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

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.

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

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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

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