Control of Trichomoniasis

Trichomoniasis Clinical Trial

Official title:

Control of Trichomoniasis - A Paradigm for STD Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00334555
• Other study ID #: F020508005
• Secondary ID: R01AI050718
• Status: Completed
• Phase: N/A
• First received: June 7, 2006
• Last updated: August 11, 2009
• Start date: May 2003
• Est. completion date: May 2008

Study information

• Verified date: August 2009
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This study is designed to try to find the best method of partner notification and treatment for partners of women with trichomonas

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 599
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Trichomonas Infections
• Trichomoniasis

Intervention

Other:
• different methods of partner notification
comparing patient referral, partner delivered medications and field intervention to treat sex partners
• partner delivered meds
patient given meds to give to her partner
• field intervention
health worker finds partners

Locations

Country	Name	City	State
United States	Jefferson County Department of Health STD Clinic	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrence of trichomonas in the index patient		6 weeks	No