A Multilevel Gaming Intervention for Persons on PrEP

 描述(由申请人提供)：使用抗逆转录病毒药物来降低感染艾滋病毒的风险(暴露前预防，PrEP)是一种有效和有前景的新预防策略。在已发表的研究中，PrEP的失败与依从性差和血浆药物水平低有关。这表明最佳的PrEP治疗将需要行为干预来促进依从性。避免风险行为的增加对于维持PrEP的保护作用也是至关重要的。干预措施将需要针对正在进行的艾滋病毒危险行为，并与使用PrEP的人(例如年轻成年男男性接触者)相关。借用最近关于艾滋病毒预防和治疗坚持的文献，利用直观、易于使用的技术和激励成分的干预措施显示出改变行为和传播的希望。这项研究将考察一项多层次技术，该技术将药物监测设备(Wisepill分配器)与基于交互式智能手机的应用程序/游戏集成在一起，具有身临其境和吸引力。这项新颖而直观的多层次技术将衡量PrEP的依从性，促进参与治疗和安全的性行为。智能手机应用程序/游戏的开发将包括符合信息-动机-行为技能(IMB)模型的内容。在游戏中，参与者将体验以行动为导向的冒险，这些冒险增加了关于他们健康的信息(例如，关于PrEP治疗和艾滋病毒的知识)，提高了动机(例如，动作人物体验了坚持下去对健康的好处)，并培养了技能(例如，利用临床医生作为合作伙伴，安全套自我效能)。坚守 来自参与者的Wisepill设备的数据将被无线集成到应用程序/游戏中，并将转化为游戏期间的增强功能。对青年进行的深入访谈和干预措施的公开试验将为干预措施的发展和程序提供信息。在PrEP的50名参与者中进行的一项小型随机对照试验研究将检验干预的初步效果(将Wisepill配药机与IMB通知的APP/GAME整合)。假设与对照组的受试者相比，IMB游戏干预的参与者将表现出：更好地坚持PrEP，更高的血液ARV水平，减少HIV危险行为，以及改善自我效能和对PrEP治疗坚持的态度。

 DESCRIPTION (provided by applicant): The use of antiretroviral medications to reduce the risk of acquiring HIV infection (Pre-exposure Prophylaxis, PrEP) is an efficacious and promising new prevention strategy. In published studies, failure of PrEP was associated with poor adherence and low plasma drug levels. This indicates that optimal PrEP treatment will require behavioral interventions to promote adherence. Averting increases in risk behavior will also be essential for maintaining PrEP's protective effects. Interventions will need to address on-going HIV risk behavior and be relevant for persons using PrEP (e.g. young adult MSM). Borrowing from recent literature in HIV prevention and treatment adherence, interventions that utilize intuitive easy to use technologies with motivational components show promise for behavior change and dissemination. This study will examine a multi-level technology that integrates a medication monitoring device (Wisepill dispenser) with an interactive smartphone based app/game that is immersive and appealing. This novel, but intuitive multi-level technology will measure PrEP adherence, promote engagement in treatment and safe sexual behavior. The smartphone app/game will be developed to include content consistent with the Information-Motivation-Behavioral Skills (IMB) Model. While gaming, participants will experience absorbing action-oriented adventures that increase information about their health (e.g. knowledge about PrEP treatment and HIV), improve motivation (e.g. action-figures experience health benefits of adherence), and build skills (e.g. utilize clinicians as partners, condom self efficacy). Adherence data from participants' Wisepill device will be integrated into the app/game wirelessly and will translate into enhancements during game play. In-depth interviews with young adults on PrEP and an open trial of the intervention will inform the development of the intervention and procedures. A small randomized controlled pilot study among 50 participants on PrEP will examine the preliminary efficacy of the intervention (integration of the Wisepill dispenser with the IMB informed app/game). It is hypothesized that, compared to subjects in the control group, participants in the IMB Gaming Intervention will show: improved adherence to PrEP, higher blood ARV levels, decreased HIV risk behaviors, and improved self efficacy and attitudes for PrEP treatment adherence.