Smoking CessationNCT05029362
SmokefreeSGM, A Text-based Smoking Cessation Intervention for Sexual and Gender Minority Groups
A study testing SmokefreeSGM in people with Smoking Cessation, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to pretest the design of a text-based smoking cessation program tailored to sexual minority individuals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- SmokefreeSGM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2022to 5 Oct 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Enrolled in another smoking cessation study
- Non-English speakers
- Having inadequate equipment/device (webcam, speakers, mic) for participating in telehealth sessions
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
The purpose of this study is to pretest the design of a text-based smoking cessation program tailored to sexual minority individuals.
- Conditions
- Smoking Cessation
- Being tested
- SmokefreeSGM
- Keywords
- LGBTQI
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmokefreeSGMBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Beta testing group | Other | Not described Receives: Behavioral: SmokefreeSGM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Usability as Assessed by the System Usability Scale (SUS)
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.
Measured: 1 month after quit date
Secondary outcomes (1)
Engagement as Assessed by the Number of Text Messages Sent and Received by Study Participants 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.
Measured: 1 month after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start5 Jan 2022
- Primary completion5 Oct 2022
- Study completion5 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Irene Tami-Maury, The University of Texas Health Science Center, Houston
- Investigators
- Irene Tami-Maury, DMD, MSc, DrPH, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05029362
- Sponsor's protocol ID
- HSC-SPH-20-0318 (aim 2)
- Other IDs
- 1K22CA237639
- Status last verified
- Jul 2025
- First submitted
- 24 Aug 2021
- Last updated
- 20 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tami-Maury I, Klaff R, Hussin A, Smith NG, Chang S, McNeill L, Reitzel LR, Shete S, Abroms LC. A Text-Based Smoking Cessation Intervention for Sexual and Gender Minority Groups: Protocol for a Feasibility Trial. JMIR Res Protoc. 2022 Dec 9;11(12):e42553. doi: 10.2196/42553.
PubMed 36485022
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SmokefreeSGM, A Text-based Smoking Cessation Intervention for Sexual and Gender Minority Groups
- ClinicalTrials.gov ID
- NCT05029362
- Acronym / sponsor ID
- HSC-SPH-20-0318 (aim 2)
- Conditions
- Smoking Cessation
- Keywords
- LGBTQI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 5 Oct 2022 (actual)
- Study completion
- 5 Oct 2022 (actual)
- First posted
- 31 Aug 2021 (actual)
- Results
- Posted 1 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to pretest the design of a text-based smoking cessation program tailored to sexual minority individuals.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Beta testing group | Other | Behavioral: SmokefreeSGM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SmokefreeSGMParticipants 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. | Behavioural | Beta testing group |
Primary outcome
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 secondary outcome
Engagement as Assessed by the Number of Text Messages Sent and Received by Study Participants After Enrollment.
Time frame: 1 month after enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36485022Tami-Maury I, Klaff R, Hussin A, Smith NG, Chang S, McNeill L, Reitzel LR, Shete S, Abroms LC. A Text-Based Smoking Cessation Intervention for Sexual and Gender Minority Groups: Protocol for a Feasibility Trial. JMIR Res Protoc. 2022 Dec 9;11(12):e42553. doi: 10.2196/42553.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irene Tami-Maury, DMD, MSc, DrPH principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SmokefreeSGM in people with Smoking Cessation, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Usability as Assessed by the System Usability Scale (SUS) (time frame: 1 month after quit date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05029362, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.