Development and Validation of a Multidimensional Intravaginal Ring Acceptability Scale Among US Women and Their Male...

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.

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.

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.

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.

Clinical Trials.gov: NCT05128136. https://clinicaltrials.gov/study/NCT05128136?intr=non-medicated%20silicone%20ring&rank=2.