Self Sampling for Rapid Turnaround Testing in the Emergency Department

NCT03676816 | Completed DMC

• 1 other identifier: 2018045
• Study Type: interventional
• Target: 533
• Locations: 1 country
• Sites: 1

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 diagnostic test for gonorrhea/chlamydia.

Conditions

Chlamydia Trachomatis; Neisseria Gonorrhoeae

Keywords

Chlamydia; Gonorrhea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Predictive value

  2-3 days

• Predictive value-Gonorrhea

  2-3 days

• Predictive value-Chlamydia

  2-3 days

• Demographics

  2-3 days

• Percentage

  2-3 days

Study Arms (1)

Vaginal self-sampling and provider performed endocervical sampling

EXPERIMENTAL

Patients will take part in both provider-performed endocervical sampling (standard care) and vaginal self-sampling.

Procedure: vaginal self sampling; Procedure: provider-performed endocervical sampling

Interventions

vaginal self sampling PROCEDURE

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.

Also known as: Cepheid, SWAB/A-50

Vaginal self-sampling and provider performed endocervical sampling

provider-performed endocervical sampling PROCEDURE

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.

Vaginal self-sampling and provider performed endocervical sampling

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult female emergency department patient felt by the provider to require gonorrhea/chlamydia endocervical testing

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Central California Faculty Medical Group: collaborator

Study Sites (1)

Community Regional Trauma and Burn Center

Fresno, California, 93721, United States

Location

Related Publications (6)

• Levitt MA, Johnson S, Engelstad L, Montana R, Stewart S. Clinical management of chlamydia and gonorrhea infection in a county teaching emergency department--concerns in overtreatment, undertreatment, and follow-up treatment success. J Emerg Med. 2003 Jul;25(1):7-11. doi: 10.1016/s0736-4679(03)00131-8.

  PMID: 12865101 BACKGROUND

• Huppert JS, Taylor RG, St Cyr S, Hesse EA, Reed JL. Point-of-care testing improves accuracy of STI care in an emergency department. Sex Transm Infect. 2013 Sep;89(6):489-94. doi: 10.1136/sextrans-2012-050994. Epub 2013 Mar 7.

  PMID: 23471445 BACKGROUND

• Holley CE, Van Pham T, Mezzadra HM, Willis GC, Witting MD. Overtreatment of gonorrhea and chlamydial infections in 2 inner-city emergency departments. Am J Emerg Med. 2015 Sep;33(9):1265-8. doi: 10.1016/j.ajem.2015.06.009. Epub 2015 Jun 12.

  PMID: 26119905 BACKGROUND

• Terkelsen D, Tolstrup J, Johnsen CH, Lund O, Larsen HK, Worning P, Unemo M, Westh H. Multidrug-resistant Neisseria gonorrhoeae infection with ceftriaxone resistance and intermediate resistance to azithromycin, Denmark, 2017. Euro Surveill. 2017 Oct;22(42):17-00659. doi: 10.2807/1560-7917.ES.2017.22.42.17-00659.

  PMID: 29067905 BACKGROUND

• Katz AR, Komeya AY, Kirkcaldy RD, Whelen AC, Soge OO, Papp JR, Kersh EN, Wasserman GM, O'Connor NP, O'Brien PS, Sato DT, Maningas EV, Kunimoto GY, Tomas JE. Cluster of Neisseria gonorrhoeae Isolates With High-level Azithromycin Resistance and Decreased Ceftriaxone Susceptibility, Hawaii, 2016. Clin Infect Dis. 2017 Sep 15;65(6):918-923. doi: 10.1093/cid/cix485.

  PMID: 28549097 BACKGROUND

• Nelson EJ, Maynard BR, Loux T, Fatla J, Gordon R, Arnold LD. The acceptability of self-sampled screening for HPV DNA: a systematic review and meta-analysis. Sex Transm Infect. 2017 Feb;93(1):56-61. doi: 10.1136/sextrans-2016-052609. Epub 2016 Oct 19.

  PMID: 28100761 BACKGROUND

MeSH Terms

Conditions

Chlamydia Infections; Gonorrhea

Condition Hierarchy (Ancestors)

Chlamydiaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases; Neisseriaceae Infections

Study Officials

• Brian Chinnock, MD

  UCSF - Fresno

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2018
• First Posted: September 19, 2018
• Study Start: September 17, 2018
• Primary Completion: June 9, 2020
• Study Completion: June 9, 2020
• Last Updated: August 5, 2021

Record last verified: 2021-07

Locations

US (1)