Trichomoniasis: Genotype and Phenotype Correlations in African American Women

NCT00998530 | Completed

• 1 other identifier: 2009-0138
• Study Type: observational
• Target: 231
• Locations: 1 country
• Sites: 4

Brief Summary

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).

Conditions

Trichomonas Infections

Keywords

Trichomonas vaginalis; trichomoniasis; MLST; Multilocus sequence typing

Outcome Measures

Primary Outcomes (1)

• Correlation of Trichomonas genotype with clinical symptoms, HIV status and patient race.

  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.

  Single visit

Study Arms (3)

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 Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to clinic sites with symptoms of a sexually transmitted disease

You may qualify if:

• Trichomonas infection

You may not qualify if:

• pregnancy

Sponsors & Collaborators

• University of Mississippi Medical Center: lead
• Mississippi State Department of Health: collaborator

Study Sites (4)

Women's Specialty Clinic at Mirror Lake

Flowood, Mississippi, 39232, United States

Location

University Physicians Grants Ferry

Flowood, Mississippi, 39292, United States

Location

Crossroads Clinics

Jackson, Mississippi, 39216, United States

Location

University Physicians Jackson Medical Mall

Jackson, Mississippi, 39216, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Trichomonas vaginalis clinical isolates

MeSH Terms

Conditions

Trichomonas Infections

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections

Study Officials

• John C Meade, PhD

  University of Mississippi Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2009
• First Posted: October 20, 2009
• Study Start: September 1, 2009
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: May 23, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share

Locations

US (4)