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| Sponsors and Collaborators: |
University of Alabama at Birmingham National Institute of Allergy and Infectious Diseases (NIAID) |
| Information provided by: | University of Alabama at Birmingham |
| ClinicalTrials.gov Identifier: | NCT00334555 |
Purpose
This study is designed to try to find the best method of partner notification and treatment for partners of women with trichomonas
| Condition | Intervention |
|
Trichomoniasis |
Other: different methods of partner notification Other: partner delivered meds Other: field intervention |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
| Official Title: | Control of Trichomoniasis - A Paradigm for STD Control |
| Estimated Enrollment: | 1200 |
| Study Start Date: | May 2003 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
usual care: Active Comparator
patient told to refer her partner for treatment
|
Other: different methods of partner notification
comparing patient referral, partner delivered medications and field intervention to treat sex partners
Other: partner delivered meds
patient given meds to give to her partner
Other: field intervention
health worker finds partners
|
|
partner delivered: Active Comparator
patient given medication to deliver to her partners
|
Other: partner delivered meds
patient given meds to give to her partner
Other: field intervention
health worker finds partners
|
|
field intervention: Active Comparator
field intervention to find partners
|
Other: field intervention
health worker finds partners
|
To carry out a randomized trial to compare the effectiveness of three methods of partner notification and treatment for sexual partners of women with vaginal trichomoniasis - patient self-referral of partners (the current practice standard), delivery of curative therapy to partners by patients themselves, or public health style Disease Intervention carried out by a specially trained Disease Intervention Specialists (DIS) locating the partners and delivering the medication in the field. Reinfection rates with trichomonas at three months of follow-up among the index women will be the measure of effectiveness.
Eligibility
| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Inclusion criteria {for Women}:
Age {> 15 years} Culture or wet prep proven T. vaginalis infection Willingness to provide informed consent and take part in study procedures
-
Exclusion Criteria:
Infection with other STD pathogens requiring Health Dept DIS intervention (syphilis or HIV) Pregnancy or currently breast feeding Recent (8 hours) ingestion of alcoholic beverages or intent to do so in the 24 hours following treatment Allergy to metronidazole The presence of a sexual partner in the clinic at the time of enrollment A history of referral by a partner already treated for trichomoniasis Report of more than four sexual partners in the preceding 30 days
Contacts and Locations| United States, Alabama | |||||
| Jefferson County Department of Health STD Clinic | |||||
| Birmingham, Alabama, United States, 35294 | |||||
| University of Alabama at Birmingham |
| National Institute of Allergy and Infectious Diseases (NIAID) |
| Principal Investigator: | Jane Schwebke, MD | University of Alabama at Birmingham |
More Information
| Responsible Party: | University of Alabama at Birmingham ( Jane Schwebke, MD ) |
| Study ID Numbers: | F020508005, R01AI050718 |
| First Received: | June 7, 2006 |
| Last Updated: | July 10, 2008 |
| ClinicalTrials.gov Identifier: | NCT00334555 |
| Health Authority: | United States: Federal Government |
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