Evaluating User Perceptions and Experience of Dual Compartment Microbicide Form.

评估用户对双室杀菌剂形式的看法和体验。

• 批准号: 8699501
• 负责人: Kate M Guthrie
• 金额: $ 46万
• 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/8699501
• 关键词: AIDS prevention; AIDS/HIV problem; Adherence; Anus; Behavioral; Characteristics; Clinical Research; Data; Development; Development Plans; Dose; Drug Delivery Systems; Drug Formulations; Drug user; Effectiveness; Enrollment; Evaluation; Female; Gender; Goals; HIV; Incidence; Indium; Individual; Instruction; Interview; Knowledge; Measures; Method Acceptability; Methods; Outcome; Participant; Perception; Performance; Pharmacologic Substance; Play; Prevention; Prevention strategy; Preventive; Property; Psychometrics; Public Health; Randomized; Regimen; Research Design; Research Personnel; Risk; Role; Sampling; Sensory; Series; Solid; Vagina; Woman; Work; base; cohort; condoms; design; experience; indexing; instrument; instrumentation; male; men; microbicide; novel; preference; prototype; randomized trial; rectal; rectal microbicide; research study; trial comparing; vaginal microbicide; validation studies; willingness

PROJECT SUMMARY (See instructions): The goal of Project 5 is to inform the design of dual compartment microbicide formulations by developing a comprehensive understanding of the user experience, and the impact of that experience on user preferences, product acceptability and, ultimately, product adherence. Project 5 incorporates a series of formative and experimental studies into the overall IPCP dual compartment microbicide development plan. Both men and women will serve as participants. Study 5.1 is a formative mixed methods study, designed to develop RAI (receptive anal intercourse)-specific user sensory perception and experience (USPE) instruments. A set of formulations that represent the range of formulation properties and characteristics believed to be best suited for dual compartment use will be studied. In-depth interviews will be used to generate FRAI-specific items to be incorporated into existing USPE instrumentation. These measures will then be used to evaluate USPE and conventional acceptability constructs with respect to the candidate microbicides being evaluated in Project 4 (USPE studies incorporated into Project 4 referred to as Study 5.2). Finally, Study 5.3 is a randomized trial comparing prototype formulations being developed in this IPCP with respect to USPE and willingness-to-use such formulations. The USPE trial (Study 5.3) will achieve two important goals: 1) psychometrically validate novel and adapted USPE instruments specifically designed for rectal microbicide evaluation, incorporating the current understanding of vaginal USPE into an omnibus conceptualization of dual compartment microbicides, and 2) evaluate users' perceptions and experiences of the physicochemical and rheological properties of rectal microbicide formulations, and how those perceptions and experiences impact conventional acceptability and willingness-to-use variables. By understanding the correspondence between the user experience and preferences, we can better inform formulation design. This knowledge, in combination with the optimization of formulation for delivery of the active pharmaceutical ingredient, will positively impact effectiveness by increasing the likelihood of the microbicide being used as intended, thus contributing to decreases in HIV incidence in those at-risk.

项目总结(见说明)： 项目5的目标是通过发展对用户体验的全面了解，以及这种体验对用户偏好、产品可接受性以及最终产品忠诚度的影响，为双室杀菌剂配方的设计提供信息。项目5将一系列形成性和试验性研究纳入了IPCP双室杀微生物剂总体开发计划。 男性和女性都将担任参与者。研究5.1是一项形成性混合方法研究，旨在开发特定于RAI(接受性肛交)的用户感觉感知和体验(USPE)工具。将研究一组配方，这些配方代表了被认为最适合双室使用的配方、性能和特性的范围。深入访谈将被用来生成FRAI特定项目，以纳入现有的USPE工具。然后，这些措施将被用来评估USPE和相对于项目4中正在评估的候选杀微生物剂的传统可接受性构建物(USPE研究纳入项目4，称为研究5.2)。最后，研究5.3是一项随机试验，比较了该IPCP正在开发的原型配方与USPE和使用此类配方的意愿。USPE试验(研究5.3)将实现两个重要目标：1)以心理测量学方法验证专门为直肠杀微生物剂评估设计的新型USPE仪器，将当前对阴道USPE的了解纳入双室杀菌剂综合概念中；2)评估使用者对直肠杀菌剂制剂的理化和流变性的认知和体验，以及这些认知和体验如何影响传统的可接受性和使用意愿变量。通过了解用户体验和偏好之间的对应关系，我们可以更好地为配方设计提供信息。这一知识，再加上有效药物成分递送配方的优化，将通过增加 杀微生物剂的使用符合预期，从而有助于降低高危人群的艾滋病毒发病率。