Chlamydia Trachomatis Clinical Trial
Official title:
Vaginal Self-sampling for Rapid Turnaround Gonorrhea/Chlamydia Testing in the Emergency Department
NCT number | NCT03676816 |
Other study ID # | 2018045 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 17, 2018 |
Est. completion date | June 9, 2020 |
Verified date | July 2021 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 533 |
Est. completion date | June 9, 2020 |
Est. primary completion date | June 9, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Community Regional Trauma and Burn Center | Fresno | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | Central California Faculty Medical Group |
United States,
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. — View 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. — View 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. — View 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. — View 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. Review. — View 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). doi: 10.2807/1560-7917.ES.2017.22.42.17-00659. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Predictive value | Vaginal self-sampling specificity, positive predictive value, negative productive value for gonorrhea/chlamydia (measured by individual patient) | 2-3 days | |
Secondary | Predictive value-Gonorrhea | Vaginal self-sampling sensitivity, specificity, positive predictive value, negative predictive value for gonorrhea | 2-3 days | |
Secondary | Predictive value-Chlamydia | Vaginal self-sampling sensitivity, specificity, positive predictive value, negative predictive value for chlamydia | 2-3 days | |
Secondary | Demographics | Concordance of vaginal self-sampling to provider-performed endocervical sampling | 2-3 days | |
Secondary | Percentage | Acceptance rate vaginal self-sample | 2-3 days | |
Secondary | Rate-Worried | Rate of patients worried about doing vaginal self-sampling and correctly | 2-3 days | |
Secondary | Rate-Prefer | Rate of patients that prefer vaginal self-sample to provider-performed endocervical sampling | 2-3 days | |
Secondary | Numeric | Number of patients that refused vaginal self-sampling | 2-3 days | |
Secondary | Descriptive | Description of reasons for refusal of vaginal self-sampling | 2-3 days |
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