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，为新型非激素阴道环的开发提供信息，以预防怀孕和性传播感染

• 批准号: 10324918
• 负责人: BARBARA A FRIEDLAND
• 金额: $ 12.04万
• 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/10324918
• 关键词: Investigating; end; user; perspectives; inform

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 生殖年龄的妇女需要多用途预防技术（MPT）产品来解决意外 怀孕和性传播感染（ETI）对其健康和良好的影响有重大影响 存在。发育中的MPT包括腔内环（IVR），其中大多数包含激素。见面 想要一种非激素方法的女性需求，人口委员会（PC）P50中心将发展 CZL-IVR，包含三种活性药物成分（API） - Copper（C），锌（Z）和乳酸（L） - 统称具有避孕，抗STI和抗细菌阴道化活性。最终用户研究对于 设计一个MPT IVR，用户将可以接受以增加吸收和一致使用的可能性。 PC P50中心项目3是由计划行为理论所告知的概念框架驱动的。 我们将使用新颖和混合的研究方法来评估以用户为中心的（例如，参与者，主观规范 以及对IVR使用的控制）和以产品为中心的（例如，物理特征，给药方案， API的益处/风险）因素影响IVR的可接受性，并有意使用非激素MPT IVR。在 AIM 1，我们将在60 18-49岁的60岁之间进行随机，开放标签的平行组，跨界研究 埃默里大学（佐治亚州亚特兰大）的妇女将被随机分配到使用四个非 - 在两次访问中，具有不同压缩强度的药物IVR。妇女会回应IVR的可接受性 测量工具（IAMT）调查表评估抗压优势对易用性的影响 （插入/删除），常规活动期间的感觉和非自愿驱逐（步行，跑步，蹲下， 等等。）当在受控的环境中佩戴每个IVR时。使用了所有四个IVR之后，女性将拥有半 结构化访谈，涉及他们对他们对理想特征的看法的练习 MPT IVR。在AIM 2中，我们将对未经药物的探索性单臂，非舒张性临床试验 原型IVR具有嵌入式温度传感器的原型IVR （一半的假子，半无效）指示连续穿IVR 30天，包括性行为 性交，厕所和月经。我们将通过每日短信衡量依从性使用IVR，每周一次 在线调查表和嵌入式温度传感器，它将记录与核心身体的出发 温度作为依从性的生物标志物。我们将评估IAMT问卷的可接受性，扩展 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我 报告确定评估未来CZL-IVR试验依从性的最佳问题。我们还将进行一个 与女性和男性伴侣的子样本进行一对一的访谈，以收集有关IVR的深入意见 可接受性。在AIM 3中，通过1,000名18-49岁妇女的全国调查，我们将实施一个离散的选择 实验以确定用户选择非 - 激素MPT IVR并进行潜在类别分析，以识别最有可能使用CZL-IVR的女性。