Non-Invasive Sexually Transmitted Disease (STD) Testing in Women Seeking Emergency Contraception or Urine Pregnancy Testing: Meeting the Needs of an At-Risk Population

This study has been completed.
Sponsor:
Collaborator:
Gen-Probe, Incorporated
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00978848
First received: September 16, 2009
Last updated: July 8, 2010
Last verified: July 2010
  Purpose

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.


Condition
Trichomonas Vaginalis Infection
Chlamydia Trachomatis
Neisseria Gonorrhoeae

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Non-Invasive STD Testing in Women Seeking Emergency Contraception or Urine Pregnancy Testing: Meeting the Needs of an At-Risk Population

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Biospecimen Retention:   Samples Without DNA

Any left over urine may be frozen for future use on infections in women


Enrollment: 305
Study Start Date: November 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
women seeking emergency contraception
Women seeking urine pregnancy testing

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Females at least age 15 at time of enrollment who are presenting at Magee-Womens Hospital for emergency contraception or urine pregnancy testing

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00978848

Locations
United States, Pennsylvania
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Gen-Probe, Incorporated
Investigators
Principal Investigator: Harold C Wiesenfeld, MD, CM University of Pittsburgh
  More Information

No publications provided

Responsible Party: Harold C. Wiesenfeld, MD, CM, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00978848     History of Changes
Other Study ID Numbers: PRO8120077
Study First Received: September 16, 2009
Last Updated: July 8, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
trichomonas
chlamydia
gonorrhea
emergency contraception
emergency contraception use

Additional relevant MeSH terms:
Emergencies
Gonorrhea
Sexually Transmitted Diseases
Trichomonas Infections
Bacterial Infections
Disease Attributes
Genital Diseases, Female
Genital Diseases, Male
Gram-Negative Bacterial Infections
Infection
Neisseriaceae Infections
Parasitic Diseases
Pathologic Processes
Protozoan Infections
Sexually Transmitted Diseases, Bacterial
Virus Diseases

ClinicalTrials.gov processed this record on October 29, 2014