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.

项目摘要 /摘要 这个指导的研究科学家发展奖（K01）的目的是为安吉拉博士提供 罗伯逊·巴齐（Robertson Bazzi）在支持她的培训，心理，研究经验和受保护的时间上 过渡到研究独立性，以开发边缘化的预防干预措施 受药物使用影响的种群。培训目标（TG）包括发展技能和专业知识 干预开发（TG1），实施科学（TG2），研究伦理（TG3）和专业 成功的学术研究职业（TG4）的发展。培训将通过 正式的结构化课程，培训研讨会和机构，定向读物的密集组合， 应用研究经验，以及与经验丰富的导师的互动 干预开发，实施科学，物质使用和抗逆转录病毒预防 （准备）预防艾滋病毒。候选人研究的总体目标是建立一个社区 - 针对注射药物的人（PWID）的基于准备干预。尽管建议艾滋病毒准备 PWID的预防，这种高风险和社会边缘化人群的吸收较低，并且 可接受性和依从性挑战仍然很众所周知。这项修订的提案，由 弱势群体的医疗保健利用模型，一种系统的干预开发方法， 和实施科学框架将达到以下特定目标：目标1：确定可修改 确定艾滋病毒未感染的PWID（n = 30）和关键线人（n = 15）之间的PREP访问和利用； 目标2：开发手动干预（TG1），以改善PWID的准备摄取和依从性 参加基于社区的注射器交换计划（SEP）；和目标3：进行随机进行飞行员 PWID的基于SEP基于SEP的PREP摄取和依从性干预的对照试验（RCT）（n = 50） 用混合方法的过程评估集中在实施结果上（TG2）。尽管存在 PWID有效的HIV预防策略（例如，通过SEP访问无菌注射器），增加 在过去的十年中，Ooid滥用的患病率正在威胁到过去的艾滋病毒预防成就。这 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的比例很高 （77％）强调需要扩大PREP的扩展，这是有效的，建议用于艾滋病毒 PWID之间的预防。通过将此K01放置在波士顿大学医学校园，该校园共同置于 通过基于社区的健康和社会服务组织，候选人将能够访问大型 PWID的人口和干预发展和实施科学领域的领先专家。而 拟议的试点试验可能无法检测到预备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可行性，最大利益相关者 可接受性，并推断出未来全尺度R01研究的效果大小估计和实施方面。