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Control of Trichomoniasis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00334555
First Posted: June 8, 2006
Last Update Posted: August 12, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:
University of Alabama at Birmingham
  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: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Control of Trichomoniasis - A Paradigm for STD Control

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • recurrence of trichomonas in the index patient [ Time Frame: 6 weeks ]

Enrollment: 599
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
Active Comparator: usual care
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
Active Comparator: partner delivered
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
Active Comparator: field intervention
field intervention to find partners
Other: field intervention
health worker finds partners

Detailed Description:
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00334555


Locations
United States, Alabama
Jefferson County Department of Health STD Clinic
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Jane Schwebke, MD University of Alabama at Birmingham
  More Information

Responsible Party: Jane Schwebke, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00334555     History of Changes
Other Study ID Numbers: F020508005
R01AI050718 ( U.S. NIH Grant/Contract )
First Submitted: June 7, 2006
First Posted: June 8, 2006
Last Update Posted: August 12, 2009
Last Verified: August 2009

Keywords provided by University of Alabama at Birmingham:
trichomoniasis
partner notification

Additional relevant MeSH terms:
Trichomonas Infections
Protozoan Infections
Parasitic Diseases