Digital adherence technologies to facilitate completion of short-course tuberculosis preventive therapy among people living with HIV

数字依从技术可促进艾滋病毒感染者完成短期结核病预防治疗

• 批准号: 10681475
• 负责人: Christopher Allen Berger
• 金额: $ 20.12万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-08 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10681475
• 关键词: Address; Adherence; Adoption; Africa South of the Sahara; Agreement; Behavior; Cause of Death; Cessation of life; Clinic; Consolidated Framework for Implementation Research; Coupled; Data; Data Analyses; Data Collection; Dedications; Diagnosis; Directly Observed Therapy; Dose; Educational workshop; Effectiveness; Enrollment; Evaluation; Evidence based intervention; Feedback; Funding; Future; Goals; HIV; HIV/AIDS; Incidence; Intervention; Interview; Low income; Maps; Mentors; Mentorship; Methodology; Methods; Modeling; Monitor; Motivation; Outcome; Parents; Participant; Patients; Persons; Physicians; Pilot Projects; Prevention; Preventive therapy; Provider; Recommendation; Regimen; Research; Research Infrastructure; Research Methodology; Research Personnel; Sampling; Scientist; Self Administration; Surveys; Technology; Testing; Training; Tuberculosis; Uganda; United States National Institutes of Health; Work; World Health Organization; active method; career; compare effectiveness; cost; cost effectiveness; design; digital; effectiveness evaluation; effectiveness outcome; feasibility trial; follow-up; high risk population; human centered design; implementation design; implementation evaluation; implementation fidelity; implementation intervention; implementation outcomes; implementation science; implementation strategy; implementation study; implementation/effectiveness; improved; isoniazid; mortality; mortality risk; novel; pilot trial; prevent; randomized trial; rifapentine; routine care; scale up; screening; service delivery; skills; success; technology platform; theories; treatment arm; trial comparing; uptake; usability

Project Summary/Abstract Tuberculosis (TB) is the leading cause of death among people living with HIV (PLHIV), responsible for over one-third of all HIV deaths worldwide. Tuberculosis preventive therapy (TPT), which can reduce TB incidence by 30-50%, is recommended for all PLHIV by the World Health Organization (WHO). Although a new 12-dose, once-weekly regimen of isoniazid and rifapentine (3HP) via directly observed therapy (DOT) is now available and recommended, treatment completion remains a concern. Additionally, DOT is not a feasible strategy for increasing TB preventive therapy uptake in high burden, low-income settings. To realize the promising potential of 3HP to reduce TB mortality among PLHIV, there is an urgent need for studies that evaluate approaches to support treatment completion with self-administered therapy. The overall objective of this proposal is to determine whether low-cost digital adherence technologies (DATs) can be used to monitor and support completion of 3HP among PLHIV. Our central hypothesis is that a theory- informed adaptation of DATs to fit users' needs will result in high levels of DAT adoption and implementation fidelity. This hypothesis is based on preliminary data from my work in using human-centered design (HCD) methods to adapt a DAT platform to address the adherence challenges faced by patients with active TB. In my mentor's stepped wedge randomized trial, this adapted DAT platform had high levels of acceptability for patients and providers, and improved completion of treatment for active TB. The proposed studies will build upon this prior work to support the use of DATs for scaling-up TB preventive therapy to a key high-risk population. To test this hypothesis in Aim 1 I will identify barriers and facilitators to the use of DATs for facilitating 3HP completion among PLHIV. In Aim 2 I will then adapt two low-cost DATs to fit users' needs using the human centered design methodology. Last, in Aim 3, I will conduct pilot trials to assess the preliminary effectiveness and implementation of each adapted DAT among PLHIV initiating 3HP. The results will provide the preliminary data needed for an NIH R01 application proposing a randomized trial to evaluate the effectiveness, implementation, and cost-effectiveness of one or both contextually adapted DATs for supporting completion of short-course TB preventive therapy among PLHIV. The proposed research aims map directly onto my training objectives including designing implementation interventions using mixed methods research (Aims 1 & 2), tailoring implementation interventions using human- centered design (Aim 2), and evaluating implementation interventions (Aim 3). Rigorous implementation science-focused training coupled with an interdisciplinary mentorship team committed to my success will catalyze me towards my career goal to become an independent physician-scientist focused on improving uptake of evidence-based interventions to reduce TB burden among PLHIV.

项目摘要/摘要 结核病（TB）是艾滋病毒（PLHIV）患者中死亡的主要原因，负责 全球所有艾滋病毒死亡的三分之一。结核病预防疗法（TPT），可以降低结核病的发病率 世界卫生组织（WHO）建议将所有PLHIV征收30-50％。虽然是一种新的12剂，但 现在可以通过直接观察到的Isoniazid和利福平（3HP）进行每周一次的治疗（DOT） 并建议，治疗完成仍然是一个问题。此外，点不是可行的策略 在高负担，低收入环境下增加结核病预防疗法的吸收。实现有前途的 3HP的潜力降低PLHIV中的结核病死亡率，迫切需要进行评估 通过自我管理疗法支持治疗完成的方法。 该提案的总体目的是确定低成本数字依从性技术（DATS）是否是否 可用于监视和支持PLHIV中3HP的完成。我们的核心假设是一种理论 - 适应DAT的知情适应以满足用户的需求，将导致高水平的DAT采用和实施 忠诚。该假设基于我在使用以人为本设计（HCD）的工作中的初步数据 适应DAT平台以解决活跃结核病患者面临的依从性挑战的方法。在我的 导师的阶梯楔随机试验，此改编的DAT平台具有很高的可接受性 患者和提供者，改善了主动结核病治疗的完成。拟议的研究将建立 一项先前的工作以支持使用DAT将TB预防疗法扩展到关键的高风险 人口。为了在AIM 1中检验这一假设，我将确定使用DAT的障碍和促进因素 促进PLHIV的3HP完成。在AIM 2中，我将调整两个低成本DAT，以适应用户的需求 以人为中心的设计方法。最后，在AIM 3中，我将进行试点试验以评估初步 在启动3HP的PLHIV中，每个改编的DAT的有效性和实施。结果将提供 NIH R01申请提出的随机试验所需的初步数据以评估 一个或两个具有上下文调整的DAT的有效性，实施和成本效益，以支持 在PLHIV中完成短途结核病预防疗法。 拟议的研究旨在直接映射到我的培训目标，包括设计实施 使用混合方法研究（目标1和2）进行干预措施，使用人类来调整实施干预措施 集中设计（AIM 2），并评估实施干预措施（AIM 3）。严格的实施 以科学为中心的培训以及致力于我成功的跨学科指导团队 催化我的职业目标，成为一名专注于改善的独立医师科学家 采用基于证据的干预措施，以减轻PLHIV之间的结核病负担。