PrEP2Prevent: An Online PrEP Navigation and Activation Intervention for YMSM

这是一个修订的(A1)R34应用程序，名为PrEP2Preventt：An Online PrEP导航和激活 对基督教青年会的干预，它建议开发和试点测试PrEP激活、导航和支持 对年轻男男性行为者的干预(基督教青年会)。这一人群的年发病率最高 也是使用PrEP的可能性最小的。我们自己的数据和一大批YMSM 表明虽然90%的人听说过PrEP，86%的人符合CDC的PrEP资格标准，但只有23%的人 曾经使用过PrEP，8%的人目前正在使用PrEP。在同一队列中，26%的人一项或多项检测呈阳性 性传播感染(STI)和HIV血清转换率在2年内为4.3%。 因此，很明显，迫切需要专门针对PrEP摄取的干预措施，同时 还涉及一系列复杂的个人(例如，药物使用、抑郁)、社会文化(例如，PrEP- 相关污名)，以及PrEP吸收的结构性障碍(例如，药物费用)。基于我们自己的研究， 我们提出了一种干预措施，包括PrEP导航；患者激活以减少PrEP相关 羞辱和提高PrEP自我效能；以及同伴/社会支持。干预将使用移动设备进行 Health(MHealth)或类似技术。具体目标是：1)进行形成性研究，以告知 开发PrEP激活、导航和支持干预，我们称之为PrEP2Prevent. 将从基督教青年会收集定性工作/焦点小组数据，并将与 准备护理提供者/导航员；2)开发并执行PrEP2预防的可用性测试，包括 干预内容和移动健康服务平台；3)评估服务的可行性和接受性 PrEP2通过对150名基督教青年会(16-24岁)进行种族/民族多样性抽样来预防。参与者将是 随机分配到干预组(PrEP2预防)或对照组(标准护理)。主要 结果是可行性和可接受性。第二个目标是评估干预措施对 我们的目标冥想机制和近端行为结果(例如，PrEP耻辱和自我 功效)。我们还将评估参与者的PrEP摄取(使用经过验证的服务使用和PrEP的生物标记物 使用)确定是否存在与参与干预相关的任何趋势。评估将 发生在基线、3个月(干预完成)和6个月时。这些数据将提供对 未来随机对照试验的可能干预效果大小(组平均值，标准差)。实施研究也将是 在RE-AIM框架的基础上进行。拟议的研究具有非常重要的意义、及时和 创新。它针对YMSM最需要的地方进行干预--即PrEP摄取。它认识到 YMSM需要工具和支持来成功导航PrEP服务，并使用mHealth来交付 干预。此外，干预可用于YMSM参与和重新参与PrEP摄取， 它有可能被改造成解决长效PrEP和抗逆转录病毒治疗(ART)的摄取问题。

This is a revised (A1) R34 application entitled, PrEP2Prevent: An Online PrEP Navigation and Activation Intervention for YMSM, which proposes to develop and pilot test a PrEP activation, navigation and support intervention for young men who have sex with men (YMSM). This population has the highest annual incidence of HIV and is also the least likely to have ever used PrEP. Our own data with a large cohort of YMSM indicates that while 90% have heard about PrEP and 86% meet CDC’s eligible criteria for PrEP, only 23% have ever used PrEP and 8% are currently on PrEP. In this same cohort, 26% tested positive for one or more sexually transmitted infections (STIs) and the HIV seroconversion rate was 4.3% during a 2 years period. Thus, it is very clear that there is an urgent need for interventions that specifically target PrEP uptake while also addressing a complex array of individual (e.g. substance use, depression), sociocultural (e.g., PrEP- related stigma), and structural (e.g., medication costs) barriers to PrEP uptake. Based on our own research, we are proposing an intervention that includes PrEP navigation; patient activation to reduce PrEP-related stigma and increase PrEP self-efficacy; and peer/social support. The intervention will be delivered using mobile health (mHealth) or similar technology. The specific aims are to: 1) Conduct formative research to inform the development of a PrEP activation, navigation and support intervention, which we call PrEP2Prevent. Qualitative working/focus group data will be collected from YMSM and focus groups will be conducted with PrEP care providers/navigators; 2) Develop and then conduct usability testing of PrEP2Prevent, including both the intervention content and mHealth delivery platform; and 3) Evaluate the feasibility and acceptability of PrEP2Prevent with a racially/ethnically diverse sample of 150 YMSM (ages 16-24 years). Participants will be randomly as assigned to the intervention (PrEP2Prevent) or control (standard of care) group. Primary outcomes are feasibility and acceptability. A secondary aim is to evaluate the impact of the intervention on our targeted meditating mechanisms and proximal behavioral outcomes (e.g., PrEP stigma and self- efficacy). We will also assess participants’ PrEP uptake (using verified service use and a biomarker of PrEP use) to determine if there are any trends associated with participation in the intervention. Assessments will occur at baseline and at 3- (intervention completion) and 6-months. These data will provide estimates of possible intervention effect sizes (group means, SDs) for a future RCT. Implementation research will also be conducted, drawing upon the RE-AIM framework. The proposed research is highly significant, timely and innovative. It targets an intervention for YMSM where they need it most — i.e., on PrEP uptake. It recognizes that YMSM require tools and support to successfully navigate PrEP services, and uses mHealth to deliver the intervention. Moreover, the intervention can be used to both engage and re-engage YMSM in PrEP uptake, and it can potentially be adapted to address uptake of long-acting PrEP and antiretroviral therapy (ART).