Acceptability Study of Vaginal Films for HIV Prevention (FACE)

This study has been completed.
Sponsor:
Collaborator:
Doris Duke Charitable Foundation
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01231763
First received: October 28, 2010
Last updated: February 8, 2011
Last verified: February 2011

October 28, 2010
February 8, 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 ] [ Designated as safety issue: No ]
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 ClinicalTrials.gov Archive Site
  • Valued vaginal product characteristics [ Time Frame: One visit lasting two hours ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Impressions about vaginal films such as ease of use, comfort, and effect on sexual pleasure via focus group discussion and questionnaires
Same as current
Not Provided
Not Provided
 
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
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Not Provided
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)
Other Name: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
84
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
Female
18 Years to 30 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01231763
PRO10080621 (UPittsburgh IRB#)
No
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP