Linking Biophysical Functions of Microbicides to User Perception & Acceptability

将杀菌剂的生物物理功能与用户感知联系起来

• 批准号: 7921125
• 负责人: Kate M Guthrie
• 金额: $ 9.53万
• 依托单位: MIRIAM HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-28 至 2011-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7921125
• 关键词: AIDS/HIV problem; Address; Behavioral; Biological; Characteristics; Cognitive; Development; Dimensions; Drug Formulations; Extravasation; Feasibility Studies; Future; Gel; Goals; Human; Interview; Joints; Knowledge; Lead; Link; Liquid substance; Measurable; Measurement; Measures; Methodology; Modeling; Perception; Performance; Phase; Property; Psychometrics; Research; Research Personnel; Science; Scientist; Specific qualifier value; Sum; System; Technology; Tissues; Vagina; Vaginal Gel; Work; base; behavior measurement; design; experience; fight against; innovation; microbicide; multidisciplinary; novel; pandemic disease; pathogen; pleasure; pre-clinical; preclinical study; prototype; research and development; success; tool; vaginal microbicide

This project directly addresses RFA-AI-06-005 request for technologies, strategies or models that contribute to new and more efficient ways of assessing and predicting microbicide acceptability within the preclinical framework of formulation development. Achieving this goal requires integration of behavioral with biophysical determinants of acceptability parameters. This project analyzes correspondence of cognitive and behavioral aspects of user ratings of microbicide characteristics and activity, with biophysical microbicide properties governing vaginal distribution/retention ("deployment") and hypothesized to correlate with human perceptions of microbicide use. During the R21 project, qualitative interviews, item development strategies and cognitive interviews will enable behavioral investigators to develop a user rating scale for use within the frameworkof preclinical feasibility studies of candidate microbicides. In parallel, formulation scientists will compute measures of biophysical functioning of 2 current over-the-counter vaginal gels, hypothesized to correlate with the behavioral constructs. Once it is shown that the behavioral tool (i.e., scale) has good psychometric characteristics, relationships between user rating measures and biophysical measures will be evaluated. Correspondence between what users can perceive/evaluate with respect to their experiences using a gel, and what biophysical properties/analysis can predict with respect to these perceptions and user ratings, will be delineated. The project goal is to demonstrate that these two measurement systems can be employed synergistically, toward optimization of 1) microbicide biophysical properties governing effective deployment and biofunctionality, and 2) user ratings of application- and vehicle-associated acceptability. In the R33 these measurement systems will be further evaluated and validated using novel GRAS gel formulations. Finally, a statistical framework that initiates prediction of user ratings of gels will be developed. The microbicide field's ability to co-determine microbicide function and acceptability will dramatically increase its ability to conceive and create optimal formulations in preclinical studies. By linking user ratings with biophysical properties, the resulting behavioral tool (scale) will better inform the preclinical microbicide pipeline, enabling products to be tailored to future users with greater certainty. In sum, this work will contribute methodology leading to rational design of microbicide formulations that co-optimize vaginal distribution and retention with user acceptability.

该项目直接解决 RFA-AI-06-005 对技术、策略或模型的请求，这些技术、策略或模型有助于 在临床前评估和预测杀菌剂可接受性的新的、更有效的方法 制剂开发框架。实现这一目标需要将行为与生物物理相结合 可接受性参数的决定因素。该项目分析了认知和行为的对应关系 杀微生物剂特性和活性的用户评级以及生物物理杀微生物剂特性 控制阴道分布/保留（“部署”）并假设与人类感知相关 杀微生物剂的使用。在 R21 项目期间，定性访谈、项目开发策略和认知 访谈将使行为调查人员能够开发一个用户评级量表，以便在以下框架内使用： 候选杀菌剂的临床前可行性研究。与此同时，配方科学家将计算 两种当前非处方阴道凝胶的生物物理功能测量，假设与相关 行为结构。一旦表明行为工具（即量表）具有良好的心理测量 将评估用户评级测量和生物物理测量之间的特征、关系。 用户可以感知/评估的关于他们使用凝胶的体验之间的对应关系， 以及哪些生物物理特性/分析可以预测这些看法和用户评分，将 被划定。该项目的目标是证明这两种测量系统可以使用 协同作用，优化 1) 控制有效部署的杀菌剂生物物理特性 和生物功能，以及 2) 用户对应用和车辆相关可接受性的评级。在 R33 中这些 测量系统将使用新型 GRAS 凝胶配方进行进一步评估和验证。最后，一个 将开发启动凝胶用户评级预测的统计框架。杀菌剂领域 共同确定杀菌剂功能和可接受性的能力将显着提高其受孕能力 并在临床前研究中创建最佳配方。通过将用户评分与生物物理特性联系起来， 由此产生的行为工具（量表）将更好地为临床前杀菌剂管道提供信息，使产品能够 更有确定性地为未来用户量身定制。总而言之，这项工作将为理性的研究提供方法论 设计能够同时优化阴道分布和保留以及用户可接受性的杀菌剂配方。