Use of a Rapid Test for Gonorrhea & Chlamydia for Women Presenting With Possible Sexually Transmitted Infections
Purpose
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.
Conditions
- Sexually Transmitted Infection
- Gonorrhea Female
- Chlamydia Females
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- Yes
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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- This is a prospective, non-blinded, randomized clinical control trial
- Primary Purpose
- Diagnostic
- Masking
- Triple (Participant, Care Provider, Investigator)
- Masking Description
- Participants, investigators, and care providers will be masked to the experimental or control arm prior to enrollment in the study. Once the participant has been enrolled in the study, they will be randomized to either the control arm or the experimental arm. Once randomization has occurred, participants, care providers, and the investigators will know which group the participants are in.
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Rapid Turnaround Test |
Patients randomized to this arm will be tested for a sexually transmitted infection (STI) with both the rapid nucleic acid amplification test (NAAT) as well as the conventional polymerase chain reaction (PCR) test. The results from the rapid turnaround test will guide providers on treatment decisions for a possible STI. The results from the PCR test will be used to verify the results of the rapid turnaround test. |
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Active Comparator Usual Care |
Patients randomized to this arm will be tested for a sexually transmitted infection (STI) using the conventional PCR test. The results from the PCR test normally take approximately 48-72 hours and these patients will likely receive treatment based on the decision of the clinical provider. The results from the PCR test will be used to verify the decision of the clinical provider to treat or withhold treatment for a possible STI. |
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More Details
- Status
- Terminated
- Sponsor
- University of Maryland, Baltimore
Study Contact
Detailed Description
All females ages 18-55 presenting to the University of Maryland Medical Center 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.