Treatment Development for Smoking Cessation and Engagement in HIV/TB Care in South Africa

南非戒烟和参与艾滋病毒/结核病护理的治疗方法开发

• 批准号: 10706874
• 负责人: Conall Michael O'Cleirigh
• 金额: $ 20.49万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-01 至 2026-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10706874
• 关键词: Abstinence; Acquired Immunodeficiency Syndrome; Acute; Address; Adherence; Administrator; Adult; Affect; Aftercare; Area; Behavioral; Caring; Cause of Death; Cessation of life; Characteristics; Chronic Disease; Chronic Obstructive Pulmonary Disease; Clinic; Cognitive; Cognitive Therapy; Counseling; Dangerousness; Data; Development; Disease Outcome; Distress; Elements; Ensure; Epidemic; Focus Groups; Funding; Future; General Population; HIV; HIV/TB; Health; Individual; Intervention; Interview; Link; Lung diseases; Maintenance; Manuals; Modeling; Morbidity - disease rate; National Institute of Drug Abuse; National Institute of Mental Health; Newly Diagnosed; Outcome; Pathway interactions; Patients; Persons; Prevalence; Procedures; Professional counselor; Protocols documentation; Provider; Public Health; Pulmonary Tuberculosis; Randomized; Randomized, Controlled Trials; Relapse; Reporting; Research; Research Personnel; Resource-limited setting; Resources; Risk; Risk Factors; Smoke; Smoker; Smoking; Smoking Cessation Intervention; Smoking treatment; South Africa; South African; Specific qualifier value; Sputum; Structure; Symptoms; Testing; Tobacco; Tobacco smoke; Tobacco use; Treatment Failure; Treatment outcome; Tuberculosis; United States; Viral Load result; Woman; Work; World Health Organization; acceptability and feasibility; antiretroviral therapy; arm; cigarette smoke; comparison control; design; effectiveness trial; effectiveness/implementation trial; evidence base; experience; follow up assessment; follow-up; future implementation; high risk; implementation intervention; implementation/effectiveness; improved; innovation; intervention refinement; low and middle-income countries; men; mortality; negative affect; novel; peri-urban; poor health outcome; programs; psychoeducation; psychoeducational; recruit; secondary outcome; skills; smoking abstinence; smoking cessation; smoking prevalence; therapy adherence; therapy development; tobacco abstinence; treatment adherence; treatment as usual; treatment strategy; trial comparing; tuberculosis treatment

Overview: This proposal directly addresses one of the most critical public health challenges impacting the health and survival of people with HIV (PWH) and/or tuberculosis (TB) in South Africa (SA): smoking. Background/Significance: Smoking reduces antiretroviral therapy (ART) adherence among PWH, compromising HIV treatment outcomes, and is linked to lower TB treatment adherence among patients newly diagnosed with TB, as well as to TB treatment failure, loss to follow up during treatment, and death during or after treatment. Preliminary studies: In this R34 application, we propose to develop a smoking cessation intervention tailored to the SA context that improves disease outcomes for both HIV and TB, bringing together our experience from two overlapping areas of research. First, we completed a randomized controlled trial (RCT) that established initial efficacy, feasibility, and acceptability of a cognitive behavioral therapy smoking cessation intervention (QUIT) for PWH in the US, which increased biologically-verified abstinence rates at 6 months compared to controls.1 Second, we recently completed an efficacy/effectiveness trial of a cognitive behavioral ART adherence intervention, which successfully increased HIV treatment adherence and reduced viral load among PWH in Cape Town.2 Therefore, our US- and SA-based investigator team has expertise in smoking cessation treatment development for individuals with chronic disease and in adapting evidence-based, cognitive behavioral strategies for treatment adherence in a low-resource setting. Approach: We now propose to extend this body of work by developing QUIT-AD, a novel intervention which will integrate our QUIT program with cognitive behavioral strategies that have been culturally adapted to improve treatment adherence among PWH and/or TB in SA. To do so, we will: more thoroughly understand (a) barriers to smoking cessation among adults with HIV and/or TB and (b) barriers to TB treatment adherence among adults with TB who use tobacco (Aim 1); adapt the QUIT protocol, adding and removing content as appropriate based on the formative data, and conduct a small proof-of-concept open trial (n = 5; Aim 2); and assess the feasibility and acceptability of the intervention in a pilot RCT to be task shifted to lay counselors (Aim 3). Secondary outcomes of the RCT will be biologically-verified point prevalence tobacco abstinence, number of cigarettes smoked in the past week, and favorable HIV/TB treatment outcome at 6 months. Outcomes/next steps: These aims will lay the groundwork for a full-scale, hybrid effectiveness/implementation trial which could change the smoking cessation treatment landscape in SA, provide an empirically supported program for PWH and/or TB, and serve as a model for future work to sustain smoking abstinence among individuals with chronic diseases in resource-limited settings.

概述：该提案直接解决了影响世界卫生组织的最关键的公共卫生挑战之一。 南非（SA）艾滋病毒（PWH）和/或结核病（TB）感染者的健康和生存：吸烟。 背景/意义：吸烟降低了PWH患者的抗逆转录病毒治疗（ART）依从性， 损害艾滋病毒治疗结果，并与新感染者结核病治疗依从性降低有关。 被诊断出患有结核病，以及结核病治疗失败、治疗期间失去随访以及治疗期间死亡 治疗后 初步研究：在这个R34应用中，我们建议开发一种量身定制的戒烟干预措施。 到SA的背景下，改善艾滋病毒和结核病的疾病结果，汇集我们的经验， 两个重叠的研究领域。首先，我们完成了一项随机对照试验（RCT）， 认知行为疗法戒烟干预（QUIT）的有效性、可行性和可接受性 美国的PWH，与对照组相比，6个月时经生物学验证的禁欲率增加。 其次，我们最近完成了一项认知行为ART依从性的功效/有效性试验， 干预措施，成功地提高了艾滋病毒治疗的依从性，并降低了开普敦PWH中的病毒载量 Town.2因此，我们的美国和SA研究团队拥有戒烟治疗方面的专业知识 发展为个人与慢性疾病和适应证据为基础的，认知行为策略 在资源匮乏的环境下坚持治疗。 方法：我们现在建议通过开发QUIT-AD来扩展这项工作，这是一种新的干预措施， 将我们的QUIT计划与认知行为策略相结合，这些策略在文化上已经适应， SA中PWH和/或TB的治疗依从性。要做到这一点，我们将：更彻底地了解（一）障碍 艾滋病毒和/或结核病成人患者戒烟的障碍和（B）成人结核病治疗依从性的障碍 吸烟的结核病患者（目标1）;调整QUIT协议，根据情况添加和删除内容 在形成性数据上，进行一项小型概念验证开放试验（n = 5;目标2）;并评估可行性 和干预的可接受性，在试点RCT的任务转移到外行辅导员（目标3）。二次 随机对照试验的结果将是生物学验证的点患病率、戒烟率、吸烟数量 在过去一周内吸烟，6个月时艾滋病毒/结核病治疗结果良好。 成果/今后的步骤：这些目标将为全面、混合的有效性/执行奠定基础 一项可能改变SA戒烟治疗前景的试验，提供了经验支持 计划，并作为未来工作的模式，以维持戒烟，其中 在资源有限的环境中，慢性病患者。