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Self Sampling for Rapid Turnaround Testing in the Emergency Department

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03676816
Recruitment Status : Recruiting
First Posted : September 19, 2018
Last Update Posted : July 16, 2020
Sponsor:
Collaborator:
Central California Faculty Medical Group
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
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 and investigational diagnostic test for gonorrhea/chlamydia.

Condition or disease Intervention/treatment Phase
Chlamydia Trachomatis Neisseria Gonorrhoeae Device: Xpert® NG/CT Device: provider-performed endocervical sampling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 615 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Vaginal Self-sampling for Rapid Turnaround Gonorrhea/Chlamydia Testing in the Emergency Department
Actual Study Start Date : September 17, 2018
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vaginal self-sampling
Patients will take part in both provider-performed endocervical sampling (standard care) and vaginal self-sampling.
Device: Xpert® NG/CT
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 Name: Cepheid, SWAB/A-50

Device: 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.

Active Comparator: Provider-performed endocervical sampling
Patients will take part in both provider-performed endocervical sampling (standard care) and vaginal self-sampling.
Device: Xpert® NG/CT
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 Name: Cepheid, SWAB/A-50

Device: 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.




Primary Outcome Measures :
  1. 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%.


Secondary Outcome Measures :
  1. 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. Predictive value-Gonorrhea [ Time Frame: 2-3 days ]
    Vaginal self-sampling sensitivity, specificity, positive predictive value, negative predictive value for gonorrhea

  3. Predictive value-Chlamydia [ Time Frame: 2-3 days ]
    Vaginal self-sampling sensitivity, specificity, positive predictive value, negative predictive value for chlamydia

  4. Demographics [ Time Frame: 2-3 days ]
    Concordance of vaginal self-sampling to provider-performed endocervical sampling

  5. Percentage [ Time Frame: 2-3 days ]
    Acceptance rate vaginal self-sample

  6. Rate-Worried [ Time Frame: 2-3 days ]
    Rate of patients worried about doing vaginal self-sampling and correctly

  7. Rate-Prefer [ Time Frame: 2-3 days ]
    Rate of patients that prefer vaginal self-sample to provider-performed endocervical sampling

  8. Numeric [ Time Frame: 2-3 days ]
    Number of patients that refused vaginal self-sampling

  9. Descriptive [ Time Frame: 2-3 days ]
    Description of reasons for refusal of vaginal self-sampling



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03676816


Contacts
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Contact: Brian Chinnock, MD 559-499-6440 bchinnock@fresno.ucsf.edu
Contact: Jannet Castaneda 559-499-6435 jcastaneda@fresno.ucsf.edu

Locations
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United States, California
Community Regional Trauma and Burn Center Recruiting
Fresno, California, United States, 93721
Contact: Brian Chinnock, MD    559-499-6400    bchinnock@fresno.ucsf.edu   
Contact: Jannet Castaneda    559-499-6435    jcastaneda@fresno.ucsf.edu   
Principal Investigator: Brian Chinnock, MD         
Sponsors and Collaborators
University of California, San Francisco
Central California Faculty Medical Group
Investigators
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Principal Investigator: Brian Chinnock, MD UCSF - Fresno
Additional Information:
Publications:

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03676816    
Other Study ID Numbers: 2018045
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: July 16, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by University of California, San Francisco:
Chlamydia
Gonorrhea
Additional relevant MeSH terms:
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Chlamydia Infections
Gonorrhea
Emergencies
Disease Attributes
Pathologic Processes
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Infection
Neisseriaceae Infections