Self Sampling for Rapid Turnaround Testing in the Emergency Department

July 29, 2021 updated by: University of California, San Francisco

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

533

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fresno, California, United States, 93721
        • Community Regional Trauma and Burn Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Vaginal self-sampling and provider performed endocervical sampling
Patients will take part in both provider-performed endocervical sampling (standard care) and vaginal self-sampling.
Procedure: vaginal self sampling
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.
Other Names:
  • Cepheid, SWAB/A-50
Procedure: provider-performed endocervical sampling
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

Central California Faculty Medical Group

Investigators

  • Principal Investigator: Brian Chinnock, MD, UCSF - Fresno

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 17, 2018

Primary Completion (ACTUAL)

June 9, 2020

Study Completion (ACTUAL)

June 9, 2020

Study Registration Dates

First Submitted

September 17, 2018

First Submitted That Met QC Criteria

September 17, 2018

First Posted (ACTUAL)

September 19, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 5, 2021

Last Update Submitted That Met QC Criteria

July 29, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018045

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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