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

Not Applicable

Terminated

• Conditions: Gonorrhea Female; Sexually Transmitted Infection; Chlamydia Females
• Interventions: Device: Cepheid Xpert CT/NG Rapid Turnaround Test; Device: Polymerase chain reaction (PCR)

• Registration Number: NCT03098394
• Lead Sponsor: University of Maryland, Baltimore

Brief Summary

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

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2017-03-27
• Study First Submitted QC: 2017-03-27
• Study First Posted: 2017-03-31
• Study Start: 2018-09-24
• Primary Completion: 2022-03-25
• Study Completion: 2023-06-20
• Results First Submitted: 2023-06-20
• Status Verified: 2023-08
• Results First Submitted QC: 2023-08-08
• Last Update Submitted: 2023-08-08
• Results First Posted: 2023-08-31
• Last Update Posted: 2023-08-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 64

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rapid Turnaround Test	Polymerase chain reaction (PCR)	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.
Usual Care	Polymerase chain reaction (PCR)	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.
Rapid Turnaround Test	Cepheid Xpert CT/NG 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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Average Score for Patient Satisfaction With Overall Experience.	7 days	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."
Average Score for Patient Satisfaction With Treatment Effectiveness.	7 days	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."
Length of Stay (Minutes)	7 days	Evaluate the effect of utilizing a rapid turnaround CT/NG test on length of stay (minutes) in the Emergency Department.
Healthcare Costs.	7 days	Evaluate the effect of utilizing a rapid PCR test on healthcare costs.
Average Score for Patient Satisfaction With Provider Explanation.	7 days	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."
Average Score for Patient Satisfaction With Wait Times During Visit.	7 days	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."
Percentage of Patients With Rapid Turnaround CT/NG (RPAT) Tests That Are CONSISTENT With Usual Care Test (PCR) in Subjects That Had Both Performed.	7 days	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).
Number of Patients That Required Follow-up Care Within 7 Days	7 days	Compare need for additional healthcare utilization between the groups.

Trial Locations

Locations (1)

University of Maryland Medical Systems; 🇺🇸 Baltimore, Maryland, United States