Ignite Creation Date:
2024-05-06 @ 7:59 AM
Last Modification Date:
2024-10-26 @ 11:54 AM
Study NCT ID:
NCT02641717
Status:
COMPLETED
Last Update Posted:
2016-08-26
First Post:
2015-12-08
Brief Title:
Validity of Patient-Collected Wet Mounts
Sponsor:
The University of Texas Health Science Center at San Antonio
Organization:
The University of Texas Health Science Center at San Antonio
Study Overview
Official Title:
Validity of Patient-Collected Wet Mounts
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
PurposeObjectives 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 DesignPlan Prospective non-randomized non-blinded trial
Methods Obtain informed consent and specimens from 40 symptomatic adult females eg abnormal discharge odor andor 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
Research DesignPlan Prospective non-randomized non-blinded trial
Methods Obtain informed consent and specimens from 40 symptomatic adult females eg abnormal discharge odor andor 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 patients 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
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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None