评估针对艾滋病病毒感染者的自动戒烟治疗效果：一项随机对照试验方案

Evaluating the Efficacy of Automated Smoking Treatment for People With HIV: Protocol for a Randomized Controlled Trial.

作者信息

Vidrine Damon J, Bui Thanh C, Businelle Michael S, Shih Ya-Chen Tina, Sutton Steven K, Shahani Lokesh, Hoover Diana Stewart, Bowles Kristina, Vidrine Jennifer I

机构信息

Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, FL, United States.

Stephenson Cancer Center, TSET Health Promotion Research Center, University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States.

出版信息

JMIR Res Protoc. 2021 Nov 17;10(11):e33183. doi: 10.2196/33183.

DOI:10.2196/33183

PMID:34787590

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8663670/

Abstract

BACKGROUND

Smoking prevalence rates among people with HIV are nearly 3 times higher than those in the general population. Nevertheless, few smoking cessation trials targeting smokers with HIV have been reported in the literature. Efforts to develop and evaluate sustainable, low-cost, and evidence-based cessation interventions for people with HIV are needed. Given the widespread proliferation of mobile phones, the potential of using mobile health apps to improve the reach and efficacy of cessation interventions is promising, but evidence of efficacy is lacking, particularly among people with HIV.

OBJECTIVE

This study will consist of a 2-group randomized controlled trial to evaluate a fully automated smartphone intervention for people with HIV seeking cessation treatment.

METHODS

Participants (N=500) will be randomized to receive either standard treatment (ST; 250/500, 50%) or automated treatment (AT; 250/500, 50%). ST participants will be connected to the Florida Quitline and will receive nicotine replacement therapy in the form of transdermal patches and lozenges. This approach, referred to as Ask Advise Connect, was developed by our team and has been implemented in numerous health systems. ST will be compared with AT, a fully automated behavioral treatment approach. AT participants will receive nicotine replacement therapy and an interactive smartphone-based intervention that comprises individually tailored audiovisual and text content. The major goal is to determine whether AT performs better in terms of facilitating long-term smoking abstinence than the more resource-intensive ST approach. Our primary aim is to evaluate the efficacy of AT in facilitating smoking cessation among people with HIV. As a secondary aim, we will explore potential mediators and moderators and conduct economic evaluations to assess the cost and cost-effectiveness of AT compared with ST.

RESULTS

The intervention content has been developed and finalized. Recruitment and enrollment will begin in the fall of 2021.

CONCLUSIONS

There is a critical need for efficacious, cost-effective, and sustainable cessation treatments for people with HIV who smoke. The AT intervention was designed to help fill this need. If efficacy is established, the AT approach will be readily adoptable by HIV clinics and community-based organizations, and it will offer an efficient way to allocate limited public health resources to tobacco control interventions.

TRIAL REGISTRATION

ClinicalTrials.gov NCT05014282; https://clinicaltrials.gov/ct2/show/NCT05014282.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/33183.

摘要

背景

感染艾滋病毒者的吸烟率几乎是普通人群的3倍。然而，文献中报道的针对感染艾滋病毒吸烟者的戒烟试验很少。需要努力开发和评估针对感染艾滋病毒者的可持续、低成本且基于证据的戒烟干预措施。鉴于手机的广泛普及，使用移动健康应用程序来提高戒烟干预措施的覆盖面和效果具有很大潜力，但缺乏疗效证据，尤其是在感染艾滋病毒者中。

目的

本研究将包括一项两组随机对照试验，以评估一种针对寻求戒烟治疗的感染艾滋病毒者的全自动智能手机干预措施。

方法

参与者（N = 500）将被随机分为接受标准治疗（ST；250/500，50%）或自动治疗（AT；250/500，50%）。ST组参与者将接入佛罗里达戒烟热线，并将接受以透皮贴片和含片形式的尼古丁替代疗法。这种方法，称为询问、建议、联系，是由我们的团队开发的，并已在众多卫生系统中实施。ST组将与AT组进行比较，AT组是一种全自动行为治疗方法。AT组参与者将接受尼古丁替代疗法和基于智能手机的交互式干预措施，该措施包括个性化定制的视听和文本内容。主要目标是确定在促进长期戒烟方面，AT组是否比资源消耗更大的ST组表现更好。我们的主要目的是评估AT组在促进感染艾滋病毒者戒烟方面的疗效。作为次要目的，我们将探索潜在的中介因素和调节因素，并进行经济评估，以评估AT组与ST组相比的成本和成本效益。