Trichomonas Vaginitis Clinical Trial
Official title:
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.
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. ;
Observational Model: Cohort, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00213018 -
Safety, Acceptability and Preliminary Effectiveness of Carraguard™ (PC-515) in Preventing HIV/STI Transmission
|
Phase 2 | |
| Completed |
NCT00978848 -
Non-Invasive Sexually Transmitted Disease Testing in Women Seeking Emergency Contraception or Urine Pregnancy Testing
|
N/A | |
| Active, not recruiting |
NCT06131749 -
Genital Tract Infections, the Vaginal Microbiome and Gestational Age at Birth Among Pregnant Women in South Africa
|
||
| Completed |
NCT03090802 -
MAMAS: Mentoring Adolescent Mothers at School
|
N/A | |
| Not yet recruiting |
NCT06438575 -
Point of Care Diagnosis of Vaginal Infections
|
N/A | |
| Completed |
NCT00213057 -
Safety and Acceptability of Carraguard™ Among HIV-negative Couples in Thailand
|
Phase 1 | |
| Not yet recruiting |
NCT06261840 -
Refining Treatment Options for Trichomonas Vaginalis Infection: A Comparative Analysis of Metronidazole and Secnidazole
|
Phase 4 | |
| Completed |
NCT00140764 -
Intravaginal Treatment of Disturbances of Vaginal Flora Among HIV Infected and Uninfected Women in Malawi
|
Phase 3 | |
| Completed |
NCT00213031 -
Safety, Acceptability and Preliminary Effectiveness of PC-515 for Vaginal Use as a Possible Microbicide
|
Phase 2 | |
| Active, not recruiting |
NCT05666778 -
Single Arm Trial of Menstrual Cups Among Economically Vulnerable Women to Reduce Bacterial Vaginosis and STIs
|
Phase 2 | |
| Completed |
NCT01361048 -
Neo-Penotran Forte Vaginal Suppository for Vaginal Trichomoniasis
|
Phase 2 | |
| Completed |
NCT04189744 -
The ASPIRE Trial - Aiming for Safe Pregnancies by Reducing Malaria and Infections of the Reproductive Tract
|
Phase 3 | |
| Not yet recruiting |
NCT05383521 -
Safety and Efficacy of Two Oral Tinidazole Regimens for Refractory Trichomonas Vaginitis
|
N/A | |
| Recruiting |
NCT04219605 -
Evaluation of a Rapid Microscopic Diagnostic System for Different Vaginitis Conditions
|