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.
Brief Title
A Trial of Positively Smoke Free Group Therapy for HIV-infected Smokers
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.
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.
Completion Date
Completion Date Type
Actual
Conditions
Tobacco Use in Persons Living With HIV
Eligibility 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
* 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
Inclusion 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
* HIV-infection
* Receives care at Montefiore Medical Center or Georgetown University
* Motivated to quit
* Willing to attend eight 90 minute group sessions
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
99 Years
Minimum Age
18 Years
NCT Id
NCT02072772
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2013-260
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Trial of Positively Smoke Free Group Therapy for HIV-infected Smokers
Primary Outcomes
Outcome Description
Biochemically-confirmed 7-day point-prevalence abstinence from cigarettes at the 6-month timepoint
Outcome Measure
6 month abstinence from cigarettes
Outcome Time Frame
6 months
Secondary Ids
Secondary Id
R01DA036445-01
Secondary Outcomes
Outcome Description
Estimated cost per incremental quit
Outcome Time Frame
6 months
Outcome Measure
Cost per incremental quit
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
99
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Jonathan Shuter
Investigator Email
jonathan.shuter@einsteinmed.org
Investigator Phone
718-920-7845