Brief Summary
The purpose of this study is to adapt an existing web-based tobacco treatment program for HIV-infected smokers into a mobile intervention delivered via smartphone. After the adaptation is completed, the investigators will test the program's efficacy at promoting abstinence in a randomized controlled trial.
Brief Title
A Mobile Intervention to Promote Cessation in HIV-infected Smokers
Detailed Description
There are nearly one million persons living with confirmed HIV infection (PLWH) in the US, 60% of them smoke cigarettes, and 75% of them are interested in quitting. Almost none are currently accessing smoking cessation interventions designed to meet their specific needs and concerns.
Cigarette smoking is a leading contributor to mortality among PLWH in the HAART era, and it is the direct cause of 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 is an intensive, multisession, cessation intervention specifically developed for PLWH smokers. It is currently available as a live, group therapy program and also as a web-based version designed for notebook or desktop computers. In its current form, the web-version is not adoptable to the smartphone platform. Pilot data from randomized, controlled, trials of both formats show promise.
The number of individuals in the US who own smartphones and who use them to access health information on the internet is steadily growing. This growth is most pronounced in the ethnic minority groups that make up the majority of the PLWH community in the US. Behavioral interventions delivered via smartphones offer the advantage of expansive reach, low cost, and immediacy of access to users. A burgeoning body of literature suggests that this may be an especially effective tool for tobacco treatment. mHealth tobacco treatment interventions for PLWH smokers have not yet been explored.
This proposal aims (1) to adapt Positively Smoke Free to the mobile format for smartphones (2) to test the feasibility (i.e. recruitment, adherence, retention, satisfaction, and cost) of mobile Positively Smoke Free (mPSF) in a cohort of 50 PLWH smokers, (3) to complete a pilot randomized controlled trial comparing biochemically confirmed 3-month abstinence rates in subjects (N=50) assigned to the mPSF condition versus those (N=50) assigned to standard care (all subjects will be offered a 3-month supply of nicotine replacement therapy) and (4) to conduct exploratory analyses of putative moderators and mediators of program efficacy.
If the mobile version of PSF is proven to be feasible and efficacious, the project will have short term impact by opening a new vista of tobacco (and other behavioral) treatment for a highly vulnerable group. Study data will provide crucial information for a definitive trial of the intervention. The long-term impact will be reduced tobacco-related morbidity and mortality among PLWH, and a clearer understanding of the role of mHealth in comprehensive HIV care.
Cigarette smoking is a leading contributor to mortality among PLWH in the HAART era, and it is the direct cause of 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 is an intensive, multisession, cessation intervention specifically developed for PLWH smokers. It is currently available as a live, group therapy program and also as a web-based version designed for notebook or desktop computers. In its current form, the web-version is not adoptable to the smartphone platform. Pilot data from randomized, controlled, trials of both formats show promise.
The number of individuals in the US who own smartphones and who use them to access health information on the internet is steadily growing. This growth is most pronounced in the ethnic minority groups that make up the majority of the PLWH community in the US. Behavioral interventions delivered via smartphones offer the advantage of expansive reach, low cost, and immediacy of access to users. A burgeoning body of literature suggests that this may be an especially effective tool for tobacco treatment. mHealth tobacco treatment interventions for PLWH smokers have not yet been explored.
This proposal aims (1) to adapt Positively Smoke Free to the mobile format for smartphones (2) to test the feasibility (i.e. recruitment, adherence, retention, satisfaction, and cost) of mobile Positively Smoke Free (mPSF) in a cohort of 50 PLWH smokers, (3) to complete a pilot randomized controlled trial comparing biochemically confirmed 3-month abstinence rates in subjects (N=50) assigned to the mPSF condition versus those (N=50) assigned to standard care (all subjects will be offered a 3-month supply of nicotine replacement therapy) and (4) to conduct exploratory analyses of putative moderators and mediators of program efficacy.
If the mobile version of PSF is proven to be feasible and efficacious, the project will have short term impact by opening a new vista of tobacco (and other behavioral) treatment for a highly vulnerable group. Study data will provide crucial information for a definitive trial of the intervention. The long-term impact will be reduced tobacco-related morbidity and mortality among PLWH, and a clearer understanding of the role of mHealth in comprehensive HIV care.
Completion Date
Completion Date Type
Actual
Conditions
Tobacco Use
HIV-1-infection
Eligibility Criteria
Inclusion Criteria:
* HIV-infected
* Current cigarette smoker
* Has a smartphone
* Interested in quitting
* Receives care at the Montefiore Center for Positive Living
Exclusion Criteria:
* Pregnancy
* Contraindication to nicotine patch use
* Fails to meet inclusion criteria above
* HIV-infected
* Current cigarette smoker
* Has a smartphone
* Interested in quitting
* Receives care at the Montefiore Center for Positive Living
Exclusion Criteria:
* Pregnancy
* Contraindication to nicotine patch use
* Fails to meet inclusion criteria above
Inclusion Criteria
Inclusion Criteria:
* HIV-infected
* Current cigarette smoker
* Has a smartphone
* Interested in quitting
* Receives care at the Montefiore Center for Positive Living
* HIV-infected
* Current cigarette smoker
* Has a smartphone
* Interested in quitting
* Receives care at the Montefiore Center for Positive Living
Gender
All
Gender Based
false
Keywords
Tobacco
Cigarette
HIV
Treatment
Mobile
Smartphone
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02432482
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2014-3094
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Mobile Intervention to Promote Cessation in HIV-infected Smokers
Primary Outcomes
Outcome Measure
Biochemically-verified (by exhaled breath carbon-monoxide level), 7-day point-prevalence-abstinence at the 3 month timepoint
Outcome Time Frame
3-months
Secondary Ids
Secondary Id
1R34DA037042-01
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)
999
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
MeSH Terms
TOBACCO USE
BEHAVIOR
STANDARD OF CARE
QUALITY INDICATORS, HEALTH CARE
QUALITY OF HEALTH CARE
HEALTH SERVICES ADMINISTRATION
HEALTH CARE QUALITY, ACCESS, AND EVALUATION