Trials / Completed
CompletedNCT01570595
Positively Smoke Free on the Web (PSFW) for Smokers Living With HIV
A Pilot Study of Positively Smoke Free on the Web (PSFW) for HIV-infected Smokers
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 138 (actual)
- Sponsor
- Georgetown University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Tobacco Use Cessation
- Tobacco Cessation
- Tobacco Use Disorder
- Tobacco Dependence
- Tobacco-Use Disorder
- Virus, Human Immunodeficiency
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Web-Based Tailored Smoking Cessation Intervention | The Experimental group will be given an ID number to log in to the quit smoking program, and complete their first log-in with a research assistant. The online program is made up of 8 separate, weekly online sessions that take approximately 15-30 minutes to complete. The entire program is meant to be completed in 7 weeks. Participants are asked to provide an email address and/or cell phone number so reminders can be sent to complete the sessions. If participants are late completing a session, they will receive a call from clinic staff as a reminder. The "standard care" group will receive advice to quit, a quit-smoking brochure, and an offer of three months of nicotine replacement therapy (nicotine patches). |
| BEHAVIORAL | Standard of Care | advice to quit, a quit-smoking brochure, and an offer of three months of nicotine replacement therapy (nicotine patches). |
Timeline
- Start date
- 2011-09-01
- Primary completion
- 2013-07-01
- Completion
- 2013-09-01
- First posted
- 2012-04-04
- Last updated
- 2014-05-12
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01570595. Inclusion in this directory is not an endorsement.