Defining end-user preferences among US women to optimize the design of a long-acting injectable hormonal contraceptive

项目摘要 注射荷尔蒙避孕是全球方法组合的重要组成部分， 甲羟孕酮(DMPA)是最常用的注射用产品。许多女性发现 注射剂比每天服用避孕药更方便和谨慎，有些人更喜欢这样 从传统方法到基于装置的长效可逆方法(如宫内节育器；植入物)。 尽管在理想情况下，DMPA的效率超过99%，但一些功能的合规性和 因此，有效性，包括每三次返回诊所的障碍/不便 几个月，副作用/月经模式改变，以及长时间/不可预测的恢复生育能力。事实上，其中一个- 一年续订率可以低至40%。达累生物科学公司正在开发一种长效注射剂 (LAI)通过精确控制药物释放速率提供依托诺孕酮的缓释， 以6个月和12个月的保护期为目标，在两个月内迅速恢复生育率 几个月，比目前可用的治疗方法更稳定的激素剂量，以及类似的预期副作用 给Nparon®(目前批准的给药依托诺孕酮的方法)。终端用户研究至关重要 用于设计用户认为可接受的LAI，以增加未来采用和 持续使用。这项与人口理事会合作进行的R43研究包括： 与美国女性进行的用户研究，以了解她们根据其他属性对LAI持续时间的偏好 (特别是对月经、副作用和恢复生育能力的影响)，LAI的可接受性与 其他避孕方法，以及持续时间偏好和可接受性之间的异质性 不同的最终用户配置文件。我们将利用亚马逊的机械土耳其(MTurk)平台高效地 对全国1,000名年龄在18-44岁的妇女进行了调查，按年龄组、城市/农村分层 居住和经常使用荷尔蒙避孕。在目标1中，我们将检查女性的LAI持续时间 偏好，考虑其他产品属性，通过实施离散选择实验(DCE)， 以及与目前可用的避孕方法相比，LAIS的可接受性。在目标2中， 我们将通过潜在类别分析(LCA)和LAI持续时间确定不同的LAI最终用户配置文件 每个人的首选项。LCA模型将包括最终用户对LAI的总体感知可接受性， 社会人口学特征、生育意愿、生育史和避孕措施 历史/一般偏好。这项研究的结果将直接告诉我们应该追求哪个持续时间(S) 并找出最有可能对使用安莱感兴趣的美国女性的特征。如果这辆R43 研究是成功的，因为确认了LAI将填补未满足的避孕药的假设 根据需求，我们将使用我们选择的LAI原型(S)进行最终用户体验评估 安莱的第一个人体阶段试验。

PROJECT ABSTRACT Injectable hormonal contraception is an important part of the method mix globally, with depot medroxyprogesterone acetate (DMPA) the most commonly used injectable product. Many women find injectables more convenient and discreet than taking a daily birth control pill, and some prefer this method to device-based longer-acting reversible methods (e.g., intrauterine devices; implants). Although with ideal use DMPA is over 99% effective, several features have limited compliance and hence effectiveness, including barriers/inconvenience associated with returning to the clinic every three months, side effects/menstrual pattern changes, and long/unpredictable return to fertility. In fact, one- year continuation rates can be as low as 40%. Daré Bioscience is developing a long-acting injectable (LAI) that provides extended release of etonogestrel with precise control over drug release rate, targeting windows of protection for six months and 12 months, a rapid return of fertility within two months, a steadier hormone dose than currently available therapies, and anticipated side effects similar to Nexplanon® (the currently-approved method of delivering etonogestrel). End-user research is critical for designing an LAI that users will find acceptable, to increase the likelihood of future uptake and consistent use. This R43 study, conducted in partnership with the Population Council, comprises end- user research with US women to understand their preferences for LAI duration in light of other attributes (particularly effect on menstruation, side effects, and return to fertility), acceptability of the LAIs vs. other contraceptive methods, and heterogeneity in duration preferences and acceptability between different end-user profiles. We will leverage Amazon’s Mechanical Turk (MTurk) platform to efficiently survey a national sample of 1,000 women ages 18-44 years, stratified by age group, urban/rural residence, and ever-use of hormonal contraception. In Aim 1, we will examine women’s LAI duration preferences, considering other product attributes, by implementing a discrete choice experiment (DCE), as well as acceptability of the LAIs compared with currently available contraceptive methods. In Aim 2, we will identify distinct LAI end-user profiles via latent class analyses (LCA), and LAI duration preferences for each. LCA models will include end users’ overall perceived acceptability of the LAIs, socio-demographic characteristics, fertility intentions, reproductive history, and contraceptive history/general preferences. Findings from this study will directly inform which LAI duration(s) to pursue and identify the characteristics of US women most likely to be interested in using an LAI. If this R43 study is successful, as defined by confirmation of hypotheses that the LAI would fill unmet contraceptive needs, we will pursue an evaluation of end-user experiences using our selected LAI prototype(s) within the first in-human Phase I trial of an LAI.