Control of Trichomoniasis

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

Detailed Description
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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.

Official Title
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Control of Trichomoniasis - A Paradigm for STD Control

Conditions
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Trichomoniasis

Intervention / Treatment
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* Other: different methods of partner notification
* Other: partner delivered meds
* Other: field intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: usual care<br>patient told to refer her partner for treatment | Other: different methods of partner notification<br>* comparing patient referral, partner delivered medications and field intervention to treat sex partners<br>Other: partner delivered meds<br>* patient given meds to give to her partner<br>Other: field intervention<br>* health worker finds partners<br>|
| Active Comparator: partner delivered<br>patient given medication to deliver to her partners | Other: partner delivered meds<br>* patient given meds to give to her partner<br>Other: field intervention<br>* health worker finds partners<br>|
| Active Comparator: field intervention<br>field intervention to find partners | Other: field intervention<br>* health worker finds partners<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence of trichomonas in the index patient |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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trichomoniasis, partner notification