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

Tobacco Use Disorder Clinical Trial

— PSFW  

Official title:

A Pilot Study of Positively Smoke Free on the Web (PSFW) for HIV-infected Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01570595
• Other study ID #: 3358936
• Secondary ID: R21CA163100 [NIH
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 14, 2012
• Last updated: May 9, 2014
• Start date: September 2011
• Est. completion date: September 2013

Study information

• Verified date: May 2014
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: September 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Disease
• HIV Infections
• Immunologic Deficiency Syndromes
• Tobacco Cessation
• Tobacco Dependence
• Tobacco Use Cessation
• Tobacco Use Disorder
• Tobacco-Use Disorder
• Virus, Human Immunodeficiency

Intervention

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

Locations

Country	Name	City	State
United States	Albert Einstein College of Medicine of Yeshiva University	Bronx	New York

Sponsors (3)

Lead Sponsor	Collaborator
Georgetown University	Albert Einstein College of Medicine of Yeshiva University, University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-hour Point-prevalence tobacco abstinence	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.	3 months	No
Secondary	Degree of Participation in Intervention (Feasibility)	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.	3 Months (duration of intervention)	No
Secondary	Knowledge and Behavior Change	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).	Day 0, 42, 121	No