Culturally-Tailored, Avatar-Led MHealth Intervention to Aid Smoking Cessation Among Sexual and Gender Minority Young Adults in New Mexico
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Participant satisfaction
研究概览
简要总结
This clinical trial assesses the acceptability and efficacy of Empowered, Queer, Quitting, and Living--New Mexico (EQQUAL-NM), a smoking cessation intervention for sexual and gender minority young adults in New Mexico. Smoking prevalence among sexual and gender minority (SGM) adults in New Mexico is more than twice as high as non-SGM adults. Helping young adult tobacco users to quit is critical, yet there have been few efforts to develop tailored treatments specifically for this population. EQQUAL-NM is a digital smoking cessation intervention designed specifically for SGM young adult smokers in New Mexico and may help them quit smoking.
详细描述
OUTLINE:
Participants are randomized to 1 of 2 groups.
GROUP I: Participants receive access to a self-guided, smartphone app-delivered quit smoking program, called EQQUAL-NM (Program A) that helps explore personal values and teaches participants about smoking triggers and skills to help them manage cravings and accept thoughts and feelings related to smoking. Participants receive text message reminders and prompts on study. Some participants also undergo collection of a saliva sample during follow-up.
GROUP II: Participants receive access to a self-guided, smartphone app-delivered quit smoking program, called EQQUAL-NM (Program B) that is based on current clinical practice guidelines for tobacco cessation to help them quit smoking. This program helps with quit advice, tracking progress on quitting smoking, and managing cravings. Participants receive text message reminders and prompts on study. Some participants also undergo collection of a saliva sample during follow-up.
After completion of study intervention, patients are followed up at 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Any outcome evaluator who has contact with participants will remain blinded to treatment group assignment until the final set of questions regarding acceptability of specific program components is asked.
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Self-identify being between 18 and 30 years of age
- •Self-identify as a sexual and/or gender minority (i.e., a sexual orientation other than straight and/or gender that doesn't match sex assigned at birth)
- •Currently reside in New Mexico, with a New Mexico mailing address, and anticipate remaining in New Mexico for the duration of the study (3 months)
- •Self-report smoking at least 1 cigarette per week in the 30 days prior to screening
- •Own an Android phone or iPhone
- •Have at least weekly internet access for the next three months
- •Willing and able to stream audio and video for this study
- •Current use of a personal email account
- •Current use of text messaging
- •Interested in participating in the study for themselves (versus [vs] someone else)
- •Self-report that they have not participated in one of Fred Hutch's/NMSU's prior smoking cessation studies
- •Understand and agree to the conditions of compensation
- •Currently not incarcerated
- •Participants must be willing to use the assigned intervention program, complete the study assessments, and agree to the online consent form in English
排除标准
- •Current use of other tobacco cessation treatments at the time of screening, including pharmacotherapy or behavioral support (but initiating these treatments during the study is allowed)
- •Member of the same household as another research participant
- •Previous use of the National Cancer Institute (NCI) QuitGuide app
- •Google voice number as sole phone number
- •Does not pass study fraud prevention protocol
结局指标
主要结局
Participant satisfaction
时间窗: At 3-month follow-up
Self-report of satisfaction overall and with specific program components will be rated on a 5-point Likert-type scale. Higher scale scores indicate higher satisfaction with the app.
Number of logins to the assigned application
时间窗: Up to 3-month follow-up
Server-recorded number of app openings over 3 months
次要结局
- Change in Contemplation Ladder scores(At baseline and at 3-month follow-up)
- Change in values-guided action(At baseline and at 3-month follow-up)
- Self-reported 7-day point prevalence abstinence (PPA) from all nicotine and tobacco products(At 3 months)
- Self-reported 30-day PPA from cigarette smoking(At 3 months)
- Biochemically confirmed 30-day PPA from all nicotine/tobacco products(At 3 months)
- Self-reported 7-day PPA from cigarette smoking(At 3 months)
- Change in acceptance of tobacco-use triggers(At baseline and at 3-month follow-up)
- Self-reported 30-day PPA from all nicotine/tobacco products(At 3 months)
- Biochemically confirmed 7-day point prevalence abstinence (PPA) from all nicotine/tobacco products(At 3 months)