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一款针对对戒烟犹豫不决的感染艾滋病毒吸烟者的新型移动健康应用程序:形成性研究和随机可行性研究。

A Novel mHealth App for Smokers Living With HIV Who Are Ambivalent About Quitting Smoking: Formative Research and Randomized Feasibility Study.

作者信息

McClure Jennifer B, Heffner Jaimee L, Krakauer Chloe, Mun Sophia, Catz Sheryl L

机构信息

Kaiser Permanente Washington Health Research Institute, Seattle, WA, United States.

Kaiser Permanente Bernard J Tyson School of Medicine, Pasadena, CA, United States.

出版信息

JMIR Form Res. 2024 Jul 8;8:e58063. doi: 10.2196/58063.

Abstract

BACKGROUND

More people who smoke and are living with HIV now die from tobacco-related diseases than HIV itself. Most people are ambivalent about quitting smoking and want to quit someday but not yet. Scalable, effective interventions are needed to motivate and support smoking cessation among people ambivalent about quitting smoking (PAQS) who are living with HIV.

OBJECTIVE

This study aims to develop an app-based intervention for PAQS who are living with HIV and assess its feasibility, acceptability, and potential impact. Results of this study will inform plans for future research and development.

METHODS

In phase 1, PAQS living with HIV (n=8) participated in user-centered design interviews to inform the final intervention app design and recruitment plan for a subsequent randomized pilot study. In phase 2, PAQS living with HIV were randomized to either a standard care control app or a similar experimental app with additional content tailored for PAQS and those with HIV. Participants were followed for 3 months. Feasibility focused on recruitment, retention, and participants' willingness to install the app. The study was not powered for statistical significance. Indices of acceptability (satisfaction and use) and impact (smoking behavior change and treatment uptake) were assessed via automated data and self-report among those who installed and used the app (n=19).

RESULTS

Recruitment for both study phases was a challenge, particularly via web-based and social media platforms. Enrollment success was greater among people living with HIV recruited from a health care provider and research registry. Once enrolled, retention for the phase 2 randomized study was good; 74% (14/19) of the participants completed the 3-month follow-up. Phase 1 findings suggested that PAQS living with HIV were receptive to using an app-based intervention to help them decide whether, when, and how to stop smoking, despite not being ready to quit smoking. Phase 2 findings further supported this conclusion based on feedback from people who agreed to use an app, but group differences were observed. Indices of acceptability favored the experimental arm, including a descriptively higher mean number of sessions and utilization badges. Similarly, indices of potential impact were descriptively higher in the experimental arm (proportion reducing smoking, making a quit attempt, or calling free tobacco quitline). No participants in either arm quit smoking at the 3-month follow-up.

CONCLUSIONS

On the basis of this formative work, PAQS living with HIV may be receptive to using a mobile health-based app intervention to help them decide whether, when, or how to stop using tobacco. Indices of acceptability and impact indicate that additional research and development are warranted.

TRIAL REGISTRATION

ClinicalTrials.gov NCT05339659; https://clinicaltrials.gov/study/NCT05339659.

摘要

背景

与感染艾滋病毒本身相比,现在更多感染艾滋病毒且吸烟的人死于与烟草相关的疾病。大多数人对戒烟态度矛盾,希望有朝一日能戒烟,但不是现在。需要可扩展、有效的干预措施来激励和支持感染艾滋病毒且对戒烟态度矛盾(PAQS)的人戒烟。

目的

本研究旨在为感染艾滋病毒的PAQS开发一种基于应用程序的干预措施,并评估其可行性、可接受性和潜在影响。本研究结果将为未来的研发计划提供参考。

方法

在第1阶段,8名感染艾滋病毒的PAQS参与了以用户为中心的设计访谈,以确定最终的干预应用程序设计和后续随机试点研究的招募计划。在第2阶段,感染艾滋病毒的PAQS被随机分配到标准护理对照应用程序或类似的实验应用程序,后者包含为PAQS和艾滋病毒感染者量身定制的额外内容。对参与者进行3个月的随访。可行性重点关注招募、留存率以及参与者安装应用程序的意愿。该研究未进行统计学显著性检验。通过自动数据和自我报告对安装并使用该应用程序的人(n = 19)进行可接受性(满意度和使用情况)和影响(吸烟行为改变和治疗接受情况)指标评估。

结果

两个研究阶段的招募都面临挑战,特别是通过基于网络和社交媒体平台进行招募时。从医疗保健提供者和研究登记处招募的艾滋病毒感染者的入组成功率更高。一旦入组,第2阶段随机研究的留存率良好;74%(14/19)的参与者完成了3个月的随访。第1阶段的研究结果表明,感染艾滋病毒的PAQS愿意使用基于应用程序的干预措施来帮助他们决定是否、何时以及如何戒烟,尽管他们还没有准备好戒烟。第2阶段的研究结果基于同意使用应用程序的人的反馈进一步支持了这一结论,但观察到了组间差异。可接受性指标有利于实验组,包括描述性地更高的平均会话次数和使用徽章数量。同样,实验组的潜在影响指标在描述性上更高(减少吸烟、尝试戒烟或拨打免费戒烟热线的比例)。在3个月的随访中,两组均无参与者戒烟。

结论

基于这项形成性工作,感染艾滋病毒的PAQS可能愿意使用基于移动健康的应用程序干预措施来帮助他们决定是否、何时或如何停止使用烟草。可接受性和影响指标表明有必要进行进一步的研发。

试验注册

ClinicalTrials.gov NCT \alpha5339659;https://clinicaltrials.gov/study/NCT05339659 。 (注:原文中“NCT\alpha5339659”疑似有误,推测应为“NCT05339659”,译文按正确编号翻译)

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c3c8/11263889/c38e1208a495/formative_v8i1e58063_fig1.jpg

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