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Trichomoniasis: Genotype and Phenotype Correlations in African American Women

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00998530
First Posted: October 20, 2009
Last Update Posted: May 9, 2017
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:
Mississippi State Department of Health
Information provided by (Responsible Party):
University of Mississippi Medical Center
  Purpose
The hypothesis to be tested in this trial is that the different epidemiologic (including racial differences) and phenotypic manifestations exhibited by Trichomonas clinical isolates during infection are correlated with their genotypic strain classification. Two specific aims are proposed to test that hypothesis. Specific aim 1. Assess the significance of genotypic or phenotypic differences in the Trichomonas strains among African American women by HIV status. Specific aim 2. Determine the significance of genotypic or phenotypic differences in the Trichomonas strains circulating among women from two different racial groups, African American women and Caucasian women. The overall goals of these specific aims are to identify racial differences in the genotypic and phenotypic characteristics of Trichomonas strains, and to develop the ability to identify and classify Trichomonas infections in order to prioritize treatment and epidemiologic follow-up of individuals infected with isolates associated with adverse clinical outcomes (HIV transmission or acquisition, pregnancy complications, virulence, or drug resistance).

Condition
Trichomonas Infections

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Trichomoniasis: Genotype and Phenotype Correlations in African American Women

Resource links provided by NLM:


Further study details as provided by University of Mississippi Medical Center:

Primary Outcome Measures:
  • Correlation of Trichomonas genotype with clinical symptoms, HIV status and patient race. [ Time Frame: Single visit ]
    Trichomonas vaginalis isolates will be genotyped using Multilocus sequence typing (MLST) and the isolate genotypes will be assessed for correlations with clinical manifestations, drug resistance, HIV status, and demographic patient information.


Biospecimen Retention:   Samples With DNA
Trichomonas vaginalis clinical isolates

Estimated Enrollment: 320
Study Start Date: September 2009
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
African American HIV+
African American women with HIV and infected with Trichomonas
Caucasian HIV-
Caucasian women who are HIV negative and infected with Trichomonas
African American HIV-
African American women who are HIV negative and are infected with Trichomonas

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting to clinic sites with symptoms of a sexually transmitted disease
Criteria

Inclusion Criteria:

  • Trichomonas infection

Exclusion Criteria:

  • pregnancy
  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): NCT00998530


Locations
United States, Mississippi
Women's Specialty Clinic at Mirror Lake
Flowood, Mississippi, United States, 39232
University Physicians Grants Ferry
Flowood, Mississippi, United States, 39292
Crossroads Clinics
Jackson, Mississippi, United States, 39216
University Physicians Jackson Medical Mall
Jackson, Mississippi, United States, 39216
Sponsors and Collaborators
University of Mississippi Medical Center
Mississippi State Department of Health
Investigators
Principal Investigator: John C Meade, PhD University of Mississippi Medical Center
  More Information

Responsible Party: University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT00998530     History of Changes
Other Study ID Numbers: 2009-0138
First Submitted: October 13, 2009
First Posted: October 20, 2009
Last Update Posted: May 9, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared with other investigators upon completion of the study and journal acceptance of manuscripts detailing study results. Data may be accessed by contacting Dr. Meade

Keywords provided by University of Mississippi Medical Center:
Trichomonas vaginalis
trichomoniasis
MLST
Multilocus sequence typing

Additional relevant MeSH terms:
Trichomonas Infections
Protozoan Infections
Parasitic Diseases