Non-Invasive Sexually Transmitted Disease Testing in Wome... | NCT00978848

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

NCT00978848

Sponsor

University of Pittsburgh

Status

Completed

Last Update Posted

May 18, 2016Estimated

Enrollment

305Actual

Phase

Not provided

Conditions

Trichomonas Vaginitis
Chlamydia Trachomatis
Neisseria Gonorrhoeae Infection

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Apr 2010Actual

Completion Date

Apr 2010Actual

First Submitted Date

Sep 16, 2009

First Submission Date that Met QC Criteria

Sep 16, 2009

First Posted Date

Sep 17, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 17, 2016

Last Update Posted Date

May 18, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Harold Wiesenfeld, Director, Division of Gynecologic Specialties & Division of Reproductive Infectious Diseases and Immunology, University of PittsburghPrincipal Investigator

Lead Sponsor

University of PittsburghOTHER

Collaborators

Name	Class
Gen-Probe, Incorporated	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

305Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Women seeking emergency contraception		Women seeking emergency contraception
Women seeking urine pregnancy testing		Women seeking urine pregnancy testing

Interventions

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Harold C Wiesenfeld, MD, CM	University of Pittsburgh	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Magee-Womens Hospital of UPMC		Pittsburgh	Pennsylvania	15213	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014247	Trichomonas Vaginitis
D006069	Gonorrhea
D014245	Trichomonas Infections
D002690	Chlamydia Infections

Ancestor Terms

ID	Term
D011528	Protozoan Infections
D010272	Parasitic Diseases
D007239	Infections
D014627	Vaginitis

Browse Leaves

Not provided

Browse Branches

Not provided