Film Acceptability Characterization and Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Preferred physical characteristics of a vaginal film product
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 30 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female 18-30 years old at time of enrollment
- •Able to provide written informed consent
排除标准
- •Not sexually active, defined as no vaginal sex at any time in the past year
- •Pregnant by self-report
结局指标
主要结局
Preferred physical characteristics of a vaginal film product
时间窗: One visit lasting two hours
Preferred texture, shape, size, and appearance of a vaginal film product via focus group discussion and questionnaires
次要结局
- Valued vaginal product characteristics(One visit lasting two hours)
- Impressions regarding vaginal films(One visit lasting two hours)
