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A Mobile Intervention to Promote Cessation in HIV-infected Smokers

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ClinicalTrials.gov Identifier: NCT02432482
Recruitment Status : Completed
First Posted : May 4, 2015
Last Update Posted : April 27, 2018
Sponsor:
Collaborators:
George Washington University
University of Michigan
Information provided by (Responsible Party):
Jonathan Shuter, Montefiore Medical Center

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.

Condition or disease Intervention/treatment Phase
Tobacco Use HIV-1-infection Behavioral: mobile Positively Smoke Free (mPSF) Behavioral: Standard care Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Mobile Intervention to Promote Cessation in HIV-infected Smokers
Actual Study Start Date : December 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: Standard care
Brief advice to quit (less than 5 minutes) Self-help brochure Offer of nicotine patches
Behavioral: Standard care
Brief advice to quit (<5 minutes) Self-help brochure Offer of nicotine patches
Other Name: SC

Experimental: mobile Positively Smoke Free (mPSF)

mPSF: a targeted, intensive behavioral cessation intervention for PLWH smokers

  • offer of nicotine patches
Behavioral: mobile Positively Smoke Free (mPSF)
mPSF is a targeted, intensive behavioral cessation intervention designed for HIV-infected smokers. It is guided by the Social Cognitive Theory model. It includes 8 weekly sessions of audio/video messages to users, daily text messages, and a variety of other smartphone capabilities, e.g. play-a-tune, play-a-game, phone-a-friend, call the quitline.
Other Name: mPSF




Primary Outcome Measures :
  1. Biochemically-verified (by exhaled breath carbon-monoxide level), 7-day point-prevalence-abstinence at the 3 month timepoint [ Time Frame: 3-months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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): NCT02432482


Locations
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United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
George Washington University
University of Michigan
Investigators
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Principal Investigator: Jonathan Shuter, MD Montefiore Medical Center/Albert Einstein College of Medicine

Publications:
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Responsible Party: Jonathan Shuter, Principal Investigator, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT02432482     History of Changes
Other Study ID Numbers: 1R34DA037042-01 ( U.S. NIH Grant/Contract )
First Posted: May 4, 2015    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018

Keywords provided by Jonathan Shuter, Montefiore Medical Center:
Tobacco
Cigarette
HIV
Treatment
Mobile
Smartphone

Additional relevant MeSH terms:
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Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action