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DNA Clearance of Uncomplicated Trichomonas Vaginalis Infections in HIV Negative Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01874158
First Posted: June 10, 2013
Last Update Posted: December 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Louisiana State University Health Sciences Center in New Orleans
Information provided by (Responsible Party):
Patricia Kissinger, Tulane University Health Sciences Center
  Purpose
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.

Condition Phase
Trichomonas Vaginitis Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: DNA Clearance of Uncomplicated Trichomonas Vaginalis Infections in HIV Negative Women

Resource links provided by NLM:


Further study details as provided by Patricia Kissinger, Tulane University Health Sciences Center:

Primary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples With DNA

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.


Enrollment: 99
Study Start Date: November 2012
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
TV postive women
All women who are TV positive by wet prep or in-pouch and meet the inclusion exclusion requirements.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
English speaking HIV- women over the age of 18 who are TV positive
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • HIV+ women
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01874158


Locations
United States, Louisiana
Delgado Personal Health Center
New Orleans, Louisiana, United States, 70112
Sponsors and Collaborators
Tulane University Health Sciences Center
Louisiana State University Health Sciences Center in New Orleans
Investigators
Principal Investigator: Patricia J Kissinger, PhD Tulane University School of Public Health and Tropical Medicine
  More Information

Responsible Party: Patricia Kissinger, Professor, Tulane University Health Sciences Center
ClinicalTrials.gov Identifier: NCT01874158     History of Changes
Other Study ID Numbers: 8115
First Submitted: June 6, 2013
First Posted: June 10, 2013
Last Update Posted: December 19, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Patricia Kissinger, Tulane University Health Sciences Center:
Trichomonas vaginalis

Additional relevant MeSH terms:
Vaginitis
Trichomonas Infections
Trichomonas Vaginitis
Vaginal Diseases
Genital Diseases, Female
Protozoan Infections
Parasitic Diseases


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