A Multisite Randomized Trial of Viral Combat: A Mobile Gaming App to Improve Adherence to PrEP

病毒战斗的多站点随机试验：一款提高 PrEP 依从性的移动游戏应用程序

• 批准号: 10684653
• 负责人: James Benjamin Brock
• 金额: $ 69.28万
• 依托单位: BROWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-17 至 2027-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10684653
• 关键词: AIDS prevention; Adherence; Administrator; African American; Age; Age Years; Anti-Retroviral Agents; Behavioral; Biological; Black race; Blood; Boston; Caring; Clinic; Clinical; Communities; Control Groups; Data; Development; Diphosphates; Dissemination and Implementation; Dose; Dryness; Effectiveness; Evaluation; Face; Future; Geography; HIV Infections; HIV risk; Hair; Health Benefit; Health Personnel; Health Promotion; Health Services; Hispanic; Hybrids; Individual; Intervention; Interview; Knowledge; Latinx; Measures; Mediator; Mississippi; Modeling; Motivation; New England; Participant; Patient Self-Report; Patients; Perception; Persons; Pharmaceutical Preparations; Phase; Population; Population Heterogeneity; Prevention strategy; Promoting Action on Research Implementation in Health Services framework; Randomized, Controlled Trials; Records; Research; Risk; Risk Reduction; Self Efficacy; Site; Spottings; Tenofovir; Testing; Treatment Efficacy; Viral; absorption; behavior measurement; clinical research site; combat; comparative efficacy; comparison control; effectiveness-implementation RCT; efficacy testing; experience; follow-up; formative assessment; future implementation; group intervention; implementation context; implementation intervention; improved; innovation; intervention delivery; member; men who have sex with men; patient population; pre-exposure prophylaxis; randomized trial; skills; social stigma; structural determinants; success

Project Summary Pre-exposure prophylaxis (PrEP), in which persons with ongoing HIV risk use antiretroviral medications to reduce their risk of acquiring HIV infection, is a promising prevention strategy. However, data show that PrEP’s effectiveness is greatly compromised by suboptimal adherence to treatment.1 Persons on PrEP face many challenges to optimal adherence and retention in care, including stigma and misperceptions about risk.2,3 Due to these challenges, the prescribing of PrEP should be accompanied by adherence interventions that are appealing to diverse populations.1,4 We developed and examined the preliminary efficacy of an action-oriented, appealing, mobile game to improve adherence to PrEP entitled Viral Combat.5,6 Viral Combat was tested in a randomized trial with 69 participants newly initiating PrEP. At the 24-week follow-up, those in the intervention group were 3.75 times (p=0.02) as likely to engage in optimal PrEP dosing (i.e. 4 or more days/week as indicated using levels of tenofovir diphosphate from dried blood spots) compared to the control group.6 In this next phase of research, we will test Viral Combat through a multisite Hybrid Type 1 effectiveness- implementation randomized controlled trial (RCT) with 200 participants ages 15-34 years, receiving PrEP care at clinical sites in the South (n=100 Jackson, MS) and New England (n=100, Providence, RI; Boston, MA). The integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework will examine the facilitators and barriers to the intervention’s implementation. Formative interviews with stakeholders will inform this intervention prior to the trial, and post-evaluation interview will summarize issues relevant to future dissemination. 45

项目摘要 暴露前预防（PrEP），即有艾滋病毒风险的人使用抗逆转录病毒药物， 减少他们感染艾滋病毒的风险，是一项有希望的预防战略。然而，数据显示， 有效性受到次优治疗依从性的极大影响。1接受PrEP的人面临许多 最佳坚持和保留护理的挑战，包括耻辱和对风险的误解。 面对这些挑战，PrEP的处方应伴随着依从性干预措施， 吸引不同人群。1，4我们开发并检查了以行动为导向的， 吸引人的，移动的游戏，以提高遵守PrEP题为病毒战斗。5，6病毒战斗进行了测试，在一个 一项随机试验，69名参与者新开始PrEP。在24周的随访中，那些在干预 组的3.75倍（p=0.02）可能从事最佳的PrEP剂量（即4天或更多天/周， 使用来自干血斑的替诺福韦二磷酸盐水平表示）与对照组相比。 下一阶段的研究，我们将测试病毒战斗通过多站点混合类型1的有效性- 实施随机对照试验（RCT），200名参与者年龄在15-34岁之间，接受PrEP护理 在南方（n=100，杰克逊，MS）和新英格兰（n=100，普罗维登斯，RI;波士顿，MA）的临床研究中心。的 卫生服务研究实施促进行动综合框架将 检查干预措施实施的促进因素和障碍。形成性面试， 利益相关者将在试验前告知此干预措施，评估后访谈将总结问题 与未来的传播有关。45