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Validity of Patient-Collected Wet Mounts

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ClinicalTrials.gov Identifier: NCT02641717
Recruitment Status : Completed
First Posted : December 29, 2015
Last Update Posted : August 26, 2016
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

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.


Condition or disease Intervention/treatment Phase
Vaginal Discharge Trichomonas Candidiasis Vaginosis, Bacterial Vaginitis Other: vaginal swab Not Applicable

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."

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Validity of Patient-Collected Wet Mounts
Study Start Date : November 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : August 2016

Arm Intervention/treatment
Experimental: All subjects
All patients enrolled in this study will self-collect a vaginal swab (experimental) then have a physician collected vaginal swab (gold standard)
Other: vaginal swab



Primary Outcome Measures :
  1. Concordance of patient-collected and clinician-collected wet mounts [ 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. ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • adult,
  • nonpregnant
  • females
  • with vaginal complaint (ie abnormal discharge, odor, itching)

Exclusion Criteria:

  • minors <18 yo
  • pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02641717


Locations
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United States, Texas
San Antonio Metropolitan Health District
San Antonio, Texas, United States, 78205
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
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Principal Investigator: Junda Woo, MD, MPH San Antonio Metropolitan Health District
Publications:
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Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT02641717    
Other Study ID Numbers: HSC20150468H
First Posted: December 29, 2015    Key Record Dates
Last Update Posted: August 26, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by The University of Texas Health Science Center at San Antonio:
patient-collected
self-collected
vaginitis
vaginosis, bacterial
candidiasis
trichomonas
vaginal discharge
Additional relevant MeSH terms:
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Candidiasis
Vaginosis, Bacterial
Trichomonas Infections
Vaginal Diseases
Vaginitis
Vaginal Discharge
Mycoses
Protozoan Infections
Parasitic Diseases
Bacterial Infections