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

Primary Purpose

Tobacco Use Cessation, Tobacco Cessation, Tobacco Use Disorder

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Web-Based Tailored Smoking Cessation Intervention
Standard of Care
Sponsored by
Georgetown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Use Cessation focused on measuring Tobacco Use Cessation, Tobacco Cessation, Tobacco Use Disorder, Tobacco Dependence, Tobacco-Use Disorder, Virus, Human Immunodeficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Albert Einstein College of Medicine of Yeshiva University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Web-Based Intervention

Standard Care

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).

Full Information

First Posted
March 14, 2012
Last Updated
May 9, 2014
Sponsor
Georgetown University
Collaborators
Albert Einstein College of Medicine, University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT01570595
Brief Title
Positively Smoke Free on the Web (PSFW) for Smokers Living With HIV
Acronym
PSFW
Official Title
A Pilot Study of Positively Smoke Free on the Web (PSFW) for HIV-infected Smokers
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Georgetown University
Collaborators
Albert Einstein College of Medicine, University of Michigan

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Web-Based Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Care
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Web-Based Tailored Smoking Cessation Intervention
Other Intervention Name(s)
Tailored Cessation, Web-Based Intervention, Web-Based Cessation
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Standard of Care
Intervention Description
advice to quit, a quit-smoking brochure, and an offer of three months of nicotine replacement therapy (nicotine patches).
Primary Outcome Measure Information:
Title
24-hour Point-prevalence tobacco abstinence
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Degree of Participation in Intervention (Feasibility)
Description
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.
Time Frame
3 Months (duration of intervention)
Title
Knowledge and Behavior Change
Description
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).
Time Frame
Day 0, 42, 121

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Albert Einstein College of Medicine of Yeshiva University
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27215559
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.
Results Reference
derived
PubMed Identifier
25118794
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.
Results Reference
derived
Links:
URL
http://www.positivelysmokefree.org
Description
Positively Smoke Free Website

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

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