Preparing for Implementation of Sustained Release Antivirals for HIV Prevention

 描述：用于预防艾滋病毒的缓释抗逆转录病毒药物(ARV)在降低新感染率方面具有巨大潜力，特别是在高危人群中。用于PrEP的长效可注射(LAI)ARV有可能解决日常口服PrEP固有的几个关键障碍，包括消除每日依从性的需要和减少披露方面的担忧。继猕猴模型保护实验成功后，GSK-744的LAI配方的第二阶段试验将于2014年开始，随后将于2016年进行第三阶段疗效试验。拟议的项目基于这样一个前提，即确定LAI PrEP产品和计划的关键结构、行为和社会动态可以对预防战略的未来成功以及向高风险人群推出有效产品的速度产生重大影响。这项建议建立在研究人员的专业知识和参与美国日常口服PrEP试验和LAI PrEP试验的基础上，专注于结构、行为和社会因素，这些因素可能有助于最佳地提供长期有效的抗逆转录病毒制剂用于预防。该项目采用多模式方法来确定可能影响长效ARV干预提供的相关医疗系统提供因素、提供者动态和患者偏好，包括从三个来源收集数据：a)参与第二阶段和第三阶段LAI PrEP试验的患者；b)参与 口腔PrEP示范实施项目；c)来自最有可能成为Lai PrEP目标的人群的参与者和提供者--与艾滋病毒感染风险最高的有色人种男子发生性行为的年轻男子。通过对这三个来源的数据进行三角测量，该项目将提供重要信息，以指导示范项目和更广泛的实施工作。本项目的具体目标是：1)确定可能影响实施抗逆转录病毒制剂以预防艾滋病毒的患者层面的结构、行为和社会因素，例如吸收、持久性和对后续行动的坚持；2)确定可能影响实施艾滋病毒预防的抗逆转录病毒制剂的系统层面因素，例如提供者培训、方案制定、获取、转诊、处方和监测；以及3)为美国最优先的人群之一--男男性行为高危青年男子(YMSM)确定实施Lai PrEP艾滋病毒预防计划的具体障碍和促进者。我们建议的交付内容与产品开发里程碑具有时间联系，包括：1)建议将社会和行为措施纳入第三阶段试验；2)基于经验的指南，可形成未来示范和实施工作的“蓝图”；以及3)针对提供者教育、临床指导和优化向高危人群交付LAI PrEP的战略的具体建议。 感染。拟议的项目将确保我们准备好充分发挥新的潜力 LAI ARV技术，最大限度地发挥其对疫情产生重大和持续影响的能力。

 DESCRIPTION: Sustained release antiretrovirals (ARVs) for HIV prevention have tremendous potential to reduce rates of new infections, especially among high-risk individuals. Long-acting injectable (LAI) ARVs for PrEP have the potential to address several key barriers inherent in daily oral PrEP, including obviating the need for daily adherence and reducing disclosure concerns. Following successful protection experiments in the macaque model, Phase II trials of the LAI formulation of GSK-744 will begin in 2014, to be followed by Phase III efficacy trials in 2016. The proposed project is based on the premise that identifying key structural, behavioral, and social dynamics of LAI PrEP products and programs can make a significant impact on the future success of the prevention strategy and the speed with which an effective product is rolled out to the highest risk populations. This proposal builds on the investigators' expertise and involvement in both daily oral PrEP trials and LAI PrEP trials in the US to focus on structural, behavioral, and social factors that might inform optimal delivery of long- active ARV formulations for prevention. The project takes a multi-modal approach to identifying relevant healthcare system delivery factors, provider dynamics, and patient preferences that might impact long-acting ARV intervention delivery, including gathering data from three sources: a) patients participating in Phase II and Phase III LAI PrEP trials; b) patients and providers participating in an demonstration-implementation project for oral PrEP; and c) participants and providers from a population most likely to be targeted for LAI PrEP -- young men who have sex with men (YMSM) of color at highest risk for HIV infection. By triangulating data from these three sources, this project will provide vital information to guide both demonstration projects and broader-scale implementation efforts. The specific aims of this project are to: 1) Identify structural, behaviora, and social factors that might influence patient-level factors relevant to implementation of LAI ARV formulations for HIV prevention, such as uptake, persistence, and adherence to follow-up; 2) Identify structural, behavioral and social factors that might influence systems-level factors relevant to implementation of LAI ARV formulations for HIV prevention, such as provider training, protocol development, access, referral, prescription, and monitoring; and 3) Identify specific barriers and facilitators to the implementation of an LAI PrEP HIV prevention program for one of the top priority populations in the US -- highest-risk young men who have sex with men (YMSM). Our proposed deliverables are time-linked to product development milestones and include: 1) recommendations for social and behavioral measures to include in Phase III trials; 2) empirically-based guidelines that can form a "blue-print" for future demonstration and implementation efforts; and 3) specific recommendations for provider education, clinical guidance, and strategies for optimizing delivery of LAI PrEP to the populations at highest risk for infection. The proposed project will ensure that we are ready to fully realize the potential of new LAI ARV technology, maximizing its ability to make a significant and sustained impact on the epidemic.