Trichomonas Vaginalis Repeat Infections Among HIV Negative Women
NCT ID: NCT01832480
Last Updated: 2019-02-12
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
623 participants
INTERVENTIONAL
2014-10-06
2017-06-05
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Trichomonas Vaginalis Recurrence Among HIV+ Women
NCT01018095
DNA Clearance of Uncomplicated Trichomonas Vaginalis Infections in HIV Negative Women
NCT01874158
A Validation Study of Genzyme Diagnostics OSOM Trichomonas Rapid Test and BVBlue Test
NCT00682851
Clinical Evaluation of the Click Sexual Health Test for the Detection of Neisseria Gonorrhoeae (NG), Trichomonas Vaginalis (TV), and Chlamydia Trachomatis (CT) in Women
NCT04098900
Bacterial Vaginosis Home Screening to Prevent STDs
NCT00667368
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
MTZ 2 g
Single dose MTZ
MTZ 2 g
MTZ 2 g
MTZ 500 mg twice daily x 7 days
Multi dose MTZ
MTZ 500 mg twice daily x 7 days
MTZ 500 mg twice daily x 7 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MTZ 500 mg twice daily x 7 days
MTZ 500 mg twice daily x 7 days
MTZ 2 g
MTZ 2 g
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* English speaking
* \>= 18 years old
Exclusion Criteria
* unable to provide informed consent
* pregnant
* breast feeding
* treated by their provider for Bacterial vaginosis (BV) at visit
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tulane University Health Sciences Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Patricia Kissinger
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Patricia Kissinger, MD
Role: PRINCIPAL_INVESTIGATOR
Tulane Univeristy
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Jefferson County Dept of Health/STD Specialty Clinic
Birmingham, Alabama, United States
CrescentCare Health and Wellness Center
New Orleans, Louisiana, United States
Crossroads Clinic
Jackson, Mississippi, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Kissinger P, Amedee A, Clark RA, Dumestre J, Theall KP, Myers L, Hagensee ME, Farley TA, Martin DH. Trichomonas vaginalis treatment reduces vaginal HIV-1 shedding. Sex Transm Dis. 2009 Jan;36(1):11-6. doi: 10.1097/OLQ.0b013e318186decf.
Kissinger P, Secor WE, Leichliter JS, Clark RA, Schmidt N, Curtin E, Martin DH. Early repeated infections with Trichomonas vaginalis among HIV-positive and HIV-negative women. Clin Infect Dis. 2008 Apr 1;46(7):994-9. doi: 10.1086/529149.
Kissinger P, Schmidt N, Mohammed H, Leichliter JS, Gift TL, Meadors B, Sanders C, Farley TA. Patient-delivered partner treatment for Trichomonas vaginalis infection: a randomized controlled trial. Sex Transm Dis. 2006 Jul;33(7):445-50. doi: 10.1097/01.olq.0000204511.84485.4c.
Kissinger P, Mena L, Levison J, Clark RA, Gatski M, Henderson H, Schmidt N, Rosenthal SL, Myers L, Martin DH. A randomized treatment trial: single versus 7-day dose of metronidazole for the treatment of Trichomonas vaginalis among HIV-infected women. J Acquir Immune Defic Syndr. 2010 Dec 15;55(5):565-71. doi: 10.1097/QAI.0b013e3181eda955.
Howe K, Kissinger PJ. Single-Dose Compared With Multidose Metronidazole for the Treatment of Trichomoniasis in Women: A Meta-Analysis. Sex Transm Dis. 2017 Jan;44(1):29-34. doi: 10.1097/OLQ.0000000000000537.
Meites E, Gaydos CA, Hobbs MM, Kissinger P, Nyirjesy P, Schwebke JR, Secor WE, Sobel JD, Workowski KA. A Review of Evidence-Based Care of Symptomatic Trichomoniasis and Asymptomatic Trichomonas vaginalis Infections. Clin Infect Dis. 2015 Dec 15;61 Suppl 8(Suppl 8):S837-48. doi: 10.1093/cid/civ738.
Kissinger P. Trichomonas vaginalis: a review of epidemiologic, clinical and treatment issues. BMC Infect Dis. 2015 Aug 5;15:307. doi: 10.1186/s12879-015-1055-0.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
4042013
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.