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

项目总结/摘要 这个指导研究科学家发展奖（K 01）的目的是提供博士安吉拉 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过渡 受物质使用影响的人口。培训目标（TG）包括培养以下方面的技能和专业知识： 干预发展（TG 1），实施科学（TG 2），研究伦理（TG 3），和专业 成功的学术研究生涯（TG 4）。培训将通过一个 密集的正式结构化课程，培训讲习班和研究所，指导阅读， 应用研究经验，并与经验丰富的导师谁是著名的专家在互动 制定干预措施、实施科学、药物使用和抗逆转录病毒暴露前预防 （PrEP）预防艾滋病毒。候选人研究的首要目标是建立一个社区- 基于PrEP的注射毒品者干预（PWID）。虽然PrEP被推荐用于艾滋病毒 在艾滋病毒/艾滋病感染者中，这一高风险和社会边缘化人群的接受率很低， 对可接受性和遵守挑战仍然知之甚少。这一修订后的提案以一项 弱势群体的医疗保健利用模式，干预发展的系统方法， 目标1：确定可修改的 未感染艾滋病毒的PWID（n=30）和关键信息提供者（n=15）中PrEP获取和使用的决定因素; 目标2：开发一种手动干预（TG 1），以改善PWID中的PrEP吸收和依从性 参加以社区为基础的注射器交换计划（SEP）;目标3：进行试点随机 基于SEP的PrEP摄取和PWID依从性干预的对照试验（RCT）（n=50） 混合方法的过程评价侧重于执行结果（TG 2）。尽管存在 有效的艾滋病毒预防策略（例如，通过SEPs获得无菌注射器）， 过去十年来滥用类阿片的流行正在威胁到以往在预防艾滋病毒方面取得的成就。的 报告过去一年接受注射器共享和/或无避孕套性交的美国PWID比例较高 (77%）强调需要扩大PrEP的提供，这是有效的，并建议用于艾滋病毒 预防PWID。通过将K 01设置在波士顿大学医学院， 与社区卫生和社会服务组织合作，候选人将能够获得大量的 艾滋病毒/艾滋病感染者和干预开发和实施科学方面的领先专家。而 拟议的试点试验可能无法检测PrEP吸收或依从性结果的变化，它将 提供必要的技能和初步数据，以确定干预措施的可行性， 可接受性，并推断未来全规模R 01研究的效应量估计和实施方面。

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.