New pathways to prevention from community TB screening in South Africa

南非社区结核病筛查预防的新途径

• 批准号: 10760095
• 负责人: ADRIENNE E SHAPIRO
• 金额: $ 20.76万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-13 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10760095
• 关键词: Adherence; Adopted; Adult; Adverse effects; COVID-19 pandemic; Caring; Cessation of life; Client; Clinic; Clinical; Communicable Diseases; Communities; Community Trial; Data; Decentralization; Dose; Drug resistance in tuberculosis; Effectiveness; Eligibility Determination; Exercise; Focus Groups; Foundations; Friends; Guidelines; HIV; Incidence; Individual; International; Interview; Laboratories; Maps; Measures; Methods; Modeling; Monitor; Morbidity - disease rate; Nurses; Participant; Pathway interactions; Patient Self-Report; Patients; Persons; Pharmaceutical Preparations; Pharmacists; Pharmacy facility; Population; Prevention; Preventive; Preventive therapy; Preventive treatment; Public Sector; Qualitative Research; Randomized; Randomized, Controlled Trials; Recommendation; Regimen; Reporting; Research; Risk; Safety; Schedule; Serum; Service delivery model; Services; South Africa; South African; Surveys; System; Therapeutic Studies; Time; Toxic effect; Translating; Travel; Treatment Protocols; Triage; Tuberculosis; Tuberculosis diagnosis; Visit; World Health Organization; acceptability and feasibility; community setting; cost; experience; gaps in access; health care delivery; high risk; implementation science; implementation strategy; improved; innovation; intervention refinement; isoniazid; mortality; participant interview; patient oriented; pill; pre-exposure prophylaxis; prevent; preventable death; programs; response; rifapentine; scale up; screening; screening program; service delivery; standard of care; supply chain; therapy adherence; therapy design; trial comparing; uptake; willingness

ABSTRACT International and South African guidelines recommend TB preventive therapy (TPT) for people with HIV (PWH) and other people at high risk for TB, including close contacts of people with TB. Despite the evidence for reduced morbidity and mortality for people with HIV (PWH) who receive TPT, and guidelines recommending use, there remains a substantial gap between people recommended to receive and people who actually receive and complete a course of TPT. The 2022 WHO Global TB Report highlighted the growing gap in access and provision of TPT, which has been aggravated by the COVID-19 pandemic. Bridging this gap is a South African and global priority. With the recent availability and evidence for newer, shorter regimens of TPT, a transformation of HIV care delivery models (in part forced by the COVID-19 pandemic) and evolving national guidelines for TPT, it is increasingly urgent to explore new patient-friendly models of TPT delivery in order to inform programmatic guidance that results in greater uptake, adherence, and completion of TPT. HIV care has benefited from the expansion of “differentiated care delivery” models, which encourage community-delivered care, infrequent clinic/facility visits, limited laboratory monitoring, and task-shifted treatment models to deliver comprehensive HIV care to stable adults in community settings. Emerging demonstration projects have found that HIV preventive medication, or PrEP, can be safely and effectively delivered by pharmacists rather than clinicians. These successful models for differentiated HIV treatment and prevention delivery may be able to be translated to include TB preventive therapy. The availability of safe, effective, short-course TB preventive therapy with limited monitoring requirements suggests that similar community-based models may be adapted to provide this similarly essential preventive treatment. We will explore two approaches of adapting HIV differentiated services to TB prevention. We hypothesize that people who receive community-delivered TPT have higher rates of completion of a course of TPT than people who receive standard-of-care clinic-based TPT. We will conduct a randomized controlled trial of community vs. clinic-based TPT delivery among people participating in a community-based TB screening program in South Africa, and explore participant reasons for completion and noncompletion with qualitative research. We will also conduct preliminary research on the feasibility and acceptability of task-shifted TPT delivery, engaging clinic- based pharmacy assistants to provide TPT to low-risk clients. Through formative research, qualitative interviews with nurses, clinic operational managers, and workflow mapping exercises, we will identify barriers and facilitators for pharmacy assistant task-shifted TPT delivery. Together, this research will establish the foundation for subsequent larger trials of patient-centered, differentiated TPT delivery approaches to increase TPT uptake and completion in South Africa and ultimately decrease morbidity and mortality from TB.

抽象的 国际和南非指南建议针对艾滋病毒患者（PWH）的结核病预防疗法（TPT） 以及其他有TB风险高的人，包括结核病患者的密切联系。尽管有减少的证据 接受TPT的艾滋病毒（PWH）患者的发病率和死亡率，并建议使用指南 仍然是建议接收的人与实际接收的人之间的巨大差距 完成TPT课程。 2022年全球结核病报告强调了访问和提供的差距不断增长 TPT，由COVID-19的大流行汇总。弥合这一差距是南非和全球 优先事项。有了最近的可用性和较新的TPT方案的证据，艾滋病毒的转变 护理交付模型（部分是由COVID-19大流行迫使的）和不断发展的TPT的国家准则 越来越迫切需要探索新的患者友好型TPT交付模型，以便为程序化提供信息 导致TPT的摄取，依从性和完成的指导。艾滋病毒护理从中受益 扩展“差异化护理交付”模型，这些模型鼓励社区提供护理，不经常 诊所/设施访问，有限的实验室监测和任务迁移治疗模型，以提供全面的 在社区环境中，艾滋病毒照顾稳定的成年人。新兴示范项目发现艾滋病毒预防性 药剂师而不是临床医生可以安全有效地提供药物或准备。这些 差异化的艾滋病毒治疗和预防交付的成功模型可以翻译成 结核病预防疗法。有限 监视要求表明，类似的基于社区的模型可能会适应类似的方式 必不可少的预防治疗。 我们将探讨将艾滋病毒差异化服务适应结核病预防的两种方法。我们假设这一点 接受社区交付的TPT的人比人更高的TPT完成率 接受基于护理标准诊所的TPT的人。我们将对社区与随机对照试验进行。 在南方参加基于社区的结核病筛查计划的人中，基于诊所的TPT交付 非洲，并通过定性研究来探索参与者完成和违规的原因。我们也会 进行有关任务转移TPT递送的可行性和可接受性的初步研究，吸引了诊所 基于药房的助理为低风险客户提供TPT。通过形成性研究，定性访谈 通过护士，诊所运营经理和工作流程映射练习，我们将确定障碍和 药房助理任务切换的TPT交付的主持人。这项研究将共同​​建立基础 随后对以患者为中心的，分化的TPT输送方法进行的更大的试验，以增加TPT的吸收 并在南非完成，并最终降低了结核病的发病率和死亡率。