Clinical trial NCT01570595: Positively Smoke Free on the Web (PSFW) for Smokers Living With HIV
Official title: A Pilot Study of Positively Smoke Free on the Web (PSFW) for HIV-infected Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Tobacco Use Cessation
Tobacco Cessation
Tobacco Use Disorder
Tobacco Dependence
Tobacco-Use Disorder
Virus, Human Immunodeficiency
Keywords: Tobacco Use Cessation
Tobacco Cessation
Tobacco Use Disorder
Tobacco Dependence
Tobacco-Use Disorder
Virus, Human Immunodeficiency
Lead sponsor: Georgetown University
Sponsor class: OTHER
Collaborators: name: Albert Einstein College of Medicine
name: University of Michigan
First posted: 2012-04-04
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 24-hour Point-prevalence tobacco abstinence
timeFrame: 3 months
Secondary outcomes:
measure: Degree of Participation in Intervention (Feasibility)
timeFrame: 3 Months (duration of intervention)
measure: Knowledge and Behavior Change
timeFrame: Day 0, 42, 121
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine of Yeshiva University
state: New York
Study officials:
References:
citation: Shuter J, Pearlman BK, Stanton CA, Moadel AB, Kim RS, Weinberger AH. Gender Differences among Smokers Living with HIV. J Int Assoc Provid AIDS Care. 2016 Sep;15(5):412-7. doi: 10.1177/2325957416649439. Epub 2016 May 23.
citation: Shuter J, Morales DA, Considine-Dunn SE, An LC, Stanton CA. Feasibility and preliminary efficacy of a web-based smoking cessation intervention for HIV-infected smokers: a randomized controlled trial. J Acquir Immune Defic Syndr. 2014 Sep 1;67(1):59-66. doi: 10.1097/QAI.0000000000000226.