DNA Clearance of Uncomplicated Trichomonas Vaginalis Infections in HIV Negative Women

This study has been completed.
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 20, 2014
Last verified: June 2014
  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 Tulane University Health Sciences Center:

Primary Outcome Measures:
  • 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.


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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01874158

Locations
United States, Alabama
Jefferson County Health Department
Birmingham, Alabama, United States, 35233
United States, Louisiana
Delgado Personal Health Center
New Orleans, Louisiana, United States, 70112
United States, Mississippi
Crossroads Clinic
Jackson, Mississippi, United States, 39213
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

No publications provided

Responsible Party: Patricia Kissinger, Professor, Tulane University Health Sciences Center
ClinicalTrials.gov Identifier: NCT01874158     History of Changes
Other Study ID Numbers: 8115
Study First Received: June 6, 2013
Last Updated: June 20, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Tulane University Health Sciences Center:
Trichomonas vaginalis

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

ClinicalTrials.gov processed this record on August 20, 2014