An intervention to improve HIV pre-exposure prophylaxis initiation, adherence and linkage to care for recently incarcerated men who inject drugs.

项目总结 这个K23应用概述了一个新的临床研究领域，以满足日益增长的公共卫生需求 由于注射吸毒者(PWID)代表了不成比例的新艾滋病毒病例数量，有限 关于支持暴露前预防(PrEP)所需的规划和与护理的联系的知识 在这一人群中的使用。这项研究的目的是确保马修·墨菲博士(PI)的未来 在HIV预防和物质使用障碍(SUD)患者使用PrEP方面的研究独立性 通过为未来的R01应用提供初步数据，最大的艾滋病毒感染风险。《公约》的具体目标 K23建议1)对20名CJ参与的男性PWID进行定性访谈，以评估障碍和 促进PrEP的启动、坚持和联系到出狱后的护理；2)制定 “准备释放”干预，并对15名男性PWID进行开放标签试点干预 3)开展“准备释放”干预措施的RCT 100名男性PWID正在从监禁中获释。为了既实现这些目标又达到 研究独立性，墨菲博士将接受针对SUD患者的艾滋病毒预防方法培训 在刑事司法(CJ)系统内，用定性研究方法查明障碍和 艾滋病毒预防护理的促进者，行为干预发展和评估的方法 作为负责任的研究行为方面的培训。导师团队，由相关领域的领先专家组成 布朗大学和附近的耶鲁大学的临床和公共卫生研究领域是 非常适合确保成功实现研究目标以及未来的研究 PI的独立性。菲利普·A·陈博士(主要导师)作为PrEP临床研究领域的领导者， 将是成功实施PrEP护理连续体的关键专家， 进行试验，评估干预措施，以改善其使用情况。本建议书的其他指导包括 Josiah Rich博士(共同导师)，全球干预发展的领导者，以改善SUD管理和 从监禁到社区过渡期间的艾滋病毒感染风险，艾米·纳恩博士(共同 Mentor)，与PrEP护理和健康不平等相关的定性方法方面的领先专家 与CJ相关人群合作的丰富经验，TraceKershaw博士(联合导师)，全球 领导制定行为干预措施，以降低患有肥胖症的人群中艾滋病毒感染的风险。 克里斯托弗·施密德(共同导师)，布朗公共卫生学院生物统计学前主席， 有临床试验设计经验，精通定量方法。

PROJECT SUMMARY This K23 application outlines a novel area of clinical research that meets a growing public health need as people who inject drugs (PWID) represent a disproportionate number of new HIV cases with limited knowledge about the programming and linkage to care needed to support pre-exposure prophylaxis (PrEP) usage among this population. The research aims are designed to ensure Dr. Matthew Murphy's (PI) future research independence in HIV prevention and PrEP use for those with substance use disorders (SUD) at the greatest risk of HIV infection by providing preliminary data for a future R01 application. The specific aims of the K23 proposal are to 1) conduct qualitative interviews with 20 CJ-involved male PWID to evaluate barriers and facilitators to PrEP initiation, adherence, and linkage to care after release from incarceration; 2) develop a “PrEPare-for-Release” intervention and conduct an open label pilot intervention with 15 male PWID who are being released from incarceration and 3) conduct an RCT of the “PrEPare-for-Release” intervention among 100 male PWID who are being released from incarceration. In order to both achieve those aims and attain research independence, Dr. Murphy will receive training in HIV prevention approaches for those with SUD within the criminal justice (CJ) system, qualitative research methodology used to identify barriers and facilitators to HIV prevention care, approaches to behavioral intervention development and evaluation as well as training in the responsible conduct of research. The mentorship team, made up of leading experts in related fields of clinical and public health research from both Brown University and nearby Yale University, are incredibly well suited to ensure both successful attainment of the research aims as well as future research independence for the PI. Dr. Philip A Chan (primary mentor), as a leader in the field of PrEP clinical research, will be a key expert on the successful implementation of the PrEP care continuum for this population and conducting trials evaluating interventions to improve its use. Additional mentorship for this proposal includes Dr. Josiah Rich (co-mentor), a global leader on intervention development to improve SUD management and HIV infection risk during the period of transition from incarceration to the community, Dr. Amy Nunn (co- mentor), a leading expert on qualitative methodology related to PrEP care and health inequalities with significant prior experience working with CJ-involved populations, Dr. Trace Kershaw (co-mentor), a global leader on behavioral intervention development to reduce HIV infection risk in populations with SUDs, and Dr. Christopher Schmid (co-mentor), former chair of biostatistics at Brown's School of Public Health with significant experience in clinical trial design and an expert in quantitative methodology.