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The Positively Quit Trial for Smoking Cessation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04449458
Recruitment Status : Recruiting
First Posted : June 26, 2020
Last Update Posted : June 26, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of South Florida

Brief Summary:
The main goal of the present study is to determine if a smoking cessation program designed for people living with certain chronic conditions and delivered via videoconferencing groups works better than a control condition--a program that is not designed to help with smoking but that does have the same number of group contact hours as the other program (this program is called the Attention Matched Control condition; AMC) for helping people with certain health conditions stop smoking. People in both groups will receive brief advice to quit and an offer of nicotine replacement therapy patches (NRT), as well as 12 videoconferencing group sessions. We will measure smoking behavior over a one year period and compare smoking rates for the treatment condition against AMC to see if the treatment condition is better at getting people living with certain health conditions to quit smoking.

Condition or disease Intervention/treatment Phase
Cigarette Smoking Behavioral: Positively Me Behavioral: Positively Living Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 482 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Positively Quit Trial: Addressing Disproportionate Smoking Rates Among People Living With HIV
Actual Study Start Date : June 10, 2020
Estimated Primary Completion Date : July 31, 2024
Estimated Study Completion Date : July 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Positively Me
Positively Me is a 12-session (8 [1.5] hour main sessions plus four booster sessions) intervention guided by Social Cognitive Theory to promote smoking cessation in people with certain health conditions.
Behavioral: Positively Me
12 session smoking cessation intervention based on Social Cognitive Theory, designed for people with certain health conditions (8 primary sessions, followed by 4 booster sessions)

Sham Comparator: Positively Living
Positively Living is a modified updated version of a healthy living intervention based on Social Cognitive Theory that is designed for people with certain health conditions and attention-matched to the experimental condition (8 [1.5] hour main sessions plus four booster sessions).
Behavioral: Positively Living
12 session healthy living intervention based on Social Cognitive Theory, designed for people with certain health conditions (8 primary sessions, followed by 4 booster sessions)




Primary Outcome Measures :
  1. Biochemically confirmed 7-day point prevalence abstinence (BC7ppa) day 360 [ Time Frame: study day 360 ]
    Participant is asked if she has smoked a cigarette, even a puff, in the past 7 days. If she reports abstinence, she also completes a cotinine swab test over video-conferencing to determining cotinine levels. Levels less than 10ng/ml will be considered abstinence. BC7ppa will be coded as abstinence-indicating if she answers "no" to the question and cotinine levels suggest abstinence.

  2. Biochemically confirmed 30-day point prevalence abstinence (BC30ppa) day 360 [ Time Frame: study day 360 ]
    Participant is asked if she has smoked a cigarette, even a puff, in the past 30 days. If she reports abstinence, she also completes a cotinine swab test over video-conferencing to determining cotinine levels. Levels less than 10ng/ml will be considered abstinence. BC30ppa will be coded as abstinence-indicating if she answers "no" to the question and cotinine levels suggest abstinence.

  3. Biochemically confirmed sustained abstinence (BC.SA) day 360 [ Time Frame: Study day 360 ]
    At day 42 (2 weeks post-quit day; provides a grace period), participant is asked the BC7ppa question (see outcome 1). Then, at each full and brief assessment going forward, beginning at day 90, participant is asked if she has smoked a cigarette, even a puff, since the last assessment. If she reports abstinence, she also completes a cotinine swab test over video-conferencing to determining cotinine levels. Levels less than 10ng/ml will be considered abstinence. BC.SA will be coded as abstinence-indicating if she answers "no" to the sustained abstinence question at each assessment and cotinine levels at each assessment suggest abstinence.


Secondary Outcome Measures :
  1. Biochemically confirmed 7-day point prevalence abstinence (BC7ppa) day 42 [ Time Frame: study day 42 ]
    Participant is asked if she has smoked a cigarette, even a puff, in the past 7 days. If she reports abstinence, she also completes a cotinine swab test over video-conferencing to determining cotinine levels. Levels less than 10ng/ml will be considered abstinence. BC7ppa will be coded as abstinence-indicating if she answers "no" to the question and cotinine levels suggest abstinence.

  2. Biochemically confirmed 7-day point prevalence abstinence (BC7ppa) day 90 [ Time Frame: study day 90 ]
    Participant is asked if she has smoked a cigarette, even a puff, in the past 7 days. If she reports abstinence, she also completes a cotinine swab test over video-conferencing to determining cotinine levels. Levels less than 10ng/ml will be considered abstinence. BC7ppa will be coded as abstinence-indicating if she answers "no" to the question and cotinine levels suggest abstinence.

  3. Biochemically confirmed 7-day point prevalence abstinence (BC7ppa) day 180 [ Time Frame: study day 180 ]
    Participant is asked if she has smoked a cigarette, even a puff, in the past 7 days. If she reports abstinence, she also completes a cotinine swab test over video-conferencing to determining cotinine levels. Levels less than 10ng/ml will be considered abstinence. BC7ppa will be coded as abstinence-indicating if she answers "no" to the question and cotinine levels suggest abstinence.

  4. Biochemically confirmed 30-day point prevalence abstinence (BC30ppa) days 90 [ Time Frame: study day 90 ]
    Participant is asked if she has smoked a cigarette, even a puff, in the past 30 days. If she reports abstinence, she also completes a cotinine swab test over video-conferencing to determining cotinine levels. Levels less than 10ng/ml will be considered abstinence. BC30ppa will be coded as abstinence-indicating if she answers "no" to the question and cotinine levels suggest abstinence.

  5. Biochemically confirmed 30-day point prevalence abstinence (BC30ppa) day 180 [ Time Frame: study day 180 ]
    Participant is asked if she has smoked a cigarette, even a puff, in the past 30 days. If she reports abstinence, she also completes a cotinine swab test over video-conferencing to determining cotinine levels. Levels less than 10ng/ml will be considered abstinence. BC30ppa will be coded as abstinence-indicating if she answers "no" to the question and cotinine levels suggest abstinence.

  6. Biochemically confirmed sustained abstinence (BC.SA) day 180 [ Time Frame: day 180 ]
    At day 42 (2 weeks post-quit day; provides a grace period), the participant is asked the BC7ppa question (see outcome 1). Then, at each full and brief assessment going forward, beginning at day 90, participant is asked if she has smoked a cigarette, even a puff, since the last assessment. If she reports abstinence, she also completes a cotinine swab test over video-conferencing to determining cotinine levels. Levels less than 10ng/ml will be considered abstinence. BC.SA will be coded as abstinence-indicating if she answers "no" to the sustained abstinence question at each assessment and cotinine levels at each assessment suggest abstinence.

  7. Self-Efficacy for Abstinence day 42 as measured by The Smoking: Self-Efficacy / Temptation Short Form (Velicor et al, 1990) [ Time Frame: study day 42 ]
    9-item measure of likelihood of temptation to smoke in certain situations, rated on a five-point scale (1=not at all tempted to smoke in these situations; 5=extremely tempted to smoke in these situations.) All 9 items are averaged, so a final score closer to 1= less temptation and greater self-efficacy; a final score score to 5= greater temptation and less self-efficacy.

  8. Self-Efficacy for Abstinence day 90 as measured by The Smoking: Self-Efficacy / Temptation Short Form (Velicor et al, 1990), mean overall score [ Time Frame: study day 90 ]
    9-item measure of likelihood of temptation to smoke in certain situations, rated on a five-point scale (1=not at all tempted to smoke in these situations; 5=extremely tempted to smoke in these situations.) All 9 items are averaged, so a final score closer to 1= less temptation and greater self-efficacy; a final score score to 5= greater temptation and less self-efficacy.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • greater than or equal to age 18 (as NRT is not FDA approved for adolescents)
  • self-report smoking cigarettes
  • positive cotinine test
  • motivated to quit
  • own a smart phone, laptop, desktop, or tablet computer
  • able to join group from a private space with Internet access
  • demonstrate the ability to connect to the HIPAA-compliant videoconferencing system, Zoom, over the internet h) speak English i) can provide Florida residency (state-issued identification or mail with person's name and Florida address) j) living with certain health conditions

Exclusion Criteria:

  • pregnant, breastfeeding, or have other contraindications to NRT
  • receiving other tobacco treatment, or
  • inability to communicate coherently in English during the video-conferencing test or other pre-enrollment interactions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04449458


Contacts
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Contact: Brittani Powell, MPH 813-586-4144 brittanip@usf.edu
Contact: Lockhart Elizabeth, PhD 813-586-4144 elockhar@usf.edu

Locations
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United States, Florida
University of South Florida, College of Public Health Recruiting
Tampa, Florida, United States, 33612
Contact: Brittani Powell, MPH    813-586-4144    brittanip@usf.edu   
Contact: Stephanie L Marhefka, PhD       smarhefk@usf.edu   
Principal Investigator: STEPHANIE L Marhefka, PhD         
Sponsors and Collaborators
University of South Florida
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Stephanie L Marhefka, PhD University of South Florida College of Public Health
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Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT04449458    
Other Study ID Numbers: Pro00040192
R01CA243800 ( U.S. NIH Grant/Contract )
First Posted: June 26, 2020    Key Record Dates
Last Update Posted: June 26, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

De-identified data obtained from the study will be shared in accordance with NIH policy and principals. Data sharing is contingent upon approval for data sharing from the institutional review board at the University of South Florida. Requests should be made to the PI. Requesters must provide evidence of training in protection of human subjects and demonstrate approval from their institutional review board, noting what procedures will take place to protect data. Requesters will also be asked to sign a confidentiality agreement noting personal measures to ensure privacy of data.

Quantitative data will be available as a de-identified excel file.

The intervention manuals for treatment and control interventions and resulting publications will be available after completion of the study (within 6 months of primary article publication).

To uphold the confidentiality of study participants, audio- and video-recordings from this study will not be shared.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Within 6 months of article publication, quantitative data will be available to those requesting it who meet access criteria
Access Criteria: Requests for data should be made to the PI. Requesters must provide evidence of training in the protection of human subjects in research, and demonstrate approval from their institutional review board for the analyses, noting what procedures will take place to protect the data. Requesters will also be asked to sign a confidentiality agreement noting personal measures to ensure privacy of data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No