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 III – 摘要 育龄妇女需要多用途预防技术 (MPT) 产品来解决意外问题 怀孕和性传播感染（STI）对她们的健康和福祉产生重大影响 存在。正在开发的 MPT 包括阴道环 (IVR)，其中大部分含有激素。为了满足 为了满足想要非激素方法的女性的需求，人口理事会 (PC) P50 中心将开发 CZL-IVR，含有三种活性药物成分 (API)——铜 (C)、锌 (Z) 和丙交酯 (L)—— 总体上具有避孕、抗性传播感染和抗菌阴道病活性。最终用户研究对于 设计用户会接受的 MPT IVR，以增加采用和一致使用的可能性。 PC P50 中心项目 3 由计划行为理论的概念框架驱动。 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，态度、主观规范 以及对 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 的益处/风险）影响 IVR 可接受性和使用非激素 MPT IVR 意向的因素。在 目标 1，我们将在 60 名 18-49 岁人群中进行一项随机、开放标签、平行分组、交叉研究 埃默里大学（佐治亚州亚特兰大）的女性将被随机分配到使用四个非 两次就诊期间不同压缩强度的药物 IVR。女性会对 IVR 可接受性做出回应 测量工具 (IAMT) 调查问卷，用于评估不同抗压强度对易用性的影响 （插入/移除）、日常活动（行走、跑步、蹲下、 等）在受控环境中佩戴每个 IVR 时。使用全部四个 IVR 后，女性将获得半 通过卡片分类练习进行结构化访谈，了解他们对某个人的理想特征的看法 MPT IVR。在目标 2 中，我们将对非药物药物进行探索性单臂、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带有嵌入式温度传感器的原型 IVR （一半经产，一半未产）被指示连续佩戴 IVR 30 天，包括性行为期间 性交、如厕和月经。我们将通过每日短信、每周短信来衡量 IVR 使用的遵守情况 在线问卷，嵌入式温度传感器，记录与核心体的偏差 温度作为依从性的生物标志物。我们将通过 IAMT 问卷扩展来评估可接受性 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检数据 报告以确定评估未来 CZL-IVR 试验依从性的最佳问题。我们还将开展一项—— 对女性和男性伴侣的子样本进行一对一访谈，收集有关 IVR 的深入意见 可接受性。在目标 3 中，通过对 1,000 名 18-49 岁女性进行的全国调查，我们将实施离散选择 进行实验以确定首选产品特性以及用户在选择非 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。