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

National Institute of Allergy and Infectious Diseases (NIAID)

Status: Unknown

Conditions: Trichomonas Vaginalis

Treatments: Device: Point of care tests

Study type: Interventional

Funder types: NIH

Identifiers

NCT00706368

K23AI063182 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 14 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

1

Experimental group

Description:

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

Treatment:

Device: Point of care tests

2

Experimental group

Description:

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

Treatment:

Device: Point of care tests