P15.12
Background: Drug delivery in prevention technology is critical, but is predicated on use adherence. The role of formulation characteristics/properties of vaginal film (i.e., impressions of size, texture, color) and film perceptibility (user sensory perceptions/experiences) was explored during insertion and vaginal sex.
Methods: 24 monogamous HIV-/STI- heterosexual couples enrolled in a mixed methods study. All (100% retention) completed 3 formulation evaluations, 1 a placebo film. Female participants provided qualitative data regarding film attributes (size: 1x1, 1x2, 1x3, 2x2-inch; texture: textured, smooth; color: clear, translucent, opaque) then inserted 1”×2” film and had vaginal sex with their partner. Both partners completed USPE surveys and in-depth qualitative interviews.
Results: Individual film characteristics were first rated separately, then a final preference for film design was given. Relatively equal numbers of women chose each film size. 13 of 23 women chose one smooth/one textured side. The majority chose translucent or opaque coloring. Data revealed a range of expectations about product performance. Some perceived the 1”×1” films as difficult to insert and less efficacious, others felt the 1”×1” film would insert easier, dissolve quicker, and result in less leakage. 2”×2” films elicited similar expectation ranges. USPE scale scores were low; women felt little-to-no lubrication, coating, leakage, etc. Design parameters called for a film that users would not be aware of and that would generate no leakage or messiness: these properties were achieved. However, low lubricity and coating sensations at initial penetration or during the first coital strokes were problematic, even causing a few couples to stop sex.
Conclusions: The addition of vaginal film to the formulation parameter space for USPEs of vaginal products offers important considerations for developers. Given previous USPE analyses, initial lubrication may impact use adherence and thus is currently being explored in new film development.
