Accuracy and Acceptability of Self-Diagnostic Methods for Vaginitis in Adolescent Females
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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 |
- Sensitivity of self performed rapid trichomonas tests [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- 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 |
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| Contact: Grace Kim, BS | 513-636-7781 | grace.kim@cchmc.org |
| United States, Ohio | |
| Cincinnati Children's Hospital Medical Center | Recruiting |
| Cincinnati, Ohio, United States, 45229 | |
| 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:
|
Trichomonas Infections Vaginitis Protozoan Infections |
Parasitic Diseases Vaginal Diseases Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 16, 2013