Acceptability Study of Vaginal Films for HIV Prevention (FACE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01231763
Recruitment Status : Completed
First Posted : November 1, 2010
Last Update Posted : February 9, 2011
Doris Duke Charitable Foundation
Information provided by:
University of Pittsburgh

October 28, 2010
November 1, 2010
February 9, 2011
November 2010
February 2011   (Final data collection date for primary outcome measure)
Preferred physical characteristics of a vaginal film product [ Time Frame: One visit lasting two hours ]
Preferred texture, shape, size, and appearance of a vaginal film product via focus group discussion and questionnaires
Same as current
Complete list of historical versions of study NCT01231763 on Archive Site
  • Valued vaginal product characteristics [ Time Frame: 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 [ Time Frame: 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
Same as current
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Acceptability Study of Vaginal Films for HIV Prevention
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).

Observational Model: Cohort
Time Perspective: Cross-Sectional
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Non-Probability Sample
Women aged 18-30 years from the Pittsburgh, Pennsylvania area who express interest in the study. Enrollment is expected to achieve racial and ethnic demographics representative of Allegheny County, Pennsylvania in terms of approximately 0.2 percent American Indian and Alaska Native, 2.5 percent Asian, and 1.5 percent Hispanic or Latino (7). Allegheny County is 82.8 percent white and 13.2 percent black or African American (7). For enrollment in this study, we would like to achieve at least 40 percent black or African American in order to collect a more diverse set of film microbicide preferences. The remainder of enrollment is expected to be white.
  • HIV Infections
  • Anti-Infective Agents
Other: No intervention (not applicable)
No intervention (not applicable)
Healthy volunteers
Intervention: Other: No intervention (not applicable)

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
February 2011
February 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 30 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
PRO10080621 (UPittsburgh IRB#)
Not Provided
Not Provided
Sharon Hillier, PhD, University of Pittsburgh
University of Pittsburgh
Doris Duke Charitable Foundation
Principal Investigator: Sharon Hillier, PhD University of Pittsburgh
University of Pittsburgh
February 2011