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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02072772|
Recruitment Status : Not yet recruiting
First Posted : February 27, 2014
Last Update Posted : February 27, 2014
|Condition or disease||Intervention/treatment||Phase|
|Tobacco Use in Persons Living With HIV||Behavioral: Positively Smoke Free group treatment Behavioral: Standard Care||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||450 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Trial of Positively Smoke Free Group Therapy for HIV-infected Smokers|
|Study Start Date :||May 2014|
|Estimated Primary Completion Date :||August 2017|
|Estimated Study Completion Date :||August 2018|
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
- 6 month abstinence from cigarettes [ Time Frame: 6 months ]Biochemically-confirmed 7-day point-prevalence abstinence from cigarettes at the 6-month timepoint
- Cost per incremental quit [ Time Frame: 6 months ]Estimated cost per incremental quit
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 ClinicalTrials.gov identifier (NCT number): NCT02072772
|Contact: Jonathan Shuter, MDemail@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator:||Jonathan Shuter, MD||Montefiore Medical Center/Albert Einstein College of Medicine|