Mobile Health and Oral Testing to Optimize Tuberculosis Contact Tracing in Colombia

项目摘要 全世界每年1000万结核病病例中有近三分之一被遗漏。TB 接触者追踪是国际上推荐的循证实践，用于发现，治疗， 以及在结核病患者的密切接触者中预防结核病。接触者追踪也被认为是一个高度 推动世卫组织和泛美卫生组织实现在中等发病率地区消除结核病目标的重要战略 哥伦比亚等国家。不幸的是，执行方面仍然存在巨大差距。具体来说， 需要1）更好的结核病筛查和检测工具，以克服症状筛查的低敏感性 无咳嗽者痰液收集困难; 2）以客户为中心 实施战略，以改善病例发现和与护理的联系。在先前与秘书处的合作中， 在哥伦比亚卡利的公共卫生部（SPH），我们推出了客户友好的教育材料， 痰液收集和运输，以及结核病的分子检测。COVID-19疫情导致 这项服务的进一步发展，以适应远程保健访问，并有必要进一步适应 这些工具符合客户的期望和新的数字健康格局。两个最有前途的 实现这些目标的创新是将下一代分子检测与非痰检测相结合， 唾液和口腔拭子等样本，以简化和改进筛查和检测算法;以及 结合聊天应用（例如，WhatsApp）和自动化客户支持工具（即，聊天机器人）作为 移动的健康（mHealth）工具，以吸引、支持和留住家庭成员。我们的科学 方法将是进行两个横断面研究与嵌套的混合方法和设计 研究改进和调整这些工具，用于接触者追踪。我们的整体目标是加强 接触者追踪的敏感性、可行性、可接受性和适当性，并为未来做好准备 家庭随机实施试验。我们提出了两个具体目标：1）确定 口腔样本对临床可能的结核病患者进行结核病分子检测的诊断性能， 家庭环境; 2）设计并反复完善移动健康战略， 针对可行性、可接受性、可用性和适当性进行了优化的接触跟踪。调查 团队在结核病诊断和临床护理、接触者追踪、以用户为中心的设计、定性 方法和实施科学，以及与SPH建立良好的伙伴关系， 为拟议的研究提供了良好的环境。这些研究将确定口腔样本是否 可用于结核病的分子诊断，并完善针对家庭结核病接触者的移动医疗战略 追踪，采用创新的设计方法，既有理论依据，又有社区参与。 这项研究将最终提供以客户为中心的实施组件的mHealth联系人 在随机对照实施试验中用于未来评价的追踪策略。

PROJECT SUMMARY Nearly one-third of the 10 million annual tuberculosis (TB) cases worldwide are missed each year. TB contact tracing is an evidence-based practice that is internationally recommended for finding, treating, and preventing TB among close contacts of TB patients. Contact tracing is also considered a highly significant strategy for advancing the WHO and PAHO goal of eliminating TB in moderate-incidence countries like Colombia by 2050. Unfortunately, large implementation gaps persist. Specifically there is need for 1) better TB screening and testing tools to overcome the low sensitivity of symptom screening and the difficulty of collecting sputum in those without cough, and 2) more client-centered implementation strategies to improve case-finding and linkage to care. In prior work with the Secretariat of Public Health (SPH) in Cali, Colombia, we introduced client-friendly education materials, home sputum collection and transport, and molecular testing for TB. The COVID-19 pandemic has led to further evolution of this service to accommodate telehealth visits, and there is need to further adapt these tools to client expectations and the new digital health landscape. Two of the most promising innovations for achieving these goals are pairing next-generation molecular testing with non-sputum samples like saliva and oral swabs to simplify and improve screening and testing algorithms; and incorporating chat apps (e.g., WhatsApp) and automated customer support tools (i.e., chatbots) as mobile health (mHealth) tools to engage, support, and retain household members. Our scientific approach will be to carry out two cross-sectional studies with nested mixed-methods and design research to refine and adapt these tools for contact tracing. Our overall objectives are to enhance the sensitivity, feasibility, acceptability, and appropriateness of contact tracing, and to prepare for a future household-randomized implementation trial. We propose two specific aims: 1) To determine the diagnostic performance of oral samples for TB molecular testing in possible TB patients in clinic and household settings; and 2) To design and iteratively refine an mHealth strategy for implementing contact tracing optimized for feasibility, acceptability, usability, and appropriateness. The investigative team has expertise in TB diagnostics and clinical care, contact tracing, user-centered design, qualitative methods, and implementation science, and a well-established partnership with the SPH that will ensure an outstanding environment for the proposed research. These studies will determine if oral samples are viable for molecular diagnosis of TB and refine an mHealth strategy for household TB contact tracing, using an innovative design approach that is both theory-informed and community-engaged. This study will ultimately deliver client-centered implementation components for an mHealth contact tracing strategy for future evaluation in a randomized, controlled implementation trial.