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

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
• Overall Status: Unknown status
• CT.gov ID: NCT00706368
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Arms: 2
• Duration (Months): 42
• Patients Per Site Per Month: 7.1

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Trichomonas Vaginalis	Device: Point of care tests	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: Apr 1, 2006
• Anticipated Primary Completion Date: Oct 1, 2009
• Anticipated Study Completion Date: Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Sensitivity of self performed rapid trichomonas tests [Throughout study]

Secondary Outcome Measures

1. Acceptability of self testing for trichomonas [Throughout study]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 35 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229

Sponsors and Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

• Principal Investigator: Jill S Huppert, MD, MPH, Children's Hospital Medical Center, Cincinnati

Study Documents (Full-Text)

None provided.

More Information

Publications

• Huppert JS, Mortensen JE, Reed JL, Kahn JA, Rich KD, Miller WC, Hobbs MM. Rapid antigen testing compares favorably with transcription-mediated amplification assay for the detection of Trichomonas vaginalis in young women. Clin Infect Dis. 2007 Jul 15;45(2):194-8. Epub 2007 Jun 6.

• ClinicalTrials.gov Identifier: NCT00706368
• Other Study ID Numbers: K23AI063182; K23AI063182
• First Posted: Jun 27, 2008
• Last Update Posted: Jun 27, 2008
• Last Verified: May 1, 2008

• Keywords provided by , ,: Sexually transmitted infections; Acceptability; Adolescent vaginitis
• Additional relevant MeSH terms: Vaginitis

Study Results

No Results Posted as of Jun 27, 2008