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OpenTrials
Completed

NCT Number: NCT01231763

Acceptability Study of Vaginal Films for HIV Prevention

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.

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Key information

Age range

18 year–30 year

Sex eligibility

Female

Study type

Observational

Primary location

Magee-Womens Hospital of UPMC, Pittsburgh, Pennsylvania, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention (not applicable)

Other

No intervention (not applicable)

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Doris Duke Charitable Foundation

Registry information

Official study title

Film Acceptability Characterization and Evaluation

Acronym: FACE

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 1, 2010
Registry last updated
Feb 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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