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

基本信息

批准号：
10402149
负责人：
James Benjamin Brock
金额：
$ 75.42万
依托单位：
BROWN UNIVERSITY
依托单位国家：
美国
项目类别：
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/10402149
关键词：
AIDS prevention Adherence Administrator 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 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 of activation protein 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 Self Efficacy Spottings Tenofovir Testing Time Viral behavior measurement black men who have sex with men clinical research site combat comparative efficacy comparison intervention data format effectiveness-implementation RCT efficacy testing experience follow-up formative assessment future implementation group intervention implementation context implementation intervention improved innovation intervention delivery member patient population pre-exposure prophylaxis randomized trial skills social stigma success

项目摘要

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

项目概要暴露前预防 (PrEP)，其中存在持续 HIV 风险的人使用抗逆转录病毒药物来预防降低感染 HIV 的风险，是一种很有前景的预防策略。然而，数据显示，PrEP 的效果很好。治疗依从性不佳会极大地影响疗效。1 PrEP 患者面临许多困难最佳依从性和保留护理面临的挑战，包括对风险的耻辱和误解。2,3 为了应对这些挑战，PrEP 处方应辅以依从性干预措施，这些措施包括：吸引不同人群。1,4 我们开发并检验了以行动为导向的、名为 Viral Combat.5,6 Viral Combat 的吸引人的手机游戏，旨在提高 PrEP 的依从性对 69 名新开始 PrEP 的参与者进行的随机试验，在 24 周的随访中，参与干预的参与者。参与最佳 PrEP 剂量（即每周 4 天或更多天）的可能性是对照组的 3.75 倍（p=0.02）与对照组相比，使用来自干血斑的替诺福韦二磷酸盐水平表示。6 下一阶段的研究，我们将通过多站点混合 1 型有效性测试病毒战斗 - 实施随机对照试验 (RCT)，有 200 名年龄 15-34 岁的参与者接受 PrEP 护理在南部（n=100 密西西比州杰克逊）和新英格兰（n=100，罗德岛州普罗维登斯；马萨诸塞州波士顿）的临床地点。卫生服务研究实施综合促进行动 (i-PARIHS) 框架将检查干预措施实施的促进因素和障碍。利益相关者将在试验前告知这一干预措施，评估后访谈将总结问题 45 与未来的传播相关。