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对艾滋病毒感染者 (PWH) 进行结核病预防治疗 (TPT) 以及其他结核病高危人群，包括结核病患者的密切接触者，尽管有证据表明这种情况有所减少。 接受 TPT 的 HIV 感染者 (PWH) 的发病率和死亡率以及建议使用的指南， 建议接受的人和实际接受的人之间仍然存在很大差距 完成 TPT 课程 2022 年世卫组织全球结核病报告强调了获取和提供方面日益扩大的差距。 南非和全球范围内的 TPT 问题因 COVID-19 大流行而加剧。 随着最近更新、更短的 TPT 治疗方案的出现和证据，艾滋病毒的转变。 护理提供模式（部分是由于 COVID-19 大流行）和不断发展的 TPT 国家指南， 越来越迫切需要探索新的患者友好的 TPT 交付模式，以便为规划提供信息 导致更多人接受、坚持和完成 TPT 的指导已受益于 TPT。 扩大“差异化护理服务”模式，鼓励社区提供护理， 诊所/设施就诊、有限的实验室监测和任务转移治疗模式，以提供全面的治疗 新兴的示范项目发现，对社区环境中稳定的成年人进行艾滋病毒护理可以预防艾滋病毒。 药物治疗（PrEP）可以由药剂师而不是牧师安全有效地提供。 差异化艾滋病毒治疗和预防的成功模式可以转化为包括 结核病预防治疗。安全、有效、短期结核病预防治疗的可用性有限。 需求监控表明，可以采用类似的基于社区的模型来提供类似的服务 防止必要的治疗。 我们将探索将艾滋病毒差异化服务应用于结核病预防的两种方法。 接受社区提供的 TPT 课程的完成率高于普通人 我们将对社区与社区进行随机对照试验。 在南部地区参与社区结核病筛查项目的人群中开展基于临床的 TPT 非洲，并通过定性研究探讨参与者完成和未完成的原因。 对任务转移 TPT 实施的可行性和可接受性进行初步研究，让临床参与 药房助理通过形成性研究、定性访谈为低风险客户提供 TPT。 与护士、诊所运营经理和工作流程映射练习一起，我们将找出障碍并 这项研究将为药房助理任务转移 TPT 交付的促进者共同奠定基础。 用于后续以患者为中心的、差异化的 TPT 递送方法的更大规模试验，以增加 TPT 的吸收 并在南非完成，并最终降低结核病的发病率和死亡率。