Use of a Rapid Turnaround Test for NG/CT to Improve Treatment of Women Presenting With Possible STIs



Status:Recruiting
Conditions:Infectious Disease, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 65
Updated:10/19/2018
Start Date:September 24, 2018
End Date:October 2019
Contact:Thomas del Ninno, MD
Email:tdelninno@em.umaryland.edu
Phone:410-328-4237

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Use of a Rapid Turnaround Test for Gonorrhea & Chlamydia to Improve Treatment of Women Presenting With Possible Sexually Transmitted Infections

The purpose of this study is to evaluate the effect of utilizing a rapid turnaround CT/NG
test on treatment of female patients in the emergency department or urgent care setting with
possible STIs.

All females ages 18-55 presenting to the UMMC Emergency Department or Urgent Care whose
provider suspects sexually transmitted infection will be offered study enrollment and be
randomly assigned to either the control or the experimental group. Both groups will have a
urinalysis, a pregnancy test, a pelvic exam, and an endocervical sample collected, but the
experimental group's urine will be used to run the rapid turnaround test (RTAT) instead of
the standard PCR. Data will be collected regarding provider decision making, length of stay
in the emergency department, patient satisfaction, clinician satisfaction, further healthcare
sought by patient, and cost surrounding each treatment.

Inclusion Criteria:

- Female patients age 18-55

- Signs or symptoms consistent with sexually transmitted infection

- Medical provider willing to consider the result of the rapid turnaround test in
decision to treat for gonorrhea/chlamydia

- Must have a urine specimen obtained and a pelvic exam performed as part of the
anticipated standard of care evaluation

- Provides informed consent

Exclusion Criteria:

- Signs of systemic infection

- Patient in whom the provider is unwilling to consider the result of the rapid
turnaround test

- Patient who reports being treated for either gonorrhea or chlamydia in the preceding 3
months

- Patients undergoing evaluation for sexual assault

- Patients that are known to be pregnant or express concern that they may be pregnant

- Incarcerated patients

- Students/Employees of the facility

- Presence of any other condition(s) that the investigator feels makes the patient
unsuitable for study inclusion.
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Baltimore, Maryland 21201
Phone: 410-328-4237
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