Clinical trial NCT03676816: Self Sampling for Rapid Turnaround Testing in the Emergency Department
Official title: Vaginal Self-sampling for Rapid Turnaround Gonorrhea/Chlamydia Testing in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chlamydia Trachomatis
Neisseria Gonorrhoeae
Keywords: Chlamydia
Gonorrhea
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Central California Faculty Medical Group
First posted: 2018-09-19
Enrollment: 533
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Eligibility 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

Primary outcomes:
measure: Noninferiority of vaginal self-sampling compared to provider performed endocervical sampling for gonorrhea/chlamydia diagnosis
timeFrame: 2-3 days
Secondary outcomes:
measure: Predictive value
timeFrame: 2-3 days
measure: Predictive value-Gonorrhea
timeFrame: 2-3 days
measure: Predictive value-Chlamydia
timeFrame: 2-3 days
measure: Demographics
timeFrame: 2-3 days
measure: Percentage
timeFrame: 2-3 days
measure: Rate-Worried
timeFrame: 2-3 days
measure: Rate-Prefer
timeFrame: 2-3 days
measure: Numeric
timeFrame: 2-3 days
measure: Descriptive
timeFrame: 2-3 days
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Community Regional Trauma and Burn Center
state: California
Study officials:
affiliation: UCSF - Fresno
name: Brian Chinnock, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.