Non-Invasive Sexually Transmitted Disease Testing in Women Seeking Emergency Contraception or Urine Pregnancy Testing

This study has been completed.
Sponsor:
Collaborator:
Gen-Probe, Incorporated
Information provided by (Responsible Party):
Harold Wiesenfeld, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00978848
First received: September 16, 2009
Last updated: May 17, 2016
Last verified: May 2016

September 16, 2009
May 17, 2016
November 2009
April 2010   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00978848 on ClinicalTrials.gov Archive Site
Not Provided
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Non-Invasive Sexually Transmitted Disease Testing in Women Seeking Emergency Contraception or Urine Pregnancy Testing
Non-Invasive Sexually Transmitted Disease Testing in Women Seeking Emergency Contraception or Urine Pregnancy Testing: Meeting the Needs of an At-Risk Population
The purpose of this study is to determine the prevalence and treatment rates of T. vaginalis, C. trachomatis, and N. gonorrhoeae in women seeking emergency contraception or urine pregnancy testing in the Magee-Womens Hospital outpatient clinic using a non-invasive urine STD test.
This study has three primary objectives: 1) to determine the prevalence of T. vaginalis, C. trachomatis, and N. gonorrhoeae in women seeking emergency contraception or urine pregnancy testing - a population likely at increased risk of acquiring STDs; 2) to determine the rate of successful treatment in women diagnosed with STDs in this venue.
Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples Without DNA
Description:
Any left over urine may be frozen for future use on infections in women
Non-Probability Sample
Females at least age 15 at time of enrollment who are presenting at Magee-Womens Hospital for emergency contraception or urine pregnancy testing
  • Trichomonas Vaginitis
  • Chlamydia Trachomatis
  • Neisseria Gonorrhoeae Infection
Not Provided
  • Women seeking emergency contraception
    Women seeking emergency contraception
  • Women seeking urine pregnancy testing
    Women seeking urine pregnancy testing
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
305
April 2010
April 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Females at least age 15 at time of enrollment who are presenting at Magee-Womens Hospital for emergency contraception or urine pregnancy testing.
  • Ability to provide written informed consent.

Exclusion Criteria:

  • Diagnosis and/or treatment for an STD within 4 weeks of enrollment in the study.
Female
15 Years and older   (Child, Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00978848
PRO8120077
No
No
Not Provided
Harold Wiesenfeld, University of Pittsburgh
University of Pittsburgh
Gen-Probe, Incorporated
Principal Investigator: Harold C Wiesenfeld, MD, CM University of Pittsburgh
University of Pittsburgh
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP