A Multisite Randomized Trial of BattleViro: A Mobile Gaming App to Improve ART Adherence for Youth

BattleViro 的多站点随机试验：一款提高青少年对 ART 依从性的移动游戏应用程序

• 批准号: 10421056
• 负责人: James Benjamin Brock
• 金额: $ 67.58万
• 依托单位: BROWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-08-24 至 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10421056
• 关键词: Accounting; Achievement; Adherence; Administrator; Adolescent and Young Adult; Analysis of Covariance; Behavioral; Biological; Boston; Caring; Cellular Phone; Centers for Disease Control and Prevention (U.S.); Chronic; Clinic; Collaborations; Collection; Control Groups; Data; Development; Devices; Disease; Electronics; Elements; HIV; HIV Infections; HIV/AIDS; Health Benefit; Individual; Information Systems; Intervention; Interview; Knowledge; Life; Measures; Mediator; Medical; Mississippi; Modeling; Motivation; Nature; New England; Participant; Patients; Pharmaceutical Preparations; Play; RNA; Research; Risk; Sample Size; Self Efficacy; Site; Social support; Subgroup; Technology; Testing; Text; Text Messaging; Time; Translating; Treatment Efficacy; United States; Viral Load result; Virus; Youth; absorption; adherence rate; age group; body system; clinical research site; comparative efficacy; comparison control; comparison intervention; data integration; efficacy testing; electronic data; experience; fighting; follow-up; hedonic; improved; mobile application; novel; portability; randomized trial; randomized, controlled study; skills; smartphone application; social engagement; structural determinants; treatment adherence; virtual reality game

Despite need for consistent adherence to medical care, youth living with HIV (YLWH) have low rates of adherence and retention in care, and are at great risk for being lost to follow-up.(5,16-18) There is a great need for adherence interventions that are novel and appealing for YLWH.(7,8,14) We developed, and preliminarily examined, a multi-level technology that integrates a 7-day smart medication device (Wisepill) WITH an immersive and appealing smartphone app/game that is attractive and engaging for YLWH.(82,83) During gameplay, YLWH fight HIV in colorful and immersive organ systems, and receive adherence related text messages with game graphics. Wisepill openings guide game-related text messages and can result in bonus points in the app/game. We tested the Multilevel Gaming Intervention in a developmental trial. The impact of the intervention was greatest among those who had newly begun ART. In participants who had newly begun ART, the intervention decreased viral load and improved ART adherence. Those newly starting ART in the intervention, compared to those newly starting ART in the control, experienced a 0.96 log viral load greater decrease and evidenced a large effect size for improved adherence as measured by Wisepill (d=1.18, 71% vs. 48% adherence at post-test). These interactions between intervention and newly starting ART were significant in ANCOVAs, accounting for baseline values (viral load: F=4.33, p=0.04, adherence: F=3.20, p=0.05). For this next proposed stage of research, we will further test the Multilevel Gaming Intervention with YLWH who are newly starting ART at clinical sites in New England and in Mississippi. A multisite randomized controlled study (48 weeks) among 120 YLWH newly starting ART will test the efficacy of the intervention compared to a control condition (who receive a non-HIV game and the Wisepill) on behavioral and biological measures. Information, Motivation, Behavioral Skills Adherence to ART Immersive iPhone Electronic, portable, 7-day medication game with text organizer/dispenser: measures adherence messaging integrates into iPhone gameHIV RNA Viral Load

尽管需要坚持医疗护理，但感染艾滋病毒的青年（YLWH）的感染率很低， 在护理中的坚持和保留，并且有很大的失访风险。（5，16 -18）有一个伟大的 需要对YLWH进行新颖且有吸引力的依从性干预。7，8，14）我们开发了， 初步审查，一个多层次的技术，集成了7天的智能药物设备（Wisepill） 一个身临其境的和有吸引力的智能手机应用程序/游戏，是有吸引力的和从事YLWH。(82 83） 在游戏过程中，YLWH在丰富多彩和身临其境的器官系统中与艾滋病毒作斗争，并接受与艾滋病毒相关的坚持。 带有游戏图形的文本消息。Wisepill开口引导游戏相关的短信，并可能导致 应用程序/游戏中的奖励积分。我们在一项发展试验中测试了多水平游戏干预。的 干预的影响在那些刚开始接受抗逆转录病毒治疗的人中最大。 开始抗逆转录病毒治疗后，干预措施降低了病毒载量，提高了抗逆转录病毒治疗的依从性。那些新开始的艺术， 与对照组中那些新开始ART的人相比，干预组的病毒载量高出0.96 log。 降低，并证明了Wisepill测量的改善依从性的大效应量（d=1.18，71% vs. 48%的测试后坚持）。这些干预和新开始的ART之间的相互作用是显着的 在ANCOVA中，考虑基线值（病毒载量：F=4.33，p=0.04，依从性：F=3.20，p=0.05）。为此 在下一个研究阶段，我们将进一步测试多层次游戏干预与YLWH谁是 在新英格兰和密西西比的临床试验点新开始ART。一项多中心随机对照研究 (48在120名新开始ART的YLWH患者中， 条件（谁收到非艾滋病毒游戏和Wisepill）的行为和生物措施。 信息，动机， 行为技能 坚持艺术 沉浸式iPhone 电子、便携式、7天用药 文本游戏 组织者/分配器：测量依从性 消息传递 整合到iPhone游戏HIV RNA病毒载量