Understanding Implementation of HIV Prevention Navigation in STD Clinics

了解性病诊所中艾滋病毒预防导航的实施

• 批准号: 9297725
• 负责人: Sarit A Golub
• 金额: $ 27.64万
• 依托单位: HUNTER COLLEGE
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-08-01 至 2017-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9297725
• 关键词: AIDS prevention; Address; Adherence; Administrator; Behavior; Behavioral; Behavioral Research; Clinic; Clinical; Clinical Trials; Color; Communities; Complex; Data; Development; Disclosure; Drug Formulations; Education; Effectiveness; Ensure; Epidemic; Formulation; Future; Guidelines; HIV Infections; Health; 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; 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.

 产品说明：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问题。在猕猴模型中成功进行保护实验后，GSK-744的LAI制剂的II期试验将于2014年开始，随后将于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战略的未来成功以及向最高风险人群推出有效产品的速度产生重大影响。该提案建立在研究人员的专业知识和参与美国每日口服PrEP试验和LAI PrEP试验的基础上，重点关注可能为预防长效ARV制剂的最佳递送提供信息的结构、行为和社会因素。该项目采用多模式方法来确定可能影响长效ARV干预措施提供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II期和III期LAI PrEP试验的患者和提供者; 口服PrEP的示范实施项目;以及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发生性关系的年轻男性（YMSM）。通过对来自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执行工作。该项目的具体目标是：1）确定可能影响与预防艾滋病毒的LAI抗逆转录病毒制剂的实施有关的患者层面因素的结构、行为和社会因素，如摄取、持续和坚持随访; 2）确定可能影响与预防艾滋病毒的LAI ARV制剂的实施相关的系统水平因素的结构、行为和社会因素，如提供者培训，协议开发，访问，转介，处方和监测;和3）确定具体的障碍和促进者，以实施一个LAI PrEP艾滋病毒预防计划，在美国的最高优先级人群之一-高风险的年轻男子谁与男性发生性关系（YMSM）。我们提出的可交付成果与产品开发里程碑有时间联系，包括：1）在III期试验中纳入的社会和行为措施建议; 2）基于实践的指南，可以为未来的演示和实施工作形成“蓝图”;和3）提供者教育、临床指导和优化LAI PrEP向最高风险人群提供的策略， 感染建议的项目将确保我们准备充分实现新的潜力， LAI抗逆转录病毒技术，最大限度地发挥其对这一流行病产生重大和持续影响的能力。