Tobacco Cessation for Sexual Minorities

There is a growing body of evidence revealing disproportionately higher rates of tobacco use among sexual and gender minority (SGM) individuals, compared to their heterosexual peers. These disparities have led organizations to support the inclusion of SGM in all local, state, and national tobacco prevention and control activities. In an attempt to leverage the online milieu for health-related interventions, mobile apps have been created to support tobacco cessation. However, evidence-based apps promoted by the National Cancer Institute are unpopular, remain poorly supported, and were not studied for use by SGM persons. Commercial apps, on the other hand, have been downloaded millions of times, contain many valuable features, and enjoy better infrastructure. Unfortunately, they are not evidence-based and have not been rigorously tested.

The University of Pittsburgh (Pitt) is currently conducting a randomized controlled trial to assess the feasibility and efficacy of using the Kwit tobacco cessation app with patients at UPMC Montefiore and Presbyterian hospitals (PI: Chu). It is a pragmatic clinical trial applying a patient-centered outcomes framework to ensure that-rather than focusing only on successful cessation-the study includes measurements for quality of life, mobility, and social interactions. We propose to extend the study to underrepresented SGM young adults.

Survey measures will be adapted as needed to address issues specific to the SGM population.

Study Overview

• Status: Terminated
• Conditions: Smoking Cessation
• Intervention / Treatment: Other: Kwit smartphone app

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18-30
• Self-identified as a sexual minority (gay, lesbian, bisexual)
• Smokers interested in cessation (>1 cigarettes/day over the past 30 days)
• Must own an Apple or Android based smartphone.

Exclusion Criteria:

• Already receiving pharmacological and/or behavioral intervention or counseling for smoking cessation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Kwit smartphone app; This arm will receive the Kwit smartphone app.

Other: Kwit smartphone app; The Kwit smartphone app combines several popular features of tobacco cessation apps, including game-like features (e.g., unlocking achievement milestones for completing cessation-related tasks), useful statistics (e.g., money saved), and an ability to share progress with friends. Users can actively engage with the app to track cravings or view progress, such as life expectancy gained. A passive component notifies users when milestones have been achieved, e.g., when blood no longer contains nicotine. Motivational messages can be actively requested at any time; they can also appear unsolicited, as when the user logs cravings.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Helpfulness, frequency of use, and ease of use of the intervention smartphone app	Assessment of feasibility: Two follow-up surveys will be administered: the first, 1-month after recruitment,and the second, 3 months after recruitment. Surveys will be administered in-person. Specific questions will be asked to rate the Kwit smartphone application's feasibility, based on a combination of helpfulness, frequency of use, and ease of use. Frustrations and helpful aspects of the application will be assesses qualitatively.; How helpful was the Kwit app?; Was the app easy to use?; Was it frustrating to use?Responses for 1-3 will be limited to Very helpful, Somewhat helpful, Neutral, Not very helpful, Not at all helpful; What, if anything, was helpful about the app? What, if anything, was not helpful about the app? Each of these responses (Q1-3) will be combined to report a single overall feasibility value. Qualitative data (Q4) will be used to modify scores as needed.	1-month and 3-month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cessation (self-report)	Descriptive statistics will be used to assess cessation outcomes. The information will be obtained via two follow-up surveys (1 month and 3 months after recruitment), with specific questions pertaining to the level of participant smoking as well as their confidence levels on maintaining cessation.; Since you joined the study, have you smoked a cigarette (even a puff)?; How soon after you joined the study did you smoke your first cigarette, even a puff?; In the past 30 days, on how many days did you smoke (even a puff)?; (On the days you smoked) how many cigarettes on average did you smoke (even a puff)?; In the past 7 days, have you smoked a cigarette, even a puff?; How confident are you that you will be able to stay quit? The overall assessment of cessation will be primarily based on the 7-day item.	1-month and 3-month
Cessation (bio-chemical)	Cessation will also be verified by a breath analysis monitor. The information will be obtained during each follow-up. Biochemical verification will be based on a 10 COppm cutoff to determine whether or not the participant has successfully quit tobacco.	1-month and 3-month

Collaborators and Investigators

• Sponsor: University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2018
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: August 21, 2018
• First Submitted That Met QC Criteria: August 21, 2018
• First Posted (Actual): August 23, 2018

Study Record Updates

• Last Update Posted (Actual): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 3, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: PRO18050656

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No