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: 8404977
• 负责人: Kate M Guthrie
• 金额: $ 46.7万
• 依托单位: IMQUEST BIOSCIENCES
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-06-22 至 2017-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8404977
• 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的目标是通过全面了解用户体验以及这种体验对用户偏好、产品可接受性和最终产品依从性的影响，为双室杀微生物剂配方的设计提供信息。项目5将一系列形成性和实验性研究纳入IPCP双室杀微生物剂总体开发计划。 男女都将参加。研究5.1是一项形成性混合方法研究，旨在开发RAI（接受性肛交）特定用户感官知觉和体验（USPE）工具。将研究一组制剂，这些制剂代表被认为最适合双室使用的制剂性质和特征范围。深入访谈将用于生成FARI特定项目，以纳入现有的USPE仪器。然后，这些指标将用于评价USPE和常规结构相对于项目4中评价的候选杀微生物剂的可接受性（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，比较了本IPCP中开发的原型制剂与USPE和使用此类制剂的意愿。USPE试验（研究5.3）将实现两个重要目标：1）从心理测量学上验证专门设计用于直肠杀微生物剂评价的新型和适应性USPE仪器，将目前对阴道USPE的理解结合到双隔室杀微生物剂的综合概念中，以及2）评价使用者对直肠杀微生物剂制剂的物理化学和流变学性质的感知和体验，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。这种知识与用于递送活性药物成分的制剂的优化相结合，将通过增加药物释放的可能性来积极地影响有效性。 因此，我们必须确保按预期使用杀微生物剂，从而有助于降低高危人群的艾滋病毒感染率。