COMPLETED

Point of Care Diagnosis of Vaginal Infections

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-06-16
Study Completion:2025-03-26
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06438575

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:14 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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. Pregnant participants who complain of vaginal discharge will be required to have at least one additional vaginal symptom to be eligible.
  2. * Seeking care at one of the participating offices.
  3. * Able and willing to provide informed consent.
  4. * 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.
  1. * Previous participation in this 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

Contacts and Locations

Principal Investigator

Sharon L Hillier, PhD
PRINCIPAL_INVESTIGATOR
University of Pittsburgh

Study Locations (Sites)

Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
United States

Collaborators and Investigators

Sponsor: Sharon L Hillier

  • Sharon L Hillier, PhD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-16
Study Completion Date2025-03-26

Study Record Updates

Study Start Date2024-06-16
Study Completion Date2025-03-26

Terms related to this study

Keywords Provided by Researchers

  • Point-of-care diagnosis
  • Vaginitis
  • Symptomatic

Additional Relevant MeSH Terms

  • Vaginitis
  • Bacterial Vaginosis
  • Yeast Vaginitis
  • Trichomonas Vaginitis