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

为了结束艾滋病毒的流行，需要作出协调一致的努力， 这是一个连续的过程，包括改善艾滋病毒感染者的护理和病毒抑制。 目前，在美国，据估计，只有不到50%的艾滋病毒携带者继续接受护理， 病毒被抑制研究表明，这些PLWH的临床结果较差，并且有风险 因此，需要创新的解决方案，以改善护理的保留率， 病毒抑制基于理论的移动健康干预措施已被证明是有希望的，在达到这些在- 风险群体和改善与艾滋病毒有关的结果。PositiveLinks是一个诊所部署的移动健康平台， 包括患者和提供者智能手机应用程序，诊所工作人员和提供者管理患者的门户网站 队列、在线实施指南和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，包括坚持，情绪和压力的日常查询，自我的图形反馈， 监控、与员工的安全消息传递、约会提醒、匿名同行支持、信息 资源和文档上传功能，以支持保险重新注册。为期12个月的前瞻性研究 研究发现，PL增加了RIC和VS，应用程序的使用与收益相关， 以及改善社会支持和耻辱感。PL是PLWH的一种有前途的现有移动健康工具，但其疗效 没有经过严格的随机试验，也没有在城市人群中进行测试。我们建议测试 积极的联系，以改善护理和病毒抑制之间的高艾滋病毒感染者队列的保留 流行城市华盛顿，DC。将从DC队列中确定受试者， 在华盛顿的14个临床站点接受HIV护理的PLWH的观察性前瞻性队列。一是 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，并根据这些调查结果进行后续调整。然后我们将进行一次疗效评估 通过在560名PLWH中的14个DC队列站点进行的群集随机对照试验进行研究。诊所将 随机分配至PL或常规治疗。我们的主要结果将包括病毒抑制，保留护理和访问 12个月时的稳定性。最后，我们将进行混合方法实施科学研究， 实施研究和RE-AIM的统一框架，以确定研究中心、患者、提供者和 系统因素是计划实施中最佳实践的特征。如果成功，这项研究将导致 开发一种新的有效的方法来改善护理和病毒抑制的保留 这可能导致下一代传播研究，这将有助于艾滋病毒的流行 控制该项目是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，并结束艾滋病毒流行病 目标，因为它是跨领域的，旨在减少卫生不平等，并改善卫生成果，以实现 在艾滋病毒的地理热点地区持续抑制病毒。

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.