Accuracy and Acceptability of Self-Diagnostic Methods for Vaginitis in Adolescent Females
Taking Charge of my Health: A Trial to Investigate the Accuracy and Acceptability of Self-Diagnostic Methods for Vaginitis in Adolescent Females
1 other identifier
interventional
300
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2006
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 25, 2008
CompletedFirst Posted
Study publicly available on registry
June 27, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedJune 27, 2008
May 1, 2008
3.5 years
June 25, 2008
June 25, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sensitivity of self performed rapid trichomonas tests
Throughout study
Secondary Outcomes (1)
Acceptability of self testing for trichomonas
Throughout study
Study Arms (2)
1
EXPERIMENTALParticipants 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
2
EXPERIMENTALParticipants 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
Interventions
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.
Eligibility Criteria
You may qualify if:
- Sexual intercourse in the last 6 months
- Agree to perform self-testing
- Agree to pelvic examination
You may not qualify if:
- Have taken antibiotics used to treat vaginal infections in the 2 weeks prior to study entry or have used vaginal creams or medications in the 2 weeks prior to study entry
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Related Publications (1)
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.
PMID: 17578778BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jill S Huppert, MD, MPH
Children's Hospital Medical Center, Cincinnati
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
Study Record Dates
First Submitted
June 25, 2008
First Posted
June 27, 2008
Study Start
April 1, 2006
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
June 27, 2008
Record last verified: 2008-05