HIV Infections Clinical Trial
Official title:
Film Acceptability Characterization and Evaluation
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.
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).
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Observational Model: Cohort, Time Perspective: Cross-Sectional
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