SmokefreeSGM Español Pilot, Beta Testing a Text-based Smoking Cessation Intervention for Sexual and Gender Minority(SGM) Groups Preferring Spanish Language

NCT06487806 | Suspended

• 1 other identifier: HSC-SPH-23-1004
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the usability, engagement and acceptability of SmokefreeSGM Español, a culturally and linguistically tailored version of SmokefreeSGM, among Spanish-speaking SGM smokers.

Conditions

Smoking Cessation

Keywords

lesbian, gay, bisexual, transgender, queer/questioning (one's sexual or gender identity), and intersex(LGBTQI)

Outcome Measures

Primary Outcomes (3)

• Perceived Usability as Assessed by the System Usability Scale (SUS)

  This is a 10-item questionnaire. Total score ranges from 0 to 100, with a higher score indicating greater usability and a score above 75 indicating better outcome

  end of intervention (1month after quit date)

• Engagement with the text-messaging program as assessed by number of text messages a participant sends, including replies to the bidirectional texts messages of SmokefreeSGM Español program

  end of intervention (1month after quit date)

• Acceptability at 1 month as Assessed by the System Usability Scale (SUS)

  This is a 10-item questionnaire. Total score ranges from 0 to 100, with a higher score indicating greater acceptability

  end of intervention (1month after quit date)

Study Arms (1)

Beta testing group

EXPERIMENTAL

Behavioral: SmokefreeSGM

Interventions

SmokefreeSGM BEHAVIORAL

Participants will be asked to set a quit date within the next 15 days before being enrolled in the SmokefreeSGM Español text messaging program. They will be mailed a 6-week supply of nicotine patches. The participants will get daily text messages for 6 weeks that will encourage them to quit smoking.

Beta testing group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Self-identify as an LGBTQ+ individual
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Currently live in the United States
• Have smoked at least 100 cigarettes in their lifetime, smoke every day, and smoke ≥ 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
• Speak fluent Spanish

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
• Current use of tobacco products other than cigarettes or electronic nicotine delivery systems (ENDS) (i.e., (e.g., cigar, cigarillo, little cigar, pipe, Hookah)
• Enrollment in another smoking cessation study

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Homosexuality, Female; Homosexuality; Bisexuality

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Sexuality; Sexual Behavior

Study Officials

• Irene Tami-Maury, DMD, MSc, DrPH

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 5, 2024
• Study Start: August 13, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)