Table 1.
ASPIRE acceptability measures
| Acceptability measurea | Response options | Assessed at visit | ||
|---|---|---|---|---|
| Enrollment | Month 3 | PUEVb | ||
| Overall acceptability | ||||
| If in the future a vaginal ring was available that provided some protection against HIV, and it was similar to the one you used in this study, how likely would you be to keep it inserted in your vagina every day? | Very unlikely, unlikely, likely, very likely | X | X | |
| Use attributes | ||||
| How difficult was it to insert the vaginal ring the last time you inserted it? | Very difficult, somewhat difficult, not difficult at all | X | X | |
| How difficult was it to take the vaginal ring out the last time you took it out? | Very difficult, somewhat difficult, not difficult at all | X | X | |
| In the past 3 months, how did it feel to have the vaginal ring inside you every day? | Usually comfortable, sometimes uncomfortable, usually uncomfortable | X | X | |
| In the past 3 months, were you aware of the vaginal ring during your normal daily activities? | Most of the time, sometimes, never | X | X | |
| Did you mind wearing the ring during menses? | Yes, no, did not wear the vaginal ring during menses, did not have menses during the study | X | ||
| Have you noticed any of the following changes in your vagina while wearing the vaginal ring: vagina was wetter, vaginas was drier? | Vagina was wetter, vagina was drier, no change noticed | X | ||
| [If wetter or drier]: was this change a problem for you? | Yes, no | |||
| Effects on sex | ||||
| In the past 3 months, how often did you feel the vaginal ring inside you when you had sex? | Most of the time, sometimes, never, did not have sex in the past 3 months | X | X | |
| In the past 3 months, did any of your partners feel the vaginal ring inside of you when you had sex? | Yes, no, don't know | X | X | |
| How does the vaginal ring affect your sexual pleasure? | Increases pleasure, does not change pleasure, decreases pleasure | X | ||
| Did you mind wearing the ring during sex? | Yes, no, did not wear the vaginal ring during sex, did not have sex during the study | X | ||
| Partner's attitude | ||||
| Was the vaginal ring acceptable to your primary partner? | Yes, no, don't know | X | ||
| Has your primary sex partner ever asked you to stop wearing the ring? | Yes, no | X | ||
aMeasures are organized by component of acceptability as outlined by Mensch et al. [11]
bPUEV product use end visit, the penultimate visit when study product dispensing was permanently discontinued (median 24 months, IQR 15–30 months)