Preventing Childhood Tuberculosis in Lesotho (PREVENT Study)

莱索托预防儿童结核病（预防研究）

• 批准号: 9060835
• 负责人: Yael R Hirsch-Moverman
• 金额: $ 12.36万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-06-15 至 2019-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9060835
• 关键词: 15 year old; Address; Adopted; Adult; Affect; Africa South of the Sahara; Age; Area; Attention; Caring; Cause of Death; Child; Childhood; Clinic; Clinical; Cluster randomized trial; Collection; Communicable Diseases; Communities; Community Outreach; Complex; Contact Tracing; Country; Data; Data Analyses; Data Collection; Disease; Effectiveness; Eligibility Determination; Ensure; Epidemic; Evaluation; Evidence based intervention; Focus Groups; Funding; Gender; Goals; Guidelines; HIV; Health; Health Personnel; Health Services; Health care facility; Household; Human immunodeficiency virus test; Incidence; Infection; Intervention; Interview; Knowledge; Lead; Lesotho; Life; Link; Mentored Research Scientist Development Award; Mentors; Methodology; Methods; Modeling; Morbidity - disease rate; Patients; Personal Satisfaction; Persons; Phase; Policies; Population; Prevalence; Prevention; Preventive therapy; Provider; Qualitative Methods; Qualitative Research; Randomized; Recommendation; Research; Research Infrastructure; Research Personnel; Research Training; Resources; Risk; Risk Factors; Services; Site; Southern Africa; Stratification; Symptoms; Testing; Training; Training Programs; Tuberculosis; United States National Institutes of Health; Village Health Workers; Woman; Work; World Health Organization; arm; base; burden of illness; career; compare effectiveness; cost effective; design; effective intervention; experience; follow-up; high risk; improved; informant; innovation; isoniazid; killings; mortality; neglect; novel; post intervention; prevent; programs; psychosocial; reproductive; scale up; screening; skills; standard of care; success; treatment strategy; trial design

DESCRIPTION (provided by applicant): In submitting this NIH Mentored Research Scientist Development Award, my overarching goal is to become an independent investigator focused on developing and testing feasible, effective interventions to prevent tuberculosis (TB) in children i resource-limited settings. This field of inquiry is critically important given the unprecedented hih pediatric TB rates in countries with high HIV prevalence and the limited availability of interventions to reduce the TB burden among children. Although TB is curable and preventable, studies have demonstrated higher mortality and morbidity in young children, particularly in HIV-infected children, highlighting the importance of preventing TB in this population. Effective interventions to inform policy and program design are urgently needed so that TB can be prevented in this population in high HIV/TB-burden, resource-limited settings. My long-term career goal is to apply acquired knowledge and experience from pediatric TB research to other infectious diseases and ultimately other conditions that affect children and threaten their well-being. The purpose of this K01 application is to propose a research and training program that will facilitate attainment of these goals. My immediate goal is to develop and test an intervention to reduce childhood TB in Lesotho, a small country in southern Africa with a substantial TB/HIV disease burden. As with many resource-limited countries, particularly in sub-Saharan Africa, there is limited implementation of proven tracing, screening, and treatment strategies for child contacts of adult TB in Lesotho. The proposed study will be situated within ICAP's established Lesotho programs, which aim to strengthen TB/HIV integration at national, district, facility, and community levels and which are led by co-mentor Dr. Andrea Howard. Using ICAP's extensive Lesotho infrastructure will enable me to lead and conduct this vital study in a timely, cost-effective manner and, most importantly, in partnership with TB control entities in-country. The study will utilize a two-arm cluster randomized trial design, randomized at health facility level, o evaluate the effectiveness and acceptability of a community-based intervention (CBI) versus standard of care (SOC) to identify child contacts of adult TB cases in Mafeteng, Lesotho, and provide them with isoniazid preventive therapy (IPT), as indicated. Ten health centers will be included in the study and randomized to deliver the CBI or SOC, with stratification by facility siz (i.e., number of registered TB patients). CBI includes structural, clinical, and psychosocial components to address the challenges faced by healthcare workers (HCW), children, and guardians in provision of IPT for child contacts. At CBI sites, HCW and village health workers (VHW) will be trained to deliver study components to adult TB cases and their child contacts. SOC sites will follow country guidelines for contact tracing, screening, and IPT provision. CBI includes 3 components to maximize effect: 1) provider training on active community contact tracing, evaluating child contacts for IPT eligibility, and IPT provision; 2) specific intervention for children and guardians on the importance of child screening, initiating and completing IPT, and HIV testing and linkage to care for HIV-infected children; and 3) community outreach teams of VHW working in concert with facility-based teams. The study will have a strong qualitative research component, which includes pre- and post-intervention focus group discussions and post-intervention guardian key informant interviews. Using a sequential explanatory phase, where quantitative data collection and analysis is followed by collection and analysis of qualitative data that may help explain previous-phase results, will permit evaluation of provider and guardian acceptability and utilization of intervention components. My research and complementary training plan will allow me to acquire the skills and knowledge to become a productive, independent investigator able to design and evaluate interventions to prevent TB in children in high TB/HIV-burden, resource-limited settings. Effective, evidence-based interventions to prevent childhood TB in such settings are urgently needed. In the proposed study, innovative methodology will assess effectiveness and acceptability of a CBI that holistically addresses the complex provider-, patient-, and guardian-related barriers to prevention of childhood TB. It is anticipated that using a feasible community-based model of care will improve TB prevention in young, vulnerable children. The study will provide evidence for the feasible implementation and scale-up of IPT provision in children while integrating much-needed TB and HIV services in children.

描述(由申请人提供)：通过提交NIH导师研究科学家发展奖，我的首要目标是成为一名独立调查员，专注于开发和测试可行、有效的干预措施，以在资源有限的环境中预防儿童结核病(TB)。这一调查领域至关重要，因为艾滋病毒高流行率国家的HIH儿科结核病发病率史无前例，而且减少儿童结核病负担的干预措施有限。虽然结核病是可治愈和可预防的，但研究表明，幼儿死亡率和发病率较高，特别是感染艾滋病毒的儿童，这突出了在这一人群中预防结核病的重要性。迫切需要有效的干预措施，为政策和方案设计提供信息，以便在艾滋病毒/结核病负担高、资源有限的情况下，在这一人群中预防结核病。我的长期职业目标是将从儿科结核病研究中获得的知识和经验应用于其他传染病，并最终应用于影响儿童并威胁他们福祉的其他疾病。这份K01申请的目的是提出一个研究和培训计划，以促进这些目标的实现。我的直接目标是开发和测试一种干预 为了减少莱索托的儿童结核病，莱索托是南部非洲的一个小国，结核病/艾滋病毒疾病负担很大。与许多资源有限的国家一样，特别是在撒哈拉以南非洲，莱索托对成年结核病儿童接触者的追踪、筛查和治疗战略的实施有限。这项拟议的研究将在ICAP已建立的莱索托项目范围内进行，该项目旨在加强国家、地区、设施和社区层面的结核病/艾滋病毒整合，由共同导师Andrea Howard博士领导。利用ICAP广泛的莱索托基础设施将使我能够及时、具有成本效益地领导和开展这项重要研究，最重要的是与该国的结核病控制实体建立伙伴关系。这项研究将利用在卫生设施水平随机进行的双臂整群随机试验设计，评估社区干预(CBI)与护理标准(SOC)的有效性和可接受性，以确定莱索托Mafeteng成人结核病病例的儿童接触者，并根据指示为他们提供异烟肼预防治疗(IPT)。10个卫生中心将被纳入这项研究，并随机提供CBI或SOC，按设施规模(即登记的结核病患者数量)分层。CBI包括结构、临床和心理社会部分，以应对医护人员(HCW)、儿童和监护人在为儿童接触提供IPT方面面临的挑战。在CBI地点，将对卫生保健工作者和乡村卫生工作者进行培训，以便向成人结核病病例及其儿童接触者提供研究内容。SOC网站将遵循接触者跟踪、筛选和IPT规定的国家指南。CBI包括3个组成部分，以最大限度地发挥作用：1)关于积极社区接触者追踪的提供者培训，评估儿童接触者的IPT资格，以及提供IPT；2)对儿童和监护人进行具体干预，了解儿童筛查、启动和完成IPT以及艾滋病毒检测和联系以照顾艾滋病毒感染儿童的重要性；以及3)vHW社区外展团队与设施团队合作。这项研究将有很强的定性研究部分，包括干预前和干预后的焦点小组讨论和干预后的监护人关键线人访谈。使用顺序解释阶段，在定量数据收集和分析之后，收集和分析定性数据，这可能有助于解释前一阶段的结果，这将允许对干预措施组成部分的提供者和监护人的可接受性和利用率进行评估。我的研究和补充培训计划将使我能够获得技能和知识，成为一名富有成效的独立调查员，能够设计和评估干预措施，在结核病/艾滋病毒负担高、资源有限的环境中预防儿童结核病。迫切需要在这种环境中采取有效的循证干预措施来预防儿童结核病。在拟议的研究中，创新的方法将评估CBI的有效性和可接受性，该CBI全面解决预防儿童结核病的提供者、患者和监护人相关的复杂障碍。预计使用一种可行的以社区为基础的护理模式将改善对年幼、脆弱儿童的结核病预防。这项研究将为在儿童中整合急需的结核病和艾滋病毒服务的同时，在儿童中实施和扩大IPT服务的可行性提供证据。