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Tobacco Use CessationPhase 1/2PSFWNCT01570595

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

A Phase 1/2 study testing Web-Based Tailored Smoking Cessation Intervention in people with Tobacco Use Cessation and Tobacco Cessation, run by Georgetown University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Web-Based Tailored Smoking Cessation Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
138 participants
Where
1 siteUnited States
Study dates
Sep 2011to Sep 2013
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Albert Einstein College of Medicine of Yeshiva University

    The Bronx, New York, 10461

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Web-Based Tailored Smoking Cessation Intervention, Standard of Care
Keywords
Tobacco Use Cessation, Tobacco Cessation, Tobacco Use Disorder, Tobacco Dependence, Tobacco-Use Disorder, Virus, Human Immunodeficiency
Medical subject headings
Tobacco Use Cessation, Tobacco Use Disorder, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Web-Based Tailored Smoking Cessation InterventionBehavioural

    Also called Tailored Cessation, Web-Based Intervention, Web-Based Cessation

    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 CareBehavioural

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

Study groups in NCT01570595
Study groupRoleWhat they receive
Web-Based InterventionExperimentalThis 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.
Receives: Behavioral: Web-Based Tailored Smoking Cessation Intervention
Standard CareActive 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).
Receives: Behavioral: Web-Based Tailored Smoking Cessation Intervention; Behavioral: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 months

Secondary outcomes (2)

  1. 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.

    Measured: 3 Months (duration of intervention)

  2. 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).

    Measured: Day 0, 42, 121

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2012 (estimated)
  2. Study startSep 2011
  3. Primary completionJul 2013
  4. Study completionSep 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
138 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01570595
Sponsor's protocol ID
3358936
Other IDs
R21CA163100
Acronym
PSFW
Status last verified
May 2014
First submitted
14 Mar 2012
Last updated
12 May 2014
Results posted
No

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.

    PubMed 27215559

  • 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.

    PubMed 25118794

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Web-Based Tailored Smoking Cessation Intervention in people with Tobacco Use Cessation and Tobacco Cessation, run by Georgetown University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

24-hour Point-prevalence tobacco abstinence (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01570595, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2014.

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