Ending Tobacco Use through Interactive Tailored Messaging for Cambodian People Living with HIV/AIDS (EndIT)

通过为柬埔寨艾滋病毒/艾滋病感染者提供交互式定制信息来结束烟草使用 (EndIT)

• 批准号: 10268451
• 负责人: Thanh C. Bui
• 金额: $ 75.14万
• 依托单位: H. LEE MOFFITT CANCER CTR & RES INST
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-17 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10268451
• 关键词: AIDS/HIV problem; Abstinence; Address; Adoption; Adult; Behavior Therapy; Biochemical; Cambodia; Cambodian; Cancer Center; Caring; Cellular Phone; Clinic; Collaborations; Complement; Comprehensive Health Care; Confidence Intervals; Control Groups; Country; Data; Developed Countries; Development; Enrollment; Evaluation; Federal Government; Female; Government Agencies; HIV; Health Promotion; Health Sciences; Healthcare; Income; Influentials; Intervention; Life; Literature; Mediator of activation protein; Modeling; Morbidity - disease rate; Oklahoma; Participant; Patient Self-Report; Pharmacological Treatment; Phase; Pilot Projects; Prevalence; Proliferating; Public Health; Randomized; Randomized Controlled Trials; Relative Risks; Reporting; Research; Research Personnel; Resources; Smoke; Smoking Cessation Intervention; Special Population; Surveys; Tobacco; Tobacco Use Cessation; Tobacco use; Tobacco-Related Carcinoma; Treatment Efficacy; Universities; University of Texas M D Anderson Cancer Center; Wireless Technology; Woman; World Health Organization; antiretroviral therapy; base; brief advice; care delivery; cigarette smoke; comparative cost effectiveness; cost effective; economic evaluation; efficacy evaluation; follow-up; high risk; improved; low income country; mHealth; male; men; mobile computing; mortality; nicotine replacement; novel; primary outcome; randomized trial; recruit; secondary outcome; self help; sexual identity; smoking cessation; smoking prevalence; standard care; tailored messaging; text messaging intervention; tobacco cessation intervention; tobacco control; treatment group; treatment program

PROJECT SUMMARY Although the prevalence of tobacco use has declined in developed nations in recent decades, the prevalence of smoking remains strikingly high in many low-income countries. In Cambodia, recent national surveys have indicated that 33%–43% of adult men and 3% of adult women smoke cigarettes. Certain special populations, such as people living with HIV (PLWH), are confronted with disproportionately high risks associated with tobacco use. Available estimates indicate that 43%–65% of male PLWH and 3%–5% of female PLWH smoke cigarettes. Although Cambodia has widespread coverage for antiretroviral treatment (ART), no known efforts have been made to provide tobacco treatment to ART recipients who smoke. Thus, complementing ART with efficacious tobacco cessation treatment offers tremendous potential to improve HIV care and to prolong life for PLWH. To address this need, we propose a randomized controlled trial with pharmacological and behavioral treatment components, including a fully automated, interactive smartphone-delivered intervention. Mobile health (mHealth) interventions are proliferating in the US, but efforts to utilize similar approaches in Cambodia are extremely limited. The World Health Organization acknowledges that mHealth is cost-effective, scalable, and sustainable, including for the least developed countries. We have already developed the mHealth platform and intervention approach proposed for this study, and we have completed a pilot study with 50 Cambodian PLWH who smoked and received care at an ART clinic. Results from this pilot indicated that the biochemically confirmed, 7-day point prevalence abstinence rates at 2-months follow-up were 40% in the group receiving the mHealth intervention vs. 8% in a standard care control group (relative risk: 5.0). In this proposed study, Cambodian PLWH of all sexual identities will be recruited through the 6 largest ART clinics in Phnom Penh, which provide comprehensive care to more than 14,000 PLWH. Participants (n=800) will be randomized to one of 2 treatment groups: Standard Care (SC; n=400), or Automated Messaging (AM; n=400). SC consists of brief advice to quit smoking delivered by research staff, self-help written materials, and an 8-week supply of nicotine replacement therapy (NRT) in the form of transdermal patches. AM consists of the SC components plus a fully automated smartphone-based treatment program that involves interactive and tailored proactive messaging. The primary outcome is biochemically confirmed self-reported 7-day point prevalence abstinence at 12-months post-study enrollment. Secondary outcomes include abstinence at 3- and 6-months post-enrollment. The primary aims are to evaluate the efficacy of AM for Cambodian PLWH who smoke and to compare the cost- effectiveness of AM vs. SC. If our findings indicate that AM is efficacious and cost-effective, our collaboration with influential Cambodian governmental agencies will facilitate wide-scale implementation to HIV clinics across the country. Thus, the project has the potential to transform HIV care delivery throughout the country and to reduce tobacco-induced cancer morbidity and mortality significantly.

项目摘要 尽管近几十年来发达国家的烟草使用流行率有所下降， 在许多低收入国家，吸烟率仍然高得惊人。在柬埔寨，最近的全国调查显示， 33%-43%的成年男性和3%的成年女性吸烟。一些特殊人群， 艾滋病毒感染者（PLWH）面临着与艾滋病相关的不成比例的高风险。 烟草使用。现有估计表明，43%-65%的男性艾滋病毒携带者和3%-5%的女性艾滋病毒携带者吸烟。 香烟虽然柬埔寨广泛提供抗逆转录病毒治疗，但没有已知的努力， 为吸烟的抗逆转录病毒疗法接受者提供烟草治疗。因此，补充艺术与 有效的戒烟治疗为改善艾滋病毒护理和延长患者生命提供了巨大的潜力。 PLWH。为了满足这一需求，我们提出了一项随机对照试验， 治疗组件，包括全自动，交互式智能手机提供的干预。移动的 医疗（mHealth）干预措施在美国正在激增，但在柬埔寨利用类似方法的努力 非常有限。世界卫生组织承认，移动医疗具有成本效益，可扩展， 可持续发展，包括最不发达国家。我们已经开发了移动健康平台 和干预方法，我们已经完成了一项试点研究，50柬埔寨 吸烟并在ART诊所接受治疗的PLWH。该试验的结果表明， 在2个月的随访中，证实的7天点患病率戒烟率为40%， 移动健康干预与标准护理对照组中的8%（相对风险：5.0）。在这项研究中， 将通过金边6个最大的抗逆转录病毒疗法诊所招募柬埔寨所有性别身份的艾滋病毒携带者， 为14，000多名艾滋病毒携带者提供全面护理。受试者（n=800）将被随机分配至 2个治疗组：标准治疗（SC; n=400）或自动消息传递（AM; n=400）。SC由简要 研究人员提供的戒烟建议，自助书面材料，以及8周的尼古丁供应 替代疗法（NRT）以透皮贴剂的形式。AM由SC组件和一个完整的 基于智能手机的自动化治疗计划，涉及互动和定制的主动消息传递。 主要结局是12个月时经生化证实的自我报告的7天时点戒烟率 研究后入组。次要结局包括入组后3个月和6个月的禁欲。的 主要目的是评估AM对柬埔寨吸烟的PLWH的疗效，并比较其成本- 如果我们的研究结果表明，AM是有效的和成本效益，我们的合作 与有影响力的柬埔寨政府机构合作， 全国各地因此，该项目有可能在全国范围内改变艾滋病毒护理的提供方式 并显著降低烟草引起的癌症发病率和死亡率。