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| Name | Class |
|---|---|
| RTI International | OTHER |
| UZ-UCSF Collaborative Research Programme | OTHER |
| Match Research | OTHER |
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The purpose of The Quatro Study is to assess the acceptability, preferences, user experience and effect on sexual behavior of four different vaginal microbicide or multi-purpose technology (MPT) delivery forms, using placebo products in 18-30 year old African women: rapidly disintegrating vaginal insert, intravaginal ring (IVR), film and gel. The study also examines adherence to the dosage forms through objective markers, developed for each dosage form prior to the commencement of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Month 1 | Other | In a cross-over design, women will be randomized to a sequence of product use. Each product will be tested by every participant for 1 month in a 4-period cross-over design. |
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| Month 2 | Other | In a cross-over design, women will be randomized to a sequence of product use. Each product will be tested by every participant for 1 month in a 4-period cross-over design. |
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| Month 3 | Other | In a cross-over design, women will be randomized to a sequence of product use. Each product will be tested by every participant for 1 month in a 4-period cross-over design. |
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| Month 4 | Other | In a cross-over design, women will be randomized to a sequence of product use. Each product will be tested by every participant for 1 month in a 4-period cross-over design. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HEC Placebo Gel | Other |
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| Placebo Vaginal Insert |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in ratings and relative preference rankings of four vaginal delivery forms | Baseline, Month 1, Month 2, Month 3, Month 4, Month 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Attributes least and most favored for the vaginal delivery forms as measured by discreet choice experiment | Month 5 | |
| Adherence assessed by self report via questionnaire | Baseline, Month 1, Month 2, Month 3, Month 4, Month 5 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jill Schwartz, MD, MPH | CONRAD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MatCH Research | Durban | South Africa | ||||
| The University of Zimbabwe-University of California San Francisco Collaborative Research Program (UZ-UCSF) |
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| Other |
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| Placebo Vaginal Film | Other |
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| Placebo Intravaginal ring (IVR) | Other |
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| Adherence assessed by objective biomarkers, utilizing antibodies, tagged recombinant proteins, biochemical assays and/or spectroscopy | Baseline, Month 1, Month 2, Month 3, Month 4, Month 5 |
| Harare |
| Zimbabwe |