Positively Smoke Free on the Web (PSFW) for Smokers Living With HIV
PSFW
A Pilot Study of Positively Smoke Free on the Web (PSFW) for HIV-infected Smokers
2 other identifiers
interventional
138
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2011
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 14, 2012
CompletedFirst Posted
Study publicly available on registry
April 4, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedMay 12, 2014
May 1, 2014
1.8 years
March 14, 2012
May 9, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Degree of Participation in Intervention (Feasibility)
3 Months (duration of intervention)
Knowledge and Behavior Change
Day 0, 42, 121
Study Arms (2)
Web-Based Intervention
EXPERIMENTALThis 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.
Standard Care
ACTIVE COMPARATORThis 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).
Interventions
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).
advice to quit, a quit-smoking brochure, and an offer of three months of nicotine replacement therapy (nicotine patches).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Georgetown Universitylead
- Albert Einstein College of Medicinecollaborator
- University of Michigancollaborator
Study Sites (1)
Albert Einstein College of Medicine of Yeshiva University
The Bronx, New York, 10461, United States
Related Publications (2)
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.
PMID: 27215559DERIVEDShuter 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.
PMID: 25118794DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2012
First Posted
April 4, 2012
Study Start
September 1, 2011
Primary Completion
July 1, 2013
Study Completion
September 1, 2013
Last Updated
May 12, 2014
Record last verified: 2014-05