DNA Clearance of Uncomplicated Trichomonas Vaginalis Infections in HIV Negative Women
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||DNA Clearance of Uncomplicated Trichomonas Vaginalis Infections in HIV Negative Women|
- TV negative by PCR, post treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]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.
|Study Start Date:||November 2012|
|Study Completion Date:||April 2014|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
TV postive women
All women who are TV positive by wet prep or in-pouch and meet the inclusion exclusion requirements.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01874158
|United States, Alabama|
|Jefferson County Health Department|
|Birmingham, Alabama, United States, 35233|
|United States, Louisiana|
|Delgado Personal Health Center|
|New Orleans, Louisiana, United States, 70112|
|United States, Mississippi|
|Jackson, Mississippi, United States, 39213|
|Principal Investigator:||Patricia J Kissinger, PhD||Tulane University School of Public Health and Tropical Medicine|