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.

当前是艾滋病预防的关键时期。从2010年开始，随机临床试验的结果表明， HIV 暴露前预防 (PrEP) 是一种安全有效的减少 HIV 感染的方法。然而， 尽管全国范围内对 PrEP 的了解和使用不断增加，但艾滋病毒仍然产生不成比例的影响 在与男性发生性关系的男性和跨性别者（MSM/TG）中，使用甲基苯丙胺（meth）- 用户面临特别高的风险。尽管 PrEP 知识水平明显很高并且表现出色 由于保险和药物覆盖范围广，西西澳的冰毒使用者很少参加当地的 PrEP 计划。 我们对使用 MSM/TG 的初步工作已经确定了 PrEP 的传统障碍和障碍 针对冰毒使用者的具体情况，包括相互竞争的优先事项（例如吸毒）；日常安排缺乏规律性 导致难以遵守预约和服药依从性；以及伴随的健康和 社会问题，特别是抑郁症和与冰毒相关的耻辱。需要额外的工作来开发新的 增加 PrEP 吸收并支持使用冰毒的 MSM/TG 的持久性和依从性的策略。 本临床试验计划拨款 (R34) 中提出的项目将开发并提供初步数据 针对使用 MSM/TG 的同行导航和基于理论的短信干预，并将提供 通过建立研究团队、开发数据收集工具来支持未来的 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 目标#1中描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 西西澳州为吸食冰毒的 MSM/TG、两家社区 PrEP 诊所和其他主要合作伙伴提供服务。在 目标 #2 和 #3，我们将使用 MSM/TG 启动 PrEP 进行 40 种甲基苯丙胺的试点随机对照试验，以评估 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来评估 我们的干预措施将 PrEP 转变为对使用冰毒的 MSM/TG 进行有效的 HIV 预防的能力。 该应用程序的优势包括重点关注几个主题，这些主题是为了改进 HIV PrEP 级联。其中包括开发和试点测试改善 PrEP 护理的干预措施 艾滋病毒感染高危人群的参与和保留，以及干预措施 支持 PrEP 药物治疗的依从性和持久性。聘请具有丰富专业知识的研究团队 国内和国际上的 PrEP、其他同伴导航和依从性咨询的发展 干预措施、艾滋病毒检测和预防规划、物质使用干预措施以及成本效益 分析，这种合作将致力于直接为未来应用中提出的功效试验提供信息， 从而最大限度地提高 PrEP 的能力，减少艾滋病毒感染风险最高的人群中的新感染。