A Mobile Intervention to Promote Cessation in HIV-infected Smokers



Status:Completed
Conditions:Smoking Cessation
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:4/29/2018
Start Date:December 2015
End Date:April 2017

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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.

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.

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
We found this trial at
1
site
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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mi
from
Bronx, NY
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