Packaging Pre-Exposure Prophylaxis (PrEP) to Prevent HIV Transmission among Women who Inject Drugs

项目总结/摘要 暴露前预防（PrEP）是一种很有前途的生物医学HIV预防策略， 恩曲他滨/富马酸替诺福韦酯（FTC/TDF），以降低HIV阴性个体的 感染艾滋病毒。有证据表明，注射毒品的妇女更容易感染艾滋病毒。 虽然PrEP可以显着减少WWID中的艾滋病毒感染，但目前， 帮助解决PrEP实施的挑战，为这个研究不足的群体。拟议的研究将涉及 通过评估一种提供PrEP护理的新方法，即， 包装PrEP以及使用社区注射器进行性传播感染的检测和治疗 交换计划（SEPs）服务。理由是：（1）SEP目前可以提供处方 药物和长期监测其他条件，如丁丙诺啡阿片类药物依赖， 提供PrEP护理是已经成功完成的自然延伸;（2）SEP是可行的 许多未感染艾滋病毒的WWID的接入点，根据目前的临床试验， 指导方针;（3）在WWID已经使用和信任的环境中提供的PrEP干预措施将增加 吸收，坚持和保留在PrEP。包装PrEP护理在注射器交换计划是高度 新颖啊据我们所知，这种方法尚未经过测试，可能代表了一种范式转变， 使这一高度脆弱人群中的妇女能够并鼓励她们参与有效的艾滋病毒生物医学治疗， 预防战略。为了评估这种方法的影响，我们将启动一个前瞻性的混合方法， 主要和次要注射器交换用户的研究。通过半结构化和深度访谈 根据《脆弱人群行为模式》和联邦贸易委员会的药物水平监测，我们将解决 以下具体目标：（1）描述WWID在PrEP护理连续体中的参与（重点是关键的 妇女可能脱离或需要额外支助才能继续接受照料的时刻）。(2)的影响进行评估 诱发，使能，和需求相关的因素对WWID的参与在PrEP护理连续。（三） 探索模型因素如何以及为什么与WWID的决策和参与PrEP护理的能力相关。 除非开发新的独立于临床的干预方法，以针对发现的PrEP的特定障碍， 在WWID中，该群体的参与度可能仍然不理想。这种方法的可重复性 大大增加了这部作品在其他环境中的翻译潜力。长期影响将是 通过提供艾滋病毒综合预防，减少艾滋病毒感染并改善妇女参与艾滋病的健康成果 包括PrEP在内的干预措施。

PROJECT SUMMARY/ ABSTRACT Pre-exposure prophylaxis (PrEP) is a promising bio-medical HIV prevention strategy that involves the use of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) by HIV negative individuals to reduce their risk of acquiring HIV. Evidence suggests women who inject drugs (WWID) are disproportionately vulnerable to HIV. While PrEP could significantly reduce HIV acquisition among WWID, at present, there is little knowledge to help address PrEP implementation challenges for this understudied group. The proposed study will address our knowledge gap about PrEP by evaluating a novel approach for the delivery of PrEP care, namely, packaging PrEP and testing and treatment for sexually transmitted infections with community-based syringe exchange program (SEPs) services. The rationale is that (1) SEPs may currently provide prescription medications and long-term monitoring for other conditions such as buprenorphine for opioid dependence, so providing PrEP care is a natural extension of what is already being done successfully; (2) SEPs are a viable access point for many HIV-uninfected WWID who would be considered eligible for PrEP under current clinical guidelines; and (3) PrEP interventions, delivered in settings already utilized and trusted by WWID, will increase uptake, adherence and retention in PrEP. Packaging PrEP care at a syringe exchange program is highly innovative. To our knowledge, this approach has not been tested and may represent a paradigm shift that enables and encourages women in this highly vulnerable population to engage in effective biomedical HIV prevention strategies. To evaluate the impact of this approach, we will initiate a prospective mixed methods study with primary and secondary syringe exchange users. Through semi-structured and in-depth interviews based on the Behavioral Model for Vulnerable Populations, and drug-level monitoring for FTC, we will address the following specific aims: (1) Describe WWID's engagement in the PrEP care continuum (focusing on critical moments when women could disengage or need additional support to remain in care). (2) Assess the impact of predisposing, enabling, and need-related factors on WWID's engagement in the PrEP care continuum. (3) Explore how and why model factors are associated with WWID's decisions and ability to engage in PrEP care. Unless new clinic-independent intervention methods are developed to target the specific barriers to PrEP found among WWID, engagement in this group is likely to remain suboptimal. The reproducibility of this approach significantly increases this work's potential for translation to other settings. The long term-impact will be a reduction in HIV and improved health outcomes of WWID through the delivery of combination HIV prevention interventions that include PrEP.