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: 10115605
• 负责人: CHRISTOPHER J HOFFMANN
• 金额: $ 61.08万
• 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/10115605
• 关键词: Acquired Immunodeficiency Syndrome; Address; Adherence; Adoption; Adult; Advocacy; Africa; Africa South of the Sahara; 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; Morbidity - disease rate; Outcome; Paper; Patient Self-Report; Patients; Pharmaceutical Preparations; Prevention; Preventive therapy; Procedures; Process; Provider; Questionnaires; Randomized; Reach, Effectiveness, Adoption, Implementation, and Maintenance; 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; antigen test; antiretroviral therapy; arm; base; behavioral economics; co-infection; cognitive load; compliance behavior; experience; forgetting; implementation fidelity; implementation intervention; implementation measures; implementation process; 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.

项目摘要 抗逆转录病毒疗法的提供显著减少了艾滋病毒相关死亡的主要原因 和非洲的发病率，包括结核病（TB）。然而，结核病仍然是人类死亡的主要原因 感染了艾滋病毒使用结核病预防性治疗（TPT）降低了结核病的发病率和死亡率，即使在接受 条尽管TPT在艾滋病毒感染者中的益处已经被知道了30年， 国家指南提供了明确的处方建议，TPT的处方很差。总体偏低 在中等收入国家，10-30%符合TPT条件的艾滋病毒感染者接受了TPT。 TPT沿着ART，依从性一般良好。多个系统和提供商级别的障碍似乎是 开贫血的TPT处方其中一些障碍导致TPT处方成为例外 而不是常规-基于复杂程序的障碍，这些程序是为了不准确的问题而实施的。初级 其中包括努力完全“排除”活动性结核病和对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）的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。该手臂也有延迟和较低的TPT处方。本研究旨在 使用选择体系结构，使TPT处方通常或“默认”，只有当 临床医生具有真实的关注（例如，对TB疾病的高度关注）。选择的有效性 将基于架构的实施策略与集群中的通常实施进行比较- 随机试验诊所将是随机化单位，所有患者均在研究诊所接受服务 实现统一的TPT。主要结果将是开始ART的患者比例 他们也接受TPT。选择架构的基本概念是，优化决策可以 导致认知负荷降低。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诊所工作流程的一致性， 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 报告的问题）。这项研究有可能在重塑TPT和其他 在南非的诊所和类似场所提供常规服务。如果这一实施战略证明 如果有效，它将有助于实现减少艾滋病毒相关死亡率和结核病发病率的国家和全球目标。