Clinical trial NCT05645354: SmokefreeSGM, A Text-based Smoking Cessation Feasibility Trial for Sexual and Gender Minority Groups
Official title: SmokefreeSGM, A Text-based Smoking Cessation Feasibility Trial for Sexual and Gender Minority Groups
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: lesbian, gay, bisexual, transgender, queer (LGBTQ)
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-12-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility as assessed by number of participants recruited for the study
timeFrame: Baseline
measure: Feasibility as assessed by number of participants that completed month 1 visit
timeFrame: end of month 1
measure: Feasibility as assessed by number of participants that completed month 3 visit
timeFrame: end of month 3
measure: Feasibility as assessed by number of participants that completed month 6 visit
timeFrame: end of month 6
measure: Feasibility as assessed by number of participants that quit smoking
timeFrame: 3 month follow up
measure: Feasibility as assessed by number of participants that quit smoking
timeFrame: 6 month follow up
Secondary outcomes:
measure: Acceptability as assessed by qualitative interviews
timeFrame: 6 months follow up
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Irene Tami-Maury, DMD,MSc,DrPH-NHSN
role: PRINCIPAL_INVESTIGATOR
References: