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

NCT ID: NCT00706368

Last Updated: 2008-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2009-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Trichomonas Vaginalis

Keywords

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Sexually transmitted infections Acceptability Adolescent vaginitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Point of care tests

Intervention Type DEVICE

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.

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

Group Type EXPERIMENTAL

Point of care tests

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role lead

Responsible Party

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CCHMC Adolescent Medicine Department

Principal Investigators

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Jill S Huppert, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

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Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Grace Kim, BS

Role: CONTACT

Phone: 513-636-7781

Email: [email protected]

References

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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. doi: 10.1086/518851. Epub 2007 Jun 6.

Reference Type BACKGROUND
PMID: 17578778 (View on PubMed)

Other Identifiers

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K23AI063182

Identifier Type: NIH

Identifier Source: secondary_id

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K23AI063182

Identifier Type: NIH

Identifier Source: org_study_id

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