Point of Care Test for Vaginal Infections

(PAT Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Sharon L Hillier, PhD

Age: Any Age

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Sharon L Hillier

Disqualifiers: Previous participation, unsafe conditions, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

Vaginal infections are a common gynecologic issue and may cause significant symptoms and discomfort for individuals. Point of care tests are used to diagnose infections in the office, with an advantage of quick diagnosis and treatment. Examples of point of care tests are urine pregnancy, rapid strep and COVID-19 tests. This study will enroll persons with vaginal complaints and compare diagnosis and treatment based on usual care to diagnosis and treatment using a Food and Drug Administration-approved point of care test for the diagnosis of vaginitis. The study is being done to better understand diagnosis, treatment, and satisfaction using point of care tests compared to usual care. Participants will be randomized to one of two study arms: Arm 1: the healthcare provider will perform their usual evaluation and tests to make the diagnosis and provide treatment, as needed. Arm 2: the provider will be asked to use the results of the point-of-care test being used in the study to make the diagnosis and provide treatment, as needed. Regardless of arm, all diagnoses and treatment will be provided through the healthcare provider. All participants will be contacted 2 weeks later to answer a questionnaire related to diagnosis, treatment, current symptoms, and satisfaction with their visit. Medical records related to vaginal complaints, up to 30 days from enrollment, will be reviewed by the study team to obtain information on symptoms, tests performed, results, and treatments prescribed.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your healthcare provider.

What data supports the effectiveness of the Xpert Xpress MVP test for diagnosing vaginal infections?

The Xpert Xpress MVP test showed high accuracy in diagnosing vaginal infections, with positive agreement rates between 93.6% and 99.0% and negative agreement rates between 92.1% and 99.8%, indicating it is a reliable tool for identifying conditions like bacterial vaginosis and yeast infections. ^{1 2 3 4 5}

How is the Xpert Xpress MVP test different from other treatments for vaginal infections?

The Xpert Xpress MVP test is unique because it is a point-of-care test, meaning it can be performed quickly and easily at the location where the patient is receiving care, without needing to send samples to a central lab. This test provides rapid and accurate results for diagnosing vaginal infections, which can help in timely treatment decisions. ^{1 2 6 7 8}

Research Team

Sharon L Hillier, PhD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for individuals experiencing symptoms of vaginal infections such as Bacterial Vaginosis, Trichomoniasis, Yeast infection, or Vaginitis. Participants will be assessed using either usual care methods or a new point-of-care test to diagnose and treat their condition.

Inclusion Criteria

Seeking care at one of the participating offices

Able and willing to provide informed consent

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

Exclusion Criteria

Previous participation in this study

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

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants receive diagnosis and treatment based on either usual care or point-of-care test results during the office visit

1 day

1 visit (in-person)

Follow-up

Participants are contacted to assess symptom resolution and satisfaction with their visit

2 weeks

1 contact (telephone)

Medical Record Review

Review of medical records related to vaginal complaints up to 30 days from enrollment

30 days

Treatment Details

Interventions

• Xpert® Xpress MVP test (Diagnostic Test)

Trial Overview The study compares the effectiveness of standard diagnostic practices (usual care) with a new FDA-approved point-of-care test called Xpert® Xpress MVP in diagnosing and treating vaginal infections. Patients are randomly assigned to one of these two approaches.

Participant Groups

Group I: Usual Care Experimental Treatment 1 Intervention

Vaginitis diagnosis and treatment will be based on usual provider evaluation and treatment during the office visit

Group II: Same Day Results Experimental Treatment 1 Intervention

the Xpert® Xpress MVP test will be run in real time as a point of care 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.

Who Is Running the Clinical Trial?

Sharon L Hillier

Lead Sponsor

Trials

1

Recruited

350+

Cepheid

Industry Sponsor

Trials

24

Recruited

10,500+

Findings from Research

The Xpert CT/NG assay demonstrated high diagnostic accuracy for detecting Chlamydia trachomatis and Neisseria gonorrhoeae in young women, with 100% sensitivity and 97.6% specificity for CT, and 100% sensitivity and specificity for NG, based on a study of 247 women in South Africa.

The OSOM Trichomonas vaginalis test showed lower sensitivity (75.0%) but perfect specificity (100%), indicating it can reliably confirm negative results, making the combination of these tests valuable for STI management in settings with high HIV/STI prevalence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic accuracy of the Xpert CT/NG and OSOM Trichomonas Rapid assays for point-of-care STI testing among young women in South Africa: a cross-sectional study. Garrett, N., Mitchev, N., Osman, F., et al.[2020]

The Xpert Xpress MVP test showed high accuracy in diagnosing vaginitis/vaginosis, with positive agreement rates between 93.6% and 99.0% and negative agreement rates between 92.1% and 99.8% for both clinician-collected and self-collected samples.

Conducted across 12 diverse clinical sites in the U.S., this study suggests that the MVP test could be a reliable diagnostic tool in both laboratory and point-of-care settings for patients with symptoms of vaginitis/vaginosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Evaluation of a New Molecular Test for the Detection of Organisms Causing Vaginitis and Vaginosis. Lillis, RA., Parker, RL., Ackerman, R., et al.[2023]

Nucleic acid amplification testing (NAAT) demonstrated high sensitivity for diagnosing vulvovaginal candidiasis (VVC) at 92.4% and 100% for Trichomonas vaginalis, making it a reliable option compared to traditional methods like microscopy and culture.

For bacterial vaginosis, NAAT showed a sensitivity of 78.7%, but the clinical criteria (Amsel criteria) were more accurate at 98.7%, indicating that while NAAT is useful, clinical evaluation remains important for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nucleic Acid Amplification Testing Compared With Cultures, Gram Stain, and Microscopy in the Diagnosis of Vaginitis. Danby, CS., Althouse, AD., Hillier, SL., et al.[2021]

The Cepheid GeneXpert CT/NG assay demonstrated high sensitivity for detecting Chlamydia trachomatis and Neisseria gonorrhoeae, with sensitivities of 97.4% to 100% across various sample types in a study of 3,109 participants.

With specificity rates above 99%, this rapid test can provide accurate results at the point of care, which may enhance the management and control of chlamydia and gonorrhea infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of the Cepheid CT/NG Xpert Rapid PCR Test for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae. Gaydos, CA., Van Der Pol, B., Jett-Goheen, M., et al.[2022]

The Affirm VPIII Microbial Identification Test demonstrated comparable detection rates for Gardnerella and Candida infections when compared to standard diagnostic methods, with sensitivity of 75.0% for Gardnerella and 82.76% for Candida.

This test offers a rapid diagnostic option for physicians treating vulvovaginitis, allowing for timely diagnosis and treatment at the point of care, which is particularly beneficial for the 195 women studied, most of whom were symptomatic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Affirm VPIII microbial identification test can be used to detect gardnerella vaginalis, Candida albicans and trichomonas vaginalis microbial infections in Korean women. Byun, SW., Park, YJ., Hur, SY.[2020]

The GeneXpert point-of-care test for chlamydia and gonorrhoea was found to be highly acceptable among primary care staff in remote Australia, improving the management of STIs by enabling timely and targeted treatment.

Staff reported increased confidence in test results and greater job satisfaction, although some challenges with manual documentation and managing positive results were noted, suggesting a need for better electronic systems to enhance efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"I Do Feel Like a Scientist at Times": A Qualitative Study of the Acceptability of Molecular Point-Of-Care Testing for Chlamydia and Gonorrhoea to Primary Care Professionals in a Remote High STI Burden Setting. Natoli, L., Guy, RJ., Shephard, M., et al.[2019]

Point-of-care testing (POCT) allows for quick and convenient diagnostic testing near the patient, which can improve the speed of medical decision-making.

The article highlights the importance of regulations surrounding provider-performed microscopy (PPM) tests, such as the fern test and fecal leukocyte tests, ensuring that these tests are conducted safely and effectively in hospital settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Provider-performed microscopy. Kiechle, FL., Gauss, I.[2009]

Self-testing for bacterial vaginosis (BV) by young women showed good agreement with clinician-performed tests, with the self-pH test demonstrating 73% sensitivity and 67% specificity compared to clinical diagnosis.

Trust in self-testing increased after participants performed the tests and discussed the results, although initial trust was lower than for clinician-performed tests, indicating potential for self-testing to enhance access to BV diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy and trust of self-testing for bacterial vaginosis. Huppert, JS., Hesse, EA., Bernard, MC., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Diagnostic accuracy of the Xpert CT/NG and OSOM Trichomonas Rapid assays for point-of-care STI testing among young women in South Africa: a cross-sectional study. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Clinical Evaluation of a New Molecular Test for the Detection of Organisms Causing Vaginitis and Vaginosis. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Nucleic Acid Amplification Testing Compared With Cultures, Gram Stain, and Microscopy in the Diagnosis of Vaginitis. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Performance of the Cepheid CT/NG Xpert Rapid PCR Test for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae. [2022]

5. Australia pubmed.ncbi.nlm.nih.gov

Affirm VPIII microbial identification test can be used to detect gardnerella vaginalis, Candida albicans and trichomonas vaginalis microbial infections in Korean women. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

"I Do Feel Like a Scientist at Times": A Qualitative Study of the Acceptability of Molecular Point-Of-Care Testing for Chlamydia and Gonorrhoea to Primary Care Professionals in a Remote High STI Burden Setting. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Provider-performed microscopy. [2009]

8. United States pubmed.ncbi.nlm.nih.gov

Accuracy and trust of self-testing for bacterial vaginosis. [2021]