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| ID | Type | Description | Link |
|---|---|---|---|
| R03TW005820 | U.S. NIH Grant/Contract | View source | |
| HD 40540-04 | |||
| P30AI027757 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Fogarty International Center of the National Institute of Health | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| National Institute of Allergy and Infectious Diseases (NIAID) |
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Randomized controlled trial (RCT) to evaluate the effectiveness of applying PurellĀ® (62% ethyl alcohol in emollient gel) to the penis of male partners of women diagnosed with BV for preventing BV recurrence after treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hygienic information plus 62% ethyl alcohol in emollient gel | Other | The male partner in each couple was asked to apply PurellĀ® to his penis at least daily, and immediately prior to and following intercourse. Couples received a brochure with information on control of STI and good hygienic practices. Brochures for intervention and control arms were similar except the intervention arm brochure provided information on how to use the study product (PurellĀ®). |
| Measure | Description | Time Frame |
|---|---|---|
| bacterial vaginosis by Nugent's score | up to 2 months following treatment |
| Measure | Description | Time Frame |
|---|---|---|
| presence of lactobacillus by culture | 2 months following treatment |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| King K. Holmes, MD, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nairobi City Council STI referral clinic (Special Treatment Clinic) | Nairobi | Kenya |
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| ID | Term |
|---|---|
| D016585 | Vaginosis, Bacterial |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014627 | Vaginitis |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| C031356 | hydroxide ion |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| hygienic information | Other | Couples received a brochure with information on control of STI and good hygienic practices. |
|
| D014623 |
| Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |