Investigating end-user perspectives to inform the development of a novel non-hormonal intravaginal ring to prevent pregnancy and sexually transmitted infections

调查最终用户的观点，为开发新型非激素阴道环以预防怀孕和性传播感染提供信息

• 批准号: 10700073
• 负责人: BARBARA A FRIEDLAND
• 金额: $ 77.22万
• 依托单位: POPULATION COUNCIL
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-22 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10700073
• 关键词: Address; Adherence; Age; Anti-Bacterial Agents; Attitude; Bacterial Vaginosis; Behavior; Behavioral Research; Benefits and Risks; Biological Markers; Body Temperature; Characteristics; Clinical; Clinical Trials; Coitus; Collaborations; Compressive Strength; Contraceptive Agents; Contraceptive methods; Copper; Cross-Over Studies; Cross-Sectional Studies; Data; Data Reporting; Defecation; Development; Dose; Esthesia; Evaluation; Excision; Exercise; Formulation; Future; Goals; Health; Hormones; Intention; Interview; Measurement; Measures; Mechanics; Menstruation; Methods; National Institute of Child Health and Human Development; Nulliparity; Participant; Pathway interactions; Patient Self-Report; Pattern; Perception; Performance; Personal Satisfaction; Pharmacologic Substance; Planning Theory; Population; Preclinical Testing; Pregnancy; Prevention; Questionnaires; Randomized; Regimen; Reporting; Reproductive Health; Research; Research Project Grants; Risk; Running; STI prevention; Sex Behavior; Sexually Transmitted Diseases; Sorting; Structure; Surveys; Technology; Temperature; Text Messaging; Time; Universities; Vagina; Vaginal Ring; Visit; Walking; Woman; Zinc; aged; arm; design; experience; experimental study; health goals; male; meetings; novel; older women; open label; parity; parous; physical property; preference; prevent; product development; prototype; reproductive; research and development; sensor; sexually active; sociodemographics; tool; unintended pregnancy; uptake

PROJECT III – ABSTRACT Women of reproductive age need multipurpose prevention technology (MPT) products to address unintended pregnancy and sexually transmitted infections (STIs) which have a significant impact on their health and well- being. MPTs in development include intravaginal rings (IVRs), most of which contain hormones. To meet the needs of women who want a non-hormonal method, the Population Council (PC) P50 Center will develop the CZL-IVR, containing three active pharmaceutical ingredients (APIs)—copper (C), zinc (Z), and lactide (L)—that collectively have contraceptive, anti-STI, and anti-bacterial vaginosis activity. End-user research is critical for designing an MPT IVR that users will find acceptable to increase the likelihood of uptake and consistent use. The PC P50 Center Project 3 is driven by a conceptual framework informed by the Theory of Planned Behavior. We will use novel and mixed research approaches to evaluate user-centered (e.g., attitudes, subjective norms and perceived control over IVR use) and product-centered (e.g., physical characteristics, dosing regimen, benefits/risks of APIs) factors influencing IVR acceptability and intention-to-use a non-hormonal MPT IVR. In Aim 1, we will conduct a randomized, open-label, parallel group, crossover study among 60 18-49-year-old women at Emory University (Atlanta, Georgia) who will be randomly assigned to the sequence of using four non- medicated IVRs of differing compression strengths, across two visits. Women will respond to an IVR Acceptability Measurement Tool (IAMT) questionnaire to assess the impact of differing compressive strengths on ease of use (insertion/removal), sensation and involuntary expulsions during routine activities (walking, running, squatting, etc.) when wearing each of the IVRs in a controlled setting. After using all four IVRs, women will have a semi- structured interview with a card-sorting exercise regarding their opinions about the ideal characteristics of an MPT IVR. In Aim 2, we will conduct an exploratory single arm, noncomparative clinical trial of a non-medicated prototype IVR with an embedded temperature sensor among 64 18-49-year-old sexually active women at Emory (half parous, half nulliparous) instructed to wear the IVR continuously for 30 days, including during sexual intercourse, toileting, and menstruation. We will measure adherence to IVR use via daily text messages, a weekly online questionnaire, and the embedded temperature sensor, which will record deviations from core body temperature as a biomarker of adherence. We will assess acceptability with the IAMT questionnaire, expanded to include the impact of the IVR on sexual acceptability. We will also compare temperature sensor data and self- reports to identify the best questions for assessing adherence in future CZL-IVR trials. We will also conduct one- on-one interviews with a subsample of women and male partners to gather in-depth opinions about IVR acceptability. In Aim 3, via a national survey in 1,000 18-49-year-old women, we will implement a discrete choice experiment to determine preferred product characteristics and trade-offs users would make in selecting a non- hormonal MPT IVR and conduct a latent class analysis to identify the women most likely to use the CZL-IVR.

项目三-摘要 育龄妇女需要多用途预防技术（MPT）产品，以解决非预期的 怀孕和性传播感染对她们的健康和身心健康有重大影响， 存在发育中的MPT包括阴道环（IVRs），其中大多数含有激素。满足 人口理事会（PC）P50中心将开发一个非激素方法的妇女的需求， CZL-IVR，含有三种活性药物成分（API）-铜（C），锌（Z）和丙交酯（L）， 共同具有避孕、抗STI和抗细菌性阴道病活性。最终用户研究对于 设计一个用户可以接受的MPT IVR，以增加使用和持续使用的可能性。 PC P50中心项目3是由计划行为理论提供的概念框架驱动的。 我们将使用新的和混合的研究方法来评估以用户为中心（例如，态度，主观规范 和对IVR使用的感知控制）和以产品为中心（例如，身体特征，给药方案， API的获益/风险）影响IVR可接受性和使用非激素MPT IVR意向的因素。在 目的1，我们将在60名18-49岁的患者中进行一项随机、开放标签、平行组、交叉研究 埃默里大学（亚特兰大，格鲁吉亚）的女性将被随机分配到使用四个非 两次访视中不同抗压强度的含药IVR。女性将对IVR可接受性做出回应 评估不同抗压强度对易用性影响的测量工具（IAMT）问卷 （插入/取出），感觉和日常活动（行走，跑步，蹲下， 等等）。当在受控设置中佩戴每个IVR时。在使用所有四种IVRs后，女性将有一个半- 结构化访谈与卡片分类练习，关于他们对理想特征的看法， MPT IVR。在目标2中，我们将进行一项探索性单臂、非比较性临床试验， 在埃默里大学的64名18-49岁性活跃女性中使用嵌入式温度传感器的原型IVR (half经产，一半未经产），指导其连续佩戴IVR 30天，包括在性生活期间 性交、性交和月经。我们将通过每日短信、每周短信和每周短信来衡量IVR使用的依从性。 在线问卷，以及嵌入式温度传感器，它将记录偏离核心机构 温度作为粘附的生物标志物。我们将使用扩展的IAMT问卷评估可接受性 包括IVR对性可接受性的影响。我们还将比较温度传感器数据和自- 报告，以确定在未来CZL-IVR试验中评估依从性的最佳问题。我们还将进行一次- 与女性和男性伴侣的子样本进行一对一访谈，以收集关于IVR的深入意见 可接受性在目标3中，通过对1，000名18-49岁女性的全国性调查，我们将实施离散选择 实验，以确定首选的产品特性和权衡用户将在选择一个非 激素MPT IVR，并进行潜在类别分析，以确定最有可能使用CZL-IVR的女性。