Adaptation and implementation of a behavioral mHealth intervention to reduce anxiety and depression and end the HIV epidemic in the rural South

摘要 未经治疗的焦虑和抑郁在农村艾滋病毒携带者中非常普遍 南方，一个受艾滋病毒流行严重影响的人口。解决心理健康问题是改善 这一人群中不同的艾滋病毒负担。然而，除了常规的临床护理外，很少有针对精神疾病的干预措施 在南方农村的PLWH的健康状况。移动医疗技术(MHealth)和社区医疗工作者(CHW)- 提供的护理是两种干预模式，解决了农村、服务不足的人口特有的障碍。 马纳瓦兰博士是哈佛大学传染病和全球医学部助理教授。 佛罗里达大学。她寻求获得K23奖项，以获得技能、经验和成为 一位独立的内科医生兼科学家专注于开发和实施新的、可扩展的干预措施 将有助于结束艾滋病毒流行的服务不足的社区。通过培训和研究 在这个奖项中概述的建议，马纳瓦兰博士将通过将 以证据为基础的干预在其他情况下对佛罗里达州现有的医疗系统有效。 在这项为期4年的研究中，马纳瓦兰博士将采用基于证据的CHW提供的咨询干预措施 通过现有的mHealth应用程序交付，作为减少焦虑和抑郁并最大限度地 在南方农村的PLWH中进行病毒抑制。在目标1中，她将与不同的 主要利益攸关方在实施研究综合框架(CFIR)的指导下，识别 为适应和实施干预措施提供信息的视角。接下来，在《目标2》中，她将组装一个 由来自关键利益相关者团体(PLWH)的12名成员组成的设计咨询团队 人口、艾滋病毒和精神卫生提供者，以及mHealth和行为科学家)，以帮助适应CHW- 为农村人口量身定做的移动健康服务提供咨询服务。干预的适应将会发生 迭代地，从目标1的数据中获得信息，并将由适应-ITT框架指导。最后，在目标3中， 她将通过一种类型1的混合有效性实施试验和评估来试行适应性干预 实施成果(覆盖范围、可采纳性、实施、维护)和初步成效 结果(病毒抑制、HIV护理保留、ART依从性以及焦虑和抑郁症状)使用 RE-AIM模型。 拟议的计划将使马纳瓦兰博士能够获得1)适应和评估 行为干预，2)移动健康科学，3)实施科学和混合试验设计，通过 与顶尖专家的指导、教学课程、专业发展计划和应用 研究。该研究将为全功率R01试验奠定基础，以评估实施情况和 调整后的干预措施在整个佛罗里达州服务不足的社区的有效性。

ABSTRACT Untreated anxiety and depression are exceedingly common in people living with HIV (PLWH) in the rural South, a population critically affected by the HIV epidemic. Addressing mental health is essential to improving the disparate HIV burden in this population. Yet outside of routine clinical care, few interventions target mental health in PLWH in the rural South. Mobile health technology (mHealth) and community health worker (CHW)- delivered care are two intervention models that address barriers unique to rural, underserved, populations. Dr. Manavalan is an assistant professor in the Division of Infectious Diseases and Global Medicine at the University of Florida. She seeks a K23 award to gain skills, experience and preliminary data needed to become an independent physician-scientist focused on developing and implementing novel and scalable interventions in underserved communities that will contribute to Ending the HIV Epidemic. Through the training and research proposal outlined in this award, Dr. Manavalan will bridge the fields of HIV and mental health by incorporating evidence-based interventions effective in other settings into existing medical systems in Florida. In this 4-year study Dr. Manavalan will adapt an evidence-based CHW-delivered counseling intervention for delivery through an existing mHealth application, as a strategy to reduce anxiety and depression and maximize viral suppression in PLWH in the rural South. In Aim 1, she will conduct robust qualitative research with diverse key stakeholders, guided by the Consolidated Framework for Implementation Research (CFIR), to discern perspectives to inform adaption and implementation of the intervention. Next, in Aim 2, she will assemble a Design Consultation Team composed of 12 members from key stakeholder groups (PLWH from the target population, HIV and mental health providers, and mHealth and behavioral scientists) to assist in adapting CHW- delivered counseling for mHealth delivery, tailored to a rural population. Adaption of the intervention will occur iteratively, be informed from data from Aim 1 and will be guided by the ADAPT-ITT framework. Lastly, in Aim 3, she will pilot the adapted intervention with a type 1 hybrid effectiveness-implementation trial and assess implementation outcomes (reach, adoptability, implementation, maintenance) and preliminary effectiveness outcomes (viral suppression, HIV care retention, ART adherence, and anxiety and depression symptoms) using the RE-AIM model. The proposed program will enable Dr. Manavalan to gain expertise in 1) adaption and evaluation of behavioral interventions, 2) mHealth science, and 3) implementation science and hybrid trial design through mentorship with leading experts, didactic coursework, professional development programs, and application of research. This study will lay the groundwork for a fully powered R01 trial to evaluate implementation and effectiveness of the adapted intervention in underserved communities throughout the state of Florida.