Positively Smoke Free on the Web (PSFW) for Smokers Living With HIV
- Conditions
- Tobacco CessationTobacco Use CessationTobacco Use DisorderTobacco-Use DisorderTobacco DependenceVirus, Human Immunodeficiency
- Interventions
- Behavioral: Web-Based Tailored Smoking Cessation InterventionBehavioral: Standard of Care
- Registration Number
- NCT01570595
- Lead Sponsor
- Georgetown University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 138
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard Care Standard of 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). Web-Based Intervention Web-Based Tailored Smoking Cessation 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. Standard Care Web-Based Tailored Smoking Cessation Intervention 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).
- Primary Outcome Measures
Name Time Method 24-hour Point-prevalence tobacco abstinence 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.
- Secondary Outcome Measures
Name Time Method Degree of Participation in Intervention (Feasibility) 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 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).
Trial Locations
- Locations (1)
Albert Einstein College of Medicine of Yeshiva University
🇺🇸Bronx, New York, United States