Back to resultsControl of Trichomoniasis
Primary Purpose
Trichomoniasis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
different methods of partner notification
partner delivered meds
field intervention
Sponsored by
About this trial
This is an interventional prevention trial for Trichomoniasis focused on measuring trichomoniasis, partner notification
Eligibility 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
Sites / Locations
- Jefferson County Department of Health STD Clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
usual care
partner delivered
field intervention
Arm Description
patient told to refer her partner for treatment
patient given medication to deliver to her partners
field intervention to find partners
Outcomes
Primary Outcome Measures
recurrence of trichomonas in the index patient
Secondary Outcome Measures
Full Information
NCT ID
NCT00334555
First Posted
June 7, 2006
Last Updated
August 11, 2009
Sponsor
University of Alabama at Birmingham
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
1. Study Identification
Unique Protocol Identification Number
NCT00334555
Brief Title
Control of Trichomoniasis
Official Title
Control of Trichomoniasis - A Paradigm for STD Control
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
4. Oversight
5. Study Description
Brief Summary
This study is designed to try to find the best method of partner notification and treatment for partners of women with trichomonas
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trichomoniasis
Keywords
trichomoniasis, partner notification
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
599 (Actual)
8. Arms, Groups, and Interventions
Arm Title
usual care
Arm Type
Active Comparator
Arm Description
patient told to refer her partner for treatment
Arm Title
partner delivered
Arm Type
Active Comparator
Arm Description
patient given medication to deliver to her partners
Arm Title
field intervention
Arm Type
Active Comparator
Arm Description
field intervention to find partners
Intervention Type
Other
Intervention Name(s)
different methods of partner notification
Intervention Description
comparing patient referral, partner delivered medications and field intervention to treat sex partners
Intervention Type
Other
Intervention Name(s)
partner delivered meds
Intervention Description
patient given meds to give to her partner
Intervention Type
Other
Intervention Name(s)
field intervention
Intervention Description
health worker finds partners
Primary Outcome Measure Information:
Title
recurrence of trichomonas in the index patient
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jane Schwebke, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jefferson County Department of Health STD Clinic
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Control of Trichomoniasis
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