NCT01231763

Acceptability Study of Vaginal Films for HIV Prevention

Film Acceptability Characterization and Evaluation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 84 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: Female
• Age: 18 Years – 30 Years
• Healthy volunteers: Accepted

Summary

This study is being done to find out what women would want in a film vaginal product for human immunodeficiency virus (HIV) prevention, especially what it should look like and how to apply it. The investigators hypothesize that women will prefer a smooth, clear, and rectangular quick-dissolve vaginal film for HIV prevention over a textured, opaque, square quick-dissolve vaginal film.

Detailed description

The lives of 25 million people have ended due to HIV-related causes since the start of the AIDS epidemic in 1981 (1). Each year, AIDS continues to claim the lives of millions of people, with an estimated two million deaths worldwide in 2008 (2). Heterosexual transmission of HIV accounts for the majority of new infections and disproportionately affects women both in the United States and globally (2, 3). There is an urgent need for agents to prevent the sexual transmission of HIV, particularly agents that may be controlled by women. Quick dissolve films such as Listerene® Breath Strips have been developed for inexpensive delivery of drugs and vitamins. As products for HIV prevention, quick dissolve films offer a host of potential advantages including low cost, control by the receptive partner, discreet and applicator-free use, low mess, portability, easy storage, stability, targeting to site of exposure, reduction of systemic toxicity by bypassing first-pass metabolism, and the incorporation of multiple active microbicidal compounds (4, 5). In the course of developing agents for HIV prevention, determination of valued characteristics is important for product refinement and for enhancement of future use likelihood. Knowledge regarding acceptability can also inform product promotion and educational campaigns (6).

Conditions

• HIV Infections
• Anti-Infective Agents

Interventions

Type	Name	Description
OTHER	No intervention (not applicable)	No intervention (not applicable)

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2010-11-01
• Last updated: 2011-02-09

Locations

2 sites across 1 country: United States