A Fully Automated and Culturally-Adapted mHealth Intervention for Smoking Cessation Among Black Smokers With HIV
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Biochemically verified smoking abstinence
研究概览
简要总结
The present investigation aims to address disparities in cigarette use outcomes among Black/African American adults with HIV. The specific aims of this study are: (1) To modify a recently developed, culturally adapted, mobile application for Black smokers by integrating information specifically relevant to Black persons with HIV/AIDS. (2) To conduct a randomized clinical trial for anxiety-sensitivity reduction and cigarette cessation among Black smokers with HIV.
详细描述
The current trial aims to refine and conduct a comprehensive cultural and HIV-sensitive adaptation of an initially tested, novel mobile intervention (MASP+) targeting anxiety sensitivity (AS) among Black/African American (daily) cigarette users with HIV/AIDS. The MASP+ app prompts users remotely throughout the day to assess mood symptoms, cigarette cravings or nicotine withdrawal symptoms, and general mental health. When respondents indicate they are struggling with cigarette urges or cravings, or if they are experiencing heightened levels of stress or anxiety, the app selects and delivers a tailored message from a library of messages and videos.
The MASP+ app has the potential to deliver highly effective and accessible treatment to a highly underserved subpopulation within the Black community considered to be at exceptionally high risk of smoking problems (social, psychological, physical) and smoking relapse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •HIV-infection (via self-report and picture of medication, lab tests, or diagnosis)
- •18+ years of age
- •Self-identify as Black / African American
- •Daily smoking (minimum of 10 cigarettes per day on average for at least 2 years)
- •Motivated to quit smoking (≥ 5 on a 10-point scale)
- •Willingness to discontinue cigarette use two weeks after baseline visit.
- •English literacy (score of 4 or greater on REALM-SF)
- •Moderate to high anxiety sensitivity (score of 5 or greater on SSASI)
- •Provide a current picture of their cigarette package to verify smoking status
- •Willing to complete all study surveys/assessments
- •Agree to use nicotine replacement medications (NRT; nicotine patch and lozenges)
- •Agree to attempt to quit smoking two weeks after completion of the baseline survey and receipt of study materials
排除标准
- •Actively receiving (ongoing) pharmacotherapy or psychotherapy directly focused on the treatment of smoking cessation, and/or substance use, not provided by the study
- •Non-fluent/limited English proficiency
- •Self-reported pregnancy or intentions to become pregnant in near future
- •Legal status that would interfere with participation
- •Being non-Black
- •Cognitive impairment (assessed via the 6-item Cognitive Impairment Test)
研究组 & 干预措施
MASP+ app & NRT
MASP+ is an intervention designed to assist Black smokers with HIV who experience elevated anxiety sensitivity to quit smoking through the use of educational videos, tailored messages, and interoceptive exercises designed to help the user overcome negative feelings of stress and nicotine withdrawal.
Nicotine patches will be made available to provide adjunctive support.
干预措施: MASP+ (Behavioral)
QuitGuide app + NRT
The QuitGuide app is a standard-of-care app that allows users to track nicotine cravings and provides motivational messages.
Nicotine patches will be made available to provide adjunctive support.
干预措施: Control (Behavioral)
结局指标
主要结局
Biochemically verified smoking abstinence
时间窗: Weeks 1,2,3,4,5,6, & 28
Our primary study outcome will be biochemically confirmed 7-day point prevalence abstinence 26 weeks following the scheduled quit day. The Bedfont iCO Smokerlyzer will be used to verify smoking status during the follow-up assessments. The monitors attach to the smartphone and will be used to remotely verify self-reported smoking abstinence during phone-based monitoring periods over the post-quit period. Our CO criteria for abstinence is consistent with numerous studies using cutoffs of \< 7 ppm. This will be used to verify smoking status, as well as change in smoking behaviors throughout the study. As well, self-report measures of the Smoking History questionnaire (SHQ) will also be used to assess self-reported abstinence.
Biochemically Verified Smoking Abstinence
时间窗: Weeks 2,3,4,5,6, & 28
Our primary study outcome will be biochemically confirmed 7-day point prevalence abstinence 26 weeks following the scheduled quit day. The Bedfont iCO Smokerlyzer will be used to verify smoking status during the follow-up assessments. The monitors attach to the smartphone and will be used to remotely verify self-reported smoking abstinence during phone-based monitoring periods over the post-quit period. Our CO criteria for abstinence is consistent with numerous studies using cutoffs of \< 7 ppm. Those with scores of 6 or below are biochemically confirmed to be abstinent.
次要结局
- Index of Engagement in HIV Care(Weeks 1 & 28)
- World Health Organization Quality of Life HIV (WHOQOL-HIV)(Weeks 1 & 28)
- ART Adherence(Weeks 1 & 28)
- Index of Engagement in HIV Care(Weeks 28)
- World Health Organization Quality of Life HIV (WHOQOL-HIV)(Weeks 28)
- Antiretroviral (ART) Adherence(Weeks 28)
研究者
Lorra Garey
Co-director of the RESTORE Lab, Research Assistant professor at the University of Houston
University of Houston