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Completed Not applicable Interventional Results available

Point of Care Diagnosis of Vaginal Infections

ClinicalTrials.gov ID: NCT06438575

Public ClinicalTrials.gov record NCT06438575. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 1:48 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Point of Care Diagnosis of Vaginal Infections to Ensure Accurate Treatment: (PAT Study)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06438575
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
Sharon L Hillier
Other
Enrollment
351 participants

Conditions and interventions

Eligibility (public fields only)

Age range
14 Years and older
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 15, 2024
Primary completion
Mar 18, 2025
Completion
Mar 25, 2025
Last update posted
Apr 7, 2026

2024 – 2025

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Magee-Womens Hospital of UPMC Pittsburgh Pennsylvania 15213

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06438575, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 7, 2026 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06438575 live on ClinicalTrials.gov.

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