Control of Trichomoniasis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

599 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2008-05-31

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

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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.

Conditions

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Trichomoniasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

different methods of partner notification

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

Intervention Type OTHER

partner delivered meds

patient given meds to give to her partner

Intervention Type OTHER

field intervention

health worker finds partners

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

\-

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No