Linking Biophysical Functions of Microbicides to User Perception & Acceptability

本项目直接解决RFA-AI-06-005对有助于实现以下目标的技术、战略或模型的要求： 评估和预测杀微生物剂在临床前可接受性的新的和更有效的方法 配方开发框架。实现这一目标需要整合行为与生物物理 可接受性参数的决定因素。本项目分析了认知和行为的对应关系， 用户对杀微生物剂特性和活性的评定，以及生物物理杀微生物剂特性 控制阴道分布/保留（“展开”），并假设与人类感知相关 杀微生物剂的使用。在R21项目中，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，用于以下框架内： 候选杀微生物剂的临床前可行性研究。与此同时，配方科学家将计算 目前2种非处方阴道凝胶的生物物理功能指标，假设与 行为结构。一旦表明行为工具（即，量表）具有良好的心理测量 将评估用户评级措施和生物物理措施之间的关系。 用户可以感知/评价的内容与其使用凝胶的体验之间的对应关系， 以及关于这些感知和用户评级，什么生物物理特性/分析可以预测， 被描绘出来。项目的目标是证明这两个测量系统可以使用 协同地，朝向优化1）控制有效部署杀微生物剂生物物理性质 和生物功能性，以及2）应用和载体相关可接受性的用户评级。在R33中， 将使用新型GRAS凝胶制剂进一步评估和验证测量系统。最后 将制定统计框架，开始预测用户对凝胶的评价。杀微生物剂场 共同决定杀微生物剂功能和可接受性的能力将显著提高其受孕能力 并在临床前研究中创建最佳配方。通过将用户评级与生物物理特性联系起来， 由此产生的行为工具（规模）将更好地告知临床前杀微生物剂管道，使产品能够 为未来用户量身定制，具有更大的确定性。总之，这项工作将有助于方法，导致合理的 设计杀微生物剂配方，共同优化阴道分布和保留与用户的可接受性。

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.