Control of Trichomoniasis

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00334555
First received: June 7, 2006
Last updated: August 11, 2009
Last verified: August 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Jane Schwebke, MD University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: Jane Schwebke, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00334555     History of Changes
Other Study ID Numbers: F020508005, R01AI050718
Study First Received: June 7, 2006
Last Updated: August 11, 2009
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Trichomonas Infections
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on September 18, 2014