Acceptability Study of Vaginal Films for HIV Prevention

HIV Infections Clinical Trial

— FACE  

Official title:

Film Acceptability Characterization and Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01231763
• Other study ID #: PRO10080621 (UPittsburgh IRB#)
• Status: Completed
• Phase: N/A
• First received: October 28, 2010
• Last updated: February 8, 2011
• Start date: November 2010
• Est. completion date: February 2011

Study information

• Verified date: February 2011
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Anti-Infective Agents
• HIV Infections

Intervention

Other:
• No intervention (not applicable)
No intervention (not applicable)

Locations

Country	Name	City	State
United States	Magee-Womens Hospital of UPMC	Pittsburgh	Pennsylvania
United States	Magee-Womens Research Institute	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Doris Duke Charitable Foundation

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

U.S. Census Bureau. Allegheny County QuickFacts. [updated 4-22-2010]; Available from: http://quickfacts.census.gov/qfd/states/42/42003.html.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preferred physical characteristics of a vaginal film product	Preferred texture, shape, size, and appearance of a vaginal film product via focus group discussion and questionnaires	One visit lasting two hours	No
Secondary	Valued vaginal product characteristics	Desired characteristics of vaginal products such as lubrication, prescription status, and contraceptive function via focus group discussion and questionnaires	One visit lasting two hours	No
Secondary	Impressions regarding vaginal films	Impressions about vaginal films such as ease of use, comfort, and effect on sexual pleasure via focus group discussion and questionnaires	One visit lasting two hours	No