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: 7513361
• 负责人: Kate M Guthrie
• 金额: $ 45.28万
• 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/7513361
• 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; Rate; Research; Research Personnel; Science; Scientist; Score; Specific qualifier value; Sum; System; Technology; Tissues; Vagina; Vaginal Gel; Work; base; behavior measurement; concept; design; experience; fight against; human study; innovation; microbicide; multidisciplinary; novel; pandemic disease; pathogen; pleasure; pre-clinical; preclinical study; prototype; research and development; success; tool

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.

描述（由申请人提供）：本项目直接解决了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。实现这一目标需要整合的行为与生物物理的可接受性参数的决定因素。该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，其中生物物理杀微生物剂特性控制阴道分布/保留（“部署”），并假设与人类对杀微生物剂使用的感知相关。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，用于候选杀微生物剂临床前可行性研究的框架内。同时，制剂科学家将计算2种当前非处方阴道凝胶的生物物理功能的测量值，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，将评估用户评级措施和生物物理措施之间的关系。将描述用户使用凝胶的体验所能感知/评估的内容与这些感知和用户评级所能预测的生物物理特性/分析之间的对应关系。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）应用和车辆相关可接受性的用户评级。在R33中，将使用新型GRAS凝胶配方对这些测量系统进行进一步评估和验证。最后，将开发一个统计框架，启动凝胶用户评级的预测。杀微生物剂领域共同决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。通过将用户评级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用户量身定制。总之，这项工作将有助于合理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的方法。