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

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.

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