- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01570595
Positively Smoke Free on the Web (PSFW) for Smokers Living With HIV (PSFW)
May 9, 2014 updated by: Georgetown University
A Pilot Study of Positively Smoke Free on the Web (PSFW) for HIV-infected Smokers
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
138
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Bronx, New York, United States, 10461
- Albert Einstein College of Medicine of Yeshiva University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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:
|
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).
|
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:
advice to quit, a quit-smoking brochure, and an offer of three months of nicotine replacement therapy (nicotine patches).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 Months (duration of intervention)
|
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).
|
Day 0, 42, 121
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Actual)
July 1, 2013
Study Completion (Actual)
September 1, 2013
Study Registration Dates
First Submitted
March 14, 2012
First Submitted That Met QC Criteria
April 2, 2012
First Posted (Estimate)
April 4, 2012
Study Record Updates
Last Update Posted (Estimate)
May 12, 2014
Last Update Submitted That Met QC Criteria
May 9, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Pathologic Processes
- Substance-Related Disorders
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Disease
- Tobacco Use Disorder
- Acquired Immunodeficiency Syndrome
- Immunologic Deficiency Syndromes
Other Study ID Numbers
- 3358936
- R21CA163100 [NIH Grant #]
- R21CA163100 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Tobacco Cessation
-
University of MiamiFlorida Department of HealthRecruitingSmoking Cessation | Tobacco Smoking | Tobacco Use CessationUnited States
-
Claremont Graduate UniversityNational Cancer Institute (NCI)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, CigaretteUnited States
-
Mayo ClinicNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, Tobacco | Smoking, CigaretteUnited States
-
University of OklahomaCompletedTobacco Cessation | Tobacco Use | Tobacco Smoking | Smoking Cessation Financial Incentives | Socioeconomic Status | Contingency ManagementUnited States
-
University of OklahomaEnrolling by invitationTobacco Cessation | Tobacco Use | Tobacco Smoking | Smoking Cessation Financial Incentives | Socioeconomic Status | Contingency Management | PregnancyUnited States
-
University of MinnesotaCompletedSmoking Cessation | Tobacco CessationUnited States
-
Uppsala UniversityKarolinska Institutet; The Swedish Research Council; Region Stockholm; Swedish... and other collaboratorsTerminatedSmoking Cessation | Tobacco CessationSweden
-
The University of Hong KongQueen Elizabeth Hospital, Hong Kong; Food and Health Bureau, Hong Kong; Queen... and other collaboratorsCompletedSmoking Cessation | Tobacco Use CessationHong Kong
-
Centre for Addiction and Mental HealthCompletedSmoking Cessation | Tobacco Use CessationCanada
-
SanofiCompletedSmoking Cessation | Tobacco Use CessationUnited States, Canada
Clinical Trials on Web-Based Tailored Smoking Cessation Intervention
-
University of RochesterNational Cancer Institute (NCI); National Library of Medicine (NLM)Completed
-
Brown UniversityTruth InitiativeCompletedAlcohol Drinking | Smoking CessationUnited States
-
Duke UniversityNational Heart, Lung, and Blood Institute (NHLBI)CompletedObesity | Physical Activity | Sleep | Communication | NutritionUnited States
-
Robert Wood Johnson FoundationKaiser PermanenteCompleted
-
University of VermontNational Institute of General Medical Sciences (NIGMS)CompletedNicotine Dependence, CigarettesUnited States
-
National Cancer Institute (NCI)CompletedUnspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Changhai HospitalNot yet recruitingPancreatitis, ChronicChina
-
University of UtahPatient-Centered Outcomes Research InstituteActive, not recruitingTobacco Use | Tobacco Smoking | Current SmokerUnited States
-
Glostrup University Hospital, CopenhagenUniversity of Aarhus; Rygestopkonsulenterne, HillerødCompleted
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedCurrent Every Day Smoker | Cigarette SmokerUnited States