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.

项目概要/摘要 结核病 (TB) 是艾滋病毒感染者 (PLHIV) 死亡的主要原因，导致超过 占全世界艾滋病毒死亡人数的三分之一。结核病预防治疗 (TPT)，可降低结核病发病率 世界卫生组织 (WHO) 建议所有 PLHIV 患者减少 30-50%。虽然是新的12剂， 现已推出通过直接观察治疗 (DOT) 每周一次的异烟肼和利福喷汀 (3HP) 方案 并建议，治疗完成仍然是一个问题。此外，DOT 并不是一个可行的策略 提高高负担、低收入环境中结核病预防治疗的采用率。实现有希望的 3HP 降低 PLHIV 结核病死亡率的潜力，迫切需要进行评估的研究 通过自我管理治疗支持治疗完成的方法。 该提案的总体目标是确定低成本数字依从技术（DAT）是否 可用于监测和支持 PLHIV 患者完成 3HP。我们的中心假设是一个理论—— 对 DAT 进行明智的调整以满足用户的需求将导致 DAT 的高水平采用和实施 保真度。这个假设是基于我使用以人为本的设计（HCD）工作中的初步数据 调整 DAT 平台以解决活动性结核病患者面临的依从性挑战的方法。在我的 根据导师的阶梯式楔形随机试验，这个改编的 DAT 平台对于以下方面具有很高的可接受性： 患者和提供者，并提高活动性结核病治疗的完成率。拟议的研究将建立 在此之前的工作基础上，支持使用 DAT 将结核病预防治疗扩大到关键的高风险人群 人口。为了检验目标 1 中的这一假设，我将确定使用 DAT 的障碍和促进因素 促进 PLHIV 患者完成 3HP。在目标 2 中，我将使用两个低成本 DAT 来适应用户的需求 以人为本的设计方法。最后，在目标 3 中，我将进行试点试验以评估初步效果 每个适应 DAT 在 PLHIV 启动 3HP 中的有效性和实施情况。结果将提供 NIH R01 申请所需的初步数据，建议进行随机试验来评估 一项或两项根据具体情况进行调整的 DAT 的有效性、实施和成本效益 艾滋病病毒感染者完成短期结核病预防治疗。 拟议的研究目标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）的干预措施，使用人类定制实施干预措施 以中心为中心的设计（目标 2），并评估实施干预措施（目标 3）。严格执行 以科学为中心的培训加上致力于我成功的跨学科指导团队将 促进我实现我的职业目标，成为一名专注于改进的独立医师科学家 采取循证干预措施以减少艾滋病毒携带者的结核病负担。