DNA Clearance of Uncomplicated Trichomonas Vaginalis Infections in HIV Negative Women

This study is currently recruiting participants.
Verified June 2013 by Tulane University Health Sciences Center
Sponsor:
Collaborator:
Louisiana State University Health Sciences Center in New Orleans
Information provided by (Responsible Party):
Patricia Kissinger, Tulane University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT01874158
First received: June 6, 2013
Last updated: June 7, 2013
Last verified: June 2013

June 6, 2013
June 7, 2013
November 2012
December 2016   (final data collection date for primary outcome measure)
TV negative by PCR, post treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Women are assessed for TV at each weekly visit by PCR. They are considered cleared of the remnant DNA after PCR is negative.
Same as current
Complete list of historical versions of study NCT01874158 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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DNA Clearance of Uncomplicated Trichomonas Vaginalis Infections in HIV Negative Women
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

1 vaginal swab collected at screening for In-pouch 3 vaginal swabs collected at enrollment, PCR, gram stain, and future microbiome study At each of 3 follow-up visits, 3 vaginal swabs, PCR, In-pouch, and future microbiome study At the 4th follow-up visit, 4 vaginal swabs, PCR, In-pouch, gram stain, and future microbiome study.

All swabs, except at screening, are self-collected.

Non-Probability Sample

English speaking HIV- women over the age of 18 who are TV positive

Trichomonas Vaginalis
Not Provided
TV postive women
All women who are TV positive by wet prep or in-pouch and meet the inclusion exclusion requirements.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 2017
December 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • HIV+ women
Female
18 Years and older
No
Contact: Patricia Kissinger, PhD kissing@tulane.edu
Contact: Norine Schmidt, MPH nschmid1@tulane.edu
United States
 
NCT01874158
8115
Yes
Patricia Kissinger, Tulane University Health Sciences Center
Tulane University Health Sciences Center
Louisiana State University Health Sciences Center in New Orleans
Principal Investigator: Patricia J Kissinger, PhD Tulane University School of Public Health and Tropical Medicine
Tulane University Health Sciences Center
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP