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.

摘要 国际和南非指南建议对艾滋病毒感染者（PWH）进行结核病预防性治疗（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， 接受TPT的HIV感染者（PWH）的发病率和死亡率，以及推荐使用的指南， 建议接收的人与实际接收的人之间仍然存在很大差距， 完成一个TPT课程。世卫组织《2022年全球结核病报告》强调了在获得和提供方面日益扩大的差距 新型冠状病毒大流行加剧了TPT的风险。弥合这一差距的是南非和全球 要务随着最近的可用性和新的证据，TPT，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国家指导方针， 越来越迫切地需要探索新的患者友好型TPT提供模式，以告知方案 指导，导致更大的吸收，坚持，并完成TPT。艾滋病毒护理受益于 扩大“差别化护理提供”模式，鼓励社区提供护理， 诊所/设施访视、有限的实验室监测和任务转移治疗模式， 在社区环境中为稳定的成年人提供艾滋病毒护理。新出现的示范项目发现， 药物或PrEP可以由药剂师而不是临床医生安全有效地提供。这些 成功的艾滋病毒差别化治疗和预防模式可以转化为包括 结核病预防治疗。安全、有效、短期结核病预防性治疗的可用性， 监测要求表明，类似的基于社区的模式可能适用于提供类似的 必要的预防性治疗。 我们将探讨两种方法，使艾滋病毒差异化服务适应结核病预防。我们假设 接受社区提供的TPT的人完成TPT课程的比例高于接受社区提供的TPT的人。 接受标准临床TPT的患者。我们将进行一项随机对照试验， 在南方参与社区结核病筛查项目的人群中进行基于诊所的TPT治疗 非洲，并探讨参与者的原因，完成和未完成的定性研究。我们还将 对任务转移TPT实施的可行性和可接受性进行初步研究， 为低风险客户提供TPT。通过形成性研究、定性访谈 与护士，诊所运营经理和工作流程映射练习，我们将识别障碍， 药房助理任务转移TPT交付的促进者。总之，这项研究将为 用于后续更大规模的以患者为中心的差异化TPT给药方法试验，以增加TPT摄取 并在南非完成，最终降低结核病的发病率和死亡率。