Preventing Childhood Tuberculosis in Lesotho (PREVENT Study)

莱索托预防儿童结核病（预防研究）

• 批准号: 8732171
• 负责人: Yael R Hirsch-Moverman
• 金额: $ 12.78万
• 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/8732171
• 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; Clinical Trials Design; 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; 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; public health relevance; randomized trial; reproductive; scale up; screening; skills; standard of care; success; treatment strategy

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）：在提交NIH指导的研究科学家发展奖时，我的总体目标是成为一名独立的研究者，致力于开发和测试可行，有效的干预措施，以防止在儿童I资源有限的环境中进行结核病（TB）。鉴于艾滋病毒率高的国家史无前例的HIH小儿结核病率且干预措施的可用性有限，以减轻儿童的结核病负担，因此这种调查领域至关重要。尽管结核病是可以治愈和可预防的，但研究表明，幼儿，尤其是在艾滋病毒感染的儿童中的死亡率和发病率更高，强调了预防该人群中结核病的重要性。迫切需要有效的干预措施来为政策和计划设计提供信息，以便在高艾滋病毒/结核病 - 荷里，资源有限的设置中可以防止结核病。我的长期职业目标是将所获得的知识和经验从小儿结核病研究中运用到其他传染病，最终会影响儿童并威胁他们的幸福感。该K01应用程序的目的是提出一项研究和培训计划，以促进这些目标。我的直接目标是开发和测试干预措施 减少莱索托的儿童结核病，莱索托（Lesotho）是南部非洲的一个小国家，具有强大的结核病/艾滋病毒疾病负担。与许多资源有限的国家，特别是在撒哈拉以南非洲的国家一样，对莱索托成人结核病儿童接触的经过验证的追踪，筛查和治疗策略的实施有限。拟议的研究将位于ICAP既定的Lesotho计划中，该计划旨在加强国家，地区，设施和社区层面的结核病/HIV整合，并由联盟Andrea Howard博士领导。使用ICAP广泛的莱索托基础设施将使我能够及时，具有成本效益的方式领导和进行这项重要研究，最重要的是，与结核病控制实体合作。该研究将利用两臂聚类随机试验设计，在医疗机构水平上随机分配，o评估基于社区的干预措施（CBI）与护理标准（SOC）的有效性和可接受性，以识别Mafeteng，Lesotho中成人TB病例的儿童接触，并为其提供Isoniaiazid预防疗法（IPT）（IPT）。该研究将包括十个健康中心，并随机分配CBI或SOC，并通过设施SIZ分层（即注册结核病患者数量）。 CBI包括结构，临床和社会心理组件，以应对医疗保健工人（HCW），儿童和监护人在提供儿童接触IPT方面面临的挑战。在CBI站点，HCW和乡村卫生工作者（VHW）将接受培训，以向成人结核病案件及其儿童接触提供学习组件。 SOC网站将遵循国家的联系，筛选和IPT规定的指南。 CBI包括3个组件，以最大程度地提高效果：1）提供者对积极的社区联系跟踪的培训，评估儿童联系人的IPT资格以及IPT Provision； 2）针对儿童和监护人的具体干预，就儿童筛查，启动和完成IPT的重要性以及艾滋病毒测试和联系以照顾感染了艾滋病毒的儿童； 3）VHW的社区外展团队与基于设施的团队合作。这项研究将具有强大的定性研究部分，其中包括干预前和后的焦点小组讨论和干预后的监护人关键的知情人访谈。使用顺序解释阶段，其中定量数据收集和分析随后是对定性数据的收集和分析，这些数据可能有助于解释以前的相期结果，将允许评估提供者和监护人的可接受性以及干预组件的利用。我的研究和补充培训计划将使我能够获得技能和知识，成为一名能够设计和评估干预措施的富有成效的独立研究人员，以防止在高结核病/艾滋病毒 - 艾滋病毒 - 荷兰人中的儿童中结核病，资源有限的设置。迫切需要采取有效的，基于证据的干预措施，以防止这种情况下的儿童结核病。在拟议的研究中，创新方法将评估CBI的有效性和可接受性，该CBI可以全面地解决复杂的提供者，患者和监护人相关的障碍，以预防儿童结核病。预计，使用可行的社区护理模型将改善年轻，脆弱儿童的结核病预防。该研究将为儿童中IPT规定的可行实施和规模扩大提供证据，同时将急需的结核病和艾滋病毒服务整合在儿童中。