Acceptability Study of Vaginal Films for HIV Prevention (FACE)
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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 |
- 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
- 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)
Other Name: 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 |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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.
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
Publications:
| 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 |
ClinicalTrials.gov processed this record on March 03, 2015