Validity of Patient-Collected Wet Mounts
Primary Purpose
Vaginal Discharge, Trichomonas, Candidiasis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
vaginal swab
Sponsored by
About this trial
This is an interventional diagnostic trial for Vaginal Discharge focused on measuring patient-collected, self-collected, vaginitis, vaginosis, bacterial, candidiasis, trichomonas, vaginal discharge
Eligibility Criteria
Inclusion Criteria:
- adult,
- nonpregnant
- females
- with vaginal complaint (ie abnormal discharge, odor, itching)
Exclusion Criteria:
- minors <18 yo
- pregnant
Sites / Locations
- San Antonio Metropolitan Health District
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
All subjects
Arm Description
All patients enrolled in this study will self-collect a vaginal swab (experimental) then have a physician collected vaginal swab (gold standard)
Outcomes
Primary Outcome Measures
Concordance of patient-collected and clinician-collected wet mounts
Assess for concordance of clue cells, yeast, trichomonads and white blood cells per high-power field between patient collected vaginal swab and physician collected vaginal swab.
Secondary Outcome Measures
Full Information
NCT ID
NCT02641717
First Posted
December 8, 2015
Last Updated
August 25, 2016
Sponsor
The University of Texas Health Science Center at San Antonio
1. Study Identification
Unique Protocol Identification Number
NCT02641717
Brief Title
Validity of Patient-Collected Wet Mounts
Official Title
Validity of Patient-Collected Wet Mounts
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Purpose/Objectives: To compare wet mount findings for clue cells, yeast, trichomonads and white blood cells per high-power field in self-collected vaginal specimens, compared to clinician-collected specimens, among symptomatic women visiting the San Antonio Metropolitan Health sexually transmitted disease clinic.
Research Design/Plan: Prospective, non-randomized, non-blinded trial
Methods: Obtain informed consent and specimens from 40 symptomatic adult females (eg abnormal discharge, odor and/or itching). Calculate concordance between clinician- and patient-collected samples using a Wilcoxon Matched-Pair test. Calculate sensitivity, specificity, positive predictive value and negative predictive value of the patient-collected wet mount, using the clinician-collected specimens as the "gold standard."
Clinical Relevance: A "wet mount," or microscopic examination, is commonly used to diagnose trichomoniasis and yeast in females, and constitutes one diagnostic element for bacterial vaginosis. While patient-collected vaginal swabs are acceptable for nucleic acid probe tests for chlamydia and gonorrhea and nucleic acid probe tests for trichomoniasis little information about patient-collected wet mounts exists in the literature. Self-collection by women before being seen by a clinician can increase the speed and efficiency of the visit. The method is highly acceptable to women. In the investigators' clinic, women routinely collect their own gonorrhea and chlamydia swabs, so adding an additional swab would not be burdensome.
Detailed Description
Studies have shown that self-collection of vaginal swabs is highly acceptable to women. Studies have also shown that patient-collected vaginal swabs are acceptable for nucleic acid probe tests for chlamydia and gonorrhea and nucleic acid probe tests for trichomoniasis; however, little information about patient-collected wet mounts exists in the literature.
The investigators' goal is to compare wet mount findings for clue cells, yeast, trichomonads and white blood cells per high-power field in self-collected vaginal specimens, compared to clinician-collected specimens, among symptomatic women visiting the San Antonio Metropolitan Health sexually transmitted disease clinic. Self-collection by women before being seen by a clinician can increase the speed and efficiency of the visit. In the investigators' clinic, women routinely collect their own gonorrhea and chlamydia swabs, so adding an additional swab would not be burdensome. Based on the reliability of patient-collected swabs for nucleic amplification tests, it is expected that patient-collected wet mounts could be as valid as conventionally collected samples.
Step-by-Step Methods: Potential study participants as described above will be approached by research staff while in the waiting area. If a patient provides informed consent, she will self-collect a wet mount specimen by inserting a cotton-tip swab in the vagina about 2 inches and rotating for 10-30 seconds; later, her clinician will collect a second specimen from the vaginal fornix and place it in a red-top tube with a small amount of normal saline. The clinician-collected sample will be labeled with the patient's identifying information and processed in the usual way by laboratory staff, with results recorded in electronic medical records. The patient-collected sample will be identified by a number only, and results recorded in a study log. The study is complete when the results of 40 patient- and clinician-collected swabs are recorded.
Data Analysis Plan: Concordance between clinician- and patient-collected samples will be calculated using a Wilcoxon Matched-Pair test. Sensitivity, specificity, positive predictive value and negative predictive value of the patient-collected wet mount will also be calculated, using the clinician-collected specimens as the "gold standard."
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Discharge, Trichomonas, Candidiasis, Vaginosis, Bacterial, Vaginitis
Keywords
patient-collected, self-collected, vaginitis, vaginosis, bacterial, candidiasis, trichomonas, vaginal discharge
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
All subjects
Arm Type
Experimental
Arm Description
All patients enrolled in this study will self-collect a vaginal swab (experimental) then have a physician collected vaginal swab (gold standard)
Intervention Type
Other
Intervention Name(s)
vaginal swab
Primary Outcome Measure Information:
Title
Concordance of patient-collected and clinician-collected wet mounts
Description
Assess for concordance of clue cells, yeast, trichomonads and white blood cells per high-power field between patient collected vaginal swab and physician collected vaginal swab.
Time Frame
to be reviewed immediately at time of collection, documented and specimens discarded. No ongoing comparison, this will only be a single point in time comparison between the physician collected specimen and the patient collected specimen.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
adult,
nonpregnant
females
with vaginal complaint (ie abnormal discharge, odor, itching)
Exclusion Criteria:
minors <18 yo
pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junda Woo, MD, MPH
Organizational Affiliation
San Antonio Metropolitan Health District
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Antonio Metropolitan Health District
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21160459
Citation
Workowski KA, Berman S; Centers for Disease Control and Prevention (CDC). Sexually transmitted diseases treatment guidelines, 2010. MMWR Recomm Rep. 2010 Dec 17;59(RR-12):1-110. Erratum In: MMWR Recomm Rep. 2011 Jan 14;60(1):18. Dosage error in article text.
Results Reference
background
PubMed Identifier
24391200
Citation
Van Der Pol B, Williams JA, Taylor SN, Cammarata CL, Rivers CA, Body BA, Nye M, Fuller D, Schwebke JR, Barnes M, Gaydos CA. Detection of Trichomonas vaginalis DNA by use of self-obtained vaginal swabs with the BD ProbeTec Qx assay on the BD Viper system. J Clin Microbiol. 2014 Mar;52(3):885-9. doi: 10.1128/JCM.02966-13. Epub 2014 Jan 3.
Results Reference
background
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Validity of Patient-Collected Wet Mounts
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