Interventions to Improve the HIV PrEP Cascade among Methamphetamine Users

现在是预防艾滋病毒的关键时刻。从2010年开始，随机临床试验的结果显示， 暴露前预防(PrEP)是减少HIV感染的一种安全有效的方法。然而， 尽管全国范围内对PrEP的了解和使用不断增加，但艾滋病毒仍然具有不成比例的影响 在与男性(MSM/TG)、使用甲基苯丙胺(冰毒)发生性行为的男性和变性人中- 处于特别高风险的用户。尽管显然具有很高的PrEP知识水平和出色的 在保险和药物覆盖范围内，西佤邦很少有冰毒使用者参加当地的PrEP计划。 我们对使用冰毒的男男性接触者/甘油三酯的初步工作已经确定了PrEP的传统障碍和障碍 具体到冰毒使用者，包括相互竞争的优先事项(例如，变得很高)；日常时间表缺乏规律性 导致难以遵守预约和坚持服药；以及随之而来的健康和 社会问题，特别是抑郁症和与冰毒有关的耻辱。还需要额外的工作来开发新的 增加PrEP摄取率并支持使用冰毒的MSM/TG中的持久性和依从性的战略。 本临床试验计划拨款(R34)中建议的项目将为以下项目开发和提供初步数据 同伴导航和基于理论的短信干预使用冰毒的MSM/TG，并将提供 通过建立研究团队，开发数据收集工具，支持未来的III期临床试验 和成本效益分析，并最终确定研究方案和程序手册。形成性工作 在AIM#1中描述的将扩展学术研究人员、公共卫生、CBO之间的现有合作 在西澳大利亚州提供冰毒服务--使用男男性接触者/甘油三酯，两家基于社区的PrEP诊所，以及其他关键合作伙伴。在……里面 目标2和3，我们将使用40种方法进行试点RCT-使用MSM/TG启动PrEP来评估 每项干预措施的可接受性和可行性。在此过程中，我们将收集初步数据以评估 我们的干预措施将PrEP塑造成有效预防使用冰毒的MSM/TG的艾滋病毒的能力。 这个应用程序的优点包括对几个主题的关注，以改善 HIV PrEP级联。这些措施包括制定和试行干预措施，以改善PrEP护理 在感染艾滋病毒的高风险个人中的参与和保留，以及干预措施 支持PrEP用药坚持和坚持不懈。聘请一支在以下领域具有实质性专业知识的研究团队 准备在国内和国际上开展其他同伴导航和依附咨询 干预措施、艾滋病毒检测和预防方案、药物使用干预措施和成本效益 分析，这一合作将直接为未来申请中提出的疗效试验提供信息，并 从而最大限度地提高预防接种计划在感染艾滋病毒风险最高的人群中减少新感染的能力。

This is a critical time for HIV prevention. Beginning in 2010, results from randomized clinical trials showed that HIV pre-exposure prophylaxis (PrEP) is a safe and efficacious method of reducing HIV acquisition. However, despite increasing knowledge about and use of PrEP nationally, HIV continues to have disproportionate impact among men and transgender persons who have sex with men (MSM/TG), with methamphetamine (meth)- users being at particularly high risk. Despite apparent high levels of PrEP knowledge and exceptional insurance and medication coverage, few meth-users in Western WA have enrolled in local PrEP programs. Our preliminary work with meth-using MSM/TG has identified both traditional barriers to PrEP and barriers specific to meth users, including competing priorities (e.g., getting high); lack of regularity in daily schedules leading to difficulties complying with appointments and medication adherence; and concomitant wellness and social concerns, notably depression and meth-related stigma. Additional work is needed to develop new strategies to increase PrEP uptake and support persistence and adherence among meth-using MSM/TG. The project proposed in this Clinical Trial Planning Grant (R34) will develop and provide preliminary data for peer navigation and theory-based text messaging interventions for meth-using MSM/TG and will provide support for a future phase III clinical trial by establishing the research team, developing tools for data collection and cost-effective analyses, and finalizing the study protocol and manual of procedures. Formative work described in Aim #1 will expand on existing collaborations between academic researchers, public health, CBOs in Western WA serving meth-using MSM/TG, two community-based PrEP clinics, and other key partners. In Aims #2 and #3, we will conduct a pilot RCT with 40 meth-using MSM/TG initiating PrEP to evaluate the acceptability and feasibility of each of the interventions. In doing so, we will collect preliminary data to assess the ability of our interventions to shape PrEP into effective HIV prevention for meth-using MSM/TG. This application's strengths include a focus on several topics that have been sought in order to improve the HIV PrEP Cascade. These include the development and pilot testing of interventions to improve PrEP care engagement and retention among individuals at substantial risk for HIV infection, as well as interventions to support PrEP medication adherence and persistence. Employing a research team with substantive expertise in PrEP both nationally and internationally, the development of other peer navigation and adherence counseling interventions, HIV testing and prevention programming, substance use interventions, and cost-effectiveness analysis, this collaboration will work to directly inform an efficacy trial to be proposed in a future application and thus maximize PrEP's ability to reduce new infections among the persons at highest risk of HIV acquisition.