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: 10662316
• 负责人: Amanda Derryck Castel
• 金额: $ 64.48万
• 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/10662316
• 关键词: Acquired Immunodeficiency Syndrome; Address; Adherence; Adult; Android; Appointment; Behavior Therapy; Caring; Case Management; Certification; Cessation of life; Characteristics; Cities; Clinic; Clinical; Cluster randomized trial; Collaborations; Computerized Medical Record; Consent; Consolidated Framework for Implementation Research; Continuity of Patient Care; Data; Development; Diagnosis; Drops; Enrollment; Epidemic; Feedback; Funding; Geography; Goals; HIV; HIV/AIDS; Health; Human immunodeficiency virus test; Information Resources; Insurance; Intervention; Laboratories; Learning; Longitudinal cohort study; Measures; Methods; Monitor; Moods; National Institute of Allergy and Infectious Disease; Outcome; Participant; Patients; Pattern; Persons; Population; Populations at Risk; 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; Visit; Washington; clinical research site; cohort; comparative efficacy; dissemination research; efficacy evaluation; efficacy study; efficacy testing; epidemic response; 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 stigma; sociodemographics; standard of care; theories; tool; transmission process; treatment as usual; usability; viral transmission; 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，需要共同努力解决艾滋病毒护理问题 连续体，包括改善艾滋病毒感染者（PLWH）的护理保留和病毒抑制。 目前，在美国，估计只有不到 50% 的感染者能得到护理，而得到护理的则更少。 病毒受到抑制。研究表明，这些感染者的临床结果较差，并且面临感染的风险 将艾滋病毒传播给他人，因此需要创新的解决方案来改善护理和后续护理的保留 病毒抑制。基于理论的移动医疗干预措施已被证明在实现这些目标方面大有希望。 风险群体和改善艾滋病毒相关结果。 PositiveLinks 是一个诊所部署的移动医疗平台， 包括患者和提供者的智能手机应用程序、诊所工作人员和提供者管理患者的门户网站 队列、在线实施指南以及用于培训和认证诊所工作人员的学习管理系统。它 具有基于理论的功能，包括每日查询依从性、情绪和压力，以及用于自我评估的图形反馈 监控、与员工的安全消息传递、预约提醒、匿名同行支持、信息 资源和文件上传功能，以支持保险重新注册。为期 12 个月的前瞻性研究 在记忆力较差的 HIV 成人患者中发现 PL 增加了 RIC 和 VS，应用程序的使用与益处相关： 以及改善的社会支持和耻辱感。 PL 是针对 PLWH 的一种很有前途的现有移动医疗工具，但其功效 尚未经过严格的随机试验或城市人群的测试。我们建议测试其功效 PositiveLinks 可提高 HIV 高感染者群体的护理保留率和病毒抑制水平 流行城市华盛顿特区。参与者将从 DC 队列中确定，这是一个纵向的 在华盛顿特区 14 个临床中心接受 HIV 护理的 PLWH 观察性前瞻性队列。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 城市队列并根据这些发现进行后续调整。然后我们将进行功效 通过在 14 个 DC 队列地点对 560 名 PLWH 进行整群随机对照试验进行的研究。诊所将 随机接受 PL 或常规护理。我们的主要成果将包括病毒抑制、护理保留和探视 12个月的稳定性。最后，我们将在以下指导下进行混合方法实施科学研究： 实施研究和 RE-AIM 综合框架，以确定地点、患者、提供者和 表征计划实施最佳实践的系统因素。如果成功，这项研究将引领 开发一种新颖有效的方法来改善护理保留和病毒抑制 PLWH 中的研究可能会导致下一代传播研究，从而有助于艾滋病毒的流行 控制。该项目响应 NIH 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 目标是跨领域的，旨在减少健康不平等，并改善健康结果，以实现 在艾滋病毒地理热点地区持续抑制病毒。