Preparing for Implementation of Sustained Release Antivirals for HIV Prevention

准备实施缓释抗病毒药物预防艾滋病毒

• 批准号: 8846752
• 负责人: Sarit A Golub
• 金额: $ 73.92万
• 依托单位: HUNTER COLLEGE
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-01-16 至 2019-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8846752
• 关键词: AIDS prevention; Address; Adherence; Administrator; Antiviral Agents; Behavior; Behavioral; Behavioral Research; Clinical; Clinical Trials; Color; Communities; Complex; Data; Development; Disclosure; Drug Formulations; Education; Effectiveness; Ensure; Epidemic; Future; Guidelines; HIV Infections; Healthcare; Healthcare Systems; Home environment; Individual; Infection; Injectable; Intervention; Link; Macaca; Modeling; Monitor; New York City; Oral; Participant; Patient Education; Patient Preferences; Patients; Pharmaceutical Preparations; Phase; Phase II/III Trial; Population; Positioning Attribute; Prevention; Prevention program; Prevention strategy; Printing; Program Development; Prophylactic treatment; Provider; Recommendation; Research; Research Personnel; Services; Source; Speed; System; Technology; Time; Training; Translating; Work; base; behavior measurement; behavioral health; combat; cost effectiveness; design; efficacy trial; experience; follow-up; frontier; high risk; men who have sex with men; phase II trial; phase III trial; product development; programs; protocol development; public health relevance; research study; social; social science research; success; truvada; uptake; young men who have sex with men

 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.

 描述：用于预防艾滋病毒的缓释抗逆转录病毒药物 (ARV) 具有降低新发感染率的巨大潜力，尤其是在高危人群中。用于 PrEP 的长效注射 (LAI) 抗逆转录病毒药物有可能解决日常口服中固有的几个关键障碍。 PrEP，包括消除日常依从性和减少披露问题，在猕猴模型中进行成功的保护实验后，GSK-744 LAI 制剂的 II 期试验将于 2019 年开始。 2014 年进行，随后于 2016 年进行 III 期疗效试验。拟议项目的前提是确定 LAI PrEP 产品和计划的关键结构、行为和社会动态可以对预防策略未来的成功产生重大影响以及向最高风险人群推出有效产品的速度 该提案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，重点关注结构、行为和社会因素。这可能会告知该项目采用多模式方法来确定可能影响长效抗逆转录病毒干预措施的相关医疗保健系统提供因素、提供者动态和患者偏好，包括从三个来源收集数据： a) 参与 II 期和 III 期 LAI PrEP 试验的患者 b) 参与的患者和提供者； 口服 PrEP 示范实施项目；以及 c) 最有可能成为 LAI PrEP 目标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男性接触者 (YMSM)。通过这三个来源，该项目将提供重要信息来指导示范项目和更广泛的实施工作。该项目的具体目标是： 1) 确定可能影响患者层面相关因素的结构、行为和社会因素。实施 LAI 抗逆转录病毒药物HIV 预防制剂，例如摄取、持续性和坚持随访； 2) 确定可能影响与实施 LAI ARV 制剂预防 HIV 相关的系统层面因素的结构、行为和社会因素，例如提供者培训、方案制定、获取、转诊、处方和监测；以及 3) 确定针对美国最优先人群之一——发生性行为的高风险预防青年男性实施 LAI PrEP HIV 计划的具体障碍和促进因素与男人(YMSM)。我们提出的交付成果与产品开发里程碑的时间相关，包括：1）针对第三阶段试验的社会和行为措施的建议；2）基于经验的指南，可以为未来形成“蓝图”。示范和实施工作；3) 针对提供者教育、临床指导和优化向高危人群提供 LAI PrEP 的策略的具体建议 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流行病产生重大和持续影响的能力。