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: 10082750
• 负责人: Amanda Derryck Castel
• 金额: $ 91.04万
• 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/10082750
• 关键词: AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Address; Adherence; Adoption; Adult; Android; Appointment; Behavior Therapy; Caring; Case Management; Cessation of life; Characteristics; Cities; Clinic; Clinical; Cluster randomized trial; Computerized Medical Record; Consent; Continuity of Patient Care; Data; Development; Diagnosis; Drops; Effectiveness; Enrollment; Epidemic; Feedback; Funding; Geography; Goals; HIV; Health; Human immunodeficiency virus test; Information Resources; Insurance; Intervention; Laboratories; Lead; Learning; Longitudinal cohort study; Maintenance; 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; 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; implementation research; implementation science; improved; innovation; mHealth; medication compliance; 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.

为了结束艾滋病毒流行，将需要共同努力解决艾滋病毒护理问题。 继续，包括改善艾滋病毒携带者的护理保留和病毒抑制。 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 病毒被抑制了。研究表明，这些PLWH的临床结果较差，并有患上 将艾滋病毒传播给其他人，因此需要创新的解决方案，以改善在护理和随后的护理中的保留 病毒抑制。基于理论的移动健康干预措施已被证明有望在以下方面实现这些目标- 风险群体和改善与艾滋病毒有关的结果。PositiveLinks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、诊所工作人员和提供商管理患者的Web门户 培训和认证诊所工作人员的在线实施指南和学习管理系统。它 具有基于理论的功能，包括对遵从性、情绪和压力的日常询问，以及针对自我的图形反馈 监控、与员工的安全消息传递、约会提醒、匿名同事支持、信息 资源和文档上传功能，以支持保险重新投保。一项为期12个月的前瞻性研究 在HIV保留不良的成年人中发现，PL增加了RIC和VS，应用程序的使用与收益相关，如 以及改善社会支持和污名。PL是一种很有前途的治疗PLWH的mHealth工具，但其疗效 还没有在严格的随机试验中进行测试，也没有在城市人口中进行测试。我们建议测试一下 PsitiveLinks可改善HIV高危人群中PLWH患者的护理保留率和病毒抑制 华盛顿特区的流行城市。参与者将从DC队列中确定，这是一个纵向 在华盛顿特区的14个临床地点接受艾滋病毒治疗的PLWH的观察性预期队列。首先，我们 将进行形成性研究，以评估PositiveLinks的可行性、可接受性和可用性 并根据这些发现进行后续的适应。然后我们会进行一次药效 通过在560名PLWH中的14个DC队列站点进行整群随机对照试验进行研究。诊所将是 随机分为PL或常规护理。我们的主要成果将包括病毒抑制、保留护理和探视 持久度为12个月。最后，我们将在指导下进行混合方法实施科学研究 实施研究和RE-AIM的整合框架，以确定站点、患者、提供商和 项目实施中体现最佳实践的系统因素。如果成功，这项研究将引领 开发一种新的有效方法来改善护理中的保留率和病毒抑制 在PLWH中，这可能导致下一代传播研究，这将有助于艾滋病毒流行 控制力。该项目响应国家卫生研究院的优先事项、国家艾滋病毒/艾滋病战略和结束艾滋病毒流行。 目标，因为它是交叉的，寻求减少健康不平等，并改善健康结果，以实现 在艾滋病毒的地理热点地区持续的病毒抑制。