Evaluation of disintegration time and acceptability of the vaginal insert
HSV-2
VAGINA, LEAKAGE
The vaginal insert was completely dissolved and absorbed into the mucosal tissues with no remnants visible for 12 (75%) participants at the earliest assessment (4 or 24 hours). For the remaining 4 participants, the insert was dissolved but there were small clear gel-like areas of spreading observed. No participant had an intact vaginal insert at the first dissolution assessment.Most participants (13, [81%]) had not previously participated in a vaginal insert study. Overall, at baseline, most participants stated they were very comfortable with inserting products into their vagina (13 [81.3%]), despite the fact that most had not previously used vaginal suppositories or inserts (12 [75.0%]). When asked their first impressions of the insert based on seeing it, all participants expressed either no preference or liked how the insert looked (16 [100%]). Open-ended responses describing first impressions included statements that it looked like a pill or bullet, and others stated it was small and/or smaller than expected. The term insert was associated with a bigger item, similar to a tampon. Two participants thought the insert looked hard and uncomfortable. Most participants at baseline stated they would be somewhat or very interested in using the product in the future if it protected against HIV-1 and HSV-2 (14 [87.5%]), which stayed consistent after using the vaginal insert in the trial. At the post treatment visit, most participants found the insert very or somewhat acceptable in size (16 [100%]), ease of insertion (16 [100%]), comfort after insertion (15 [93.8%]), dissolvability (15 [93.8%]), residue (13 [81.3%]), leakage (14 [87.5%]), scent (15 [93.8%]), color (16 [100%]), and discreetness (15 [93.8%]) (Acceptability of insert characteristics.