Point of Care Diagnosis of Vaginal Infections to Ensure Accurate Treatment: (PAT Study)
Phase: NA
Conditions: Vaginitis, Bacterial Vaginosis, Yeast Vaginitis, Trichomonas Vaginitis
Sponsor: Sharon L Hillier

Point of Care Diagnosis of Vaginal Infections to Ensure Accurate Treatment: 
(PAT Study) 
 
NCT06438575 
 
August 9, 2024 

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Point of Care Diagnosis of Vaginal Infections to Ensure Accurate Treatment: 
(PAT Study) 
 
 
 
Source of Support: 
Cepheid  
 
 
 
  
 
 
 
Principal Investigator: 
Sharon Hillier, PhD 
University of Pittsburgh 
Magee-Womens Research Institute 
Pittsburgh, PA USA 
 
 
 
 
Study Sites: 
UPMC Magee-Womens Hospital 
300 Halket Street 
Pittsburgh, PA 15213 
 
Magee-Womens Research Institute 
204 Craft Avenue, Lab A530 
Pittsburgh, PA 
 
 
 
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Table of Contents 
 
LIST OF ABBREVIATIONS AND ACRONYMS ......................................................................... 3 
PROTOCOL SUMMARY ........................................................................................................... 4 
1. 
Background ....................................................................................................................... 5 
2. 
Study Objectives ............................................................................................................... 7 
2.1 Primary Objective: ............................................................................................................ 7 
2.2 Secondary Objectives: ...................................................................................................... 7 
2.3 Exploratory Objective: ....................................................................................................... 7 
3. 
Study Population .............................................................................................................. 7 
3.1 Recruitment: ..................................................................................................................... 8 
3.2 Inclusion Criteria: .............................................................................................................. 8 
3.3 Exclusion Criteria: ............................................................................................................. 9 
3.4 Potential Risks: ................................................................................................................. 9 
4. 
Study Procedures ............................................................................................................. 9 
4.1 Arm 1: ..............................................................................................................................10 
4.2 Arm 2: ..............................................................................................................................10 
4.3 PROVIDER SUB STUDY: ...............................................................................................12 
4.4 Electronic Medical Record Abstraction: ...........................................................................13 
5. 
Specimen  Processing and Testing ................................................................................13 
5.1 Biohazard Containment ...................................................................................................14 
6. 
ASSESSMENT OF SAFETY AND CLINICAL MANAGEMENT .........................................14 
6.1 Risk Management ............................................................................................................14 
7. 
Biostatistical Data and Analysis .....................................................................................14 
7.1 Sample size calculations .................................................................................................14 
7.2 Primary Endpoint Analysis ...............................................................................................15 
7.3 Secondary and Exploratory Endpoint Analyses ...............................................................15 
8. 
Costs and Payments: .......................................................................................................15 
8.1 FUNDING ........................................................................................................................16 
9. 
REFERENCES ..................................................................................................................18 
 
 
 
 

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LIST OF ABBREVIATIONS AND ACRONYMS 
 
 
BV 
Bacterial vaginosis 
CLIA 
Clinical Laboratory Improvement Amendments 
CDC 
Center for Disease Control 
CRF 
Case Report Form 
DNA 
Deoxyribonucleic acid 
FDA 
Food and Drug Administration 
HIPAA 
Health Insurance Portability and Accountability Act 
IRB 
Institutional Review Board 
KOH 
Potassium hydroxide 
MWH 
UPMC Magee Womens Hospital 
MWRIF 
Magee-Womens Research Institute and Foundation 
NAAT 
Nucleic Acid Amplification Test 
OB/GYN 
Obstetric/gynecology(ic) 
PAT 
Point of care for Accurate Treatment 
PGIC 
Patient Global Impression of Change 
PGIS 
Patient Global Impression of Severity 
PHI 
Protected Health Information 
PTID 
Participant identifier 
POC 
Point of Care 
SDS 
Sheehan Disability Scale 
STI 
Sexually transmitted infection 
TV 
Trichomonas vaginalis 
UPMC 
University of Pittsburgh Medical Center 
US 
United States 
VVC 
Vulvovaginal candidiasis 
 
 
 
 
 
 
 
 
 
 
 

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PROTOCOL SUMMARY 
 
Short Title: 
 
      PAT (Point of care for Accurate Treatment)  
 
Principal Investigator: Sharon Hillier, PhD  
 
Sample Size: 
Approximately 300 participants 
 
Study Population:  
Individuals 14 years and older, assigned female sex at birth, who are 
seeking care at a UPMC Magee-Womens Hospital (MWH) participating 
PAT study office complaining of symptoms of vaginitis 
 
Study Duration: 
Approximately two weeks of follow-up per participant with a projected 
accrual period of approximately 12 months 
 
Study Sites: 
Obstetric/gynecologic (OB/GYN) practices/offices located within UPMC 
Magee-Womens Hospital (MWH) and outpatient centers affiliated with 
the Department of OB/GYN or MWH 
 
Study Design: 
Two arm, randomized, single center trial of usual care vs. Xpert® 
Xpress MVP (multiplex vaginal panel; Cepheid, Sunnyvale, CA) 
directed care for vaginitis diagnosis and treatment 
 
Individuals who are complaining of vaginitis symptoms and are seeking 
care at one of the PAT study participating offices/departments within or 
affiliated with MWH will be invited to participate.  In this study, the office 
visit will serve as the enrollment (index) visit.  Following informed 
consent, participants will complete a brief questionnaire and self-collect 
three vaginal swabs for three tests that are FDA-cleared for vaginitis 
diagnosis:  Xpert® Xpress MVP, BD MAX™ Vaginal Panel (Becton-
Dickinson, Franklin Lakes, NJ), and BD AffirmTM VPIII Microbial 
Identification Test (AffirmTM VPIII; Becton-Dickinson).  Participants will 
be randomized (1:1) into one of two arms after collecting swabs.     
 
In Arm 1, vaginitis diagnosis and treatment will be based on usual 
provider evaluation and treatment during the office visit.  The Xpert® 
Xpress MVP test will be batched with delayed results made available 
to the provider following the participant’s 2-week study follow-up 
telephone contact.   
 
In Arm 2, the Xpert® Xpress MVP test will be run in real time as a point 
of care (POC) test at the time of the office visit and the results will be 
made available to the provider in approximately one hour.  Providers 
will be asked to use the MVP test result for diagnosis and treatment of 
the participant.   
 

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All participants, regardless of arm, will complete a follow-up telephone 
contact approximately two weeks after their office/medical visit to 
assess symptom resolution and satisfaction.      
 
The study will include review and collection of electronic medical record 
information related to the office/medical visit (i.e., evaluation, testing, 
diagnosis and treatment). 
 
A Healthcare Provider Sub study will also be performed as part of the PAT study.  The sub study 
will include a baseline questionnaire completed by clinicians at participating offices and then a 
follow-up questionnaire administered to clinicians who were involved in the PAT study as 
described below.  The sub study will help investigators to understand how providers feel about 
POC testing for vaginitis.   
.   
 
1. Background 
Bacterial vaginosis (BV), Trichomonas vaginalis (TV) infection and vulvovaginal candidiasis 
(VVC) are common in reproductive age women.  The prevalence of BV and TV in the US are 29% 
and 3%, respectively, but can vary depending on the study population1,2.  Adverse sequelae 
associated with BV3-5 and TV7-9 include increased acquisition of sexually transmitted infections 
including HIV and pregnancy complications including preterm birth. While the prevalence of VVC 
cases is unknown, 20% of women are colonized by Candida species in the absence of signs 
and/or symptoms, and 70% are colonized over a year10.  Approximately 75% of women will 
experience at least one episode of VVC infection requiring treatment during their lifetimes11.  
 
The Centers for Disease Control (CDC) guidelines describes the point-of-care tests that can be 
performed as an adjunct to a clinical history and physical examination to support diagnosis of 
vaginal discharge syndromes12. These tests include: measurement of vaginal pH, “whiff” test 
[addition of potassium hydroxide (KOH) to vaginal fluid for assessment of amine odor], and 
microscopic examination of fresh samples of the discharge to identify presence of clue cells, 
motile trichomonads, and/or budding yeast/pseudohyphae. The sensitivity and specificity of 
microscopic detection of clue cells, yeast, and trichomonads by clinicians can vary considerably13-
14. Despite these limitations, the low cost and convenience of point-of-care testing have 
contributed to their continued use.  In a variety of studies conducted, laboratory testing (Nugent 
score, yeast culture, FDA-approved and independent molecular assays) performed better than 
clinician-diagnosed vaginitis15-17. CDC guidelines recommend use of alternative commercially 
available point-of-care tests or clinical laboratory testing in settings where pH paper, KOH, and 
wet prep evaluation by microscopy are not available12. 
 
In a published study of 290 women seeking health care for symptoms of vaginitis, more than half 
had a lab-diagnosed condition, with 30% of women having BV, 34% having VVC and 7% having 
TV based on laboratory testing18. This study documented that only one in five women having 
symptoms of vaginitis had CDC-recommended point-of-care testing, such as assessment of 
vaginal pH, microscopic examination of vaginal fluid, or the whiff test, is performed when women 

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present with vaginal symptoms in primary women’s health care settings. Overall, four of 10 
women seeking health care for symptoms of vaginitis in this study were prescribed inappropriate 
treatments. Return visits for symptoms of vaginitis were common, occurring over the next 3 
months in 20% of the women. The frequency of return visits ranged from 17% of women with 
VVC, 35% of women having BV, and 42% of women with TV.  Surprisingly, follow-up visits for 
vaginal symptoms were also common for women having no lab-diagnosed vaginitis at the index 
visit, with 12% of women returning with symptoms of vaginitis. The women who were prescribed 
unneeded treatment were significantly more likely to return with symptoms of vaginitis in the 
subsequent three months versus those who were not treated (22% versus 6%, p=0.02).  Empiric 
treatment of women having symptoms of vaginitis is common and is perceived to cause no harm. 
However, these data suggest that empiric treatment of women having symptoms, but no infectious 
cause of vaginitis, may result in more symptom-triggered visits and a greater health care burden. 
Similarly, low rates of clinical evaluation of vaginitis have been reported among women referred 
for management of recurrent vaginitis19.  
 
Advances in highly sensitive nucleic acid amplification testing (NAAT) for the microorganisms 
associated with vaginal infections have provided an opportunity to employ more sensitive and 
specific methods for diagnosis of these infections. The BD MAX™ Vaginal Panel provides results 
by an algorithmic analysis of molecular DNA detection of Lactobacillus species (L. crispatus and 
L. jensenii) in addition to Gardnerella vaginalis, Fannyhessea vaginae (formerly Atopobium 
vaginae), Amygdalobacter indicum (formerly BVAB2), and Megasphaera lornae (formerly 
Megasphaera type 1). This test has 90.5% sensitivity and 85.8% specificity for BV diagnosis, 
compared with Amsel criteria and Nugent score20. It also provides results for Candida species 
and T. vaginalis. The Aptima® BV (Hologic, Inc., San Diego, CA) detects G. vaginalis, 
Fannyhessea vaginae (A. vaginae), and certain Lactobacillus species including L. crispatus, L. 
jensenii, and L. gasseri, with sensitivity and specificity ranging from 95.0% to 97.3% and 85.8% 
to 89.6%, respectively (using either clinician- or patient-collected vaginal swabs) 12.  
 
The Xpert® Xpress MVP is a new on-demand NAAT developed by Cepheid, to aid in the 
diagnosis of vaginal infections in women with a clinical presentation of vaginitis/vaginosis. The 
test is simple to use and detects DNA targets from anaerobic bacteria associated with BV (A. 
vaginae, A. indicum, and M. lornae), Candida species and T. vaginalis.  Cepheid has recently 
received 510(k) clearance and CLIA Waiver for Xpert® Xpress MVP. When compared to 
moderately complex nucleic acid amplification tests performed in a laboratory by trained 
technologists, the Xpert® Xpress MVP demonstrated high positive percent agreement ranging 
from 93.6 to 99.0%, and negative percent agreement ranging from 92.1% to 99.8% for both 
clinician-collected samples and patient-collected samples21.  
The overarching objective of the proposed study is to evaluate whether same day testing using 
the Xpert® Xpress MVP test in a patient care setting results in a higher degree of appropriate 
treatment of vaginitis compared to standard of care for women having vaginitis symptoms.  
 

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2. Study Objectives 
2.1 Primary Objective: 
1. To compare the proportion of study participants who are prescribed appropriate 
treatment at index visit or within 24 hours of index visit based on the provider 
assessment conducted at the time of the office/medical visit (Arm 1) to the proportion 
of study participants who are prescribed appropriate treatment when Xpert® Xpress 
MVP testing is performed and reported on the day of the office visit (Arm 2). 
a.  Appropriate treatment is defined as CDC recommended or FDA approved 
treatment based on diagnosis from the self-collected samples. A positive result 
from both FDA cleared molecular tests (Xpert® Xpress MVP; BD MAX™ Vaginal 
Panel) will be considered the gold standard for the diagnosis of vaginitis/vaginosis 
for data analysis.  
2.2 Secondary Objectives: 
1. To compare the accuracy of provider’s diagnosis of vaginitis (usual care) to the diagnosis 
of vaginitis based on the results of the Xpert® Xpress MVP test at the office/medical visit.  
2. To compare the proportion of women who experience resolution of vaginitis symptoms at 
the two week follow up contact after undergoing evaluation with a novel POC molecular 
test to the proportion of women with resolution of vaginitis symptoms after evaluation by 
their provider’s usual care. 
3. To evaluate participant satisfaction with usual care vs point of care testing for vaginitis. 
Questionnaires will be administered to all participants at the office visit and approximately 
two weeks after enrollment. 
4. To compare the accuracy of a nonamplified probe-based platform (BD AffirmTM VPIII) that 
tests for Candida, Trichomonas vaginalis and Gardnerella vaginalis compared to the 
results of two FDA-cleared molecular tests for diagnosis of vaginitis/vaginosis: two NAAT 
platforms (Xpert® Xpress MVP; BD MAX™ Vaginal Panel). 
2.3 Exploratory Objectives:  
1.  Assess the impact of vaginitis symptoms on patient quality of life and productivity through 
use of the Sheehan Disability Scale (SDS), which will be administered at enrollment. Results 
will be assessed overall and stratified by participant-reported severity based on the Patient 
Global Impression of Severity (PGIS) instrument. 
2.  To assess provider satisfaction/treatment confidence with usual care assessment vs 
Xpert® Xpress MVP testing through the Healthcare Provider Sub Study.  
 
3. Study Population 
The inclusion and exclusion criteria in this section will be utilized to ensure the appropriate 
selection of study participants.  

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3.1 Recruitment: 
Approximately 300 individuals, 14 years and older, assigned female sex at birth, seeking care at 
a  PAT study participating office/department with symptoms of vaginitis (i.e. vaginal discharge, 
vaginal odor, vulvar or vaginal itch, vulvar or vaginal discomfort such as irritation, burning, pain or 
vulvar edema) will be invited to participate.  Pregnant participants who report vaginal discharge 
will be required to have at least one additional symptom of vaginitis to participate as physiologic 
vaginal discharge is common during pregnancy.   
 
Participants will be recruited by research staff from participating gynecologic/obstetric practices 
and MWH outpatient centers located within/affiliated with UPMC MWH.  Recruitment will be under 
the direction of Dr. Harold Wiesenfeld who serves as Vice Chair, Gynecologic Services at UPMC 
MWH.  MWH is the sole teaching site for Obstetrics and Gynecology (OB/GYN) for the University 
of Pittsburgh School of Medicine.  Care is provided by faculty physicians, advance practice 
providers and OB/GYN house staff.   
 
Research staff may pre-screen electronic schedules/records to identify individuals seeking care 
for vaginitis symptoms.  Potential participants may also be identified/referred by staff who is 
providing their clinical care. . Interested participants may be provided with a brief description of 
the study and/or may be provided with the informed consent document to review for further study 
details/information. Paper or electronic consent may be utilized, as IRB approved.   If approved 
by the IRB, interested individuals can sign informed consent in advance of their appointment.  
Other participants might be identified on the day of their office visit.  For instance, if an individual 
is not identified or reached prior to their appointment, or an individual presents for a medical visit 
and has vaginitis complaints, they could be introduced to the study and if interested, be consented 
and enrolled in person.  
This recruitment strategy is likely to capture a diverse population as individuals visiting MWH 
practices for routine care are approximately 20-80% White, 20-80% African American and 20% 
other ethnicities including Hispanic, Asian, Indian and Native American.   
In a recently published study of 290 women seeking health care within the UPMC system for 
symptoms of vaginitis, more than half had a lab-diagnosed condition, with 30% of women having 
BV, 34% having VVC and 7% having TV based on laboratory testing18.  The distribution of vaginal 
infections is anticipated to be similar in the PAT study as we are enrolling participants from similar 
communities/offices.   
 
Informed consent will be obtained prior to conducting any study procedures.  
3.2 Inclusion Criteria:  
(Individuals must meet all of the following criteria to qualify) 
1. Individuals who are assigned female sex at birth, by participant report 
2. At least 14 years of age 
3. Complaining of at least one symptom of vaginitis:  vaginal discharge, vaginal odor, vulvar 
or vaginal itch. Women having vulvar or vaginal discomfort such as irritation, burning, pain 
of less than 2 months duration are also eligible.  
Note:  pregnant participants who complain of vaginal discharge will be required to have at 
least one additional vaginal symptom to be eligible. 

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4. Seeking care at one of the PAT participating offices and/or outpatient centers.  
5. Able and willing to provide informed consent.  
6. Willing to undergo all study-related assessments and procedures, including self-collection 
of vaginal swabs, answering questions/surveys, agreeing to the review and collection of 
information from their medical record from the office (enrollment/index) visit and up to 4 
weeks after the office visit.  
3.3 Exclusion Criteria:  
(Individuals who meet any of the following criteria will be excluded) 
1. Previous participation in the PAT study.  
2. Any condition, that in the opinion of the investigator, would preclude provision of consent, 
make participation in the study unsafe, complicate interpretation of study outcome data, 
or otherwise interfere with achieving the study objectives 
3.4 Potential Risks: 
• 
No invasive procedures or investigational medications are involved, so potential risks of 
participation in this study are minimal. 
 
• 
Answering questions may be uncomfortable or embarrassing 
 
• 
Self-collection of vaginal swabs may cause some discomfort, but there is virtually no risk 
for the collection of swabs containing polyester or nylon fibers. 
 
• 
Participants may be inconvenienced by participation in this study. 
 
• 
There is a potential for a breach of confidentiality to occur.  There is a possibility for people 
other than the researchers involved in this study to gain access to the participant’s 
research information.  Extensive measures are taken to prevent this from occurring.   
 
4. Study Procedures 
Participants may be identified through pre-screening of schedules/electronic medical records and 
may be contacted/consented in advance of a scheduled appointment as permitted by the 
University of Pittsburgh Institutional Review Board (IRB). IRB approved flyers may also be used 
to recruit participants.  Consent may be obtained by paper or electronically as approved by the 
IRB. If the patient is not reached or identified in advance of the visit, the patient may be 
approached at the time of their visit by study personnel.   Following written/electronic informed 
consent, participants will be assigned a unique participant study number for the questionnaire and 
associated specimens.   
 
After providing informed consent and confirming eligibility, the participant will be asked to 
complete a baseline questionnaire and collect vaginal specimens; the order of specimen 

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collection and questionnaire is not important and will depend largely on office flow. Questions 
will include demographics, current symptoms, recent relevant treatment in past 30 days, history 
of recurrent vaginitis in past 12 months, and baseline validated symptom score (PGIS) and the 
Sheehan Disability Scale (SDS).   
 
Upon arrival for the office/medical visit, the participant will be provided instructions to self-collect 
vaginal swabs for the following three kits: 
• 
Xpert® Swab Specimen Collection kit for the Xpert® Xpress MVP on the GeneXpert 
Xpress Instrument System 
• 
BD Molecular Swab Collection kit for the BD MAX Vaginal Panel on the BD MAX™ 
System 
• 
BD Affirm™ Ambient Temperature Transport System (ATTS) for the BD Affirm™ VPIII 
on the B-D MicroProbe® Processor. 
 
Kits will be preassembled by researchers with the appropriate collection kits and swabs.  
Collection order of the swabs will be randomized to prevent collection bias.  Patients/participants 
who are reached in advance of their office appointment (i.e. the day before or within 24 hours of 
the scheduled appointment) may be asked to come to the research clinic to complete research 
activities (i.e. informed consent, collection of swabs, completion of questionnaire).   
 
After swab collection, the participant will be randomly assigned to Arm 1 or Arm 2.  The 
randomization will be assigned through REDCap.  Participants will be made aware of which arm 
they were assigned to and will be handed a card to provide to their healthcare provider to make 
them aware they are in the PAT study and which arm they are assigned to (usual care vs. Xpert® 
Xpress MVP results).  The card will also indicate what time the MVP results will be available 
(approximately one hour from the time of collection) for participants in Arm 2.  
4.1 Arm 1:  
For Arm 1 (usual care), the Xpert® Xpress MVP testing will be stored at room temperature and 
tested within 17 days of receiving the sample, as permitted, per manufacturer test instructions.  
The results of the MVP test will be entered into the electronic medical record as determined by 
the MWH Point of Care (POC) Committee AFTER the participant’s two-week telephone contact.   
MVP test results will be available to the provider and participant through the EMR.  The other two 
swab samples (BD Affirm™ ATTS and BD Molecular Swab Collection Kit) from participants in 
Arm 1 will be transported to the MWRI Lab for processing.  The results of these tests are for 
research purposes only and will not be given to providers or entered into the medical record.  
4.2 Arm 2: 
For Arm 2, the Xpert® Xpress MVP test will be performed in real time (using the self-collected 
swab) in clinical areas at UPMC MWH by clinical non-laboratory research staff.  GeneXpert 
Xpress Instrument Systems, provided by the sponsor, will be placed strategically in or near 
appropriate clinical space as determined by available space and in consultation with the 
hospital/office staff.  The Xpert® Xpress MVP test takes approximately one hour to result.  

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Research staff will place the result the EMR once resulted.   The other two swab samples (BD 
Affirm™ ATTS and BD Molecular Swab Collection Kit) from participants in Arm 2 will be 
transported to the MWRI Lab for processing.  The results of these tests are for research purposes 
only and will not be given to providers or entered into the medical record.  
 
For participants randomized to Arm 2, healthcare providers will be aware they are in the study.  
The provider will be reminded that they will receive the Xpert® Xpress MVP test result within 
approximately an hour of collection.  The provider will be asked to use the Xpert® Xpress MVP 
result to diagnose and treat the participant but will not be required to do so.  Results will be entered 
into the electronic medical record/made available to the provider and participant as determined 
by the MWH Point of Care (POC) Committee.  To simulate real world practice and to allow 
flexibility, providing the test result and treatment to the participant may vary among providers.  For 
instance, in some practices, the provider may choose to have the patient wait in the office/center 
until the Xpert® Xpress MVP result is available and then discuss the diagnosis and provide 
treatment in person, while other providers may allow the patient to leave the office/center, review 
the result once available, and contact the patient with the diagnosis and treatment later that day.   
 
                        Data will be abstracted from the EMR by a researcher.  The data collected will include items such 
as demographics, chief complaint, assessment of vaginal discharge, provider impression and 
treatment, as applicable. Any additional testing done by the provider will also be collected 
including wet mount microscopy, vaginal pH, whiff test, cultures, and sexually transmitted infection 
(STI) testing. Data will be entered into the PAT REDCap (Research Electronic Data Capture) 
database by unique PTID by a researcher.  
In both arms, the two additional swabs will be tested in the MWRI Lab for Trichomonas vaginalis, 
Candida species and Gardnerella vaginalis using the BD Affirm™ VPIII and for Candida, 
Trichomonas vaginalis and bacterial vaginosis using the BD MAX™ Vaginal Panel.  The results 
from the BD Affirm™ VPIII and BD MAX™ Vaginal Panel will be used for research purposes only 
and will not be shared with the provider or participant, regardless of the arm of the study.  The BD 
MAX™ result will be used to evaluate the Primary Objective, as appropriate treatment is defined 
as CDC recommended or FDA approved treatment based on diagnosis from concordant NAAT 
(Xpert® Xpress MVP and BD MAX™ Vaginal Panel) results from the self-collected enrollment 
swabs.  The results from the Xpert® Xpress MVP and BD MAX™ Vaginal Panel will be compared 
to the Affirm VPIII results as a secondary objective to assess the accuracy of this testing system.  
 
Participants will be contacted approximately two weeks (14-day target with window of 10-21 days) 
following the visit to complete a follow-up questionnaire including questions such as current (or 
resolution of) symptoms, compliance with treatment, additional care or treatment, and 
satisfaction/comfort with self-collection of swabs, satisfaction with diagnosis and treatment, and 
a validated symptom score (PGIC).  The questionnaires will take less than ten minutes to 
complete; answers will be entered into the PAT Study REDCap database by research staff.   
 
For participants in Arm 1, following the 2-week follow-up contact, the researcher will share the 
Xpert® Xpress MVP results with the office staff, and enter the results into the electronic medical 

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record as determined by the MWH Point of Care (POC) Committee.  It will be the responsibility of 
the provider to provide additional treatment if needed.   
 
Up to four weeks following enrollment, a researcher will perform an EMR chart review to include 
but not limited to the following:  
• 
Collection of data from the office/medical (enrollment/index) visit, including provider 
information, assessment and treatment prescribed 
• 
Review/collection of tests performed/ordered at the office/medical visit and associated results, 
to include STI testing 
• 
Subsequent contact, testing and/or vaginitis treatment following enrollment and/or based on 
delayed Xpert® Xpress MVP results. 
• 
Treatment switches 
 
4.3  HEALTHCARE PROVIDER SUB STUDY: 
The PAT study will also include a sub study to collect data from providers at UPMC MWH to better 
understand how providers feel about POC testing for vaginitis.   
 
Prior to starting the PAT study, all providers from participating offices will be invited to complete 
a baseline survey that will include questions about current practices of diagnosing vaginitis, 
perceived need and interest in POC vaginitis testing, participant vs provider collected swabs, etc.  
The questionnaire will take approximately five minutes to complete, will be anonymous and will 
be done either by paper or directly through REDCap.   
 
Following completion of the PAT study, providers who have had patients participate in the PAT 
study will be eligible to participate in the Healthcare Provider Sub Study. Interested providers will 
be invited to sign an informed consent and then will be provided with a (paper/electronic REDCap) 
survey to complete.  The survey will include questions that are similar to the baseline 
questionnaire with additional questions regarding demographics (i.e. gender, age, practice years) 
their experience in the study, such as getting test results in the same day and confidence in 
accuracy of results.       
 
Providers who cared for patients participating in the PAT Study are under no obligation to consent 
to the sub study.  The risks of participating in the sub study are minimal and include inconvenience 
and breach of confidentiality.  The data collected from providers will be entered into REDCap by 
provider type (i.e. MD, NP, PA, CNM) but not by provider name to protect the (provider) 
participant’s confidentiality.   
 
Providers who consent and complete the final survey will be compensated for their time, as 
approved by the IRB.      
 

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4.3.1 Inclusion Criteria: 
1. Able and willing to provide informed consent 
2. Provided clinical care to at least one PAT study participant on the date of 
their study enrollment 
3. Willing to undergo all study-related assessments including answering 
questions/surveys 
4.4 Electronic Medical Record Abstraction: 
A researcher who is familiar with/has access to the EMR will abstract information from the 
participant’s chart from the office (enrollment/index) visit and up to approximately one month 
following the enrollment visit.  The data abstracted will be information from the office visit for 
vaginitis including but not limited to demographics, chief complaint, length of symptoms, 
assessment of discharge, associated testing, impression and treatment.  Any subsequent visits 
or encounters over approximately one month will be reviewed by a researcher to capture test 
results, prescribed treatment, treatment switches, etc. Information may also be reviewed/collected 
on subsequent contacts and treatment.   
 
The abstracted data may be documented on a paper case report form and then entered into the 
PAT study REDCap database or may be directly entered into the database.   The REDCap system 
is housed at the University of Pittsburgh; the database will be built and maintained by the data 
management team in Pittsburgh and will be used to enter and manage study data. REDCap is a 
secure, web-based application designed for clinical trial data collection. REDCap employs various 
methods to protect the data stored in the software application’s backend database against data 
breaches.  
 
5. Specimen  Processing and Testing 
The sites will adhere to the standards of good clinical laboratory practice and standard operating 
procedures for proper collection, processing, labeling, handling, transport, and storage of 
specimens.  
 
• 
Laboratory Test Procedures 
o Cepheid Xpert® Xpress MVP: Immediately upon collection, the vaginal swab will be 
transferred to the Xpert® Swab Specimen Collection Kit and stored at ambient 
temperature (15-28°C).  Specimen collection, storage and transport will be according 
to the manufacturer's instructions.  
 
Arm 1:  The sample will be tested within 17 days of collection.  The clinical 
research staff will provide the result to the provider after completion of the 
participant’s two week follow-up telephone contact. 
 
Arm 2: The sample will be run by a clinical researcher as a point of care test 
in/near one of the PAT study participating offices.  The result will immediately 
be given to the provider/entered into the EMR. Providers who agree to 
participate in this study will be asked to use the result of the FDA cleared test 
for diagnosis and treatment, but they will not be required to do so. 

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o BD MAX™ Vaginal Panel swab: Immediately upon collection, the vaginal swab will be 
transferred to the BD sample buffer tube, capped tightly, and stored at 15-30oC until 
transport to the MWRI Lab.  Specimen collection, storage and transport will be 
according to the manufacturer’s instructions. 
 
The sample will be processed and tested by MWRI Lab.  Results will be for 
research purposes only and will not be given to providers or participants. 
 
o BD Affirm™ VPIII: Immediately upon collection, the vaginal swab will be transferred to 
the BD Affirm™ VPIII ATTS and stored at ambient temperature (15-30°C) until 
transport to the MWRI Lab.  Specimen collection, storage and transport will be 
according to the manufacturer's instructions. 
 
The samples will be processed and tested by MWRI Lab.  Results will be for 
research purposes only and will not be shared with providers or participants.  
 
5.1 Biohazard Containment 
As the transmission of HIV and other blood-borne pathogens can occur through contact with 
biological specimens, appropriate blood and secretion precautions and training will be employed 
by all personnel in collection, handling and processing of all specimens for this study. 
Biohazardous waste will be contained according to institutional, and all other applicable 
regulations.   
 
6. ASSESSMENT OF SAFETY AND CLINICAL MANAGEMENT 
6.1 Risk Management  
Participants will be encouraged to ask questions to ensure they understand the research study 
and procedures.  No adverse events are expected to occur from collection of multiple vaginal 
swabs, therefore no adverse events will be collected for this study.   
 
When feasible, electronic case report forms (eCRFs) will be the first point of data entry for this 
protocol and will also serve as the source documents.   
 
This study will be conducted in compliance with the protocol and applicable regulatory 
requirements.  All paper research charts are maintained in locked files in a locked room.  The 
research staff, under the direction of the primary investigator, may create and maintain electronic 
logs on password-protected computers connected to the UPMC/Magee-Womens Research 
Institute network in the Reproductive Infectious Diseases research offices.   
 
7. Biostatistical Data and Analysis 
7.1 Sample size calculations 
The primary endpoint is the proportion of study participants prescribed appropriate treatment at 
index visit or within 24 hours of index as defined by use of a CDC recommended treatment 
regimen and/or a treatment approved for that indication by the US FDA for vaginitis/vaginosis. A 
previous study found that 40% of women received inappropriate treatment for vaginitis in 
community practice settings (18). We anticipate a higher proportion of women are being treated 
appropriately at the proposed study site since UPMC MWH is a teaching hospital that specializes 

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in healthcare for women. For the present study, we are making the assumption that 75% of women 
will receive appropriate treatment in the standard of care arm. We hypothesize that women in the 
study arm in which study clinicians and patients are provided with same day access to Xpert® 
Xpress MVP will have a higher proportion of women receiving appropriate treatment. A sample 
size of 150 participants in each arm will have 91% power to detect a difference of at least 15 
percentage points in each arm of the study based on a Fishers exact test evaluated at the 2-sided 
.05 significance level. 
7.2 Primary Endpoint Analysis 
The proportion of women prescribed appropriate treatment at index visit or within 24 hours of 
index between the two arms (usual care versus Xpert® Xpress MVP testing) will be assessed 
using Fisher’s exact test. 
7.3 Secondary and Exploratory Endpoint Analyses 
Patient and Provider satisfaction with usual care versus point of care testing will be evaluated on 
a 5-point Likert scale with 1 being very satisfied to 5 being very dissatisfied. Responses will be 
dichotomized for analyses (very satisfied and satisfied versus all others). Differences in patient 
and provider satisfaction with and the proportion of women who experience resolution of vaginitis 
symptoms after treatment based on usual care and point of care testing will be evaluated using 
Fisher’s exact test.   
 
A positive result from both of the two FDA cleared molecular tests (Xpert® Xpress MVP; BD 
MAX™ Vaginal Panel) will be considered the gold standard for the diagnosis of vaginitis/vaginosis 
for analysis. Samples yielding discordant results will be retested using the reserve sample. 
Samples which are discordant after retesting will be evaluated separately.  
 
Fisher’s exact test will be used to compare the provider’s diagnosis of vaginitis based on usual 
care to the diagnosis based on the results of point of care testing. The sensitivity, specificity, 
negative and positive predictive values of the BD AffirmTM VPIII test for Candida, Trichomonas 
vaginalis and Gardnerella vaginalis will be calculated and compared to those of the two FDA-
cleared tests using the test for equality of proportions.  
 
Patient quality of life and productivity will be assessed using the Sheehan Disability Scale (SDS) 
where 0 indicates no functional impairment and 30 high functional impairment. Descriptive 
statistics will be used to assess overall SDS scores. Differences in SDS scores by participant-
reported severity will be evaluated using Kruskal-Wallis (continuous SDS score) and Fisher’s 
exact (categorized SDS score) tests. 
8. Costs and Payments: 
The cost for the testing for vaginitis using the self-collected molecular methods will be covered by 
the study in both arms of the study.  The cost of routine clinical care visits, which may include 
other diagnostic testing will not be covered by the study.  Treatment may be prescribed by the 
healthcare provider according to usual care; the cost of this treatment will not be covered by the 
study. 
 
Participants who complete the study will be compensated as approved by the University of 
Pittsburgh IRB.  Participants may also be offered MWH garage parking passes for the office visit.  
Healthcare providers who participate in the sub study will be compensated for survey completion, 
as approved by the University of Pittsburgh IRB.  

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8.1 FUNDING 
Funding for this investigator-initiated study is being provided by Cepheid. 
 
 
 

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Schedule of Participant Study Visits and Evaluations: 
Study Procedures 
Visit 1 
Visit 2 
Visit type 
Enrollment 
Follow-Up 
Telephone 
Contact 
Time 
0 
2 weeks 
Length of Visit 
20 min 
10 min 
Informed consent 
x 
 
Eligibility 
x 
 
PGIS (Symptom severity) 
x 
 
PGIC (Symptom severity – change) 
 
x 
Sheehan-disability-scale (Productivity; daily activity) 
x 
 
Self-collect three vaginal swabs 
x 
 
Randomization 
x 
 
Provide Xpert® Xpress MVP results to provider – Arm 1 
 
x 
Provide Xpert® Xpress MVP results to provider – Arm 2 
x 
 
Diagnosis based on usual care at time of visit – Arm 1 
x 
 
Diagnosis based on Xpert® Xpress MVP result at 
time/day of visit – Arm 2 
x 
 
Participant Compensation 
 
x 
Collect/update/review contact/locator information 
x 
 
Chart review to extract visit details, diagnosis, tx and 
results* 
x 
x 
 
*May occur up to 4 weeks following office (enrollment/index) visit

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9. REFERENCES 
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States, 2001-2004: associations with symptoms, sexual behaviors, and reproductive health. 
Sex Transm Dis 2007;34:864–9.  
2. Sutton M, Sternberg M, Koumans EH, et al. The prevalence of Trichomonas vaginalis infection 
among reproductive-age women in the United States, 2001-2004. Clin Infect Dis 
2007;45:1319–26.  
3. Brotman RM, Klebanoff MA, Nansel TR, et al. Bacterial vaginosis assessed by gram stain and 
diminished colonization resistance to incident gonococcal, chlamydial, and trichomonal genital 
infection. J Infect Dis 2010;202:1907–15.  
4. Nelson DB, Hanlon A, Hassan S, et al. Preterm labor and bacterial vaginosis-associated 
bacteria among urban women. J Perinat Med 2009;37:130–4. 
5. Cohen CR, Lingappa JR, Baeten JM, et al. Bacterial vaginosis associated with increased risk 
of female-to-male HIV-1 transmission: a prospective cohort analysis among African couples. 
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6. McClelland RS, Sangare L, Hassan WM, et al. Infection with Trichomonas vaginalis increases 
the risk of HIV-1 acquisition. J Infect Dis 2007;195:698–702.  
7. Van Der Pol B, Kwok C, Pierre-Louis B, et al. Trichomonas vaginalis infection and human 
immunodeficiency virus acquisition in African women. J Infect Dis 2008;197:548–54. 
8. Kissinger P, Amedee A, Clark RA, et al. Trichomonas vaginalis treatment reduces vaginal 
HIV-1 shedding.  Sex Transm Dis 2009; 36: 11-16.   
9. Cotch MF, Pastorek JG, 2nd, Nugent RP, et al. Trichomonas vaginalis associated with low 
birth weight and preterm delivery. Sex Transm Dis 1997;24:353–60. 
10. Beigi RH, Meyn LA, Moore DM, Krohn MA, Hillier SL. Vaginal yeast colonization in 
nonpregnant women: a longitudinal study. Obstet Gynecol. 2004; 104:926-30 
11. Yano J, Sobel JD, Nyirjesy P, et al. Current patient perspectives of vulvovaginal candidiasis: 
incidence, symptoms, management and post-treatment outcomes. BMC Womens Health. 
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12. Centers for Disease Control and Prevention.  2021.  Sexually transmitted diseases treatment 
guidelines, 2021.  Morbidity and Mortality Weekly Report 70(4).   
13. Bornstein J, Lakovsky Y, Lavi I, Bar-Am A, Abramovici H.  The classic approach to diagnosis 
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methods for detecting Trichomonas vaginalis in symptomatic women.  Int J STD AIDS. 2014.    
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16. Schwebke JR, Gaydos CA, Nyirjesy P, Paradis S, Kodsi S, Cooper CK. Diagnostic 
performance of a molecular test versus clinician assessment of vaginitis. J Clin Microbiol. 
2018;56: e00252-18 

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17. Hilbert DW, Smith WL, Chadwick SG, et al.  Development and validation of a highly accurate 
quantitative real-time PCR assay for the diagnosis of bacterial vaginosis.  J Clin Microbiol.  
2016.  doi: 10.1128/JCM.03104-15 
18. Hillier SL, Austin M, Macio I, Meyn LA, Badway D, Beigi R. Diagnosis and treatment of vaginal 
discharge syndromes in community practice settings. Clin Infect Dis. 2021;72:1538-1543.  
19. Wiesenfeld HC, Macio I. The infrequent use of office-based diagnostic tests for vaginitis. Am 
J Obstet Gynecol 1999;181:39-41 
20. Aguirre-Quiñonero A, Sáez de Castillo-Sedano I, Calvo-Muro F, Canut-Blasco A. Accuracy 
of the BD MAX™ vaginal panel in the diagnosis of infectious vaginitis. Eur J Clin Micro Infect 
Dis 2019; 38:877–882 
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Nachamkin I, Crane L, Brown J, Huang C, Liu X, Van Der Pol B. Clinical evaluation of a new 
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