Trichomonas Vaginalis Repeat Infections Among HIV Negative Women

Phase 3

Completed

• Conditions: Vaginitis Trichomonal or Due to Trichomonas
• Interventions: Drug: MTZ 2 g; Drug: MTZ 500 mg twice daily x 7 days

• Registration Number: NCT01832480
• Lead Sponsor: Tulane University Health Sciences Center

Brief Summary

The overall goal of this project is to determine the influence of patient treatment and host factors on repeat Trichomonas vaginalis (TV) infections among HIV-negative women

Detailed Description

This study is a phase III randomized clinical trial. HIV-negative women who test positive for TV at their routine gynecological exam at participating clinics will be referred to the nurse/study coordinator to screen for eligibility, provide a description of the study, and obtain written, informed consent (N=700). Subjects will undergo an audio computer assisted self- interview (ACASI), and will self-collect vaginal swabs for Trichomonas testing by InPouch and Nucleic Acid Amplification Test (NAAT), Gram stain testing, and a future microbiome specimen. They will be randomized into one of two arms; metronidazole (MTZ) 2 g single dose (CDC recommended treatment regimen) or MTZ 500 mg twice daily x 7-day dose (CDC alternative treatment regimen). All enrolled women will be scheduled for a follow-up visit at four weeks post treatment completion (window 3-13 weeks).

Study Timeline

• Study First Submitted: 2013-04-04
• Study First Submitted QC: 2013-04-11
• Study First Posted: 2013-04-16
• Study Start: 2014-10-06
• Primary Completion: 2017-06-05
• Study Completion: 2017-06-05
• Results First Submitted: 2018-09-10
• Status Verified: 2019-01
• Results First Submitted QC: 2019-01-22
• Last Update Submitted: 2019-01-22
• Results First Posted: 2019-02-12
• Last Update Posted: 2019-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 623

Inclusion Criteria

• female
• English speaking
• >= 18 years old

Exclusion Criteria

• HIV-infected
• unable to provide informed consent
• pregnant
• breast feeding
• treated by their provider for Bacterial vaginosis (BV) at visit

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MTZ 2 g	MTZ 2 g	Single dose MTZ
MTZ 500 mg twice daily x 7 days	MTZ 500 mg twice daily x 7 days	Multi dose MTZ

Primary Outcome Measures

Name	Time	Method
Number of Subjects That Were Trichomonas Vaginalis (TV) Positive After Treatment With Metronidazole (MTZ)	4 weeks post treatment completion	Presence of TV is assessed by nucleic acid amplification test (NAAT) of vaginal swab collected 4 weeks post treatment completion.

Trial Locations

Locations (3)

CrescentCare Health and Wellness Center; 🇺🇸 New Orleans, Louisiana, United States

Jefferson County Dept of Health/STD Specialty Clinic; 🇺🇸 Birmingham, Alabama, United States

Crossroads Clinic; 🇺🇸 Jackson, Mississippi, United States