Interventions to Improve the HIV PrEP Cascade among Methamphetamine Users

改善甲基苯丙胺使用者中 HIV PrEP 级联的干预措施

• 批准号: 9408154
• 负责人: Joanne Donna Stekler
• 金额: $ 23.25万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-08-01 至 2020-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9408154
• 关键词: AIDS prevention; Address; Adherence; Alcohol or Other Drugs use; Appointment; Awareness; Behavior; Blood; Caring; Cities; Clinic; Clinic Visits; Clinical Trials; Collaborations; Communities; Cost Effectiveness Analysis; Counseling; County; Data; Data Collection; Development; Effectiveness of Interventions; Enrollment; Evaluation; Future; Gays; Grant; HIV; HIV Infections; Health; Healthcare; Human immunodeficiency virus test; Incidence; Individual; Infection; Insurance; International; Intervention; Interview; Knowledge; Laboratories; Manuals; Measures; Mental Depression; Methamphetamine; Methods; Monitor; Oral; Patient Self-Report; Persons; Pharmaceutical Preparations; Phase III Clinical Trials; Prevention; Procedures; Protocols documentation; Provider; Public Health; Randomized; Randomized Clinical Trials; Recruitment Activity; Reporting; Research; Research Personnel; Risk; Schedule; Sex Behavior; Shapes; Spottings; Surveys; Testing; Text; Time; Training; Washington; Work; arm; base; clinical care; clinical research site; cost; cost effective; cost effectiveness; design; efficacy trial; experience; follow-up; high risk; high risk men; improved; informant; medication compliance; meetings; men; men who have sex with men; methamphetamine use; methamphetamine user; peer; pre-exposure prophylaxis; prevent; programs; public health intervention; screening; sex; social; social stigma; standard of care; theories; therapy design; tool; transgender; transgender women; truvada; uptake

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.

这是预防艾滋病毒的关键时期。从2010年开始，随机临床试验的结果表明 HIV暴露前预防（PREP）是减少HIV获取的安全有效方法。然而， 尽管在全国范围内越来越了解和使用PREP，但HIV仍会产生不成比例的影响 在与男性发生性关系（MSM/TG）的男性和变性人中，甲基苯丙胺（甲基苯丙胺） - 用户的风险特别高。尽管明显高水平的准备知识和非凡的知识 保险和药物覆盖范围，西澳大利亚州西部很少有甲基苯丙胺用户参加了当地的预备计划。 我们使用MECH的MSM/TG的初步工作已经确定了传统的准备障碍和障碍 特定于甲基苯丙胺用户，包括竞争优先级（例如，越来越高）；每日时间表缺乏规律性 导致遵守任命和药物依从性的困难；和伴随的健康和 社会问题，特别是抑郁症和与甲基苯丙胺有关的污名。开发新的需要额外的工作 使用MECM/TG之间的持续性和依从性的策略。 本临床试验计划赠款（R34）中提出的项目将开发并提供初步数据 使用MECM/TG的同行导航和基于理论的文本消息干预措施，将提供 通过建立研究团队，开发数据收集工具来支持未来III期临床试验 以及成本效益的分析，并最终确定研究方案和手册。形成性工作 AIM＃1中描述的将扩大学术研究人员，公共卫生，CBO之间的现有合作 西澳大利亚州西澳大利亚州，使用甲基苯丙胺的MSM/TG，两个基于社区的预科诊所和其他主要合作伙伴。在 AIMS＃2和＃3，我们将使用40 MECH/TG的PILOT RCT发起PREP来评估 每种干预措施的可接受性和可行性。这样，我们将收集初步数据以评估 我们的干预措施将PREP塑造成有效的HIV预防MSM/TG的能力。 该应用程序的优势包括关注几个寻求的主题，以改善 艾滋病毒准备级联。这些包括对改善准备护理的干预措施的开发和试点测试 艾滋病毒感染风险很大的个体之间的参与和保留，以及干预措施 支持准备药物的依从性和持久性。雇用具有实质专业知识的研究团队 在国内和国际上准备其他同行导航和依从性咨询的发展 干预措施，艾滋病毒测试和预防编程，药物使用干预措施和成本效益 分析，这种合作将致力于直接告知效力试验，以在将来的申请中提出 因此，最大化Prep减少艾滋病毒收购风险最高的人中新感染的能力。