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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Tobacco Use in Persons Living With HIV

Intervention / Treatment
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* Behavioral: Positively Smoke Free group treatment
* Behavioral: Standard Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Positively Smoke Free group treatment<br>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<br>* See Arm Description<br>|
| Active Comparator: Standard care<br>Brief (<5 minutes) advice to quit Offer of nicotine patches Self-help brochure | Behavioral: Standard Care<br>* See Arm Description<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 month abstinence from cigarettes | Biochemically-confirmed 7-day point-prevalence abstinence from cigarettes at the 6-month timepoint | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost per incremental quit | Estimated cost per incremental quit | 6 months |