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并非如此 目前在罗马尼亚是医药处方，尽管需求正在迅速增长。循证知识是 迫切需要指导PrEP在罗马尼亚的有效推广。首先，罗马尼亚的增幅位居第二。 15个中东欧(CEE)国家的艾滋病毒发病率，其中男同性恋者和双性恋者为1人 在为数不多的推动流行病的群体中；然而，没有为基于性别的管理制定国家艾滋病毒方案。第二，在一个 大型2019年GBM报告，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，罗马尼亚在中东欧表现出了一些最强烈的同性恋恐惧症态度， 隐藏和未充分利用医疗保健的GBM。因此，许多罗马尼亚GBM自己获得PrEP 并且在没有医疗指导的情况下使用它，从而增加了他们的艾滋病毒和其他健康风险。向未满足的人发表讲话 罗马尼亚GBM的艾滋病毒预防需求，我们现有的美国-罗马尼亚团队建议引入一种 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Spark，这是一种面对面的动机干预，旨在了解 2)P3(准备好的，受保护的， 已授权)，这是一款PrEP遵从性支持应用程序，利用社交网络和基于游戏的 元素，具有应用内门户，可进行个性化的实时遵守咨询。我们将与我们的当地人合作 由具有GBM能力的保健提供者和GBM组成的合作伙伴联盟创建PrEP罗马尼亚，由两者组成 面对面(改编Spark以建立PrEP吸收和遵守的初始动力)和mHealth(改编 P3提供持续的基于APP的PrEP激励、教育和遵守支持)组件。目标1 (R21)。在MOS2-11中，使用适应-ITT模式，我们将系统地结合和文化适应星火 和P3。目标2(R21)。在MOS 12-20，我们将在单臂试点中招收20个GBM，以测试PrEP罗马尼亚的可行性 (例如，就诊次数)、可接受性(例如，干预人员礼仪反馈、GBM访谈 咨询、应用可用性和PrEP使用)，以及PrEP摄取(例如，填写处方)、依从性(即，自我 报告，生物标志物验证)和持久性(即，仍在PrEP上)。R21-R33过渡目标。在MOS中 21日至24日，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MOS1-4中，我们 将对罗马尼亚的PrEP进行必要的调整。在MOS 5-30中，我们将随机选择120个符合PrEP条件的GBM 两个城市接受1)罗马尼亚PrEP或2)PrEP教育条件。我们将研究差异 在3个月和6个月时跨臂摄取PrEP、依从性、持久性(自我报告和生物标记物验证) 在PrEP启动后。目标4(R33)。在MOS31-36中，我们将确定个人和制度障碍，并 通过审查目标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面谈，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.