Flexible InteRvention Strategy for TB prevention (FIRST) study

项目总结 儿童严重的结核病负担，他们有很大的风险迅速发展为严重的结核病和 死亡，要求实施有效的结核病预防治疗(TPT)，这是缓解 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负担高的环境中预防儿童结核病的管理(CCM)方法。然而， 在资源少、结核病发病率高的国家实施CCM所面临的挑战危及其成功。CCM 传统上是在卫生机构提供的，但鉴于以设施为基础的CCM战略取得的有限成功， 还需要其他实施模式。为了克服获得护理和耻辱等挑战， 对基于社区的CCM策略的使用越来越感兴趣，这需要进行筛查和 在社区中提供TPT。患者参与医疗选择，例如在哪里接受服务， 已经受到限制，特别是在资源不足的情况下。然而，这种情况正在改变，因为人们意识到 患者参与决策可能会改善医疗保健的质量和结果。 在我目前的K01(预防研究)的基础上，我评估了一项仅基于社区的干预措施 部分有效，并利用我目前的R21(保护研究)的初步结果，在那里我发现 即使在同一社区内，不同家庭对幼儿成功实施CCM的障碍也不尽相同。 提出结核病预防弹性干预策略(一)研究。这项研究将对一个家庭进行试点测试- 以中心为中心的灵活的CCM模式，在这种模式下，家庭可以选择是否希望他们的孩子接受设施- 或以社区为基础的结核病预防服务。第一架将由现有公司在Eswatini的Manzini地区交付 结核病服务人员(主动病例探查员[ACFS]和护士)到所有接触儿童的家庭，接受培训， 由研究的护士导师提供的指导和质量保证。干预措施将包括家庭- 与索引结核病患者和儿童接触者的家人集中讨论并分享决策。CCM 级联步骤可在卫生设施和/或社区提供，但TPT启动将在#年进行 卫生设施。护士导师将每月对项目指标进行审查，并提供结构化的 向包括护士和ACF在内的医疗保健提供者提供反馈。将采用参与式合作方式 与利益攸关方共同细化首个干预策略，并在试点中检验其可行性和可接受性。 通过使用创新工具进行有效的CCM可能会对儿童结核病的发病率产生重大影响 在埃斯瓦蒂尼和其他结核病和艾滋病毒感染率高的环境中，儿童特别容易受到感染。这个 拟议的研究是我的K01和R21支持的研究的自然进展，并将导致独立的 调查路线，因为试点测试的结果将使我能够提交更大集群的R01 在埃斯瓦蒂尼评估FIRST的有效性、成本效益和可接受性的随机试验。

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.