Trichomonas VaginitisNCT01874158
DNA Clearance of Uncomplicated Trichomonas Vaginalis Infections in HIV Negative Women
An observational study of Trichomonas Vaginitis, run by Tulane University Health Sciences Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Trichomonas Vaginitis
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: English speaking HIV- women over the age of 18 who are TV positive
Who may be able to join
- English speaking females
- >18 years old
- HIV-negative
- a patient at the Delgado Personal Health Center
Who cannot join
- HIV+ women
Trial locations and contacts
1 site in 1 country.
United States1 site
Delgado Personal Health Center
New Orleans, Louisiana, 70112
About this study
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.
Read the 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.
- Conditions
- Trichomonas Vaginitis
- Keywords
- Trichomonas vaginalis
- Medical subject headings
- Trichomonas Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| TV postive women | All women who are TV positive by wet prep or in-pouch and meet the inclusion exclusion requirements. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2013 (estimated)
- Study startNov 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trichomonas VaginitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tulane University Health Sciences Center
- Sponsor type
- University, hospital or other
- Collaborators
- Louisiana State University Health Sciences Center in New Orleans
- Responsible party
- Principal investigator, Patricia Kissinger, Tulane University Health Sciences Center
- Investigators
- Patricia J Kissinger, PhD, Principal investigator, Tulane University School of Public Health and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01874158
- Sponsor's protocol ID
- 8115
- Status last verified
- Dec 2016
- First submitted
- 6 Jun 2013
- Last updated
- 19 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DNA Clearance of Uncomplicated Trichomonas Vaginalis Infections in HIV Negative Women
- ClinicalTrials.gov ID
- NCT01874158
- Acronym / sponsor ID
- 8115
- Conditions
- Trichomonas Vaginitis
- Keywords
- Trichomonas vaginalis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Tulane University Health Sciences CenterUniversity, hospital or other
- Collaborators
- Louisiana State University Health Sciences Center in New Orleans
- Study start
- Nov 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 10 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TV postive women | – | –All women who are TV positive by wet prep or in-pouch and meet the inclusion exclusion requirements. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- English speaking HIV- women over the age of 18 who are TV positive
Key inclusion criteria (4 listed)
- English speaking females
- >18 years old
- HIV-negative
- a patient at the Delgado Personal Health Center
Key exclusion criteria (1 listed)
- HIV+ women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2016.
- Individual participant dataSharing planned: No
Related trials for Trichomonas Vaginitis
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Refining Treatment Options for Trichomonas Vaginalis Infection: A Comparative Analysis of Metronidazole and Secnidazole
Trichomonas Vaginitis, Bacterial Vaginitis
Active, not recruiting
Point-of-care Tests for Vaginal Discharge in Nepal
Vaginal Discharge, Sexually Transmitted Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia J Kissinger, PhD principal investigator
Tulane University School of Public Health and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trichomonas Vaginitis, run by Tulane University Health Sciences Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TV negative by PCR, post treatment (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2016.