Positively Smoke Free on the Web (PSFW) for Smokers Living With HIV (PSFW)
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| ClinicalTrials.gov Identifier: NCT01570595 |
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Recruitment Status
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Completed
First Posted
: April 4, 2012
Last Update Posted
: May 12, 2014
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Sponsor:
Georgetown University
Collaborators:
Albert Einstein College of Medicine, Inc.
University of Michigan
Information provided by (Responsible Party):
Georgetown University
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Tobacco Use Cessation Tobacco Cessation Tobacco Use Disorder Tobacco Dependence Tobacco-Use Disorder Virus, Human Immunodeficiency | Behavioral: Web-Based Tailored Smoking Cessation Intervention Behavioral: Standard of Care | Phase 1 Phase 2 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 138 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Pilot Study of Positively Smoke Free on the Web (PSFW) for HIV-infected Smokers |
| Study Start Date : | September 2011 |
| Actual Primary Completion Date : | July 2013 |
| Actual Study Completion Date : | September 2013 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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.
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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).
Other Names:
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Active Comparator: 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).
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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).
Other Names:
Behavioral: Standard of Care
advice to quit, a quit-smoking brochure, and an offer of three months of nicotine replacement therapy (nicotine patches).
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Primary Outcome Measures
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- 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 Outcome Measures
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- Degree of Participation in Intervention (Feasibility) [ Time Frame: 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 [ Time Frame: 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).
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01570595
Locations
| United States, New York | |
| Albert Einstein College of Medicine of Yeshiva University | |
| Bronx, New York, United States, 10461 | |
Sponsors and Collaborators
Georgetown University
Albert Einstein College of Medicine, Inc.
University of Michigan
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Georgetown University |
| ClinicalTrials.gov Identifier: | NCT01570595 History of Changes |
| Other Study ID Numbers: |
3358936 R21CA163100 [NIH Grant #] R21CA163100 ( U.S. NIH Grant/Contract ) |
| First Posted: | April 4, 2012 Key Record Dates |
| Last Update Posted: | May 12, 2014 |
| Last Verified: | May 2014 |
Keywords provided by Georgetown University:
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Tobacco Use Cessation Tobacco Cessation Tobacco Use Disorder |
Tobacco Dependence Tobacco-Use Disorder Virus, Human Immunodeficiency |
Additional relevant MeSH terms:
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Disease Immunologic Deficiency Syndromes Tobacco Use Disorder Acquired Immunodeficiency Syndrome HIV Infections Pathologic Processes Immune System Diseases Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Nicotine Ganglionic Stimulants Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |