CClinicalTrials.gg
CompletedNCT00334555Updated Aug 12, 2009

Control of Trichomoniasis

An interventional study of different methods of partner notification and partner delivered meds in Trichomoniasis, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2009-08-12.

Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
599
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Trichomoniasis

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Keywords

  • trichomoniasis
  • partner notification
03

In context

Trichomonas Infections

32 studies on the registry are indexed under Trichomonas Infections; 5 are open to participants now.

This study's enrollment of 599 is above the median of 270 across 19 interventional studies indexed under Trichomonas Infections.

Browse Trichomonas Infections studies →

Lead sponsor

University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.

Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
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

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
599 participants (actual)

Study arms

  • Active comparator
    usual care

    patient told to refer her partner for treatment

    Other: different methods of partner notification · Other: partner delivered meds · Other: field intervention

  • Active comparator
    partner delivered

    patient given medication to deliver to her partners

    Other: partner delivered meds · Other: field intervention

  • Active comparator
    field intervention

    field intervention to find partners

    Other: field intervention

Interventions

  • Otherdifferent methods of partner notification

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

  • Otherpartner delivered meds

    patient given meds to give to her partner

  • Otherfield intervention

    health worker finds partners

06

What researchers measure

Primary outcomes

  1. recurrence of trichomonas in the index patient

    Time frame: 6 weeks

07

Study locations

1 site
  • Jefferson County Department of Health STD Clinic
    Birmingham, Alabama 35294, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00334555
Lead sponsor
University of Alabama at Birmingham
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
First posted
Jun 8, 2006
Start date
May 2003
Primary completion
May 2008
Completion
May 2008
Last update
Aug 12, 2009

Study contacts

Jane Schwebke, MD
principal investigator · University of Alabama at Birmingham
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.

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