A Mobile Intervention to Promote Cessation in HIV-infected Smokers
2 other identifiers
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2014
CompletedFirst Posted
Study publicly available on registry
May 4, 2015
CompletedStudy Start
First participant enrolled
December 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedMay 31, 2023
May 1, 2023
1 year
October 23, 2014
May 29, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Biochemically-verified (by exhaled breath carbon-monoxide level), 7-day point-prevalence-abstinence at the 3 month timepoint
3-months
Study Arms (2)
Standard care
ACTIVE COMPARATORBrief advice to quit (less than 5 minutes) Self-help brochure Offer of nicotine patches
mobile Positively Smoke Free (mPSF)
EXPERIMENTALmPSF: a targeted, intensive behavioral cessation intervention for PLWH smokers * offer of nicotine patches
Interventions
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.
Brief advice to quit (\<5 minutes) Self-help brochure Offer of nicotine patches
Eligibility Criteria
You may qualify if:
- HIV-infected
- Current cigarette smoker
- Has a smartphone
- Interested in quitting
- Receives care at the Montefiore Center for Positive Living
You may not qualify if:
- Pregnancy
- Contraindication to nicotine patch use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Montefiore Medical Centerlead
- George Washington Universitycollaborator
- University of Michigancollaborator
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (1)
Montefiore Medical Center
The Bronx, New York, 10467, United States
Related Publications (1)
Shuter J, Morales DA, Considine-Dunn SE, An LC, Stanton CA. Feasibility and preliminary efficacy of a web-based smoking cessation intervention for HIV-infected smokers: a randomized controlled trial. J Acquir Immune Defic Syndr. 2014 Sep 1;67(1):59-66. doi: 10.1097/QAI.0000000000000226.
PMID: 25118794BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan Shuter, MD
Montefiore Medical Center/Albert Einstein College of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2014
First Posted
May 4, 2015
Study Start
December 1, 2015
Primary Completion
December 1, 2016
Study Completion
April 1, 2017
Last Updated
May 31, 2023
Record last verified: 2023-05