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

基本信息

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
项目类别：
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

项目摘要

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该问题的最关键的公共卫生挑战之一南非（SA）的艾滋病毒（PWH）和/或结核病（TB）患者的健康和生存：吸烟。背景/意义：吸烟降低了PWH中的抗逆转录病毒疗法（ART）依从性，损害HIV治疗结果，并与新近患者的结核病治疗依从性降低有关被诊断为结核病，以及结核病治疗失败，治疗期间的随访以及或在OR期间死亡的损失治疗后。初步研究：在此R34应用中，我们建议开发量身定制的戒烟干预措施在改善艾滋病毒和结核病疾病结果的SA环境中，从两个重叠的研究领域。首先，我们完成了一个随机对照试验（RCT），该试验确定了初始认知行为疗法戒烟干预措施（退出）的功效，可行性和可接受性美国的PWH，与对照相比，美国在6个月的生物学验证的节制率提高了。1 其次，我们最近完成了认知行为艺术遵守的功效/有效性试验干预措施，成功增加了斗篷中PWH中PWH中HIV治疗的依从性和降低的病毒载荷 2因此，我们的美国和基于SA的调查员团队在戒烟治疗方面具有专业知识患有慢性疾病的个体的发展以及适应循证，认知行为策略的发展用于在低资源环境中的治疗依从性。方法：我们现在建议通过开发退出AD来扩展这项工作，这是一种新颖的干预措施将我们的戒烟计划与已在文化上适应改善的认知行为策略相结合 SA中PWH和/或TB之间的治疗依从性。为此，我们将：更彻底地理解（a）障碍在患有艾滋病毒和/或结核病的成年人中戒烟，以及（b）成年人结核病治疗的障碍与使用烟草的结核病（AIM 1）；调整退出协议，添加和删除内容，适当基于在形成性数据上，并进行了小型概念验证公开试验（n = 5; aim 2）;并评估可行性在飞行员RCT中的干预措施的可接受性将任务转移到外行辅导员（AIM 3）。次要 RCT的结果将是生物学验证的点流行烟草禁欲的烟气数量在过去的一周中抽烟，并在6个月时在6个月时吸烟。成果/下一步：这些目标将为全面的混合有效性/实施奠定基础可以改变SA中的戒烟治疗景观的试验，提供经验支持 PWH和/或TB的计划，并作为未来工作以维持戒烟的模型在资源有限的环境中患有慢性疾病的人。