )
First Posted: February 27, 2014    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018