Control of Trichomoniasis

Not Applicable

Completed

• Conditions: Trichomoniasis
• Interventions: Other: different methods of partner notification; Other: partner delivered meds; Other: field intervention

• Registration Number: NCT00334555
• Lead Sponsor: University of Alabama at Birmingham

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.

Study Timeline

• Study Start: 2003-05
• Study First Submitted: 2006-06-07
• Study First Submitted QC: 2006-06-07
• Study First Posted: 2006-06-08
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-11
• Last Update Posted: 2009-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 599

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
usual care	different methods of partner notification	patient told to refer her partner for treatment
usual care	partner delivered meds	patient told to refer her partner for treatment
usual care	field intervention	patient told to refer her partner for treatment
partner delivered	partner delivered meds	patient given medication to deliver to her partners
partner delivered	field intervention	patient given medication to deliver to her partners
field intervention	field intervention	field intervention to find partners

Primary Outcome Measures

Name	Time	Method
recurrence of trichomonas in the index patient	6 weeks

Trial Locations

Locations (1)

Jefferson County Department of Health STD Clinic; 🇺🇸 Birmingham, Alabama, United States