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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by Montefiore Medical Center
Sponsor:
Collaborator:
Georgetown University School of Medicine
Information provided by (Responsible Party):
Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT02072772
First received: February 25, 2014
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

The purpose of this study is to determine whether Positively Smoke Free group therapy is more effective at promoting cessation than standard care.


Condition Intervention
Tobacco Use in Persons Living With HIV
Behavioral: Positively Smoke Free group treatment
Behavioral: Standard Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Trial of Positively Smoke Free Group Therapy for HIV-infected Smokers

Resource links provided by NLM:


Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • 6 month abstinence from cigarettes [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Biochemically-confirmed 7-day point-prevalence abstinence from cigarettes at the 6-month timepoint


Secondary Outcome Measures:
  • Cost per incremental quit [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Estimated cost per incremental quit


Estimated Enrollment: 450
Study Start Date: May 2014
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02072772

Contacts
Contact: Jonathan Shuter, MD 718-920-7845 jshuter@montefiore.org

Locations
United States, District of Columbia
Georgetown University Medical Center Not yet recruiting
Washington, District of Columbia, United States, 20007
Contact: Cassandra Stanton, PhD    202-687-1172    Stantoncas337@georgetown.edu   
United States, New York
Montefiore Medical Center Not yet recruiting
Bronx, New York, United States, 10804
Contact: Jonathan Shuter, MD    718-920-7845    jshuter@montefiore.org   
Sponsors and Collaborators
Montefiore Medical Center
Georgetown University School of Medicine
Investigators
Principal Investigator: Jonathan Shuter, MD Montefiore Medical Center/Albert Einstein College of Medicine
  More Information

Publications:
Responsible Party: Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT02072772     History of Changes
Other Study ID Numbers: 1 R01 DA036445-01
Study First Received: February 25, 2014
Last Updated: February 26, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 26, 2014