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| ID | Type | Description | Link |
|---|---|---|---|
| U19AI077289 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| ImQuest Pharmaceuticals, Inc. | INDUSTRY |
| The Miriam Hospital | OTHER |
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This study will compare two investigational techniques for measuring how vaginal gels spread and coat the vagina. This study will also explore the experiences and opinions of women using this vaginal gel. We want to understand how the characteristics of a gel, such as a gel's thickness or consistency, affect how the gel spreads and feels in the body. We hope to use the information we learn from this study to develop future vaginal gels that could be combined with medications and used to slow down or stop the spread of sexually transmitted infections.
The pharmacokinetics of a microbicide gel, i.e. the time- and space-dependent distribution of its active microbicidal ingredient(s) (APIs) throughout the body, derives from the time- and space-dependent distribution of the gel itself within the vaginal canal. That distribution may also serve as a physical barrier that retards migration of semen-borne HIV virions to epithelial surfaces. Within the vagina, the gel creates local physical forces ("stresses") against the epithelial surfaces; and its distribution along the canal might be so extensive that gel leaks out from the introitus. A woman may have sensations of those stresses and also feel gel leakage. Thus, intravaginal microbicide gel distribution is central to both its biological functioning (to deliver APIs and also to slow HIV transport) and the behavioral perception of it by users (i.e. how it "feels" and whether that experience is pleasurable or not). The latter, in turn, can govern acceptability of the gel and adherence to designated gel use in clinical trials. This study will characterize and correlate gel distribution and women's sensory perceptions and preferences of that distribution, for two relevant volumes (2 mL and 4 mL) of a current microbicide placebo gel. An optical vaginal imaging device will measure gel distribution in the vagina. A computer-assisted self-interview (CASI) survey will capture women's perceptions and preferences.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 mL vaginal gel | Experimental | 2 mL gel inserted vaginally for completion of vaginal gel imaging and computer aided self interview. |
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| 4 mL vaginal gel | Experimental | 4 mL gel inserted vaginally for completion of vaginal gel imaging and computer aided self interview. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vaginal gel imaging | Other | Imaging of vaginal gel distribution using two investigational techniques (low coherence interferometry and fluorimetry). |
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| Measure | Description | Time Frame |
|---|---|---|
| number and frequency of adverse events | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| extent of vaginal gel coating | extent of vaginal gel coating is measured by: algebraic and harmonic mean gel thickness, total vaginal surface area with detectable gel coating, fraction of total vaginal surface area containing detectable gel coating, linear extent of gel coating along the vaginal canal, ratio of linear extent of coating to the length of the vaginal canal | at imaging visit 1 (between 1-6 weeks after enrollment) and at imaging visit 2 (between 1 - 6 weeks after imaging visit 1) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David F. Katz, Ph.D. | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
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| computer aided self interview | Behavioral | Questionnaire to gather the perceptions and preferences of the subject with respect to the vaginal gel. |
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| uniformity of vaginal gel coating | uniformity of vaginal gel coating is measured by: coefficient of variation of local coating thickness and the number, location, and sizes of individual bare spots of uncoated vaginal surface within the overall gel coating envelope | at imaging visit 1 (between 1-6 weeks after enrollment) and at imaging visit 2 (between 1 - 6 weeks after imaging visit 1) |
| subject perception and preference of vaginal gel | responses to the computer aided self interview questions, grouped into the following scales: Leaks with Application, Ease of Application, Portability, Intravaginal Feel, Perception of Leakage with Ambulation, Leaking with Ambulation, Leakage Across Time, Sticky with Ambulation, Perception of Natural Wetness, and Lubrication Moisture on Ambulation. | at imaging visit 1 (between 1-6 weeks after enrollment) and at imaging visit 2 (between 1 - 6 weeks after imaging visit 1) |