Taking Charge of my Health: A Trial to Investigate the Accuracy and Acceptability of Self-Diagnostic Methods for Vaginitis in Adolescent Females
Sponsor study identifier
NIH
Secondary identifiers
NIH
interventional
300
1 country
1
Study Start
April 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Symptoms of vaginitis are common among adolescent females, although studies have shown that neither experienced clinicians nor patients can accurately diagnose the cause of vaginitis based on symptoms alone. The purpose of this study is to investigate the accuracy and acceptability of self-diagnostic methods for vaginitis in adolescent females.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2006
Date type not reportedThis date has not been verified as actual or estimated.
June 25, 2008
Actual (reported)June 27, 2008
Actual (reported)October 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Sensitivity of self performed rapid trichomonas tests
Throughout study
Acceptability of self testing for trichomonas
Throughout study
Participants in this group will perform self-tests for the first half of the study and will have clinical examinations for the second half of the study
Participants in this group will have clinical examinations for the first half of the study and will perform self-tests for the second half of the study
Several point-of-care tests are offered: OSOM TV rapid trichomonas test; OSOM BV Blue rapid test; pHEMalert vaginal pH test. All subjects receive the OSOM TV test, while the other two are optional.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Huppert JS, Mortensen JE, Reed JL, Kahn JA, Rich KD, Miller WC, Hobbs MM. Rapid antigen testing compares favorably with transcription-mediated amplification assay for the detection of Trichomonas vaginalis in young women. Clin Infect Dis. 2007 Jul 15;45(2):194-8. doi: 10.1086/518851. Epub 2007 Jun 6.
Jill S Huppert, MD, MPH
Children's Hospital Medical Center, Cincinnati
First Submitted
June 25, 2008
First Posted
June 27, 2008
Study Start
April 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2009
Estimated (date passed)Clinical Study of STI Screening to Prevent Adverse Birth and New-born Outcomes (Philani Ndiphile)
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 27, 2008
Record last verified: 2008-05
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Source: ClinicalTrials.gov.
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