Positively Smoke Free on the Web (PSFW) for Smokers Living With HIV - Full Text View

Purpose

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	Intervention	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Pilot Study of Positively Smoke Free on the Web (PSFW) for HIV-infected Smokers

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS Smoking

U.S. FDA Resources

Further study details as provided by Georgetown University:

Primary Outcome Measures:

24-hour Point-prevalence tobacco abstinence [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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:

Degree of Participation in Intervention (Feasibility) [ Time Frame: 3 Months (duration of intervention) ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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).

Estimated Enrollment:	138
Study Start Date:	September 2011
Estimated Study Completion Date:	September 2013
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	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: Tailored Cessation Web-Based Intervention Web-Based Cessation
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).	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: Tailored Cessation Web-Based Intervention Web-Based Cessation Behavioral: Standard of Care advice to quit, a quit-smoking brochure, and an offer of three months of nicotine replacement therapy (nicotine patches).

Arms

Assigned Interventions

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.

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:

Tailored Cessation
Web-Based Intervention
Web-Based Cessation

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).

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:

Tailored Cessation
Web-Based Intervention
Web-Based Cessation

Behavioral: Standard of Care

advice to quit, a quit-smoking brochure, and an offer of three months of nicotine replacement therapy (nicotine patches).

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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 of Yeshiva University

University of Michigan

More Information

Additional Information:

Positively Smoke Free Website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Georgetown University
ClinicalTrials.gov Identifier:	NCT01570595 History of Changes
Other Study ID Numbers:	3358936, R21CA163100 [NIH Grant #]
Study First Received:	March 14, 2012
Last Updated:	March 28, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Georgetown University:

Tobacco Use Cessation
Tobacco Cessation
Tobacco Use Disorder

Tobacco Dependence
Tobacco-Use Disorder
Virus, Human Immunodeficiency

Additional relevant MeSH terms:

Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Tobacco Use Disorder
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections

Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 21, 2013