Pragmatic Efficacy Trial of mHealth to Improve HIV Outcomes in the DC Cohort

移动医疗改善 DC 队列中艾滋病毒结果的实用功效试验

• 批准号: 10219935
• 负责人: Amanda Derryck Castel
• 金额: $ 69.25万
• 依托单位: GEORGE WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-20 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10219935
• 关键词: AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Address; Adherence; Adult; Android; Appointment; Behavior Therapy; Caring; Case Management; Cessation of life; Characteristics; Cities; Clinic; Clinical; Cluster randomized trial; Computerized Medical Record; Consent; Consolidated Framework for Implementation Research; Continuity of Patient Care; Data; Development; Diagnosis; Drops; Enrollment; Epidemic; Feedback; Funding; Geography; Goals; HIV; Health; Human immunodeficiency virus test; Information Resources; Insurance; Intervention; Laboratories; Lead; Learning; Longitudinal cohort study; Measures; Methods; Monitor; Moods; National Institute of Allergy and Infectious Disease; Outcome; Participant; Patients; Pattern; Persons; Population; Prevalence; Procedures; Prospective Studies; Prospective cohort; Provider; Public Health; Quality of Care; Randomized; Randomized Controlled Trials; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Research; Research Methodology; Risk; Risk Factors; Sampling; Secure; Site; Social support; Stress; System; Testing; Training; United States Health Resources and Services Administration; United States National Institutes of Health; Universities; Urban Population; Viral; Viral Load result; Virginia; Virus; Visit; Washington; base; clinical research site; cohort; comparative efficacy; dissemination research; efficacy study; efficacy testing; follow-up; health inequalities; implementation research; implementation science; improved; innovation; mHealth; medication compliance; morphogens; next generation; novel; peer support; pragmatic efficacy trial; primary outcome; programs; prospective; randomized trial; smartphone Application; social; social stigma; sociodemographics; standard of care; theories; tool; transmission process; treatment as usual; usability; web portal

In order to achieve the end of the HIV epidemic, concerted efforts will be needed to address the HIV care continuum, including improving retention in care and viral suppression among persons living with HIV (PLWH). Currently, in the U.S., it is estimated that less than 50% of PLWH are retained in care and even fewer are virally suppressed. Studies have shown that these PLWH have poorer clinical outcomes and are at risk of transmitting HIV to others, hence the need for innovative solutions to improve retention in care and subsequent viral suppression. Theory-based mHealth interventions have been shown to be promising in reaching these at- risk groups and improving HIV-related outcomes. PositiveLinks is a clinic-deployed mHealth platform that includes patient and provider smartphone apps, a web portal for clinic staff and providers to manage patient cohorts, an online implementation guide, and a learning management system to train and certify clinic staff. It has theory-based features including daily queries of adherence, mood, and stress, graphical feedback for self- monitoring, secure messaging with staff, appointment reminders, anonymized peer support, information resources, and document upload capability to support insurance re-enrollment. A 12-month prospective study in poorly retained adults with HIV found that PL increased RIC and VS, with app usage related to benefit as well as improved social support and stigma. PL is a promising existing mHealth tool for PLWH, but its efficacy has not been tested in a rigorous randomized trial, nor in urban populations. We propose to test the efficacy of PositiveLinks to improve retention in care and viral suppression among a cohort of PLWH in a high HIV prevalence city of Washington, DC. Participants will be identified from the DC Cohort, a longitudinal observational prospective cohort of PLWH receiving HIV care at 14 clinical sites in Washington, DC. First, we will conduct formative research to assess the feasibility, acceptability and usability of PositiveLinks among this urban cohort and conduct subsequent adaptations based on these findings. We will then conduct an efficacy study through a cluster randomized controlled trial at 14 DC Cohort sites among 560 PLWH. Clinics will be randomized to PL or usual care. Our primary outcomes will include viral suppression, retention in care and visit constancy at 12 months. Finally, we will conduct mixed methods implementation science research guided by the Consolidated Framework for Implementation Research and RE-AIM to identify site, patient, provider, and system factors that characterize best practices in program implementation. If successful, this research will lead to the development of a novel and efficacious approach to improving retention in care and viral suppression among PLWH which could lead to next-generation dissemination research that will contribute to HIV epidemic control. This project is responsive to NIH priorities, National HIV/AIDS Strategy, and Ending the HIV Epidemic goals as it is cross-cutting, seeks to reduce health inequities, and to improve health outcomes to achieve sustained viral suppression in a geographic hotspot for HIV.

为了实现艾滋病毒流行的终结，将需要一致的努力来解决艾滋病毒护理 连续体，包括改善艾滋病毒（PLWH）患者的护理和病毒抑制的保留。 目前，在美国，据估计，只有不到50％的PLWH保留在护理中，甚至更少 病毒抑制。研究表明，这些PLWH的临床结果较差，有可能 将艾滋病毒传递给他人，因此需要创新的解决方案来改善护理的保留率和随后 病毒抑制。基于理论的MHealth干预措施已被证明是有希望的 风险组并改善与HIV相关的结果。 Pitivelinks是一个诊所部署的MHealth平台 包括患者和提供商智能手机应用程序，临床人员和提供者的网络门户网站 同伙，在线实施指南以及培训和认证诊所人员的学习管理系统。它 具有基于理论的特征，包括依从性，情绪和压力的每日查询，自我的图形反馈 与员工，约会提醒，匿名同行支持，信息，信息，信息，信息，信息，信息 资源并记录上传能力以支持保险重新注册。一项为期12个月的前瞻性研究 在患有艾滋病毒的成年人中保留的成年人中发现，PL增加了RIC和VS，其APP用法与受益有关 以及改善社会支持和污名。 PL是PLWH的有希望的现有MHealth工具，但其功效 尚未在严格的随机试验中或城市人口中进行测试。我们建议测试 在高艾滋病毒中的PLWH队列中，有效地提高了护理和病毒抑制的保留率 华盛顿特区的普遍城市。参与者将从DC队列（纵向）中识别 在华盛顿特区的14个临床部位接受HIV护理的PLWH的观测前瞻性队列。首先，我们 将进行形成性研究，以评估actitivelinks的可行性，可接受性和可用性 根据这些发现，城市队列并进行了随后的适应。然后我们将发挥功效 通过在560 PLWH中的14个DC队列站点进行的簇随机对照试验进行研究。诊所将是 随机分配给PL或通常的护理。我们的主要结果将包括病毒抑制，保留和访问 12个月的恒定。最后，我们将进行由以下方式实施的混合方法。 实施研究的合并框架，并重新确定网站，患者，提供商和 在程序实施中表征最佳实践的系统因素。如果成功，这项研究将领导 开发一种新颖有效的方法来改善护理和病毒抑制的保留率 在可能导致下一代传播研究的PLWH中，这将导致HIV流行 控制。该项目对NIH优先事项，国家艾滋病毒/艾滋病战略有反应，并结束艾滋病毒流行病 横切的目标，试图减少健康不平等，并改善健康成果以实现 艾滋病毒的地理热点中持续的病毒抑制。