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：
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
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/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

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

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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

项目摘要暴露前预防（PREP），其中持续艾滋病毒风险的人使用抗逆转录病毒药物降低他们获得艾滋病毒感染的风险是预防策略。但是，数据显示Prep的次优遵守治疗极大地损害了有效性。最佳依从性和保留保健的挑战，包括对风险的污名和误解。2,3 应对这些挑战，应通过遵守干预措施来完成准备的处方 1,4我们开发并研究了面向行动，以动作为导向的初步效率吸引人的手机游戏以提高依从性为“病毒战斗”的准备。5,6病毒战斗已在一场与69名参与者的随机试验新启动。在24周的随访中，干预组的可能是3.75次（p = 0.02），可能进行最佳准备剂量（即4个或更多天/周）与对照组相比，使用干血点的替诺福韦二磷酸水平表示。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15-34岁的参与者接受预备护理在南部的临床站点（n = 100杰克逊，密西西比州）和新英格兰（n = 100，普罗维登斯，RI；马萨诸塞州波士顿）。综合促进卫生服务研究实施（I-PARIHS）框架的行动将检查干预实施的促进者和障碍。格式采访利益相关者将在审判前通知此干预措施，并评估后面试将总结问题与未来的传播有关。 45