Validity of Patient-Collected Wet Mounts

NCT02641717 | Completed

• 1 other identifier: HSC20150468H
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaginal Discharge; Trichomonas; Candidiasis; Vaginosis, Bacterial; Vaginitis

Keywords

patient-collected; self-collected; vaginitis; vaginosis, bacterial; candidiasis; trichomonas; vaginal discharge

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

Study Arms (1)

All subjects

EXPERIMENTAL

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

Interventions

vaginal swab OTHER

All subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• minors \<18 yo
• pregnant

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

San Antonio Metropolitan Health District

San Antonio, Texas, 78205, United States

Location

Related Publications (2)

• 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.

  PMID: 21160459 BACKGROUND

• 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.

  PMID: 24391200 BACKGROUND

MeSH Terms

Conditions

Vaginal Discharge; Trichomonas Infections; Candidiasis; Vaginosis, Bacterial; Vaginitis

Condition Hierarchy (Ancestors)

Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Protozoan Infections; Parasitic Diseases; Infections; Mycoses; Bacterial Infections and Mycoses; Bacterial Infections

Study Officials

• Junda Woo, MD, MPH

  San Antonio Metropolitan Health District

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2015
• First Posted: December 29, 2015
• Study Start: November 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: August 1, 2016
• Last Updated: August 26, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)