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

This study has been completed.
Sponsor:
Collaborators:
Albert Einstein College of Medicine of Yeshiva University
University of Michigan
Information provided by (Responsible Party):
Georgetown University
ClinicalTrials.gov Identifier:
NCT01570595
First received: March 14, 2012
Last updated: May 9, 2014
Last verified: May 2014
  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:


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).


Enrollment: 138
Study Start Date: September 2011
Study Completion Date: September 2013
Primary Completion Date: July 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).

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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: May 9, 2014
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
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014