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

在注射吸毒者中实施暴露前预防以预防艾滋病毒

• 批准号: 9341537
• 负责人: Angela Robertson Bazzi
• 金额: $ 15.46万
• 依托单位: BOSTON UNIVERSITY MEDICAL CAMPUS
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-04-01 至 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9341537
• 关键词: AIDS prevention; Achievement; Address; Adherence; Adoption; Affect; Alcohol or Other Drugs use; Anti-Retroviral Agents; Applied Research; Area; Behavior Therapy; Boston; Centers for Disease Control and Prevention (U.S.); Communities; Comorbidity; Complex; Data; Development; Disease Outbreaks; Drug usage; Educational workshop; Evaluation; Feedback; Future; Goals; HIV; HIV Infections; Health; Health Services Accessibility; Healthcare; Hepatitis C; Heroin; Incidence; Indiana; Injecting drug user; Injection of therapeutic agent; Institutes; International; Intervention; Interview; Knowledge; Light; Link; Manuals; Massachusetts; Measures; Medical; Mental Health; Mentored Research Scientist Development Award; Mentors; Methods; Modeling; NIH Office of AIDS Research; Needle Sharing; Needle-Exchange Programs; Opioid; Oral; Outcome; Physicians; Population; Population Heterogeneity; Positioning Attribute; Prevalence; Prevention; Prevention strategy; Preventive Intervention; Process; Public Health; Qualitative Methods; Randomized; Randomized Controlled Trials; Reading; Recommendation; Regimen; Reporting; Research; Research Ethics; Risk Behaviors; Scientist; Services; Shares syringes; Social Work; Sterility; Structure; Syringes; Tenofovir; Test Result; Testing; Time; Training; Treatment Efficacy; Universities; Vulnerable Populations; Work; arm; base; career; efficacy trial; emtricitabine; evidence base; experience; health care service utilization; high risk; implementation science; improved; informant; injection drug use; medication compliance; novel; opioid misuse; physical conditioning; pilot trial; pre-exposure prophylaxis; prescription opioid; prevent; public health relevance; sex; skills; social; standard of care; therapy development; transmission process; treatment adherence; trial design; truvada; uptake

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.

项目概要/摘要 该导师研究科学家发展奖（K01）的目的是为安吉拉博士提供 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 在制定针对无家可归者的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的培训目标（TG）包括培养以下方面的技能和专业知识。 干预发展（TG1）、实施科学（TG2）、研究伦理（TG3）和专业 成功的学术研究生涯的发展（TG4）将通过培训来完成。 正式结构化课程、培训研讨会和机构、定向阅读的密集结合， 应用研究经验，以及与经验丰富的著名专家导师的互动 干预措施的制定实施、科学、药物使用和抗逆转录病毒暴露前预防 （PrEP）用于艾滋病毒预防。候选人研究的总体目标是建立一个社区- 尽管 PrEP 被推荐用于 HIV 注射者（PWID）。 注射吸毒者中的预防措施，这一高风险和社会边缘化人群的接受率很低，并且 对这一修订后的提案的可接受性和遵守性挑战仍知之甚少，该提案以《建议》为指导。 弱势群体的医疗保健利用模式，干预开发的系统方法， 和实施科学框架，将实现以下具体目标： 目标 1：确定可修改的 未感染艾滋病毒的吸毒者 (n=30) 和关键知情人 (n=15) 中 PrEP 获取和利用的决定因素； 目标 2：制定手动干预措施 (TG1)，以提高吸毒者对 PrEP 的采用和依从性 参加基于社区的注射器交换计划 (SEP)；以及 目标 3：进行随机试点 基于 SEP 的 PrEP 摄取和注射吸毒者依从性干预的对照试验 (RCT) (n=50) 尽管存在混合方法过程评估，重点关注实施结果（TG2）。 针对吸毒者的有效艾滋病毒预防策略（例如，通过 SEP 获得无菌注射器） 过去十年中阿片类药物滥用的盛行正在威胁着过去在艾滋病毒预防方面取得的成就。 高比例的美国注射吸毒者报告去年曾共用接受注射器和/或无套性行为 (77%) 强调需要扩大 PrEP 的提供，这对 HIV 有效并被推荐 通过将这个 K01 安置在位于同一地点的波士顿大学医学校区，来预防注射吸毒者。 通过基于社区的健康和社会服务组织，候选人将能够获得大量信息 吸毒者群体以及干预措施开发和科学实施方面的领先专家。 拟议的试点试验可能无法检测 PrEP 吸收或依从结果的变化，但它将 提供必要的技能和初步数据，以确定干预的可行性，最大化利益相关者 可接受性，并推断未来全面 R01 研究的效应大小估计和实施方面。