Prevent TB: Application of choice architecture to implement TB preventive therapy in South Africa

预防结核病：应用选择架构在南非实施结核病预防治疗

• 批准号: 9927031
• 负责人: CHRISTOPHER J HOFFMANN
• 金额: $ 57.82万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-02-28 至 2025-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/9927031
• 关键词: Acquired Immunodeficiency Syndrome; Address; Adherence; Adoption; Adult; Advocacy; Africa; Africa South of the Sahara; Antigens; Architecture; Area; Automobile Driving; Caring; Cause of Death; Cessation of life; Characteristics; Clinic; Clinical; Cluster randomized trial; Cognitive; Complex; Country; Cryptococcus; Decision Making; Diagnosis; Disease; Drug resistance; Effectiveness; Emergency Situation; Environment; Exposure to; Goals; Guidelines; HIV; Health; Health Personnel; Hepatotoxicity; Immunization; Incidence; Individual; International; Intervention; Interview; Knowledge; Lead; Leadership; Liver; Maintenance; Measurement; Measures; Morbidity - disease rate; Outcome; Paper; Patient Self-Report; Patients; Pharmaceutical Preparations; Prevention; Preventive therapy; Procedures; Process; Provider; Questionnaires; Randomized; Recommendation; Reporting; Research; Research Priority; Risk; Services; South Africa; South African; Structure; System; Testing; Theory of Change; Time; Tuberculosis; Uncertainty; United States National Institutes of Health; Work; antiretroviral therapy; arm; base; behavioral economics; co-infection; cognitive load; compliance behavior; experience; forgetting; implementation strategy; improved; low and middle-income countries; mortality; patient oriented; prescription opioid; pressure; prevent; primary outcome; programs; provider-level barriers; randomized trial; recruit; theories; therapy adherence; trial comparing

PROJECT SUMMARY The availability of antiretroviral therapy (ART) has markedly reduced leading causes of HIV-related mortality and morbidity in Africa, including tuberculosis (TB). Yet TB remains the leading cause of death among people with HIV. Use of TB preventive therapy (TPT) reduces TB incidence and death, even among people receiving ART. Although the benefits of TPT among people with HIV have been known for 30 years and international and national guidelines provide clear prescribing recommendations, TPT is poorly prescribed. Overall in low and middle income countries 10-30% of people with HIV eligible for TPT receive it. For those who do receive TPT along with ART, adherence is generally good. Multiple system and provider level barriers appear to be driving anemic TPT prescribing. Several of these barriers have caused TPT prescribing to be the exception rather that the routine – barriers based on complex procedures implemented for inaccurate concerns. Primary among are efforts to completely “rule-out” active TB and concerns for potential liver problems with TPT. Notably, a study focused on more complex (and more sensitive) TB diagnosis resulted in increased mortality in the arm with greater TB diagnosis. That arm also had delayed and lower TPT prescribing. This study seeks to use choice architecture to make TPT prescribing the usual or “default” with not-prescribing occurring only when the clinician has a real concern (e.g. high concern for TB disease). The effectiveness of the choice architecture-based implementation strategy will be compared to the usual implementation in a cluster- randomized trial. Clinics will be the unit of randomization with all patients receiving services at a study clinic receiving uniform TPT implementation. The primary outcome will be the proportion of patients initiating ART who also receive TPT. The underlying concept of choice architecture is that optimizing decision making can lead to reduced cognitive load. Thus we propose to compare cognitive load regarding TPT prescribing between study arms. We will also assess congruence of the prescribing approach with clinic work flow, acceptability to providers, implementation measures, and patient-level implementation (e.g. receipt of TPT, adherence, patient reported problems). This study has the potential to lead the way in reshaping the delivery of TPT and other routine services in clinics in South Africa and similar settings. Should this implementation strategy prove effective it will contribute to national and global goals to reduce HIV-associated mortality and TB incidence.

项目概要 抗逆转录病毒疗法（ART）的出现显着减少了艾滋病毒相关死亡率的主要原因 以及非洲的发病率，包括结核病 (TB)。然而结核病仍然是人们死亡的主要原因 患有艾滋病毒。结核病预防治疗 (TPT) 的使用可降低结核病发病率和死亡率，即使是在接受结核病治疗的人群中也是如此 艺术。尽管 TPT 对 HIV 感染者的益处已为人所知 30 年，而且国际上也 尽管国家指南提供了明确的处方建议，但 TPT 的处方却很差。总体处于低位 在中等收入国家，10-30% 的艾滋病毒感染者有资格接受 TPT。对于那些确实收到的人 TPT 与 ART 一起，依从性总体良好。多个系统和提供商级别的障碍似乎是 驾驶贫血 TPT 处方。其中一些障碍导致 TPT 处方成为例外 而不是例行公事——基于因不准确的担忧而实施的复杂程序的障碍。基本的 其中包括完全“排除”活动性结核病的努力以及对 TPT 潜在肝脏问题的担忧。 值得注意的是，一项专注于更复杂（和更敏感）结核病诊断的研究导致死亡率增加 结核病诊断率较高的手臂。该组的 TPT 处方也延迟且较低。这项研究旨在 使用选择架构使 TPT 处方成为通常或“默认”处方，仅在以下情况下不处方： 临床医生确实关心（例如高度关注结核病）。选择的有效性 基于架构的实施策略将与集群中的通常实施进行比较 随机试验。诊所将是随机化的单位，所有患者都在研究诊所接受服务 接受统一的TPT实施。主要结果是开始 ART 的患者比例 也接受 TPT 的人。选择架构的基本概念是优化决策可以 导致认知负荷减轻。因此，我们建议比较 TPT 处方的认知负荷 研究武器。我们还将评估处方方法与临床工作流程的一致性、可接受性 提供者、实施措施和患者层面的实施（例如 TPT 的接收、依从性、患者水平） 报告的问题）。这项研究有可能在重塑 TPT 和其他药物的实施方面发挥引领作用。 南非和类似环境中诊所的常规服务。如果这个实施策略被证明 它将有助于实现降低艾滋病毒相关死亡率和结核病发病率的国家和全球目标。