Linking Biophysical Functions of Microbicides to User Perception & Acceptability

描述（由申请人提供）：本项目直接解决RFA-AI-06-005对技术、策略或模型的要求，这些技术、策略或模型有助于在制剂开发的临床前框架内评估和预测杀微生物剂可接受性的新的和更有效的方法。实现这一目标需要将可接受性参数的行为决定因素与生物物理决定因素结合起来。本项目分析了杀微生物剂特性和活性的用户评级的认知和行为方面的对应关系，以及控制阴道分布/保留（“部署”）的杀微生物剂生物物理特性，并假设与人类对杀微生物剂使用的感知相关。在R21项目中，定性访谈、项目开发策略和认知访谈将使行为研究者能够开发一个用户评级量表，用于候选杀微生物剂的临床前可行性研究框架内。同时，配方科学家将计算目前两种非处方阴道凝胶的生物物理功能测量，假设与行为结构相关。一旦表明行为工具（即量表）具有良好的心理测量特征，将评估用户评分措施与生物物理措施之间的关系。将描述用户可以感知/评估他们使用凝胶的体验，以及生物物理特性/分析可以预测这些感知和用户评级之间的对应关系。该项目的目标是证明这两种测量系统可以协同使用，以优化1)控制有效部署和生物功能的杀微生物剂生物物理特性，以及2)应用程序和车辆相关可接受性的用户评级。在R33中，这些测量系统将使用新的GRAS凝胶配方进一步评估和验证。最后，将开发一个统计框架，用于预测凝胶的用户评级。杀微生物剂领域共同确定杀微生物剂功能和可接受性的能力将大大提高其在临床前研究中构思和创造最佳配方的能力。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微生物剂管道提供信息，使产品能够更确定地为未来的用户量身定制。总之，这项工作将有助于合理设计杀菌剂配方，共同优化阴道分布和保留与用户可接受性。

DESCRIPTION (provided by applicant): 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 framework of 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.