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

为在生物医学预防机会较少的中东欧国家实施暴露前预防做好准备

• 批准号: 10618604
• 负责人: Corina Lelutiu-Weinberger
• 金额: $ 1.19万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-09 至 2022-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10618604
• 关键词: Preparing; pre; exposure; prophylaxis; implementation

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.

项目概要 尽管暴露前预防 (PrEP) 在预防 HIV 感染方面有效，但 PrEP 并不能有效预防 HIV 感染。 尽管循证知识的需求正在迅速增长，但目前罗马尼亚仍采用医疗处方。 罗马尼亚迫切需要指导 PrEP 的有效推广 首先，罗马尼亚的增长率位居第二。 15 个中东欧 (CEE) 国家的艾滋病毒发病率，男同性恋和双性恋男性 (GBM) 是其中之一 少数流行病驱动群体；然而，没有针对 GBM 的国家艾滋病毒规划。 2019 年 GBM 大型报告显示，罗马尼亚是 PrEP 使用差距最大的 44 个欧洲国家中的第 8 个 (1%) 和需求 (70%) 第三，罗马尼亚在中东欧地区表现出一些最严重的恐同态度，继续保持这种态度。 经过测试，许多罗马尼亚 GBM 自行获得 PrEP。 并在没有医疗指导的情况下使用它，从而增加了艾滋病毒和其他健康风险。 罗马尼亚 GBM 的艾滋病毒预防需求，我们成立的美国-罗马尼亚团队建议引入 罗马尼亚的文化响应性暴露前预防 (PrEP) 计划 我们将整合和调整两个计划。 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措施 使用增强性健康方法坚持 PrEP；以及 2) P3（准备、受保护、 emPowered），一款 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，并提供个性化实时依从咨询的应用程序内门户。我们将与当地合作。 由具有 GBM 资格的卫生服务提供者和 GBM 组成的合作伙伴联盟将创建 PrEP 罗马尼亚，由双方组成 面对面（改编为 SPARK，为 PrEP 的采用和依从性建立初始动力）和移动医疗（改编为 P3 提供持续的基于应用程序的 PrEP 动机、教育和依从性支持）目标 1。 (R21) 在 mos 2-11 中，使用 ADAPT-ITT 模型，我们将系统地结合和文化适应 SPARK。 目标 2 (R21) 在 mos 12-20 中，我们将招募 20 名 GBM 进行单臂试点，以测试 PrEP 罗马尼亚的可行性。 （例如，医疗就诊出勤率）、可接受性（例如，干预人员方案反馈、GBM 访谈） 咨询、应用程序可用性和 PrEP 使用），以及 PrEP 的采用（例如，配药）、依从性（即，自我 报告，生物标志物验证）和持续性（即仍在 PrEP）3 个月 R21-R33 过渡目标。 21-24 日，我们将总结罗马尼亚 PrEP 的承诺和预期的 R33 计划（R33）。 将在第 5-30 个月对 PrEP 罗马尼亚进行必要的调整，我们将随机抽取 120 名符合 PrEP 资格的 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。 在 3 个月和 6 个月的 PrEP 吸收、依从性、持久性（自我报告和验证的生物标志物）方面各有不同 PrEP 后启动目标 4 (R33) 在 mos 31-36 中，我们将确定个人和机构障碍以及 罗马尼亚实施 PrEP 的促进者通过审查目标 3 的可行性和可接受性数据，并通过 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。