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)是艾滋病毒携带者(PLHIV)的主要死亡原因，导致超过 占全球艾滋病毒死亡人数的三分之一。结核病预防治疗(TPT)，可以降低结核病发病率 世界卫生组织(WHO)建议对所有PLHIV患者使用30-50%。尽管新的12剂， 通过直接观察疗法(DOT)，每周一次的异烟肼和利福喷丁(3HP)方案现已推出 并建议，完成治疗仍然是一个令人担忧的问题。此外，DOT不是一种可行的策略 在高负担、低收入环境中增加结核病预防治疗的接受率。为了实现有希望的 3HP在PLHIV中降低结核病死亡率的潜力，迫切需要研究评估 支持自我给药疗法完成治疗的方法。 该提案的总体目标是确定低成本数字坚持技术(DAT) 可用于监测和支持PLHIV中3HP的完成。我们的中心假设是一个理论- 明智地调整DAT以满足用户需求将导致高水平的DAT采用和实施 富达。这一假设是基于我在使用以人为中心的设计(HCD)工作中的初步数据。 方法采用DAT平台来解决活动性肺结核患者面临的依从性挑战。在我的 Mentor的阶梯式楔形随机试验，这一改编的DAT平台对 患者和提供者，以及改善活动性结核病治疗的完成率。拟议的研究将建立 在这项先前工作的基础上，支持使用DAT将结核病预防治疗扩大到关键的高风险 人口。为了在目标1中验证这一假设，我将确定使用DAT的障碍和促进者 在PLHIV中促进3HP的完成。在目标2中，我将调整两个低成本DAT以满足用户的需求 以人为本的设计方法学。最后，在目标3中，我将进行试点试验，以评估初步 PLHIV启动3HP中每种适应的DAT的有效性和实施。结果将提供 NIH R01应用程序所需的初步数据建议进行随机试验以评估 一个或两个适应环境的DAT的有效性、实施和成本效益，以支持 完成艾滋病病毒感染者的短程结核病预防治疗。 建议的研究目标与我的培训目标直接对应，包括设计和实施 使用混合方法研究的干预措施(目标1和2)，使用人类-- 以设计为中心(目标2)和评价实施干预措施(目标3)。严格执行 以科学为重点的培训加上一个致力于我成功的跨学科指导团队将会 催化我朝着我的职业目标前进，成为一名专注于改进的独立医生-科学家 采取循证干预措施以减少艾滋病患者的结核病负担。