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临床试验/NCT06487806
NCT06487806暂停不适用

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

The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年8月13日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
入组人数
20
试验地点
2
主要终点
Perceived Usability as Assessed by the System Usability Scale (SUS)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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

时间窗: end of intervention (1month after quit date)

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

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

时间窗: end of intervention (1month after quit date)

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

时间窗: end of intervention (1month after quit date)

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Irene Tami-Maury

Assistant Professor

The University of Texas Health Science Center, Houston

研究点 (2)

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