Acceptability Study of Vaginal Films for HIV Prevention (FACE)
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| ClinicalTrials.gov Identifier: NCT01231763 |
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Recruitment Status :
Completed
First Posted : November 1, 2010
Last Update Posted : February 9, 2011
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| HIV Infections Anti-Infective Agents | Other: No intervention (not applicable) |
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 Type : | Observational |
| Actual Enrollment : | 84 participants |
| Observational Model: | Cohort |
| Time Perspective: | Cross-Sectional |
| Official Title: | Film Acceptability Characterization and Evaluation |
| Study Start Date : | November 2010 |
| Actual Primary Completion Date : | February 2011 |
| Actual Study Completion Date : | February 2011 |
| Group/Cohort | Intervention/treatment |
|---|---|
| Healthy volunteers |
Other: No intervention (not applicable)
No intervention (not applicable) |
- Preferred physical characteristics of a vaginal film product [ Time Frame: One visit lasting two hours ]Preferred texture, shape, size, and appearance of a vaginal film product via focus group discussion and questionnaires
- Valued vaginal product characteristics [ Time Frame: 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 [ Time Frame: 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
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| Ages Eligible for Study: | 18 Years to 30 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01231763
| United States, Pennsylvania | |
| Magee-Womens Hospital of UPMC | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Magee-Womens Research Institute | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Principal Investigator: | Sharon Hillier, PhD | University of Pittsburgh |
Publications:
| Responsible Party: | Sharon Hillier, PhD, University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT01231763 History of Changes |
| Other Study ID Numbers: |
PRO10080621 (UPittsburgh IRB#) |
| First Posted: | November 1, 2010 Key Record Dates |
| Last Update Posted: | February 9, 2011 |
| Last Verified: | February 2011 |
Keywords provided by University of Pittsburgh:
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HIV prevention Vaginal film Microbicide Administration, intravaginal |
Additional relevant MeSH terms:
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HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |