A Pilot Study of Positively Smoke Free on the Web (PSFW) for HIV-infected Smokers
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Georgetown University
- Enrollment
- 138
- Locations
- 1
- Primary Endpoint
- 24-hour Point-prevalence tobacco abstinence
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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).
Intervention: Web-Based Tailored Smoking Cessation Intervention (Behavioral)
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: Web-Based Tailored Smoking Cessation Intervention (Behavioral)
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).
Intervention: Standard of Care (Behavioral)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Degree of Participation in Intervention (Feasibility)(3 Months (duration of intervention))
- Knowledge and Behavior Change(Day 0, 42, 121)