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

NCT ID: NCT06487806

Last Updated: 2025-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-13

Study Completion Date

2027-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Smoking Cessation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Beta testing group

Group Type EXPERIMENTAL

SmokefreeSGM

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Irene Tami-Maury

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Irene Tami-Maury, DMD, MSc, DrPH

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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HSC-SPH-23-1004

Identifier Type: -

Identifier Source: org_study_id

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