Real time Tuberculosis Medication Adherence Intervention in Rural Southwestern Uganda

首席调查员(最后、第一、中间)：Musiimenta，Angella 项目总结 据估计，乌干达每年有6万人被诊断出患有结核病，在22个国家中排名第16 世界上结核病病例最高的国家。乌干达利用DOTS的国家目标(直接 观察治疗(短程)成功治疗85%的确诊结核病患者没有得到满足。 目前，全国只发现了49.6%的结核病病例，其中73%的病例得到了成功治疗。这些点 战略遭遇了许多社会经济挑战，导致它被许多 乌干达的医院。乌干达的许多结核病病例在很大程度上归因于结核病药物依从性差。 不遵守结核病药物治疗的原因包括缺乏对患者的随访，患者缺乏前往的交通工具 去诊所拿药，患者健忘。有证据表明，实时遵守监测 与短信提醒和社会支持通知相联系，可以消除持续坚持抗逆转录病毒治疗的障碍。 到目前为止，这些针对低资源环境下结核病用药依从性挑战的新型干预措施包括 有限的。流行的基于短信的结核病用药依从性研究报告结果喜忧参半，不 在战略上将干预措施与错过的剂量联系起来，在很大程度上已在发达国家实施。 到目前为止，对结核病药物使用的实时依从性监测技术知之甚少 在资源有限的情况下坚持。通过艺术坚持学习，我获得了以下经验 电子依从性监测技术，我现在想将其扩展到结核病药物。对于这款K43 获奖，我的目标是调查与短信联系的实时遵守监测技术的使用情况 乌干达西南部农村地区结核病用药依从性的提醒和通知。 我将进行形成性定性研究，以确定最佳的短信提醒、通知和初始 实时监测依从性的可行性。我将在一年内招募20名结核病患者和10名医疗保健提供者 姆巴拉拉地区转诊医院(MRRH)的结核病诊所。借鉴统一的接受理论和 技术的使用和医疗保健利用的模式，我将使用半结构化访谈来评估 在短信提醒的首选语言、长度、内容、时间(数量， 频率、时间表)、保护机密性和患者隐私的策略、预测的适当障碍 对短信的响应、对社会支持的偏好、对使用社会支持者的看法、患者 了解报文和电子遵守情况监控器的使用、采用实时的障碍 与短信提醒和通知相关的遵守情况监测干预，以及障碍和 坚持用药的动机。其目的将是向开发人员通报必要的技术 进行实时干预，包括无线监控器和短信提醒和通知。 我将开发并测试一种实时依从性监测干预措施，对象为60名结核病患者 治疗，以及40名社会支持者。我将开发并定量测试实时遵守情况监测 对60名发起结核病治疗的个人和40名社会支持者进行干预。我会随机挑选参与者 (1：1：1)到以下武器：1)固定和链接的短信提醒，2)向社会支持者发送短信通知， (3)不发短信(对照组)。所有参与者都将接受为期6个月的遵守情况实时监测。我会继续努力 我在与Haberer博士(R34MH100940)一起使用Wisepill设备进行的研究中的经验，并利用 CommConnect平台和Yo！将语音解决方案作为网关(请参阅合作信函)。初级阶段 结果将是百分之百的忠诚度。次要结果将包括依从性、结核病治愈率、 治疗完成率、治疗成功率、门诊就诊次数和死亡率。 我将确定综合遵守监测的影响机制和背景 提醒和社会支持干预。我将探索参与者在干预臂中的经验 (20名参与者和20名社会支持者)通过定性访谈。采访的目的是为了引出 关于参与者和社会支持者经历的详细质量数据，特别强调 了解短信提醒的效果机制、支持的形式和动态、经验 短信提醒/通知，以及遇到的技术问题。然后我会确定短信的类型 (每日短信与链接短信)，以及实时显示最有希望的社会支持的性质 对抗结核药物依从性和治愈的干预，将通过支持的R01进行全面评估 随机对照试验。 本次K43大奖建议的研究和培训组合将利用我现有的电子技术 遵守情况监测和全球健康计划的实施。它将使我能够使用 来自哈佛大学医学院、耶鲁大学公共卫生学院和 ，并最终成为一名富有成效和有影响力的独立调查员，专注于 在资源有限的情况下，使用技术辅助干预措施改善用药依从性。 项目说明

Principal Investigator(Last, First, Middle): Musiimenta, Angella PROJECT SUMMARY With an estimated 60,000 people diagnosed with TB annually, Uganda holds the 16th position of the 22 countries with highest cases of TB in the world. The Uganda national target of utilizing the DOTS (Direct Observed Treatment Short Course) to successfully treat 85% of patients diagnosed with TB has not been met. Currently, the country only detects 49.6% TB case detection, of which it successfully treats 73%. The DOTS strategy has suffered many socioeconomic challenges, which have resulted into its abandonment by many of the Ugandan hospitals. Poor TB medication adherence greatly attribute to the many cases of TB in Uganda. Causes of non-adherence to TB medication include lack of patient follow-up, patients’ lack of transport to go to the clinics to pick up drugs, patients’ forgetfulness. There is evidence that real time adherence monitoring linked with SMS reminders and social support notifications can address barriers to sustained ART adherence. Such novel interventions addressing TB medication adherence challenges in low resource settings to date are limited. The prevailing SMS-based studies for TB medication adherence report mixed results, do not strategically link interventions with missed doses, and have largely been implemented in developed countries. To date, little is known about the use of real-time adherence monitoring technologies for TB medication adherence in resource-limited settings. Through the ART adherence studies, I have gained experience in electronic adherence monitoring technologies, which I would like now to expand to TB medication. For this K43 award, my goal is to investigate the use of real time adherence monitoring technology linked with SMS reminders and notifications for TB medication adherence in rural southwestern Uganda. I will carry out a formative qualitative study to identify optimal SMS reminders, notifications, and initial feasibility of real time adherence monitoring. I will recruit 20 TB patients and 10 healthcare providers in a TB clinic in Mbarara Regional Referral Hospital (MRRH). Drawing from the Unified Theory of Acceptance and Use of Technology, and the Model of Healthcare Utilization, I will use semi-structured interviews to assess the optimal intervention in terms of the preferred language of SMS reminders, length, content, timing (number, frequency, schedule), strategies to protect confidentiality and patient privacy, predicted barriers to appropriate response to SMS messaging, preferences of social support, perceptions of using social supporters, patient understanding of messages and usage of the electronic adherence monitor, barriers to adoption of real time adherence monitoring intervention linked to SMS reminders and notifications, as well as barriers and motivators to medication adherence. The purpose will be to inform the development the technology necessary to conduct a real-time intervention involving a wireless monitor and SMS reminders and notifications. I will develop and Test a real-time adherence monitoring intervention with 60 individuals initiating TB treatment, and 40 social supporters. I will develop and quantitatively test a real-time adherence monitoring intervention with 60 individuals initiating TB treatment, and 40 social supporters. I will randomize participants (1:1:1) to the following arms: 1) Fixed and linked SMS reminders, 2) SMS notifications to social supporters, and 3) no SMS (control). All participants will have adherence monitored in real-time for 6 months. I will build on my experience in the study conducted with Dr. Haberer (R34MH100940) using the Wisepill device, and utilize the CommConnect platform and Yo! Voice Solutions as a gateway (see letters of collaboration). The primary outcome will be percent adherence. Secondary outcomes will include gaps in adherence, TB cure rate, treatment completion rate, treatment success rate, clinic appointment attendance, and mortality. I will determine the mechanisms of effect and context of an integrated adherence monitoring, SMS reminders and social support interventions. I will explore experiences of participants in the intervention arm (20 participants and 20 social supporters) through qualitative interviews. The goal of the interviews is to elicit detailed qualitative data on the experiences of participants and social supporters with special emphasis on understanding mechanisms of effects of the SMS reminders, forms and dynamics of support, experiences with the SMS reminders/notifications, and technical problems encountered. I will then determine the types of SMS (daily versus linked SMS), and the nature of social support that show the most promise for real time intervention on anti-TB medication adherence and cure, which will fully be evaluated through an R01 supported randomized control trial. The portfolio of research and training proposed for this K43 award will draw on my existing skills in electronic adherence monitoring, and global health program implementation. It will enable me to work with a multidisciplinary team of mentors from Harvard Medical School University, Yale School of Public Health, and Mbarara University, and ultimately become a productive and influential independent investigator focused on using technology-assisted interventions to improve medication adherence in resource limited settings. Project Description