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



Status:Completed
Conditions:Tobacco Consumers
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:4/29/2018
Start Date:May 2014
End Date:March 2018

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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.

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.

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
We found this trial at
2
sites
3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 687-7695
Georgetown University Medical Center Georgetown University Medical Center is committed to excellence in research, education...
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