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

July 9, 2025 updated by: Irene Tami-Maury, The University of Texas Health Science Center, Houston
The purpose of this study is to pretest the design of a text-based smoking cessation program tailored to sexual minority individuals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Smoke five or more cigarettes per day, has smoked at least 100 cigarettes in their lifetime and smokes everyday
  • Have an interest in quitting smoking in the next 15 days
  • Have a cellphone number with an unlimited short messaging service (SMS) plan
  • Have US mailing and email addresses
  • Positive cotinine saliva test results

Exclusion Criteria:

  • Individuals who are found to have a prepaid cell phone
  • Individuals who are found to have a cellphone number that does not work or is registered to someone else
  • Pregnant or breastfeeding women
  • Contraindication for nicotine patch
  • Regular use of tobacco products other than cigarettes
  • Current use of tobacco cessation medications
  • Enrolled in another smoking cessation study
  • Non-English speakers
  • Having inadequate equipment/device (webcam, speakers, mic) for participating in telehealth sessions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Beta testing group
Participants will have access to a text-based smoking cessation program tailored to sexual minority individuals (SmokefreeSGM). The text-based program will be beta-tested by these participants for a period of 2 weeks before and 10 weeks after their quit date. Messages originated from the text-based smoking cessation program will be sent by a fictitious quit coach who will offer evidence-based advice on quitting smoking based on real-life experiences of sexual minority individuals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived Usability as Assessed by the System Usability Scale (SUS)
Time Frame: 1 month after quit date
The 10-item System Usability Scale (SUS) was used to assess the usability of the SmokefreeSGM text messaging program. Total score ranges from 0 to 100, with a higher score indicating greater acceptability and a score above 75 indicating that the program is perceived as acceptable.
1 month after quit date

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Engagement as Assessed by the Number of Text Messages Sent and Received by Study Participants After Enrollment.
Time Frame: 1 month after enrollment
A participant's engagement rate was determined by dividing the total number of participant responses to the bidirectional text messages (numerator) by the total number of bidirectional text messages sent by the text-based platform (denominator). Participants who had rates ≤33.3% were classified as having low engagement, 33.3-66.6% moderate engagement, and ≥66.7% high engagement. Data are reported categorically as number of participants who have low, moderate, or high engagement.
1 month after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Irene Tami-Maury, DMD, MSc, DrPH, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2022

Primary Completion (Actual)

October 5, 2022

Study Completion (Actual)

October 5, 2022

Study Registration Dates

First Submitted

August 24, 2021

First Submitted That Met QC Criteria

August 27, 2021

First Posted (Actual)

August 31, 2021

Study Record Updates

Last Update Posted (Actual)

July 20, 2025

Last Update Submitted That Met QC Criteria

July 9, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HSC-SPH-20-0318 (aim 2)
  • 1K22CA237639 (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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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