Ending Tobacco Use Through Interactive Tailored Messaging for Cambodian People With HIV (Project EndIT): Protocol for a Randomized Controlled Trial.
Ending Tobacco Use Through Interactive Tailored Messaging for Cambodian People With HIV (Project EndIT): Protocol for a Randomized Controlled Trial.
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DOI：
10.2196/48923
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发表时间：
2023-06-29
影响因子：
1.7
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中科院分区：
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在许多低收入和中等收入国家（LMICs），吸烟率仍然很高，包括东南亚国家柬埔寨。吸烟对艾滋病毒感染者尤其有害。在柬埔寨，大约43%-65%的男性艾滋病毒感染者和3%-5%的女性艾滋病毒感染者吸烟。因此，柬埔寨艾滋病毒感染者迫切需要具有成本效益的戒烟干预措施。本文介绍了随机对照试验的设计，方法和数据分析计划，以评估基于理论的移动的健康戒烟干预措施在柬埔寨艾滋病毒感染者中的有效性。这项2组随机对照试验比较了移动的基于健康的自动消息（AM）干预与标准护理（SC）在促进柬埔寨艾滋病毒感染者戒烟方面的疗效。目前吸烟并正在接受抗逆转录病毒治疗的柬埔寨HIV感染者（目标，N=800）将被随机分配至（1）SC或（2）AM干预。SC参与者将收到戒烟的简短建议，书面自助材料，尼古丁贴片，并将完成26周的每周应用程序交付的饮食评估。AM受试者将接受所有SC组件（但将完成吸烟相关的每周评估，而不是饮食评估），此外还将接受由每周评估驱动的全自动定制消息传递程序，以促进戒烟。在基于阶段的戒烟模型中，戒烟过程分为4个阶段：动机，准备（precessation），戒烟（戒烟日期至戒烟后2周）和维持（戒烟后6个月）。我们的AM计划针对这些阶段中的过程，包括增加戒烟动机，增强自我效能，获得社会支持，科普尼古丁戒断症状和压力的技能，以及保持禁欲的技能。所有参与者将完成基线和3个月、6个月和12个月的亲自随访评估。主要结局是12个月时经生化证实的禁欲，次要结局是3个月和6个月的禁欲。将探讨潜在的介质和调节剂的治疗效果，并评估成本效益。本研究获得了所有相关的国内和国际机构和伦理审查委员会的批准。参与者招募于二零二三年一月开始。数据收集预计将于2025年底完成。通过证明AM相对于SC具有更高的疗效和成本效益，这项研究有可能改变柬埔寨的艾滋病毒护理和预防烟草相关疾病。此外，还可对该方法进行调整，以用于其他柬埔寨人口和其他中低收入国家。最终，AM戒烟方法可以大大改善发展中国家及其他地区的公共健康。ClinicalTrials.gov NCT 05746442; https://clinicaltrials.gov/ct2/show/NCT05746442 PRR1-10.2196/48923
The prevalence of smoking remains high in many low- and middle-income countries (LMICs), including the Southeast Asian nation of Cambodia. Smoking is especially hazardous for people with HIV. In Cambodia, approximately 43%-65% of men with HIV and 3%-5% of women with HIV smoke cigarettes. Thus, there is a critical need for cost-effective smoking cessation interventions for Cambodian people with HIV. This paper describes the design, methods, and data analysis plans for a randomized controlled trial assessing the efficacy of a theory-based mobile health smoking cessation intervention in Cambodian people with HIV. This 2-group randomized controlled trial compares the efficacy of a mobile health–based automated messaging (AM) intervention versus standard care (SC) in facilitating smoking cessation among Cambodian people with HIV. Cambodian people with HIV who currently smoke and are receiving antiretroviral treatment (target, N=800) will be randomized to (1) SC or (2) the AM intervention. SC participants will receive brief advice to quit smoking, written self-help materials, nicotine patches, and will complete weekly app-delivered dietary assessments for 26 weeks. AM participants will receive all SC components (but will complete smoking-related weekly assessments instead of dietary assessments), in addition to a fully automated tailored messaging program driven by the weekly assessments to facilitate smoking cessation. In the Phase-Based Model of smoking cessation, the cessation process is partitioned into 4 phases: motivation, preparation (precessation), cessation (quit date to 2 weeks post quit), and maintenance (up to 6 months post quit). Our AM program targets processes within these phases, including increasing motivation to quit, enhancing self-efficacy, obtaining social support, skills to cope with nicotine withdrawal symptoms and stress, and skills to maintain abstinence. All participants will complete baseline and 3-, 6-, and 12-month in-person follow-up assessments. The primary outcome is biochemically confirmed abstinence at 12 months, with 3- and 6-month abstinence as secondary outcomes. Potential mediators and moderators underlying treatment effects will be explored, and cost-effectiveness will be assessed. This study was approved by all relevant domestic and international institutional and ethical review boards. Participant recruitment commenced in January 2023. Data collection is expected to conclude by the end of 2025. By demonstrating the greater efficacy and cost-effectiveness of AM relative to SC, this study has the potential to transform HIV care in Cambodia and prevent tobacco-related diseases. Furthermore, it may be adapted for use in other Cambodian populations and in other low- and middle-income countries. Ultimately, the AM approach to smoking cessation could greatly improve public health in the developing world and beyond. ClinicalTrials.gov NCT05746442; https://clinicaltrials.gov/ct2/show/NCT05746442 PRR1-10.2196/48923