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

NCT00978848 | Completed

• 1 other identifier: PRO8120077
• Study Type: observational
• Target: 305
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Trichomonas Vaginitis; Chlamydia Trachomatis; Neisseria Gonorrhoeae Infection

Keywords

trichomonas; chlamydia; gonorrhea; emergency contraception; emergency contraception use

Study Arms (2)

Women seeking emergency contraception

Women seeking emergency contraception

Women seeking urine pregnancy testing

Women seeking urine pregnancy testing

Eligibility Criteria

• Age: 15 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• Diagnosis and/or treatment for an STD within 4 weeks of enrollment in the study.

Sponsors & Collaborators

• University of Pittsburgh: lead
• Gen-Probe, Incorporated: collaborator

Study Sites (1)

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Trichomonas Vaginitis; Gonorrhea; Trichomonas Infections; Chlamydia Infections

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Chlamydiaceae Infections

Study Officials

• Harold C Wiesenfeld, MD, CM

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Division of Gynecologic Specialties & Division of Reproductive Infectious Diseases and Immunology

Study Record Dates

• First Submitted: September 16, 2009
• First Posted: September 17, 2009
• Study Start: November 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: May 18, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)