A Mobile Intervention to Promote Cessation in HIV-infected Smokers

May 29, 2023 updated by: Montefiore Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • mPSF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Biochemically-verified (by exhaled breath carbon-monoxide level), 7-day point-prevalence-abstinence at the 3 month timepoint
Time Frame: 3-months
3-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Collaborators

National Institute on Drug Abuse (NIDA)
University of Michigan
George Washington University

Investigators

  • Principal Investigator: Jonathan Shuter, MD, Montefiore Medical Center/Albert Einstein College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

October 23, 2014

First Submitted That Met QC Criteria

April 28, 2015

First Posted (Estimated)

May 4, 2015

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 29, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2014-3094
  • 1R34DA037042-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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