背景:吸烟和感染艾滋病毒的黑人成年人经历巨大的压力源(例如,种族歧视和艾滋病毒的污名)阻碍了戒烟的成功并使与吸烟有关的健康差距长期存在。这些压力源也使吸烟和感染艾滋病毒的黑人成年人增加了感受压力升高的风险(例如,焦虑和不舒服的身体感觉)和吸烟来控制症状。反过来,这个人群更有可能吸烟来管理相互感受的压力,这导致该组中更糟糕的HIV相关结果。然而,没有专门的治疗方法来解决戒烟问题,相互感受的压力,以及对携带艾滋病毒的黑人吸烟者的艾滋病毒管理。
目的:本研究旨在测试一种针对可燃吸烟的文化适应性和新颖的移动干预措施,艾滋病毒治疗的参与和坚持,和焦虑敏感性(对感受间压力的困难和反应性的代表)在感染艾滋病毒的黑人吸烟者中(即,吸烟和艾滋病毒的移动焦虑敏感性计划[MASP+])。该应用程序的各种文化定制组件正在评估其帮助用户戒烟的能力,管理生理压力,改善医疗保健管理。
方法:本研究是一项随机对照试验,招募携带HIV的黑色可燃吸烟者(N=72),并随机分配使用(1)国家癌症研究所的QuitGuide应用程序或(2)MASP+。研究程序包括一个基于网络的prescreener;主动干预期6周;基于智能手机的评估,包括为期6周的每日基于应用程序的生态瞬时评估(每天4次生态瞬时评估);在第6周对所有研究条件下的参与者使用ZoomVideoCommunications软件进行基于视频的定性访谈;以及在0、1、2(退出日期)进行基于智能手机的后续评估,基线后3、4、5、6和28周(戒烟日期后26周)。
结果:主要结果包括生化验证的7天点禁欲患病率,艾滋病毒相关的生活质量,使用抗逆转录病毒疗法,以及退出日期后26周的艾滋病毒护理预约依从性。还收集和评估了定性数据,以获得反馈,以指导进一步定制应用程序内容和评估疗效。
结论:这项研究的结果将确定MASP+应用程序是否能成功帮助戒烟,艾滋病毒治疗参与,以及感染艾滋病毒的黑人的生理压力结果。如果成功,这项研究将为解决这一高危人群的主要身心健康困难的新方法的有效性提供证据。如果结果是有希望的,本研究的数据将用于更新和定制MASP+应用程序,以便在一项完全有效的随机对照试验中进行测试,该试验将评估其在现实世界行为健康和社会服务环境中的疗效.
背景:ClinicalTrials.govNCT05709002;https://clinicaltrials.gov/study/NCT05709002。
■PRR1-10.2196/52090。
Black adults who smoke and have HIV experience immense stressors (eg, racial discrimination and HIV stigma) that impede smoking cessation success and perpetuate smoking-related health disparities. These stressors also place Black adults who smoke and have HIV at an increased risk of elevated interoceptive stress (eg, anxiety and uncomfortable bodily sensations) and smoking to manage symptoms. In turn, this population is more likely to smoke to manage interoceptive stress, which contributes to worse HIV-related outcomes in this group. However, no specialized treatment exists to address smoking cessation, interoceptive stress, and HIV management for Black smokers with HIV.
This
study aims to test a culturally adapted and novel mobile intervention that targets combustible cigarette smoking, HIV treatment engagement and adherence, and anxiety sensitivity (a proxy for difficulty and responsivity to interoceptive stress) among Black smokers with HIV (ie, Mobile Anxiety Sensitivity Program for Smoking and HIV [MASP+]). Various culturally tailored components of the app are being evaluated for their ability to help users quit smoking, manage physiological stress, and improve health care management.
This
study is a pilot randomized controlled
trial in which Black combustible cigarette smokers with HIV (N=72) are being recruited and randomly assigned to use either (1) the National Cancer Institute\'s QuitGuide app or (2) MASP+. Study procedures include a web-based prescreener; active intervention period for 6 weeks; smartphone-based assessments, including daily app-based ecological momentary assessments for 6 weeks (4 ecological momentary assessments each day); a video-based qualitative interview using Zoom Video Communications software at week 6 for participants in all study conditions; and smartphone-based follow-up assessments at 0, 1, 2 (quit date), 3, 4, 5, 6, and 28 weeks postbaseline (26 weeks postquitting date).
Primary outcomes include biochemically verified 7-day point prevalence of abstinence, HIV-related quality of life, use of antiretroviral therapy, and HIV care appointment adherence at 26 weeks postquitting date. Qualitative data are also being collected and assessed to obtain feedback that will guide further tailoring of app content and evaluation of efficacy.
The results of this study will determine whether the MASP+ app serves as a successful aid for combustible cigarette smoking cessation, HIV treatment engagement, and physiological stress outcomes among Black people with HIV infection. If successful, this study will provide evidence for the efficacy of a new means of addressing major mental and physical health difficulties for this high-risk population. If the results are promising, the data from this
study will be used to update and tailor the MASP+ app for testing in a fully powered randomized controlled
trial that will evaluate its efficacy in real-world behavioral health and social service settings.
ClinicalTrials.gov NCT05709002; https://clinicaltrials.gov/
study/NCT05709002.
PRR1-10.2196/52090.