FACE: Acceptability Study of Vaginal Films for HIV Prevention
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Healthy volunteers
|
Other: No intervention (not applicable)
No intervention (not applicable)
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Female 18-30 years old at time of enrollment
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Able to provide written informed consent
Exclusion Criteria:
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Not sexually active, defined as no vaginal sex at any time in the past year
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Pregnant by self-report
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Magee-Womens Hospital of UPMC | Pittsburgh | Pennsylvania | United States | 15213 |
| 2 | Magee-Womens Research Institute | Pittsburgh | Pennsylvania | United States | 15213 |
Sponsors and Collaborators
- University of Pittsburgh
- Doris Duke Charitable Foundation
Investigators
- Principal Investigator: Sharon Hillier, PhD, University of Pittsburgh
Study Documents (Full-Text)
None provided.More Information
Publications
- Centers for Disease Control and Prevention (CDC). Subpopulation estimates from the HIV incidence surveillance system--United States, 2006. MMWR Morb Mortal Wkly Rep. 2008 Sep 12;57(36):985-9.
- Joint United Nations Programme on AIDS, WHO. AIDS Epidemic Update. 2009 Available from: http://data.unaids.org/pub/Report/2009/JC1700_Epi_Update_2009_en.pdf.
- Joint United Nations Programme on HIV/AIDS. 08 Report on the global AIDS epidemic. 2008 Available from: http://www.unaids.org/en/KnowledgeCentre/HIVData/GlobalReport/2008/2008_Global_report.asp.
- Mantell JE, Myer L, Carballo-Diéguez A, Stein Z, Ramjee G, Morar NS, Harrison PF. Microbicide acceptability research: current approaches and future directions. Soc Sci Med. 2005 Jan;60(2):319-30. Review.
- Romano J, Malcolm RK, Garg S, Rohan LC, Kaptur PE. Microbicide delivery: formulation technologies and strategies. Curr Opin HIV AIDS. 2008 Sep;3(5):558-66. doi: 10.1097/COH.0b013e328305b96e.
- Sassi AB, McCullough KD, Cost MR, Hillier SL, Rohan LC. Permeability of tritiated water through human cervical and vaginal tissue. J Pharm Sci. 2004 Aug;93(8):2009-16.
- U.S. Census Bureau. Allegheny County QuickFacts. [updated 4-22-2010]; Available from: http://quickfacts.census.gov/qfd/states/42/42003.html.
- PRO10080621 (UPittsburgh IRB#)