Clinical Utility of Rapid CT/NG Testing in the ED

Johns Hopkins University

Status: Completed

Conditions: Sexually Transmitted Diseases

Treatments: Other: Rapid Testing

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02200224

U54EB007958 (U.S. NIH Grant/Contract)

JHUIRB00026782

Details and patient eligibility

About

The purpose of this study is to:

1. determine the clinical impact of rapid Chlamydia Trachomatis (CT), Neisseria Gonorrhoeae (NG) testing on antibiotic over and under treatment for CT/NG in women evaluated in the Emergency Department (ED) for a Sexually Transmitted Infection (STI).
2. determine the clinical impact of rapid Trichomonas Vaginalis (TV) testing on antibiotic under and over treatment for TV in women evaluated in the ED for an STI
3. evaluate the feasibility of integrating rapid Chlamydia Trachomatis (CT), Neisseria Gonorrhoeae (NG) and TV testing in the Emergency Department setting.

To evaluate the impact or rapid CT/NG/TV testing an patient comprehension of Sexually Transmitted Infection diagnosis.

Enrollment: 300 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• The study population includes women between the age of 18 and 50 who present to the ED and are going to receive CT/NG testing in the ED.

Exclusion criteria

• Patients will be excluded if they are unable to provide informed consent or are not English speaking.

Trial design

300 participants in 2 patient groups

Rapid Testing/Treatment Group

Experimental group

Description:

All subjects enrolled in the rapid testing group will receive rapid CT/NG and TV testing in addition to the CT/NG Nucleic Acid Amplification Test (NAAT) and wet mount testing that is currently used in the ED.

Treatment:

Other: Rapid Testing

Control

No Intervention group

Description:

All subjects enrolled in the control group will receive CT/NG and TV testing according to the current standard of care for Johns Hopkins ED.