美国女性及其男性伴侣多维阴道环可接受性量表的开发与验证
Development and Validation of a Multidimensional Intravaginal Ring Acceptability Scale Among US Women and Their Male Partners.
作者信息
Gottert Ann, Friedland Barbara A, Plagianos Marlena, Zieman Brady, Sales Jessica M, Atrio Jessica, Shetty Shakti, Sant'Anna Marinho Caio, Roselli Nicole, Merkatz Ruth, Bruce Irene, Haddad Lisa B
机构信息
Population Council, Social and Behavioral Sciences Research, Washington, District of Columbia, USA.
Population Council, Center for Biomedical Research, New York, New York, USA.
出版信息
Perspect Sex Reprod Health. 2025 Jun;57(2):144-153. doi: 10.1111/psrh.70009. Epub 2025 Apr 11.
OBJECTIVE
Intravaginal rings (IVRs) are marketed or in development for contraception and other indications. We sought to develop and validate the IVR Acceptability Scale (IVR-AS) as a multidimensional, standardized tool for assessing IVR acceptability among end-users in the United States.
METHODS
Scale items reflect specific aspects of IVR acceptability for women and male partners. Response options range from 1 (not-at-all acceptable) to 5 (highly acceptable). We evaluated the IVR-AS within a randomized, crossover clinical trial of three nonmedicated silicone IVRs of differing external diameters (46, 56, 66 mm) in heterosexual couples who used each for ~30 days, then completed a self-administered survey. We conducted exploratory factor analysis and multivariable regression to assess convergent validity. Follow-up in-depth interviews with all participants explored scale salience.
RESULTS
Twenty-four couples participated (mean age 27). The final 19-item women's scale (Cronbach's alpha = 0.93) included six subdimensions: ease of use; experience and sensation; effect on sexual desire/engagement, and effect on vaginal sex (all alphas > 0.78). The final eight-item men's scale comprised two subdimensions: effect on sexual desire/engagement and effect on vaginal sex (all alphas > 0.89). For both sexes, higher overall/subdimension scores were consistently associated with favorable assessments of the ring, for example, ease of insertion/removal; adherence (most p < 0.001). The 46/56 mm IVRs had higher overall and subdimension scores than the 66 mm IVR (most p < 0.001). Qualitative reports reinforced the salience of scale subdimensions and item content.
CONCLUSION
The IVR-AS captures multiple dimensions of IVR acceptability among women and their partners. The scales demonstrated excellent reliability and convergent validity. Further validation is warranted in future studies.
TRIAL REGISTRATION
Clinical Trials.gov: NCT05128136. https://clinicaltrials.gov/study/NCT05128136?intr=non-medicated%20silicone%20ring&rank=2.
目的
阴道环（IVR）已上市或正在研发用于避孕及其他适应症。我们试图开发并验证阴道环可接受性量表（IVR - AS），作为一种多维标准化工具，用于评估美国终端用户对阴道环的可接受性。
方法
量表项目反映了女性及其男性伴侣对阴道环可接受性的具体方面。回答选项从1（完全不可接受）到5（高度可接受）。我们在一项随机交叉临床试验中评估了IVR - AS，该试验涉及三种不同外径（46、56、66毫米）的非药物硅胶阴道环，异性恋夫妇使用每种阴道环约30天，然后完成一份自我管理的调查问卷。我们进行了探索性因素分析和多变量回归以评估收敛效度。对所有参与者进行的后续深入访谈探讨了量表的显著性。
结果
24对夫妇参与（平均年龄27岁）。最终的19项女性量表（克朗巴哈系数α = 0.93）包括六个子维度：易用性；体验和感觉；对性欲/性参与的影响，以及对阴道性行为的影响（所有α系数> 0.78）。最终的8项男性量表包括两个子维度：对性欲/性参与的影响和对阴道性行为的影响（所有α系数> 0.89）。对于两性而言，较高的总体/子维度得分始终与对阴道环的良好评价相关，例如，插入/取出的容易程度；依从性（大多数p < 0.001）。46/56毫米的阴道环比66毫米的阴道环具有更高的总体和子维度得分（大多数p < 0.001）。定性报告强化了量表子维度和项目内容的显著性。
结论
IVR - AS涵盖了女性及其伴侣对阴道环可接受性的多个维度。这些量表显示出出色的信度和收敛效度。未来的研究有必要进行进一步验证。
试验注册
ClinicalTrials.gov：NCT05128136。https://clinicaltrials.gov/study/NCT05128136?intr=non - medicated%20silicone%20ring&rank=2。
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