Anti-Infective Agents, HIV Infections
Conditions
Keywords
HIV prevention, Vaginal film, Microbicide, Administration, intravaginal
Brief 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).
Interventions
OTHERNo intervention (not applicable)
No intervention (not applicable)
Sponsors
Doris Duke Charitable Foundation
University of Pittsburgh
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
* Female 18-30 years old at time of enrollment * Able to provide written informed consent
Exclusion criteria
* Not sexually active, defined as no vaginal sex at any time in the past year * Pregnant by self-report
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preferred physical characteristics of a vaginal film product | One visit lasting two hours | Preferred texture, shape, size, and appearance of a vaginal film product via focus group discussion and questionnaires |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Valued vaginal product characteristics | One visit lasting two hours | Desired characteristics of vaginal products such as lubrication, prescription status, and contraceptive function via focus group discussion and questionnaires |
| Impressions regarding vaginal films | One visit lasting two hours | Impressions about vaginal films such as ease of use, comfort, and effect on sexual pleasure via focus group discussion and questionnaires |
Countries
United States
Outcome results
None listed