Self Sampling for Rapid Turnaround Testing in the Emergency Department

Study Overview
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Brief Summary
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Consenting adult female patient felt by the provider to require gonorrhea/chlamydia endocervical testing will be asked to provide an additional self sample specimen. The specimen will be sent to the laboratory using conventional diagnostic test for gonorrhea/chlamydia.

Detailed Description
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Study protocol: Initial emergency department history and physical examination (standard procedure). a. Provider identifies patient who is felt to require gonorrhea/chlamydia testing. i. Provider will contact study staff to consent patient. b. Study staff identifies patient who is felt by provider to require gonorrhea/chlamydia testing. i. Study staff will ask provider if they could move forward with consenting patient. c. Provider who is study staff identifies patient who is felt to require gonorrhea/chlamydia testing. Study staff will attempt to consent patient. If inclusion criteria are met, and there are no exclusion criteria, written informed consent is obtained. If the patient changes her mind and refuses consent at this point, a notation is written on the front of the research packet, and it is turned in with a refusal notice on the packet. If patient refuses to participate in the self-sampling portion of the study, we will ask patients if they would like to fill out the first half of the patient survey that will contain no personal identification information besides their initials. If patient agrees to participate in the self-sampling, the patient is asked to fill out both page one and page two of the survey after consent is obtained. An attempt is made to write down at least two contact telephone numbers for patients who have given informed consent on page 2 of the patient survey. The patient obtains vaginal self-sample in the restroom/exam room. A preprinted single-use instruction sheet is given to patient detailing sample collection. Vaginal self-sampling collection container has preprinted instructions/requisition and a preprinted label on the Cepheid sample tube to the lab denoting this as research sample. Paper requisition form is also included with the sample which helps with documentation and assigning this sample to be billed to the research study and not to the patient. The patient returns the collection container after obtaining the sample to study staff that consented the patient. The collection container will be sent to the lab via pneumatic tube station. Vaginal self-sampling result is documented in Epic with designation showing differentiation from provider-performed endocervical sampling. Provider-performed endocervical sampling is performed once the patient is assigned a provider and given a private area to conduct a provider-performed endocervical sampling (standard procedure). a. The collection container is sent to the lab, and the final result is noted in the medical record as per standard practice (standard procedure). Retrospective chart review is performed three days after patient consented in order to obtain provider-performed endocervical sampling results. Patient will be contacted only if there is a false-negative. A positive with either the self-sample or provider collected sample is considered positive, and patient will not be called back about that

Official Title
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Vaginal Self-sampling for Rapid Turnaround Gonorrhea/Chlamydia Testing in the Emergency Department

Conditions
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Chlamydia Trachomatis, Neisseria Gonorrhoeae

Intervention / Treatment
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* Procedure: vaginal self sampling
* Procedure: provider-performed endocervical sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult female emergency department patient felt by the provider to require gonorrhea/chlamydia endocervical testing Exclusion Criteria: Non-English speakers with the exception of Spanish speakers (once a Spanish-language informed consent document is approved by the Community Medical Center Institutional Review Board) Prisoner Age <18 years old Active psychiatric condition felt to preclude the ability to give informed consent Treated for gonorrhea/chlamydia within previous four weeks

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaginal self-sampling and provider performed endocervical sampling<br>Patients will take part in both provider-performed endocervical sampling (standard care) and vaginal self-sampling. | Procedure: vaginal self sampling<br>* This is a prospective, non-inferiority trial comparing two methods of collection using a US Food and Drug Administration- cleared 90-minute rapid nucleic acid amplification assay, the Xpert CT/NG assay. Any adult female patient admitted to the Emergency Department at Community Regional Medical Center felt by the provider to require gonorrhea/chlamydia endocervical testing may be entered in the study.<br>* Other names: Cepheid, SWAB/A-50;Procedure: provider-performed endocervical sampling<br>* provider-performed endocervical sampling is the gold standard for both gonorrhea and chlamydia. The provider takes a endocervical sample which will get sent to the laboratory as the standard care in comparison to the device being studied.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Noninferiority of vaginal self-sampling compared to provider performed endocervical sampling for gonorrhea/chlamydia diagnosis | In order for vaginal self-sampling to be considered clinically noninferior to the standard provider-performed endocervical sampling method of collection, we established a minimum sensitivity of 90%. This was based on previous research showing Sexually Transmitted Infection (STI) clinicians' top priority for a point of care STI test is a minimum sensitivity of 90%. In addition, a previous ED study examining urine gonorrhea/chlamydia diagnosis using the same point of care test as this study also used a minimum sensitivity of 90%. (9) Thus, our primary outcome measure was examining for the noninferiority of VSS sensitivity for gonorrhea/chlamydia, with noninferiority being demonstrated if the sensitivity is >=90%. | 2-3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive value | Vaginal self-sampling specificity, positive predictive value, negative productive value for gonorrhea/chlamydia (measured by individual patient) | 2-3 days | 
| Predictive value-Gonorrhea | Vaginal self-sampling sensitivity, specificity, positive predictive value, negative predictive value for gonorrhea | 2-3 days | 
| Predictive value-Chlamydia | Vaginal self-sampling sensitivity, specificity, positive predictive value, negative predictive value for chlamydia | 2-3 days | 
| Demographics | Concordance of vaginal self-sampling to provider-performed endocervical sampling | 2-3 days | 
| Percentage | Acceptance rate vaginal self-sample | 2-3 days | 
| Rate-Worried | Rate of patients worried about doing vaginal self-sampling and correctly | 2-3 days | 
| Rate-Prefer | Rate of patients that prefer vaginal self-sample to provider-performed endocervical sampling | 2-3 days | 
| Numeric | Number of patients that refused vaginal self-sampling | 2-3 days | 
| Descriptive | Description of reasons for refusal of vaginal self-sampling | 2-3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chlamydia, Gonorrhea