SmokefreeSGM, A Text-based Smoking Cessation Feasibility Trial for Sexual and Gender Minority Groups

Study Overview
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Brief Summary
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The purpose of this study is to test the feasibility and acceptability of Smokefree Sexual and Gender Minority (SGM), an SGM-tailored version of the SmokefreeTXT text messaging program

Official Title
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SmokefreeSGM, A Text-based Smoking Cessation Feasibility Trial for Sexual and Gender Minority Groups

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: SmokefreeSGM
* Behavioral: SmokefreeTXT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Self-identify as an LGBTQ+ individual Currently live in Texas Have smoked at least 100 cigarettes in their lifetime, smoke every day, and smoke greater than or equal to 5 cigarettes a day Are willing to quit smoking in the next 15 days Have a cell phone number with an unlimited short message service (SMS) plan Have a positive cotinine saliva test to indicate their smoking status Exclusion Criteria: Have a prepaid cell phone plan (pay-as-you-go plan) Have a cell phone number that does not work and/or is registered to someone else Have inadequate equipment/devices (i.e., webcam, speakers, mic) for participating in telehealth sessions via Microsoft Teams, Webex, or Zoom AND cannot meet in-person Pregnant or breastfeeding persons (nicotine patches are not generally recommended to this groups since nicotine can affect fetal and neonatal brain development) Contraindication for nicotine patches. Absolute contraindications include: severe eczema or serious skin conditions, allergy to nicotine patches, pregnancy, breastfeeding, heart attack in the past 2 months, ongoing angina, peptic ulcer disease, arrhythmia, or uncontrolled blood pressure. Potential contraindications include: stroke in the past 6 months, insulin therapy, and a current diagnosis of liver, kidney, or heart disease. Study participants reporting a potential contraindication will require approval from their primary care provider and/or other treating physician (e.g., psychiatrist) to use nicotine patches. If the request is denied or not returned in 2 weeks, potential study participants will be excluded from the study. Current use of tobacco cessation medications Enrollment in another smoking cessation study Non-English speakers

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SmokefreeSGM<br> | Behavioral: SmokefreeSGM<br>* Participants will be enrolled in a text-based smoking cessation program specifically designed to respond to the needs of LGBTQ+ smokers.<br>|
| Active Comparator: SmokefreeTXT<br> | Behavioral: SmokefreeTXT<br>* Participants will be enrolled in a text-based smoking cessation program specifically designed to respond to the needs of the general population<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility as assessed by number of participants recruited for the study |  | Baseline | 
| Feasibility as assessed by number of participants that completed month 1 visit |  | end of month 1 | 
| Feasibility as assessed by number of participants that completed month 3 visit |  | end of month 3 | 
| Feasibility as assessed by number of participants that completed month 6 visit |  | end of month 6 | 
| Feasibility as assessed by number of participants that quit smoking |  | 3 month follow up | 
| Feasibility as assessed by number of participants that quit smoking |  | 6 month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability as assessed by qualitative interviews |  | 6 months follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lesbian, gay, bisexual, transgender, queer (LGBTQ)