Acceptability Study of Vaginal Films for HIV Prevention
NCT ID: NCT01231763
Last Updated: 2011-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
84 participants
OBSERVATIONAL
2010-11-30
2011-02-28
Brief Summary
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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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Detailed Description
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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).
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Healthy volunteers
No intervention (not applicable)
No intervention (not applicable)
Interventions
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No intervention (not applicable)
No intervention (not applicable)
Eligibility Criteria
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Inclusion Criteria
* Able to provide written informed consent
Exclusion Criteria
* Pregnant by self-report
18 Years
30 Years
FEMALE
Yes
Sponsors
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Doris Duke Charitable Foundation
OTHER
University of Pittsburgh
OTHER
Responsible Party
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University of Pittsburgh
Principal Investigators
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Sharon Hillier, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States
Magee-Womens Research Institute
Pittsburgh, Pennsylvania, United States
Countries
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References
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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.
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.
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.
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. doi: 10.1002/jps.20107.
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.
Mantell JE, Myer L, Carballo-Dieguez 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. doi: 10.1016/j.socscimed.2004.05.011.
U.S. Census Bureau. Allegheny County QuickFacts. [updated 4-22-2010]; Available from: http://quickfacts.census.gov/qfd/states/42/42003.html.
Other Identifiers
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PRO10080621 (UPittsburgh IRB#)
Identifier Type: -
Identifier Source: org_study_id
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