Preparing for pre-exposure prophylaxis implementation in Central-Eastern European Countries with low access to biomedical prevention

项目摘要 尽管暴露前预防（PrEP）在预防艾滋病毒感染方面有效，但PrEP 目前在罗马尼亚的医疗处方，虽然需求正在迅速增长。基于证据的知识是 迫切需要指导PrEP在罗马尼亚的有效推广。首先，罗马尼亚是增长率第二高的国家， 15个中东欧国家的艾滋病毒发病率，其中男同性恋和双性恋男子是其中之一 然而，没有针对GBM的国家艾滋病毒方案。第二，在一个 2019年GBM大型报告显示，罗马尼亚是44个欧洲国家中PrEP使用率差距最大的第8个国家。 （1%）和需求（70%）。第三，罗马尼亚在中东欧地区表现出一些最高的同性恋恐惧态度， GBM隐藏和未充分利用医疗保健。因此，许多罗马尼亚GBM自己获得PrEP 在没有医疗指导的情况下使用，从而增加了他们的艾滋病毒和其他健康风险。解决未得到满足的问题 罗马尼亚GBM的艾滋病毒预防需求，我们建立的美国-罗马尼亚团队建议引入一个 罗马尼亚的文化响应暴露前预防（PrEP）计划。我们将整合和调整两个 我们在美国开发和测试的工具1）SPARK，一种面对面的激励干预， 和坚持PrEP使用授权的性健康方法;和2）P3（准备，保护， emPowered），一个PrEP依从性支持应用程序，利用引人入胜的社交网络和基于游戏的 元素，与一个应用程序内的门户网站，为个性化的生活坚持辅导.我们将与当地 GBM主管的卫生提供者和GBM的合作伙伴联盟创建PrEP罗马尼亚，由双方组成 面对面（适应SPARK，以建立PrEP吸收和坚持的初始动机）和mHealth（适应 P3提供持续的基于应用程序的PrEP动机，教育和依从性支持）组件。要求1 （R21）。在mos 2-11中，使用ADAPT-ITT模型，我们将系统地联合收割机和文化适应SPARK 所以P3。目标2（R21）。在12-20月，我们将在单臂试点中招募20名GBM，以测试PrEP罗马尼亚的可行性 (e.g.,医疗访问出席），可接受性（例如，干预人员协议反馈，GBM访谈， 咨询，应用程序可用性和PrEP使用），和PrEP摄取（例如，已填写的处方），依从性（即，自 报告，生物标志物验证）和持久性（即，仍在PrEP上）3个月。R21-R33过渡目标。在莫斯 21-24，我们将总结PrEP罗马尼亚的承诺和预期的R33计划。目标3（R33）。在mos 1-4中，我们 将对PrEP罗马尼亚进行必要的调整。在第5-30个月，我们将随机抽取120例符合PrEP条件的GBM， 两个城市接受1）PrEP罗马尼亚或2）PrEP教育条件。我们将研究差异 3个月和6个月时各组PrEP摄取、依从性、持续性（自我报告和生物标志物验证） PrEP启动后。目标4（R33）。在mos 31-36中，我们将确定个人和机构障碍， 通过检查目标3的可行性和可接受性数据，以及通过 提供者、诊所主任和GBM访谈，为未来的混合有效性实施试验提供信息。

Project Summary Despite the effectiveness of pre-exposure prophylaxis (PrEP) in preventing HIV acquisition, PrEP is not currently medically prescribed in Romania, although demand is rapidly growing. Evidence-based knowledge is urgently needed to guide PrEP’s effective rollout in Romania. First, Romania has the 2nd highest increasing HIV incidence of 15 Central-Eastern European (CEE) countries, with gay and bisexual men (GBM) being one of the few epidemic-driving groups; however, there is no national HIV programming for GBM. Second, in a large 2019 GBM report, Romania was the 8th of 44 European countries with the largest gap between PrEP use (1%) and demand (70%). Third, Romania displays some of the highest homophobic attitudes in CEE, keeping GBM in hiding and underutilizing healthcare. Consequently, many Romanian GBM obtain PrEP on their own and use it without medical guidance, thereby increasing their HIV and other health risks. To address the unmet HIV-prevention needs of Romanian GBM, our established US-Romanian team proposes to introduce a culturally-responsive pre-exposure prophylaxis (PrEP) program in Romania. We will integrate and adapt two tools that we developed and tested in the US 1) SPARK, an in-person motivational intervention for uptake of and adherence to PrEP using an empowering sexual health approach; and 2) P3 (Prepared, Protected, emPowered), a PrEP adherence support app that utilizes engaging social networking and game-based elements, with an in-app portal for individualized live adherence counseling. We will work with our local Partner Consortium of GBM-competent health providers and GBM to create PrEP Romania, composed of both in-person (adapted SPARK to build initial motivation for PrEP uptake and adherence) and mHealth (adapted P3 to provide ongoing app-based PrEP motivation, education, and adherence support) components. Aim 1 (R21). In mos 2-11, using the ADAPT-ITT Model, we will systematically combine and culturally adapt SPARK and P3. Aim 2 (R21). In mos 12-20, we will enroll 20 GBM in a one-arm pilot to test PrEP Romania’s feasibility (e.g., medical visit attendance), acceptability (e.g., intervention staff protocol feedback, GBM interviews about counseling, app usability, and PrEP use), and PrEP uptake (e.g., filled prescriptions), adherence (i.e., self- reported, biomarker verified) and persistence (i.e., still on PrEP) at 3 mos. R21-R33 Transition Aim. In mos 21-24, we will summarize PrEP Romania’s promise and anticipated R33 plans. Aim 3 (R33). In mos 1-4, we will make necessary adjustments to PrEP Romania. In mos 5-30, we will randomize 120 PrEP-eligible GBM in two cities to receive either 1) PrEP Romania or 2) a PrEP education condition. We will examine differences across arms in PrEP uptake, adherence, persistence (self-reported and biomarker verified) at 3- and 6-mos post-PrEP initiation. Aim 4 (R33). In mos 31-36, we will identify individual and institutional barriers and facilitators of implementing PrEP Romania by examining Aim 3 feasibility and acceptability data, and via provider, clinic director, and GBM interviews to inform a future hybrid effectiveness-implementation trial.