Acceptability Study of Vaginal Films for HIV Prevention

Study Overview
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Brief Summary
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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
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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).

Official Title
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Film Acceptability Characterization and Evaluation

Conditions
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HIV Infections, Anti-Infective Agents

Intervention / Treatment
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* Other: No intervention (not applicable)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy volunteers<br> | Other: No intervention (not applicable)<br>* No intervention (not applicable)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV prevention, Vaginal film, Microbicide, Administration, intravaginal