Patient-centered intervention to prevent tuberculosis among children < 5 years old

以患者为中心的干预措施预防 5 岁以下儿童结核病

• 批准号: 10341112
• 负责人: Larissa Otero
• 金额: $ 13.3万
• 依托单位: UNIVERSIDAD PERUANA CAYETANO HEREDIA
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-16 至 2024-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10341112
• 关键词: 5 year old; Adherence; Adult; Affective; Aftercare; Americas; Area; Award; Behavior Therapy; Behavioral; Cessation of life; Child; Child health care; Childhood; Clinic; Cluster randomized trial; Cognitive; Communities; Counseling; Data; Data Analyses; Diagnosis; Discipline; Disease; Education; Educational Intervention; Educational Materials; Effectiveness of Interventions; Evaluation; Exposure to; Failure; Fostering; Funding; Funding Mechanisms; Goals; Grant; Health; Health Personnel; Health Policy; Health Promotion; Health system; Household; Incentives; Incidence; Income; Institution; International; Intervention; K-Series Research Career Programs; Knowledge; Measures; Mentors; Mentorship; Morbidity - disease rate; Motivation; Outcome; Pamphlets; Participant; Pediatrics; Persons; Peru; Pharmaceutical Preparations; Prevention; Prevention trial; Preventive; Preventive therapy; Preventive treatment; Qualitative Methods; Randomized; Randomized Controlled Trials; Regimen; Reporting; Research; Research Personnel; Research Proposals; Research Training; Risk; Sampling; Sea; Testing; Text Messaging; Time; Training; Training Support; Treatment Efficacy; Tuberculosis; Tuberculosis diagnosis; Urine; World Health Organization; Writing; acceptability and feasibility; arm; base; career; design; design verification; eHealth; effective intervention; effectiveness evaluation; effectiveness study; efficacy testing; experience; field study; global health; health communication; high risk; implementation science; improved; intervention delivery; isoniazid; mHealth; mobile computing; mortality; multidisciplinary; patient oriented; prevent; prevention evaluation; recruit; responsible research conduct; risk perception; routine care; skills; standard of care; systematic review; theories; therapy adherence; tool; treatment arm; treatment trial; tuberculosis treatment

Summary Isoniazid preventive therapy (IPT) reduces the risk of tuberculosis in over 60%. Young children are at higher risk of developing severe forms of TB, though this can be prevented with a full course of IPT. Preliminary data from the study districts indicate that 70% of eligible children start IPT, and 30% complete it. Counseling to caretakers to complete IPT depends on the knowledge, motivation and time of the research staff. Caretakers have a limited understanding of the importance of IPT and the higher risk of TB in the young child. Very few interventions have evaluated strategies to improve IPT completion among children. This career development award seeks 1) to design and validate three tools: an educational booklet for caretakers, SMS reminders to be sent weekly throughout the 24 week IPT course, a children storybook to be given in weekly installments throughout the 24 week IPT course and 2) test the efficacy of an intervention combining the three tools in increasing IPT completion and determine its acceptability and feasibility. The design and validation will be done using qualitative methods and an iterative approach with direct participation of the intended audience (caretakers and children) and the health care workers. A pilot randomized control trial will determine the efficacy of the combined intervention. I will recruit 60 caretakers and children and randomize them (1:1) to an intervention (receives the three tools) and control (standard of care) group. I will follow them up throughout the duration of the six months course. Intermediate outcomes will be the presence of isoniazid in urine, and the reach and fidelity in the delivery of the intervention. The results will inform the design of a cluster-randomized trial to study the effectiveness of the combined intervention to prevent pediatric TB, and submit it for R01 funding. If successful, it would deliver a scalable approach to reduce pediatric TB. I will be supported by a multi-disciplinary mentoring team whose expertise span the disciplines related to my career plan: Tuberculosis treatment and prevention trials and evaluation of interventions (Dr. Sterling), pediatrics studies (Dr. Ochoa), qualitative methods and health promotion (Dr. Bayer), implementation science, (Dr. Zunt), TB prevention and control in Peru (Dr. Seas), evaluation of interventions and quantitative data analysis (Dr. Van der Stuyft). With them, I have designed a training plan to fill the gaps in knowledge and skills I need to succeed in my goals. I will get additional training in health promotion, mobile health, health communication, evaluation of interventions and implementation science. I will also acquire skills in grant writing and I will pursue continuous training in responsible conduct of research. This mentored research training support will enable me to achieve my goal of becoming a leading global health researcher at Universidad Peruana Cayetano Heredia, actively collaborating with top international institutions and fostering health policies with rigorous evidence.

总结 异烟肼预防性治疗（IPT）可降低60%以上的结核病风险。幼儿在 更高的风险发展严重形式的结核病，虽然这可以预防与一个完整的过程IPT。 来自研究地区的初步数据表明，70%符合条件的儿童开始了IPT，30%完成了IPT。 辅导照顾者完成IPT取决于知识，动机和时间的研究 工作人员看护者对IPT的重要性和年轻人患结核病的风险较高的认识有限 孩子很少有干预措施评估了提高儿童完成IPT的战略。这个职业 发展奖寻求1）设计和验证三个工具：一个教育小册子的照顾者，短信 在24周的IPT课程中每周发送提醒，每周提供儿童故事书 在24周的IPT课程中分期进行，2）测试结合三种干预措施的有效性 提高IPT完成率的工具，并确定其可接受性和可行性。设计和验证将 使用定性方法和迭代方法，并让目标受众直接参与 （照顾者和儿童）和卫生保健工作者。一项初步随机对照试验将确定 综合干预的效果。我将招募60名照顾者和儿童，并将他们随机（1：1）分配到一个 干预组（接受三种工具）和对照组（标准护理）。我将在整个 为期六个月的课程。中间结果将是尿液中存在异烟肼， 在干预的交付中达到和忠实。研究结果将为设计一个集群随机 研究联合干预预防儿童结核病的有效性的试验，并提交R01 经费如果成功，它将提供一种可扩展的方法来减少儿童结核病。 我将得到一个多学科指导团队的支持，该团队的专业知识涵盖相关学科， 我的职业规划：结核病治疗和预防试验和干预措施的评价（斯特林博士）， 儿科研究（Ochoa博士），定性方法和健康促进（Bayer博士），实施科学， (Dr. Zunt）、秘鲁的结核病预防和控制（Seas博士）、干预措施评价和定量数据 分析（货车德施图夫特博士）。与他们一起，我设计了一个培训计划，以填补知识和技能的空白 我必须成功地实现我的目标。我将接受健康促进、移动的健康、健康 沟通、干预措施评价和执行科学。我还将获得撰写拨款的技能 我将继续接受负责任的研究培训。这指导了研究培训 支持将使我能够实现我的目标，成为一个领先的全球健康研究员在大学 Peruana Cayetano Heredia，积极与顶级国际机构合作，促进卫生政策 严格的证据。

项目成果

Recurrent TB: a systematic review and meta-analysis of the incidence rates and the proportions of relapses and reinfections.

• DOI: 10.1136/thoraxjnl-2020-215449
• 发表时间: 2021-05
• 期刊: Thorax
• 影响因子: 10
• 作者: Vega V;Rodríguez S;Van der Stuyft P;Seas C;Otero L
• 通讯作者: Otero L

Lung cancer occurrence after an episode of tuberculosis: a systematic review and meta-analysis.

• DOI: 10.1183/16000617.0025-2022
• 发表时间: 2022-09-30
• 期刊: European respiratory review : an official journal of the European Respiratory Society

Isoniazid preventive therapy completion in children under 5 years old who are contacts of tuberculosis cases in Lima, Peru: study protocol for an open-label, cluster-randomized superiority trial.

• DOI: 10.1186/s13063-022-07062-6
• 发表时间: 2023-01-24
• 期刊: Trials
• 影响因子: 2.5

Risk factors for pulmonary tuberculosis recurrence, relapse and reinfection: a systematic review and meta-analysis.

肺结核复发、复发和再感染的危险因素：系统评价和荟萃分析。

• DOI: 10.1136/bmjresp-2023-002281
• 发表时间: 2024
• 期刊: BMJ open respiratory research
• 影响因子: 4.1
• 作者: Vega,Victor;Cabrera-Sanchez,Javier;Rodríguez,Sharon;Verdonck,Kristien;Seas,Carlos;Otero,Larissa;VanderStuyft,Patrick
• 通讯作者: VanderStuyft,Patrick