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

Phase 1

Completed

• Conditions: Tobacco Cessation; Tobacco Use Cessation; Tobacco Use Disorder; Tobacco-Use Disorder; Tobacco Dependence; Virus, Human Immunodeficiency

• 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.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-03-14
• Study First Submitted QC: 2012-04-02
• Study First Posted: 2012-04-04
• Primary Completion: 2013-07
• Study Completion: 2013-09
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-09
• Last Update Posted: 2014-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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