NCT00334555

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
599

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

June 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 8, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

August 12, 2009

Status Verified

August 1, 2009

Enrollment Period

5 years

First QC Date

June 7, 2006

Last Update Submit

August 11, 2009

Conditions

Trichomoniasis

Keywords

trichomoniasispartner notification

Outcome Measures

Primary Outcomes (1)

  • recurrence of trichomonas in the index patient

    6 weeks

Study Arms (3)

usual care

ACTIVE COMPARATOR

patient told to refer her partner for treatment

Other: different methods of partner notificationOther: partner delivered medsOther: field intervention

partner delivered

ACTIVE COMPARATOR

patient given medication to deliver to her partners

Other: partner delivered medsOther: field intervention

field intervention

ACTIVE COMPARATOR

field intervention to find partners

Other: field intervention

Interventions

different methods of partner notificationOTHER

comparing patient referral, partner delivered medications and field intervention to treat sex partners

usual care
partner delivered medsOTHER

patient given meds to give to her partner

partner deliveredusual care
field interventionOTHER

health worker finds partners

field interventionpartner deliveredusual care

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age {\> 15 years} Culture or wet prep proven T. vaginalis infection Willingness to provide informed consent and take part in study procedures

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jefferson County Department of Health STD Clinic

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Trichomonas Infections

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfections

Study Officials

  • Jane Schwebke, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 7, 2006

First Posted

June 8, 2006

Study Start

May 1, 2003

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

August 12, 2009

Record last verified: 2009-08

Locations

US(1)