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; 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.

项目摘要（请参阅说明）： 项目5的目的是通过对用户体验的全面了解以及该体验对用户偏好，产品可接受性以及最终的产品依从性的影响来告知双隔室微生物配方的设计。项目5将一系列形成性研究和实验研究纳入了IPCP双室菌心开发计划中。 男人和女人都将担任参与者。研究5.1是一项形成性混合方法研究，旨在发展RAI（接受性肛门性交）特定的用户感觉感知和经验（USPE）工具。将研究一组代表最适合双重隔室使用的配方属性和特性范围的配方。深入的访谈将用于生成特定于Frai的项目，以纳入现有的USPE仪器中。然后，这些措施将用于评估USPE和常规可接受性构建体相对于在项目4中评估的候选微生物剂（USPE研究纳入项目4的USPE研究5.2）。最后，研究5.3是一项随机试验，比较了本IPCP在USPE和使用此类配方意愿的意愿方面开发的原型制剂。 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这些看法和经验会影响常规的可接受性和意愿到使用的变量。通过了解用户体验和偏好之间的对应关系，我们可以更好地为公式设计提供信息。这些知识结合了优化用于活性药物成分的配方的优化，将通过增加的可能性来积极影响有效性 菌心被按预期使用，从而导致危险中的艾滋病毒发病率降低。