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Completed

NCT Number: NCT01832480

Trichomonas Vaginalis Repeat Infections Among HIV Negative Women

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

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Key information

Conditions

Vaginitis Trichomonal or Due to Trichomonas Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Parasitic Diseases Protozoan Infections Trichomonas Infections Trichomonas Vaginitis Urogenital Diseases Vaginal Diseases Vaginitis

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

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

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MTZ 500 mg twice daily x 7 days

Drug

MTZ 500 mg twice daily x 7 days

Other names: Multi-dose MTZ

MTZ 2 g

Drug

MTZ 2 g

Other names: Single dose MTZ

Primary outcomes

  1. Number of Subjects That Were Trichomonas Vaginalis (TV) Positive After Treatment With Metronidazole (MTZ)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tulane University Health Sciences Center

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Apr 16, 2013
Registry last updated
Feb 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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