Gualeni Benedetta, Hughes Louise, Stauber Isabelle, Ackers Louise, Gorman Angela, Gashuga Dorothy, Dzabala Nettie, Chimimba Frider, Chikowe Ibrahim, Coulman Sion A, Birchall James C
School of Pharmacy and Pharmaceutical Sciences, Cardiff University, Redwood Building, King Edward VII Avenue, Cardiff, CF10 3NB, UK.
Maddison Limited, Walnut Tree Yard, Lower Street, Fittleworth, RH20 1JE, UK.
Gates Open Res. 2021 Jul 30;5:96. doi: 10.12688/gatesopenres.13233.2. eCollection 2021.
It is estimated that 225 million women worldwide have an unmet need for family planning, and more than half live in low- and middle-income countries. Increasing the choice of contraceptive methods available can reduce this unmet need. Microneedle drug delivery systems represent a new technology for minimally invasive self-administration of contraceptives. We explored stakeholders' views on different aspects of a proposed microneedle-based hormonal contraceptive delivery system. The feedback was used to iteratively develop this delivery system. Focus group discussions and semi-structured interviews were conducted with potential stakeholders (women and trans males of childbearing age, their partners, and health professionals and organisations that provide family planning advice and contraception services) in Uganda, The Gambia, Malawi, and the UK, exploring concept acceptability and gathering feedback on different aspects of design and usability of the proposed delivery system. Participants viewed the concept of a new, microneedle-based contraceptive favourably. In Uganda, participants were presented with 7 different prototype applicators and identified desirable features of a preferred delivery device; their input reducing the number of prototypes that were subsequently evaluated by stakeholders in The Gambia and the UK. Participants in these countries helped to identify and/or confirm the most desirable characteristics of the applicator, resulting in design consolidation into a refined concept applicator. The final, optimised applicator prototype was validated during user research in Malawi. This human-centred design approach was also used to iteratively develop an information leaflet for the device. During these user studies, other preferred aspects of a contraceptive delivery system were also evaluated, such as anatomical site of application, duration of action, and return to fertility. A new microneedle-based contraceptive delivery system was iteratively developed using a human-centred design approach and was favourably received by potential stakeholders. The product is now being refined for testing in pre-clinical studies.
据估计，全球有2.25亿女性存在未满足的计划生育需求，其中一半以上生活在低收入和中等收入国家。增加可用避孕方法的选择可以减少这种未满足的需求。微针给药系统是一种用于避孕药微创自我给药的新技术。我们探讨了利益相关者对拟议的基于微针的激素避孕给药系统不同方面的看法。这些反馈被用于迭代开发该给药系统。在乌干达、冈比亚、马拉维和英国，我们与潜在的利益相关者（育龄女性和跨性别男性、他们的伴侣以及提供计划生育咨询和避孕服务的卫生专业人员及组织）进行了焦点小组讨论和半结构化访谈，探讨概念的可接受性，并收集对拟议给药系统设计和可用性不同方面的反馈。参与者对新型基于微针的避孕药概念持积极态度。在乌干达，向参与者展示了7种不同的原型涂抹器，并确定了首选给药装置的理想特征；他们的意见减少了随后在冈比亚和英国由利益相关者评估的原型数量。这些国家的参与者帮助确定和/或确认了涂抹器最理想的特征，从而将设计整合为一个经过改进的概念涂抹器。最终优化的涂抹器原型在马拉维的用户研究中得到了验证。这种以用户为中心的设计方法还被用于迭代开发该设备的信息手册。在这些用户研究中，还评估了避孕给药系统的其他理想方面，如应用的解剖部位、作用持续时间和恢复生育能力。一种新型基于微针的避孕给药系统采用以用户为中心的设计方法进行了迭代开发，并受到了潜在利益相关者的好评。该产品目前正在进行改进，以便在临床前研究中进行测试。
