DNA Clearance of Uncomplicated Trichomonas Vaginalis Infections in HIV Negative Women

Completed

• Conditions: Trichomonas Vaginitis

• Registration Number: NCT01874158
• Lead Sponsor: Tulane University Health Sciences Center

Brief Summary

The objective of this study is to screen treated Trichomonas vaginalis (TV) positive women weekly using culture and Polymerase Chain Reaction (PCR) to determine how long TV DNA is detectable post treatment and to examine potential confounders to clearance such as bacterial vaginosis.

Detailed Description

Trichomonas vaginalis (TV), the most common sexually transmitted infection in the world, is associated with inflammation of the vagina, cervix, and urethra; low birth weight; preterm delivery; pelvic inflammatory disease; and may increase the risk of acquiring and transmitting genital herpes and HIV. Repeat infections are common, ranging from 5% - 31%, and have similar health outcomes as primary infections. Given the high prevalence of TV, the absence of a national screening program, the deleterious reproductive outcomes associated with TV and the potential for a TV infection to increase HIV transmission, reducing repeat TV infections is an important targeted public health approach. However, rescreening for TV should not happen until there is sufficient time for the parasites and DNA to clear from the vaginal cavity after treatment. HIV negative women who attend Delgado Personal Health Center will be asked to enroll in the screening component in order to test them for TV using InPouch culture along with the standard TV screening of wet preparation. The objective of this study is to screen treated TV positive women weekly using culture and Polymerase Chain Reaction to determine how long TV DNA is detectable post treatment and to examine potential confounders to clearance such as bacterial vaginosis. The outcome of interest will be a negative PCR result indicating that TV DNA has cleared.

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-06-06
• Study First Submitted QC: 2013-06-07
• Study First Posted: 2013-06-10
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-16
• Last Update Posted: 2016-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 99

Inclusion Criteria

• English speaking females
• >18 years old
• HIV-negative
• a patient at the Delgado Personal Health Center

Exclusion Criteria

• HIV+ women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TV negative by PCR, post treatment	4 weeks	Women are assessed for TV at each weekly visit by PCR. They are considered cleared of the remnant DNA after PCR is negative.

Trial Locations

Locations (1)

Delgado Personal Health Center; 🇺🇸 New Orleans, Louisiana, United States