Implementing pre-exposure prophylaxis for HIV prevention among people who inject drugs

项目摘要/摘要 该指导研究科学家发展奖(K01)的目标是为Angela博士提供 Robertson Bazzi拥有支持她所需的培训、指导、研究经验和受保护的时间 在为边缘化群体制定预防干预措施方面向研究独立性过渡 受药物使用影响的人群。培训目标(TGS)包括开发以下方面的技能和专业知识 干预发展(TG1)、实施科学(TG2)、研究伦理(TG3)和专业 为成功的学术研究事业发展(TG4)。培训将通过 将正规的结构化课程、培训讲习班和机构、定向阅读、 应用研究经验，以及与经验丰富的导师的互动，这些导师都是 干预发展、实施科学、物质使用和暴露前的抗逆转录病毒预防 (准备)预防艾滋病毒。候选人研究的首要目标是发展一个社区- 为注射吸毒者提供基于PrEP的干预(PWID)。尽管PrEP被推荐用于HIV 在PWID中的预防，在这一高危和社会边缘人群中的吸毒率一直较低，以及 可接受性和遵守挑战仍然知之甚少。这项修订后的提案是由一个 弱势人群的医疗保健利用模式，干预发展的系统方法， 和执行科学框架，将满足以下具体目标：目标1：确定可修改的 未感染艾滋病毒的PWID(n=30)和主要告密者(n=15)获取和使用PrEP的决定因素； 目标2：开发人工干预(TG1)以改善PWID患者对PrEP的摄取和依从性 参加以社区为基础的注射器交换计划(SEP)；和目标3：进行随机试验 基于SEP的PrEP摄取和依从性干预治疗PWID的对照试验(RCT)(n=50) 采用混合方法，进程评价侧重于执行成果(TG2)。尽管存在着 针对PWID的有效艾滋病毒预防战略(例如，通过SEPS获得无菌注射器)，不断增加 过去十年中阿片类药物滥用的盛行正在威胁过去在艾滋病毒预防方面取得的成就。这个 报告过去一年共用注射器和/或无套性行为的美国PWID比例很高 (77%)强调需要扩大PrEP的交付，这是有效的，建议用于艾滋病毒 PWID中的预防。通过将K01设在波士顿大学医学院，该校区位于同一地点 通过以社区为基础的健康和社会服务组织，候选人将能够获得 PWID的人口和干预发展和实施科学方面的领先专家。而当 拟议的试点试验可能无法检测PrEP摄取或依从性结果的变化，它将 提供必要的技能和初步数据以确定干预的可行性，最大限度地扩大利益相关者 可接受性，并推断效果大小估计和实施方面的未来全面的R01研究。

Project Summary / Abstract The objective of this Mentored Research Scientist Development Award (K01) is to provide Dr. Angela Robertson Bazzi with the training, mentoring, research experience, and protected time needed to support her transition to research independence in the development of prevention interventions for marginalized populations affected by substance use. Training goals (TGs) include developing skills and expertise in intervention development (TG1), implementation science (TG2), research ethics (TG3), and professional development for a successful academic research career (TG4). Training will be accomplished through an intensive combination of formal structured courses, training workshops and institutes, directed readings, applied research experience, and interactions with experienced mentors who are renowned experts in intervention development, implementation science, substance use, and antiretroviral pre-exposure prophylaxis (PrEP) for HIV prevention. The overarching objective of the candidate’s research is to develop a community- based PrEP intervention for people who inject drugs (PWID). Although PrEP is recommended for HIV prevention among PWID, uptake in this high risk and socially marginalized population has been low, and acceptability and adherence challenges remain poorly understood. This revised proposal, which is guided by a model of healthcare utilization for vulnerable populations, a systematic approach to intervention development, and implementation science frameworks, will meet the following specific aims: Aim 1: identify the modifiable determinants of PrEP access and utilization among HIV-uninfected PWID (n=30) and key informants (n=15); Aim 2: develop a manualized intervention (TG1) to improve PrEP uptake and adherence among PWID attending a community-based syringe exchange program (SEP); and Aim 3: conduct a pilot randomized controlled trial (RCT) of the resulting SEP-based PrEP uptake and adherence intervention for PWID (n=50) with a mixed methods process evaluation focused on implementation outcomes (TG2). Despite the existence of effective HIV prevention strategies for PWID (e.g., access to sterile syringes through SEPs), the increasing prevalence of opioid misuse over the past decade is threatening past achievements in HIV prevention. The high proportion of U.S. PWID who report past-year receptive syringe sharing and/or condomless intercourse (77%) highlights a need for expanded delivery of PrEP, which is efficacious and recommended for HIV prevention among PWID. By situating this K01 on the Boston University Medical Campus, which is co-located with community-based health and social service organizations, the candidate will be able to access a large population of PWID and leading experts in intervention development and implementation science. While the proposed pilot trial may not be powered to detect changes in PrEP uptake or adherence outcomes, it will provide the necessary skills and preliminary data to determine intervention feasibility, maximize stakeholder acceptability, and infer effect size estimates and implementation aspects for a future full-scale R01 study.