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

This study is enrolling participants by invitation only.

Sponsor:

Collaborators:

Albert Einstein College of Medicine of Yeshiva University

University of Michigan

Information provided by (Responsible Party):

Georgetown University

ClinicalTrials.gov Identifier:

NCT01570595

First received: March 14, 2012

Last updated: March 28, 2013

Last verified: March 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	March 14, 2012
Last Updated Date	March 28, 2013
Start Date ^ICMJE	September 2011
Estimated Primary Completion Date	May 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 2, 2012)	24-hour Point-prevalence tobacco abstinence [ Time Frame: 3 months ] [ Designated as safety issue: No ] 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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01570595 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 28, 2013)	Degree of Participation in Intervention (Feasibility) [ Time Frame: 3 Months (duration of intervention) ] [ Designated as safety issue: No ] 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 ] [ Designated as safety issue: No ] 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).
Original Secondary Outcome Measures ^ICMJE (submitted: April 2, 2012)	Degree of Participation in Intervention (Feasibility) [ Time Frame: 3 Months (duration of intervention) ] [ Designated as safety issue: No ] 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 ] [ Designated as safety issue: No ] 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).
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Positively Smoke Free on the Web (PSFW) for Smokers Living With HIV
Official Title ^ICMJE	A Pilot Study of Positively Smoke Free on the Web (PSFW) for HIV-infected Smokers
Brief Summary	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.
Detailed Description	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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 1 Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Tobacco Use Cessation Tobacco Cessation Tobacco Use Disorder Tobacco Dependence Tobacco-Use Disorder Virus, Human Immunodeficiency
Intervention ^ICMJE	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).
Study Arm (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Enrolling by invitation
Estimated Enrollment ^ICMJE	138
Estimated Completion Date	September 2013
Estimated Primary Completion Date	May 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01570595
Other Study ID Numbers ^ICMJE	3358936, R21CA163100 [NIH Grant #]
Has Data Monitoring Committee	Not Provided
Responsible Party	Georgetown University
Study Sponsor ^ICMJE	Georgetown University
Collaborators ^ICMJE	Albert Einstein College of Medicine of Yeshiva University University of Michigan
Investigators ^ICMJE	Not Provided
Information Provided By	Georgetown University
Verification Date	March 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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