PrEP2Prevent: An Online PrEP Navigation and Activation Intervention for YMSM

这是一个修订后的（A1）R34申请，标题为，PrEP 2 Prevent：在线PrEP导航和激活 YMSM的干预措施，建议开发和试点测试PrEP激活，导航和支持 对男男性行为青年的干预。这一人群的年发病率最高 艾滋病毒感染者，也是最不可能使用PrEP的人。我们自己的数据与一个大型YMSM队列 表明，虽然90%的人听说过PrEP，86%的人符合CDC的PrEP合格标准，但只有23% 曾经使用过PrEP，8%目前正在使用PrEP。在同一队列中，26%的人对一种或多种 性传播感染（STI）和艾滋病毒血清转换率为4.3%，在2年的时间。 因此，很明显，迫切需要专门针对PrEP摄取的干预措施， 还涉及一系列复杂的个人（例如，物质使用，抑郁症），社会文化（例如，PrEP- 相关的耻辱），和结构（例如，药物费用）的障碍。根据我们自己的研究， 我们提出了一项干预措施，其中包括PrEP导航;患者激活以减少PrEP相关的 耻辱和提高PrEP自我效能;和同伴/社会支持。将使用移动的进行干预 健康（mHealth）或类似技术。具体目标是：1）进行形成性研究， 开发PrEP激活，导航和支持干预，我们称之为PrEP 2 Prevent。 定性工作/焦点小组数据将从YMSM收集，焦点小组将与 PrEP护理提供者/导航员; 2）开发并进行PrEP 2 Prevent的可用性测试，包括 干预内容和移动健康提供平台;以及3）评估 PrEP 2 Prevent使用150名YMSM（年龄16-24岁）的种族/民族多样化样本。参与者将被 随机分配到干预组（PrEP 2 Prevent）或对照组（标准护理）。初级 结果是可行性和可接受性。第二个目的是评估干预措施对以下方面的影响： 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吸收（使用经验证的服务使用和PrEP生物标志物 使用）以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 未来RCT的可能干预效应量（组平均值，SD）。实施研究还将 借鉴RE-AIM框架进行。该研究具有重要意义，及时性和 新颖啊它针对YMSM最需要的干预措施-即，关于PrEP摄取。它承认 YMSM需要工具和支持来成功地导航PrEP服务，并使用mHealth来提供 干预此外，干预可用于参与和重新参与YMSM的PrEP摄取， 它可以潜在地适用于解决长效PrEP和抗逆转录病毒疗法（ART）的摄取。

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).