Randomized Control Trial of Positive Peers mHealth app as a clinic-based intervention to optimize HIV outcomes among young, minority persons living with HIV

积极同伴移动医疗应用程序的随机对照试验作为一种基于临床的干预措施，以优化年轻的少数族裔艾滋病毒感染者的艾滋病毒结果

• 批准号: 10819912
• 负责人: ANN K AVERY
• 金额: $ 122.72万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-24 至 2028-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10819912
• 关键词: Address; Adherence; Administrator; Adoption; Age; Age Years; Area; Calendar; Caring; Cellular Phone; Clinic; Clinical; Clothing; Collection; Communication; Communities; Data; Development; Diagnosis; Disparity population; Drug usage; Effectiveness; Electronics; Eligibility Determination; Epidemic; Ethnic Origin; Event; Food; Geography; HIV; HIV diagnosis; HIV disparities; Health; Hospitals; Housing; Intervention; Location; Medical; Medical Records; Methods; Minority Groups; Mobile Health Application; Modality; Newly Diagnosed; Occupations; Outcome; Participant; Persons; Pharmaceutical Preparations; Phase; Poverty; Predictive Factor; Race; Randomized; Randomized, Controlled Trials; Research; Resources; Risk; Risk Factors; Science; Self Management; Sexual and Gender Minorities; Site; Social support; Stigmatization; Stream; Training; United States; United States Health Resources and Services Administration; Viral; active lifestyle; attentional control; care outcomes; care providers; cis-male; clinical care; clinical research site; cohort; compare effectiveness; cost; design; effectiveness evaluation; effectiveness testing; feasibility testing; health management; housing instability; improved; innovation; mHealth; medication compliance; men; men of color; men who have sex with men; mind/body; minority disparity; minority patient; mobile application; online community; patient population; peer; peer support; phenomenological models; programs; randomized controlled design; randomized, clinical trials; sex; skills; smartphone application; social; social media; social stigma; success; support tools; theories; tool; transgender women; treatment arm; treatment as usual; trial design; trustworthiness; usability; women of color; young adult

Project Summary/Abstract The Positive Peers mobile app is an original platform developed by and for the hardest to reach HIV disparity populations, young people with HIV who identify as racial, ethnic and/or sexual/ gender minorities. This app holds potential to provide extensive, customizable, self- management tools (i.e., wellness tracker, community forum, chat, frequent original blogs) to young people with HIV anywhere in the US. The Positive Peers app provides health information, health management tools and virtual community support. While the app itself offers a safe place for young persons with HIV to get health information and support, it's use is enhanced by the presence of local peer administrators who provide navigation, support and coaching to users. The proposed study seeks to evaluate its effectiveness in improving viral suppression among minority disparity populations 18-30 years of age who are either newly diagnosed, out of care or not virally suppressed using a randomized control trial design supplemented by an observational cohort of persons who decline to use the app. Clinics in six high priority Ending the HIV epidemic jurisdictions will train staff as app administrators and utilize the app as a clinic- based tool. Our primary objective is to improve HIV outcomes by offering peer interaction, targeted retention and adherence messaging, and interactive trackers and reminders in one smartphone app. Our specific aims are: Aim 1: Compare the effectiveness of HIV care supported by the PPA to usual care for retention in HIV care and viral suppression of newly diagnosed or re-engaged high priority younger adults with HIV. Aim 2: To identify factors that predict user engagement with primary PPA components and associated effects on retention in care, viral suppression, and HIV related perceived stigma. Aim 3: To determine intervention adoption, usability, fidelity, and cost across study sites. These aims will be addressed in a parallel cohort design randomized controlled trial of 250 newly diagnosed or out of care YPWH from designated high priority sites. Participants will be allocated 1:1 to receive the PPA app upon study entry or to a delayed intervention arm where they will receive the usual care with attention controls for 6 months. This will allow for effectiveness evaluation during the earliest phase of adjustment to the diagnosis while also allowing for longitudinal outcome effects.

项目总结/摘要 Positive Peers移动的应用程序是由最难的人开发的原创平台 接触艾滋病毒差异人口，即认为自己是种族、族裔和/或族裔的艾滋病毒感染者， 性/性别少数群体。这个应用程序有潜力提供广泛的，可定制的，自我- 管理工具（即，健康追踪器、社区论坛、聊天、频繁的原创博客）， 美国任何地方的艾滋病毒感染者。Positive Peers应用程序提供健康信息， 健康管理工具和虚拟社区支持。虽然应用程序本身提供了一个安全的地方， 对于感染艾滋病毒的年轻人来说，为了获得健康信息和支持， 本地同行管理员的存在，为用户提供导航、支持和指导。 拟议的研究旨在评估其在改善病毒抑制方面的有效性 在18-30岁的少数群体中， 使用随机对照试验设计，辅以 拒绝使用该应用程序的人的观察队列。六个高优先级诊所 艾滋病毒流行管辖区将培训工作人员作为应用程序管理员，并将应用程序用作诊所- 基于工具我们的主要目标是通过提供同伴互动， 有针对性的保留和遵守消息，以及交互式跟踪器和提醒在一个 智能手机应用程序。我们的具体目标是： 目标1：比较PPA支持的艾滋病毒护理与常规护理的效果 在艾滋病毒护理和病毒抑制的新诊断或重新从事高度优先的年轻人 感染了艾滋病毒 目标2：确定预测用户参与主要PPA组件的因素， 相关影响的保留护理，病毒抑制和艾滋病毒相关的感知耻辱。 目的3：确定研究中心的干预措施采用、可用性、保真度和成本。 这些目标将在一项250例受试者的平行队列设计随机对照试验中得到解决。 从指定的高度优先地点新诊断或脱离护理的YPWH。参与者将被 按1：1分配至研究入组时接受PPA应用程序或延迟干预组， 他们将接受为期6个月的常规护理和注意力控制。这将允许 在调整诊断的最早阶段进行有效性评估，同时 考虑到纵向结果效应。