Preclinical User Accptability Studies Long Acting Vaginal Gels, Intravaginal Ring

长效阴道凝胶、阴道环的临床前用户可接受性研究

• 批准号: 8106330
• 负责人: Kate M Guthrie
• 金额: $ 16.85万
• 依托单位: IMQUEST BIOSCIENCES
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8106330
• 关键词: AIDS/HIV problem; Accounting; Behavior assessment; Behavioral; Biological; Characteristics; Data; Development; Developmental Process; Devices; Dimensions; Drug Delivery Systems; Drug Formulations; Excision; Extravasation; Gel; Goals; HIV; Human; Image; Joints; Knowledge; Lead; Link; Liquid substance; Measurable; Measurement; Measures; Mechanics; Methodology; Perception; Performance; Process; Property; Protocols documentation; Public Health; Research; Resources; Science; Social Environment; System; Tissues; Vagina; Vaginal Gel; Vaginal Ring; Woman; Work; behavior measurement; design; experience; fight against; in vivo; innovation; meetings; microbicide; pandemic disease; pathogen; pleasure; pre-clinical; programs; research study; residence; success; tool

The development of safe, effective and acceptable microbicides is imperative in the fight against HIV/AIDS. The success of microbicide products will derive from the synergy of their biological functionality and user acceptability. Biological functionality is the integrated result of safe and effective anti-HIV compounds incorporated into formulations or devices that successfully deliver those compounds to target tissues, fluids and pathogens. Acceptability is a multi-factorial phenomenon that accounts for the personal, dyadic, productrelated and social contexts that potentiate - or not - a woman's decision to use a microbicide. Acceptability depends strongly upon delivery systems with biophysical functions and /or mechanical and materials properties that are most conducive to human use. Without both, microbicides' potential to impact the public health crisis of HIV/AIDS will be largely limited. Project 3 will integrate and extend our growing knowledge and methodologies in preclinical microbicide formulation and delivery device sciences, with their counterpart in early human studies of acceptability. It will extend current behavioral strategies for studying gel acceptability in preclinical frameworks, and expand those strategies to intravaginal ring (IVR) applications. Project 3 will first modify existing behavioral tools that measure topical gel acceptability dimensions for preclinical formulation development; the new tools will incorporate expanded acceptability dimensions to account for the use of long-acting gels and IVR devices developed in this U19. We will then extend our current preclinical in vivo human studies methodology, integrating imaging experiments with behavioral assessment. This will enable joint determination of two critical components of microbicide success: user acceptability and gel functionality. Further, we will use the expanded measures to analyze the correspondence between behavioral measures and biophysical measures, creating a statistical framework enabling prediction of user ratings of long-acting gel experiences from gel performance measures. Finally, we will examine user ratings of acceptability dimensions associated with these delivery systems, and propose initial preclinical standards of acceptability for long-acting gels and IVRs.

开发安全、有效和可接受的杀微生物剂是防治艾滋病毒/艾滋病的当务之急。 杀微生物剂产品的成功将源于其生物功能和用户的协同作用 可接受性。生物功能是安全有效的抗艾滋病毒化合物的综合结果 加入到制剂或设备中，成功地将这些化合物输送到靶组织、液体 和病原体。可接受性是一种多因素现象，它解释了个人的、二元的、与产品相关的 以及强化--或不强化--女性使用杀微生物剂的决定的社会背景。可接受性 强烈依赖具有生物物理功能和/或机械和材料的输送系统 最有利于人类使用的属性。如果两者都没有，杀菌剂对公众的潜在影响 艾滋病毒/艾滋病的健康危机将在很大程度上受到限制。项目3将整合和扩展我们不断增长的知识 临床前杀微生物剂制剂和给药设备科学中的方法和方法 在早期的人类可接受性研究中。这将扩展目前研究凝胶的行为策略 临床前框架的可接受性，并将这些策略扩展到阴道内环(IVR)应用。 项目3将首先修改现有的行为工具，这些工具测量局部凝胶的可接受性维度 临床前配方开发；新工具将纳入扩展的可接受维度，以 说明在U19中开发的长效凝胶和IVR设备的使用情况。然后我们将延长我们的 当前临床前活体人体研究方法学，将成像实验与行为学实验相结合 评估。这将使联合确定杀微生物剂成功的两个关键因素成为可能：用户 可接受性和凝胶功能。此外，我们将利用扩大后的措施来分析 行为测量和生物物理测量之间的对应关系，创建了一个统计框架 能够根据凝胶性能测量预测用户对长效凝胶体验的评级。最后， 我们将检查与这些交付系统相关的用户可接受性维度的评级，以及 提出长效凝胶和静脉注射用药可接受性的初步临床前标准。