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

尽管需要持续坚持医疗护理，但感染艾滋病毒的青少年 (YLWH) 的感染率较低 坚持和保留护理，并且有很大的失访风险。(5,16-18) 需要新颖且对 YLWH 有吸引力的依从性干预措施。(7,8,14) 我们开发了，并且 初步检验，集成7天智能用药装置（Wisepill）的多层次技术 具有身临其境且有吸引力的智能手机应用程序/游戏，对 YLWH 具有吸引力和吸引力。(82,83) 在游戏过程中，YLWH 在色彩缤纷、身临其境的器官系统中对抗 HIV，并获得相关的依从性 带有游戏图形的短信。 Wisepill 开口会引导与游戏相关的短信，并可能导致 应用程序/游戏中的奖励积分。我们在发育试验中测试了多层次游戏干预。这 对于刚开始接受抗逆转录病毒治疗的人来说，干预措施的影响最大。在新近参加过的参与者中 开始 ART 后，干预措施降低了病毒载量并提高了 ART 依从性。那些刚开始 ART 的人 与对照组中新开始 ART 的患者相比，干预措施的病毒载量增加了 0.96 个对数 减少，并证明通过 Wisepill 测量，依从性改善的效果很大（d=1.18，71% vs. 测试后的依从性为 48%）。干预和新开始的 ART 之间的这些相互作用是显着的 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）。为了这 在下一阶段的研究中，我们将与 YLWH 一起进一步测试多层次游戏干预，他们是 新英格兰和密西西比州的临床中心最近开始了 ART。多中心随机对照研究 （第 48 周）在 120 名新开始 ART 的 YLWH 中将测试干预措施与对照相比的功效 条件（接受非 HIV 游戏和 Wisepill）的行为和生物测量。 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 带文字的游戏 组织者/分配者：衡量遵守情况 消息传递 集成到 iPhone 游戏中HIV RNA 病毒载量