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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Sexually Transmitted Infection, Gonorrhea Female, Chlamydia Females

Intervention / Treatment
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* Device: Cepheid Xpert CT/NG Rapid Turnaround Test
* Device: Polymerase chain reaction (PCR)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a prospective, non-blinded, randomized clinical control trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rapid Turnaround Test<br>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. | Device: Cepheid Xpert CT/NG Rapid Turnaround Test<br>* This diagnostic test will be used to help clinicians determine the need for antibiotic prescriptions in patients with a suspected sexually tract infection.<br>* Other names: GeneXpert;Device: Polymerase chain reaction (PCR)<br>* This is the standard of care for diagnosis of a suspected sexually transmitted infection.<br>* Other names: PCR;|
| Active Comparator: Usual Care<br>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. | Device: Polymerase chain reaction (PCR)<br>* This is the standard of care for diagnosis of a suspected sexually transmitted infection.<br>* Other names: PCR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Treated With Antibiotics | Evaluate the effect of a rapid turnaround CT/NG test compared to standard of care on antibiotic prescription for female patients with STI. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Stay (Minutes) | Evaluate the effect of utilizing a rapid turnaround CT/NG test on length of stay (minutes) in the Emergency Department. | 7 days | 
| Percentage of Patients With Rapid Turnaround CT/NG (RPAT) Tests That Are CONSISTENT With Usual Care Test (PCR) in Subjects That Had Both Performed. | Compare the congruence of test results between the rapid turnaround CT/NG test with the usual care test (send out PCR) in subjects that have both performed (Experimental Group). | 7 days | 
| Healthcare Costs. | Evaluate the effect of utilizing a rapid PCR test on healthcare costs. | 7 days | 
| Average Score for Patient Satisfaction With Provider Explanation. | Evaluate patient satisfaction with provider's explanations for the 2 diagnostic groups. Patients were asked to rate their satisfaction with their provider's explanations on a five point scale, with 0 being not at all satisfied and 4 being very satisfied. | 7 days | 
| Average Score for Patient Satisfaction With Treatment Effectiveness. | Evaluate patient satisfaction with treatment effectiveness for the 2 diagnostic groups. Patients were asked to rate their satisfaction with their treatment effectiveness on a five point scale, with 0 being not at all satisfied and 4 being very satisfied. | 7 days | 
| Average Score for Patient Satisfaction With Overall Experience. | Evaluate patient satisfaction with overall experience during visit for the 2 diagnostic groups. Patients were asked to rate their satisfaction with their wait times on a five point scale, with 0 being not at all satisfied and 4 being very satisfied. | 7 days | 
| Number of Patients That Required Follow-up Care Within 7 Days | Compare need for additional healthcare utilization between the groups. | 7 days | 
| Average Score for Patient Satisfaction With Wait Times During Visit. | Evaluate patient satisfaction with wait times during visit for the 2 diagnostic groups. Patients were asked to rate their satisfaction with their wait times on a five point scale, with 0 being not at all satisfied and 4 being very satisfied. | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rapid turnaround test, RTAT, Gonorrhea, Chlamydia, STI