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参与者在1期临床试验中使用多用途阴道环来预防艾滋病毒和怀孕的经验:从使用者那里学习,以提高可接受性

Mary Kate Shapley-Quinn¹, Mei Song², Beatrice A Chen^2,3

¹Women's Global Health Imperative, RTI International, Berkeley, CA, United States.

Frontiers in reproductive health

|July 24, 2023

概括

这项研究发现,虽然用于预防艾滋病毒和怀孕的双重用途阴道环的概念具有吸引力,但当前的多用途预防技术 (MPT) 环具有功能挑战和副作用,限制了用户接受. 需要进一步开发以解决这些问题,以便在未来接受MPT环.

科学领域:

生殖健康生殖健康
预防传染病预防传染病
生物医学工程生物医学工程

背景情况:

全球高艾滋病毒发病率和意外怀孕需要新的预防方法.
多用途预防技术 (MPT) 正在开发中,以提供对艾滋病毒和怀孕的同时保护.
阴道环是一种有前途的MPT输送系统,原因是用户控制的好处,如自由裁量权和可逆性.

研究的目的:

在第一阶段试验中评估3个月多用途预防技术 (MPT) 阴道环的安全性,耐受性和用户体验.
评估用户对MPT环连续使用与循环使用相关的功能挑战和副作用的反.

主要方法:

一个第一阶段临床试验,涉及25名低风险参与者在美国.
随机化为90天的连续使用或28天的循环使用与2天的删除周期.
研究后进行了深入采访,以收集用户的定性反.

主要成果:

一般来说,MPT环被很好地容忍,参与者支持双重用途的概念.
大多数参与者报告了显著的功能挑战 (例如,滑动,排斥) 和副作用 (例如,出血变化),这减少了他们对当前环配方的兴趣.
使用连续治疗方案的参与者比循环治疗组的参与者报告了更多的积极体验.
少数人发现戒指具有吸引力,副作用最小,没有保留问题.

结论:

虽然MPT环概念是有希望的,但当前产品的可用性挑战和副作用阻碍了广泛接受.
用户反突出了产品优化的关键需求,以解决未来MPT环实施之前的功能问题和副作用.
早期的最终用户反对于指导有效和可接受的多用途预防技术的开发是无价的.

关键词:

预防艾滋病毒预防艾滋病毒可以接受的可接受性.避孕药可以作为避孕药.多用途预防技术多用途预防技术质量上的影响是有质量的.阴道环阴道环

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