A Pilot Study of Positively Smoke Free on the Web (PSFW) for HIV-infected Smokers
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Tobacco Use Cessation
- Sponsor
- Georgetown University
- Enrollment
- 138
- Locations
- 1
- Primary Endpoint
- 24-hour Point-prevalence tobacco abstinence
- Status
- Completed
- Last Updated
- 11 years ago
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.
Investigators
Eligibility Criteria
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
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)