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Positively Smoke Free on the Web (PSFW) for Smokers Living With HIV (PSFW)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01570595
First Posted: April 4, 2012
Last Update Posted: May 12, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Albert Einstein College of Medicine, Inc.
University of Michigan
Information provided by (Responsible Party):
Georgetown University
March 14, 2012
April 4, 2012
May 12, 2014
September 2011
July 2013   (Final data collection date for primary outcome measure)
24-hour Point-prevalence tobacco abstinence [ Time Frame: 3 months ]
The proportion of each group achieving 24-hour point prevalence abstinence at Visit 3 (i.e., abstinence on or around Day 121 - 3 months post-Quit Day in the Intervention condition) by exhaled carbon monoxide, an accepted method for biochemical validation of abstinence.
Same as current
Complete list of historical versions of study NCT01570595 on ClinicalTrials.gov Archive Site
  • Degree of Participation in Intervention (Feasibility) [ Time Frame: 3 Months (duration of intervention) ]
    Intervention feasibility will be assessed using variables such as total # of logins, # of sessions viewed, # of web pages viewed, # of mouse clicks on interactive features, total time logged on to the site (automatic logoff occurs after 30 minutes of inactivity), proportion completing the final study visit, program satisfaction survey results, and total # of reminder phone calls/texts placed by clinic staff.
  • Knowledge and Behavior Change [ Time Frame: Day 0, 42, 121 ]
    Validated measures will be used to collect data on continuous abstinence, number of quit attempts, and current daily cigarette consumption. Composite quit indices will be analyzed, especially the combination of 3 month continuous abstinence with expired carbon monoxide (ECO) confirmation. We will also analyze results of validated measures that have known associations with cessation outcomes (tobacco knowledge, depression, anxiety, motivation to quit, self-concept, perceived risks/benefits, self-efficacy, and decisional balance).
  • Degree of Participation in Intervention (Feasibility) [ Time Frame: 3 Months (duration of intervention) ]
    Intervention feasibility will be assessed using variables such as total # of logins, # of sessions viewed, # of web pages viewed, # of mouse clicks on interactive features, total time logged on to the site (automatic logoff occurs after 30 minutes of inactivity), proportion completing the final study visit, program satisfaction survey results, and total # of reminder phone calls/texts placed by clinic staff.
  • Knowledge and Behavior Change [ Time Frame: Day 0, 42, 121 ]
    Validated measures will be used to collect data on continuous abstinence, number of quit attempts, and current daily cigarette consumption. Composite quit indices will be analyzed, especially the combination of 3 month continuous abstinence with ECO confirmation. We will also analyze results of validated measures that have known associations with cessation outcomes (tobacco knowledge, depression, anxiety, motivation to quit, self-concept, perceived risks/benefits, self-efficacy, and decisional balance).
Not Provided
Not Provided
 
Positively Smoke Free on the Web (PSFW) for Smokers Living With HIV
A Pilot Study of Positively Smoke Free on the Web (PSFW) for HIV-infected Smokers
The purpose of this study is to evaluate the first web-based cessation program developed expressly for people living with HIV who smoke tobacco. Main study goals are (1) to evaluate the website's feasibility (i.e., recruitment, adherence, retention, and satisfaction) and (2) to complete a prospective, randomized controlled trial comparing the efficacy of the online program to standard care with a primary outcome of 3 month point-prevalence abstinence.
Positively Smoke Free on the Web is the first web-based cessation program developed expressly for people living with HIV (PLWH) who smoke tobacco. It is a resource that is ready for clinical use, but its feasibility and efficacy have yet to be studied. Main study goals are (1) to evaluate the website's feasibility (i.e., recruitment, adherence, retention, and satisfaction) in a cohort of 69 PLWH smokers, and (2) to complete a prospective, randomized controlled trial comparing the efficacy of the online program to standard care (total N = 138) with a primary outcome of 3 month point-prevalence abstinence.
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Tobacco Use Cessation
  • Tobacco Cessation
  • Tobacco Use Disorder
  • Tobacco Dependence
  • Tobacco-Use Disorder
  • Virus, Human Immunodeficiency
  • Behavioral: Web-Based Tailored Smoking Cessation Intervention
    The Experimental group will be given an ID number to log in to the quit smoking program, and complete their first log-in with a research assistant. The online program is made up of 8 separate, weekly online sessions that take approximately 15-30 minutes to complete. The entire program is meant to be completed in 7 weeks. Participants are asked to provide an email address and/or cell phone number so reminders can be sent to complete the sessions. If participants are late completing a session, they will receive a call from clinic staff as a reminder. The "standard care" group will receive advice to quit, a quit-smoking brochure, and an offer of three months of nicotine replacement therapy (nicotine patches).
    Other Names:
    • Tailored Cessation
    • Web-Based Intervention
    • Web-Based Cessation
  • Behavioral: Standard of Care
    advice to quit, a quit-smoking brochure, and an offer of three months of nicotine replacement therapy (nicotine patches).
  • Experimental: Web-Based Intervention
    This group will be asked to participate in the online quit smoking program. At their first visit, they will be given an ID number to log in to the quit smoking program, and they will complete their first log in with the research assistant. The online program is made up of 8 separate online sessions that are supposed to be completed approximately once per week. Each sessions is written to take an average reader 15-30 minutes to complete. The entire program is meant to be completed in 7 weeks. At the first visit, participants are asked to provide an email address and/or cell phone number so reminders can be sent, by email or text message, to complete the sessions. If participants are late completing a session, they may receive call from clinic staff as a reminder.
    Intervention: Behavioral: Web-Based Tailored Smoking Cessation Intervention
  • Active Comparator: Standard Care
    This group will receive "standard care" for their smoking, including advice to quit, a quit-smoking brochure, and an offer of three months of nicotine replacement therapy (nicotine patches).
    Interventions:
    • Behavioral: Web-Based Tailored Smoking Cessation Intervention
    • Behavioral: Standard of Care
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
138
September 2013
July 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Laboratory confirmation of HIV infection
  • Montefiore Medical Center Infectious Disease Clinic patient
  • Current tobacco user
  • Affirmed motivation to quit within the next 6 months
  • Have home access to the Internet
  • Read above 4th grade level (by REALM)
  • Willingness to grant informed consent and undergo randomization

Exclusion Criteria:

  • Pregnant or breastfeeding women
  • People with contraindications to nicotine replacement therapy
  • People currently receiving other tobacco treatment
  • Spouses, partners, and/or roommates of current study participants
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01570595
3358936
R21CA163100 [NIH Grant #]
R21CA163100 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Not Provided
Georgetown University
Georgetown University
  • Albert Einstein College of Medicine, Inc.
  • University of Michigan
Not Provided
Georgetown University
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP