Acceptability Study of Vaginal Films for HIV Prevention

Completed

• Conditions: HIV Infections; Anti-Infective Agents
• Interventions: Other: No intervention (not applicable)

• Registration Number: NCT01231763
• Lead Sponsor: University of Pittsburgh

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.

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 Timeline

• Study First Submitted: 2010-10-28
• Study First Submitted QC: 2010-10-29
• Study Start: 2010-11
• Study First Posted: 2010-11-01
• Status Verified: 2011-02
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Last Update Submitted: 2011-02-08
• Last Update Posted: 2011-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 84

Inclusion Criteria

• Female 18-30 years old at time of enrollment
• Able to provide written informed consent

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Exclusion Criteria

• Not sexually active, defined as no vaginal sex at any time in the past year
• Pregnant by self-report

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy volunteers	No intervention (not applicable)	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (2)

Magee-Womens Research Institute; 🇺🇸 Pittsburgh, Pennsylvania, United States

Magee-Womens Hospital of UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States