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DNA Clearance of Uncomplicated Trichomonas Vaginalis Infections in HIV Negative Women

Sponsor
Tulane University Health Sciences Center (Other)
Overall Status
Completed
CT.gov ID
NCT01874158
Collaborator
Louisiana State University Health Sciences Center in New Orleans (Other)
99
Enrollment
1
Location
17
Duration (Months)
5.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    99 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    DNA Clearance of Uncomplicated Trichomonas Vaginalis Infections in HIV Negative Women
    Study Start Date :
    Nov 1, 2012
    Actual Primary Completion Date :
    Apr 1, 2014
    Actual Study Completion Date :
    Apr 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    TV postive women

    All women who are TV positive by wet prep or in-pouch and meet the inclusion exclusion requirements.

    Outcome Measures

    Primary Outcome Measures

    1. TV negative by PCR, post treatment [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Patricia Kissinger, Professor, Tulane University Health Sciences Center
    ClinicalTrials.gov Identifier:
    NCT01874158
    Other Study ID Numbers:
    • 8115
    First Posted:
    Jun 10, 2013
    Last Update Posted:
    Dec 19, 2016
    Last Verified:
    Dec 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Patricia Kissinger, Professor, Tulane University Health Sciences Center
    Trichomonas vaginalis
    Additional relevant MeSH terms:
    Trichomonas Infections
    Trichomonas Vaginitis
    Vaginitis

    Study Results

    No Results Posted as of Dec 19, 2016