- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05029362
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
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.
Collaborators
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.
Clinical Trials on Smoking Cessation
-
University of Southern CaliforniaAmerican Cancer Society, Inc.CompletedSmoking | Smoking Cessation | Smoking, Cigarette | Smoking Behaviors | Cessation, SmokingUnited States
-
National University of SingaporeRecruitingSmoking &Amp; Tobacco CessationSingapore
-
Nabi BiopharmaceuticalsNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco CessationUnited States
-
Claremont Graduate UniversityNational Cancer Institute (NCI)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, CigaretteUnited States
-
Emory UniversityNational Cancer Institute (NCI); National Institutes of Health (NIH)Completed
-
Heidelberg UniversityPfizerTerminatedSmoking | Smoking Cessation | Tobacco Use CessationGermany
-
Mayo ClinicNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, Tobacco | Smoking, CigaretteUnited States
-
Sultan Qaboos UniversityCompletedSmoking Cessation | Tobacco Use Cessation | Smoking PreventionOman
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedSmoking &Amp; Tobacco CessationUnited States
-
The University of Hong KongCompletedSmoking Cessation Counseling Ability | Smoking Cessation Counseling PracticeHong Kong
Clinical Trials on SmokefreeSGM
-
The University of Texas Health Science Center,...National Cancer Institute (NCI)CompletedSmokefreeSGM, A Text-based Smoking Cessation Feasibility Trial for Sexual and Gender Minority GroupsSmoking CessationUnited States
-
The University of Texas Health Science Center,...Suspended