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

NCT05645354 | Completed Results

• 2 other identifiers: HSC-SPH-22-0717K22CA237639
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Smoking Cessation

Keywords

lesbian, gay, bisexual, transgender, queer (LGBTQ)

Outcome Measures

Primary Outcomes (5)

• 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

• Acceptability as Assessed by Number of Participants Who Completed Qualitative Interviews

  6 months follow up

Secondary Outcomes (3)

• Number of Participants That Quit Smoking

  1 month follow up

• Number of Participants That Quit Smoking

  3 month follow up

• Number of Participants That Quit Smoking

  6 month follow up

Study Arms (2)

SmokefreeSGM

EXPERIMENTAL

Behavioral: SmokefreeSGM

SmokefreeTXT

ACTIVE COMPARATOR

Behavioral: SmokefreeTXT

Interventions

SmokefreeSGM BEHAVIORAL

Participants will be enrolled in a text-based smoking cessation program specifically designed to respond to the needs of LGBTQ+ smokers.

SmokefreeSGM

SmokefreeTXT BEHAVIORAL

Participants will be enrolled in a text-based smoking cessation program specifically designed to respond to the needs of the general population

SmokefreeTXT

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Self-identified as a lesbian, gay, bisexual, transgender or queer individual
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-identify as an LGBTQ+ individual
• Currently live in the United States
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Tundealao S, Oubda MC, Klaff R, Reininger B, McNeill L, Tami-Maury I. Pragmatic recruitment strategies for a text-based smoking cessation intervention for sexual and gender minority groups. Discov Public Health. 2025;22(1):743. doi: 10.1186/s12982-025-01117-0. Epub 2025 Nov 24.

  PMID: 41306822 DERIVED

MeSH Terms

Conditions

Smoking Cessation; Homosexuality, Female; Homosexuality; Bisexuality

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Sexuality; Sexual Behavior

Results Point of Contact

• Title: Irene Tami-Maury, DMD,MSc,DrPH-NHSN
• Organization: The University of Texas Health Science Center at Houston

Irene.M.Tami-Maury@uth.tmc.edu

713-500-9234

Study Officials

• Irene Tami-Maury, DMD, DrPH, MSc

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: December 9, 2022
• Study Start: November 10, 2022
• Primary Completion: July 9, 2024
• Study Completion: July 9, 2024
• Last Updated: August 17, 2025
• Results First Posted: August 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)