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

March 14, 2012
March 28, 2013
September 2011
May 2013   (final data collection date for primary outcome measure)
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.
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) ] [ 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).
  • 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).
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
138
September 2013
May 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01570595
3358936, R21CA163100 [NIH Grant #]
Not Provided
Georgetown University
Georgetown University
  • Albert Einstein College of Medicine of Yeshiva University
  • University of Michigan
Not Provided
Georgetown University
March 2013

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