Recruiting

Observational Study

Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Code:

NCT00706368

Conditions

Trichomonas Vaginalis

Eligibility Criteria

Sex: Female

Age: 14 - 35

Healthy Volunteers: Accepted

Interventions

Point of care tests

Study Details

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.

Conditions

Trichomonas Vaginalis

Study ID

NCT00706368

Start date

Apr, 2006

Status verified date

May, 2008

Completion date

Oct, 2009

Anticipated

Primary completion date

Oct, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 14 - 35

Healthy Volunteers: Accepted

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

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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

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

Interventions

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.

Primary outcome measure

  • Sensitivity of self performed rapid trichomonas tests [ Time Frame: Throughout study ]

Central Contacts and Locations

Central contacts

Grace Kim, BS

513-636-7781grace.kim@cchmc.org

Locations

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

More Information

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Last update posted

Jun 27, 2008

Last verified

May, 2008

Keywords

  • Sexually transmitted infections
  • Acceptability
  • Adolescent vaginitis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID) on 2008-06-27.