DNA Clearance of Uncomplicated Trichomonas Vaginalis Infections in HIV Negative Women

Trichomonas Vaginitis Clinical Trial

Official title:

DNA Clearance of Uncomplicated Trichomonas Vaginalis Infections in HIV Negative Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01874158
• Other study ID #: 8115
• Status: Completed
• Phase: Phase 4
• First received: June 6, 2013
• Last updated: December 16, 2016
• Start date: November 2012
• Est. completion date: April 2014

Study information

• Verified date: December 2016
• Source: Tulane University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• English speaking females

• >18 years old

• HIV-negative

• a patient at the Delgado Personal Health Center

Exclusion Criteria:

• HIV+ women

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Trichomonas Infections
• Trichomonas Vaginitis
• Vaginitis

Locations

Country	Name	City	State
United States	Delgado Personal Health Center	New Orleans	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Tulane University Health Sciences Center	Louisiana State University Health Sciences Center in New Orleans

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TV negative by PCR, post treatment	Women are assessed for TV at each weekly visit by PCR. They are considered cleared of the remnant DNA after PCR is negative.	4 weeks	No