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

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

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.

Study Overview

• Status: Suspended
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: SmokefreeSGM

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

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
• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Beta testing group	Behavioral: SmokefreeSGM; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: June 27, 2024
• First Submitted That Met QC Criteria: June 27, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Actual): July 11, 2025
• Last Update Submitted That Met QC Criteria: July 9, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: lesbian, gay, bisexual, transgender, queer/questioning (one's sexual or gender identity), and intersex(LGBTQI)
• Other Study ID Numbers: HSC-SPH-23-1004

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