Interventions to Improve the HIV PrEP Cascade among Methamphetamine Users

这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， HIV暴露前预防（PrEP）是一种安全有效的减少HIV感染的方法。然而，在这方面， 尽管在全国范围内对PrEP的了解和使用有所增加，但艾滋病毒仍然具有不成比例的影响 在男性和变性人谁与男性发生性关系（男男性行为者/变性人），与甲基苯丙胺（甲基）- 用户的风险特别高。尽管PrEP知识水平明显较高， 保险和药物覆盖，西澳很少有冰毒使用者参加当地的PrEP计划。 我们对使用meth-using MSM/TG的初步工作已经确定了PrEP的传统障碍和障碍 特定于冰毒使用者，包括竞争优先级（例如，越来越高）;缺乏规律性的日常安排 导致难以遵守预约和药物依从性;以及伴随的健康和 社会问题，特别是抑郁症和与冰毒有关的耻辱。需要开展更多的工作， 战略，以增加PrEP吸收和支持持久性和坚持之间的方法使用MSM/TG。 本临床试验计划补助金（R34）中提出的项目将开发并提供初步数据， 同伴导航和基于理论的短信干预方法使用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 以及成本效益分析，并最终确定研究方案和程序手册。形成性工作 目标1中所述的将扩大学术研究人员、公共卫生、社区组织之间的现有合作， 在西澳大利亚州，为使用冰毒的男男性接触者/变性人提供服务，两个基于社区的PrEP诊所，以及其他主要合作伙伴。在 目标#2和#3，我们将进行一项试点随机对照试验，其中40名使用方法的MSM/TG启动PrEP，以评估 每项干预措施的可接受性和可行性。为此，我们将收集初步数据， 我们的干预措施能够将PrEP塑造成有效的艾滋病毒预防方法使用MSM/TG。 该应用程序的优势包括专注于几个主题，这些主题是为了提高 HIV PrEP级联。这些措施包括制定和试点测试干预措施，以改善PrEP护理 艾滋病毒感染高风险人群的参与和保留，以及采取干预措施， 支持PrEP药物依从性和持久性。聘用一个在以下方面具有实质性专门知识的研究团队： PrEP在国内和国际上，其他同行导航和坚持咨询的发展 干预措施、艾滋病毒检测和预防规划、药物使用干预措施和成本效益 分析，这种合作将直接为未来申请中提出的疗效试验提供信息， 从而最大限度地提高PrEP的能力，以减少艾滋病毒感染风险最高的人群中的新感染。

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.