DNA Clearance of Uncomplicated Trichomonas Vaginalis Infections in HIV Negative Women
|ClinicalTrials.gov Identifier: NCT01874158|
Recruitment Status : Completed
First Posted : June 10, 2013
Last Update Posted : December 19, 2016
|Condition or disease||Phase|
|Trichomonas Vaginitis||Phase 4|
|Study Type :||Observational|
|Actual Enrollment :||99 participants|
|Official Title:||DNA Clearance of Uncomplicated Trichomonas Vaginalis Infections in HIV Negative Women|
|Study Start Date :||November 2012|
|Primary Completion Date :||April 2014|
|Study Completion Date :||April 2014|
TV postive women
All women who are TV positive by wet prep or in-pouch and meet the inclusion exclusion requirements.
- TV negative by PCR, post treatment [ Time Frame: 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01874158
|United States, Louisiana|
|Delgado Personal Health Center|
|New Orleans, Louisiana, United States, 70112|
|Principal Investigator:||Patricia J Kissinger, PhD||Tulane University School of Public Health and Tropical Medicine|