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Trichomoniasis: Genotype and Phenotype Correlations in African American Women

This study is currently recruiting participants.
Verified April 2012 by University of Mississippi Medical Center
Sponsor:
Collaborator:
Mississippi State Department of Health
Information provided by (Responsible Party):
University of Mississippi Medical Center
ClinicalTrials.gov Identifier:
NCT00998530
First received: October 13, 2009
Last updated: April 11, 2012
Last verified: April 2012
History of Changes
  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:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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 2012
Estimated Primary Completion Date: December 2012 (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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00998530

Contacts
Contact: John C Meade, PhD (601) 984-1914 jmeade@umc.edu
Contact: Jermaine E Gray, MD (601) 984-5314 jegray@umc.edu

Locations
United States, Mississippi
Women's Specialty Clinic at Mirror Lake Recruiting
Flowood, Mississippi, United States, 39232
Contact: Jermaine E Gray, MD     601-984-5314     jegray@umc.edu    
Principal Investigator: Jermaine E Gray, MD            
University Physicians Grants Ferry Recruiting
Flowood, Mississippi, United States, 39292
Contact: Jermaine E Gray, MD     601-984-5314        
Principal Investigator: Jermaine E Gray, MD            
University Physicians Jackson Medical Mall Recruiting
Jackson, Mississippi, United States, 39216
Contact: Jermaine E Gray, MD     601-984-5314        
Principal Investigator: Jermaine E Gray, MD            
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

No publications provided

Responsible Party: University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT00998530     History of Changes
Other Study ID Numbers: 2009-0138
Study First Received: October 13, 2009
Last Updated: April 11, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 19, 2013