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

项目三--摘要 育龄妇女需要多用途预防技术(MPT)产品来解决意外情况 怀孕和性传播感染(STI)对她们的健康和健康有重大影响- 是存在的。正在开发的MPT包括阴道内环(IVR)，其中大多数含有激素。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，包含三种活性药物成分(API)-铜(C)、锌(Z)和丙交酯(L)- 集体具有避孕、抗性传播感染和抗细菌性阴道病的活性。终端用户研究对以下方面至关重要 设计一种用户认为可以接受的MPT IVR，以增加接受和一致使用的可能性。 PC P50中心项目3是由计划行为理论提供信息的概念框架驱动的。 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，物理特征，给药方案， 原料药的好处/风险)影响IVR可接受性和使用非激素MPT IVR的意向的因素。在……里面 目的1.我们将在60名18-49岁的青少年中进行随机、开放标签、平行分组、交叉研究 在埃默里大学(佐治亚州亚特兰大)的女性，她们将被随机分配到使用四个非 在两次就诊期间，使用不同压缩强度的药物IVR。女性将对IVR的可接受性做出反应 评估不同抗压强度对易用性影响的测量工具(IAMT)问卷 (插入/移除)、感觉和日常活动中的非自愿驱逐(行走、跑步、蹲下、 等)当在受控环境中佩戴每一个IVR时。在使用了所有四种静脉注射受体后，女性将有一个半- 通过卡片分类练习进行结构化访谈，了解他们对员工理想特征的看法 MPT IVR。在目标2中，我们将进行一项非药物治疗的探索性单臂非对照临床试验。 埃默里医院18-49岁性活跃女性植入体温传感器的试管婴儿试管婴儿 (半产妇、半未产妇)被指示连续佩戴IVR 30天，包括在性行为期间 性交、如厕和月经。我们将通过每天的短信，每周一次来衡量对IVR使用的遵守情况 在线问卷，以及嵌入式温度传感器，它将记录偏离核心身体的偏差 温度作为粘附性的生物标记物。我们将使用扩展后的IAMT问卷来评估可接受性 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身 报告，以确定在未来的CZL-IVR试验中评估依从性的最佳问题。我们还将进行一次- 对部分女性和男性伴侣进行一对一采访，以收集对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，我们将实施一项离散选择 试验以确定首选产品特性和用户在选择非 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。

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.