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
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
623
MTZ 500 mg twice daily x 7 days
MTZ 2 g
Jefferson County Dept of Health/STD Specialty Clinic
Birmingham, Alabama, United States
CrescentCare Health and Wellness Center
New Orleans, Louisiana, United States
Crossroads Clinic
Jackson, Mississippi, United States
Number of Subjects That Were Trichomonas Vaginalis (TV) Positive After Treatment With Metronidazole (MTZ)
Presence of TV is assessed by nucleic acid amplification test (NAAT) of vaginal swab collected 4 weeks post treatment completion.
Time frame: 4 weeks post treatment completion
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