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

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

Study Overview

• Status: Recruiting
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: SmokefreeSGM; Behavioral: SmokefreeTXT

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Irene Tami-Maury, DMD,MSc,DrPH-NHSN; Phone Number: 713-500-9234; Email: Irene.M.Tami-Maury@uth.tmc.edu
• Study Contact Backup: Name: Rebecca Klaff; Phone Number: 713-500-9000; Email: Rebecca.L.Klaff@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Irene Tami-Maury, DMD,MSc,DrPH-NHSN; Phone Number: 713-500-9234; Email: Irene.M.Tami-Maury@uth.tmc.edu
      • Contact: Rebecca Klaff; Phone Number: 713-500-9000; Email: Rebecca.L.Klaff@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Irene Tami-Maury, DMD,MSc,DrPH-NHSN, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2022
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: December 1, 2022
• First Submitted That Met QC Criteria: December 1, 2022
• First Posted (Actual): December 9, 2022

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: lesbian, gay, bisexual, transgender, queer (LGBTQ)
• Other Study ID Numbers: HSC-SPH-22-0717; K22CA237639 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No