Acceptability Study of Vaginal Films for HIV Prevention - Full Text View

Purpose

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	Intervention
HIV Infections Anti-Infective Agents	Other: No intervention (not applicable)


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Cross-Sectional
Official Title:	Film Acceptability Characterization and Evaluation

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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


Enrollment:	84
Study Start Date:	November 2010
Study Completion Date:	February 2011
Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Healthy volunteers	Other: No intervention (not applicable) No intervention (not applicable)

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).

Eligibility


Ages Eligible for Study:	18 Years to 30 Years (Adult)
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

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.

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01231763

Locations


United States, Pennsylvania
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
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

More Information

Publications:

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.

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-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.

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


Responsible Party:	Sharon Hillier, PhD, University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT01231763 History of Changes
Other Study ID Numbers:	PRO10080621 (UPittsburgh IRB#)
Study First Received:	October 28, 2010
Last Updated:	February 8, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pittsburgh:


HIV prevention Vaginal film Microbicide Administration, intravaginal

Additional relevant MeSH terms:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases	Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases

ClinicalTrials.gov processed this record on September 28, 2016

Acceptability Study of Vaginal Films for HIV Prevention (FACE)