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

Primary Purpose

Trichomonas Vaginalis

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Point of care tests
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Trichomonas Vaginalis focused on measuring Sexually transmitted infections, Acceptability, Adolescent vaginitis

Eligibility Criteria

14 Years - 35 Years (Child, Adult)FemaleAccepts 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

Sites / Locations

  • Cincinnati Children's Hospital Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm 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

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

Outcomes

Primary Outcome Measures

Sensitivity of self performed rapid trichomonas tests

Secondary Outcome Measures

Acceptability of self testing for trichomonas

Full Information

First Posted
June 25, 2008
Last Updated
June 25, 2008
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00706368
Brief Title
Accuracy and Acceptability of Self-Diagnostic Methods for Vaginitis in Adolescent Females
Official Title
Taking Charge of my Health: A Trial to Investigate the Accuracy and Acceptability of Self-Diagnostic Methods for Vaginitis in Adolescent Females
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Unknown status
Study Start Date
April 2006 (undefined)
Primary Completion Date
October 2009 (Anticipated)
Study Completion Date
October 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trichomonas Vaginalis
Keywords
Sexually transmitted infections, Acceptability, Adolescent vaginitis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm 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
Arm Title
2
Arm Type
Experimental
Arm 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
Intervention Type
Device
Intervention Name(s)
Point of care tests
Intervention Description
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 Information:
Title
Sensitivity of self performed rapid trichomonas tests
Time Frame
Throughout study
Secondary Outcome Measure Information:
Title
Acceptability of self testing for trichomonas
Time Frame
Throughout study

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Grace Kim, BS
Phone
513-636-7781
Email
grace.kim@cchmc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill S Huppert, MD, MPH
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
17578778
Citation
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.
Results Reference
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Accuracy and Acceptability of Self-Diagnostic Methods for Vaginitis in Adolescent Females

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