Self Sampling for Rapid Turnaround Testing in the Emergency Department

Study protocol:

1. 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.

2. Study staff will attempt to consent patient.

1. If inclusion criteria are met, and there are no exclusion criteria, written
informed consent is obtained.

2. 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.

3. 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.

4. 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.

5. The patient obtains vaginal self-sample in the restroom/exam room.

1. A preprinted single-use instruction sheet is given to patient detailing sample
collection.

2. 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.

3. 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.

4. The patient returns the collection container after obtaining the sample to study
staff that consented the patient.

5. The collection container will be sent to the lab via pneumatic tube station.

6. Vaginal self-sampling result is documented in Epic with designation showing
differentiation from provider-performed endocervical sampling.

6. 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).

7. Retrospective chart review is performed three days after patient consented in order to
obtain provider-performed endocervical sampling results.

8. 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

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