Accuracy and Acceptability of Self-Diagnostic Methods for Vaginitis in Adolescent Females

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by National Institute of Allergy and Infectious Diseases (NIAID).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00706368
First received: June 25, 2008
Last updated: NA
Last verified: May 2008
History: No changes posted
  Purpose

Symptoms of vaginitis are common among adolescent females, although studies have shown that neither experienced clinicians nor patients can accurately diagnose the cause of vaginitis based on symptoms alone. The purpose of this study is to investigate the accuracy and acceptability of self-diagnostic methods for vaginitis in adolescent females.


Condition Intervention
Trichomonas Vaginalis
Device: Point of care tests

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Taking Charge of my Health: A Trial to Investigate the Accuracy and Acceptability of Self-Diagnostic Methods for Vaginitis in Adolescent Females

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Sensitivity of self performed rapid trichomonas tests [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Acceptability of self testing for trichomonas [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: April 2006
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants in this group will perform self-tests for the first half of the study and will have clinical examinations for the second half of the study
Device: Point of care tests
Several point-of-care tests are offered: OSOM TV rapid trichomonas test; OSOM BV Blue rapid test; pHEMalert vaginal pH test. All subjects receive the OSOM TV test, while the other two are optional.
Experimental: 2
Participants in this group will have clinical examinations for the first half of the study and will perform self-tests for the second half of the study
Device: Point of care tests
Several point-of-care tests are offered: OSOM TV rapid trichomonas test; OSOM BV Blue rapid test; pHEMalert vaginal pH test. All subjects receive the OSOM TV test, while the other two are optional.

Detailed Description:

Vaginal symptoms are common among adolescent females. Vaginal symptoms can result from alterations in the normal flora such as candidiasis or bacterial vaginosis (BV), or from sexually transmitted infections (STIs) such as trichomonas vaginalis (Tv). However, studies have shown that neither experienced clinicians or patients can accurately diagnose the etiology of vaginitis based on symptoms alone, and the standard evaluation (pelvic examination and wet mount) has limitations.

As an alternative to the standard evaluation, there are several objective, point-of-care tests that can be performed on vaginal secretions, which could be useful in discriminating between the various causes of vaginitis. These include a rapid test for trichomonas vaginalis, a rapid test for bacterial vaginosis, and the vaginal pH and amine test. The aims of this study are to explore the feasibility, accuracy (e.g., correlation, sensitivity, specificity) and acceptability of self-performed versus clinician-performed tests for vaginitis in adolescent females.

Approximately 300 adolescent females will undergo self- and clinician-testing for both STI and non-STI vaginitis. Subjects will be randomized into two groups. Group 1 will perform self-testing for the first half of the study before receiving clinician-testing for the remainder of the study. Group 2 participants will receive clinician-testing for the first half of the study before performing self-testing for the remainder of the study. All participants will have a discussion with the clinician to compare the results of self-performed tests with the results obtained by the clinician. Investigators will assess their acceptance of self- and clinician-testing before testing, after testing, and after the discussion with the clinician.

  Eligibility

Ages Eligible for Study:   14 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Sexual intercourse in the last 6 months
  • Agree to perform self-testing
  • Agree to pelvic examination

Exclusion Criteria:

  • Have taken antibiotics used to treat vaginal infections in the 2 weeks prior to study entry or have used vaginal creams or medications in the 2 weeks prior to study entry
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00706368

Contacts
Contact: Grace Kim, BS 513-636-7781 grace.kim@cchmc.org

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Investigators
Principal Investigator: Jill S Huppert, MD, MPH Children's Hospital Medical Center, Cincinnati
  More Information

Publications:
Responsible Party: Jill Huppert M.D., MPH, CCHMC Adolescent Medicine Department
ClinicalTrials.gov Identifier: NCT00706368     History of Changes
Other Study ID Numbers: K23 AI063182, K23 AI063182
Study First Received: June 25, 2008
Last Updated: June 25, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Sexually transmitted infections
Acceptability
Adolescent vaginitis

Additional relevant MeSH terms:
Vaginitis
Genital Diseases, Female
Vaginal Diseases

ClinicalTrials.gov processed this record on October 22, 2014