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OpenTrials
Completed

NCT Number: NCT01874158

DNA Clearance of Uncomplicated Trichomonas Vaginalis Infections in HIV Negative Women

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Delgado Personal Health Center

New Orleans, Louisiana, 70112, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • HIV+ women

Treatment and study plan

Primary outcomes

  1. TV negative by PCR, post treatment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tulane University Health Sciences Center

Other

Collaborators

  • Louisiana State University Health Sciences Center in New Orleans

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 10, 2013
Registry last updated
Dec 19, 2016

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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