Flexible InteRvention Strategy for TB prevention (FIRST) study

项目摘要 儿童结核病负担沉重，他们面临迅速发展为严重结核病的巨大风险， 需要实施有效的结核病预防性治疗（TPT），这对于减轻 儿童结核病相关发病率和死亡率。世界卫生组织建议儿童接触 在结核病和艾滋病毒高负担环境中预防儿童结核病的CCM方法。然而，在这方面， 在资源匮乏、结核病高发国家实施CCM面临的挑战危及其成功。CCM 传统上是在卫生机构提供的，但鉴于基于机构的CCM战略取得的成功有限， 需要其他实施模式。为了克服获得护理和污名化等挑战， 越来越多的人对使用以社区为基础的CCM战略感兴趣，这需要进行筛查， 在社区提供TPT。患者参与医疗保健选择，例如在哪里接受服务， 尤其是在资源匮乏的环境中。然而，随着人们认识到， 患者参与决策可以提高医疗保健的质量和结果。 在我目前的K 01（预防研究）的基础上，我评估了一项基于社区的干预措施， 部分有效，并利用我目前的R21（RBT研究）的初步结果，我发现， 幼儿成功CCM的障碍因家庭而异，即使在同一社区内， 提出结核病预防灵活干预策略（FIRST）研究。这项研究将试点测试一个家庭- 以灵活的CCM模式为中心，家庭选择是否希望其子女接受设施， 或社区结核病预防服务。FIRST将在斯威士兰的曼齐尼地区交付， 向所有儿童接触者家庭提供结核病服务人员（主动病例发现者[ACF]和护士），并接受培训， 指导，并由研究的护士导师提供质量保证。干预将包括家庭- 与指示结核病患者和儿童接触者的家人进行集中讨论并共同决策。CCM 可以在卫生机构和/或社区提供级联步骤，但TPT启动将在 卫生设施。护士导师将每月审查计划指标，并提供结构化的 反馈给医疗保健提供者，包括护士和ACF。将采用参与式合作办法 与利益攸关方一起完善FIRST干预战略，并对其可行性和可接受性进行试点测试。 通过使用创新工具进行有效的CCM可对儿童结核病发病率产生重大影响 无论是在斯威士兰还是在结核病和艾滋病毒感染率高的其他地区，儿童都特别容易受到感染。的 拟议的研究是我的K 01和R21支持的研究的自然进展，将导致一个独立的 作为调查的一部分，试点测试的结果将使我能够提交更大群集的R 01 一项随机试验，评价FIRST在斯威士兰的有效性、成本效益和可接受性。

PROJECT SUMMARY The significant TB burden in children, who are at great risk of progressing rapidly to severe TB disease and death, demands implementation of effective TB preventive treatment (TPT), which is paramount in mitigating TB-related morbidity and mortality in children. The World Health Organization recommends the Child Contact Management (CCM) approach to preventing TB in children in high TB and HIV burden settings. However, challenges to CCM implementation in low-resource, high TB incidence countries jeopardize its success. CCM has traditionally been delivered at health facilities, but given the limited success of facility-based CCM strategies, other implementation models are needed. To overcome challenges such as access to care and stigma, there has been a growing interest in the use of community-based CCM strategies, which entails both screening and TPT provision in the community. Patients’ involvement in healthcare choices, such as where to receive services, has been limited, especially in low-resource settings. However, this is changing with the realization that increased patient participation in decision-making may improve the quality and outcome of healthcare. Building off my current K01 (PREVENT study), where I evaluated a community-based intervention that was only partially effective, and utilizing preliminary results from my current R21 (PROTECT study), where I found that barriers to successful CCM for young children vary from family to family even within the same community, I propose the Flexible InteRvention Strategy for TB prevention (FIRST) study. This study will pilot test a family- centered flexible CCM model in which families choose whether they would like their children to receive facility- or community-based TB prevention services. FIRST will be delivered in the Manzini region of Eswatini by existing TB service personnel (Active Case Finders [ACFs] and nurses) to all families of child contacts, with training, mentoring, and quality assurance provided by the study’s Nurse Mentor. The intervention will include family- centered discussions and shared decision-making with the index TB patient and the child contact’s family. CCM cascade steps may be delivered at health facilities and/or in the community but TPT initiation will take place in health facilities. The Nurse Mentor will conduct monthly reviews of program indicators and provide structured feedback to healthcare providers, including nurses and ACFs. A participatory collaborative approach will be used with stakeholders to refine the FIRST intervention strategy and pilot test its feasibility and acceptability. Effective CCM through use of innovative tools could have substantial impact on morbidity from childhood TB both in Eswatini and in other settings with high TB and HIV rates, where children are particularly vulnerable. The proposed study is a natural progression of my K01- and R21-supported research and will lead to an independent line of investigation as the results from the pilot test will enable me to submit an R01 of a larger cluster randomized trial evaluating the effectiveness, cost-effectiveness, and acceptability of FIRST in Eswatini.