Chlamydia TrachomatisNCT03676816
Self Sampling for Rapid Turnaround Testing in the Emergency Department
A study testing vaginal self sampling and provider-performed endocervical sampling in people with Chlamydia Trachomatis and Neisseria Gonorrhoeae, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Chlamydia Trachomatis, Neisseria Gonorrhoeae
- What is being tested?
- vaginal self sampling and provider-performed endocervical sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 533 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2018to 9 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult female emergency department patient felt by the provider to require gonorrhea/chlamydia endocervical testing
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Community Regional Trauma and Burn Center
Fresno, California, 93721
About this study
Official title: 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.
Read the detailed description
Study protocol:
- Initial emergency department history and physical examination (standard procedure).
- Provider identifies patient who is felt to require gonorrhea/chlamydia testing.
- 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.
- Provider who is study staff identifies patient who is felt to require gonorrhea/chlamydia testing.
- Study staff will attempt to consent patient.
- If inclusion criteria are met, and there are no exclusion criteria, written informed consent is obtained.
- 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.
- 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.
- 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.
- The patient obtains vaginal self-sample in the restroom/exam room.
- A preprinted single-use instruction sheet is given to patient detailing sample collection.
- 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.
- 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.
- The patient returns the collection container after obtaining the sample to study staff that consented the patient.
- The collection container will be sent to the lab via pneumatic tube station.
- Vaginal self-sampling result is documented in Epic with designation showing differentiation from provider-performed endocervical sampling.
- 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).
- The collection container is sent to the lab, and the final result is noted in the medical record as per standard practice (standard procedure).
- Retrospective chart review is performed three days after patient consented in order to obtain provider-performed endocervical sampling results.
- 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
- Conditions
- Chlamydia Trachomatis, Neisseria Gonorrhoeae
- Being tested
- vaginal self sampling, provider-performed endocervical sampling
- Keywords
- Chlamydia, Gonorrhea
- Medical subject headings
- Chlamydia Infections, Gonorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaginal self samplingProcedure or surgery
Also called Cepheid, SWAB/A-50
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.
provider-performed endocervical samplingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: vaginal self sampling; Procedure: provider-performed endocervical sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 2-3 days
Secondary outcomes (9)
Predictive value
Vaginal self-sampling specificity, positive predictive value, negative productive value for gonorrhea/chlamydia (measured by individual patient)
Measured: 2-3 days
Predictive value-Gonorrhea
Vaginal self-sampling sensitivity, specificity, positive predictive value, negative predictive value for gonorrhea
Measured: 2-3 days
Predictive value-Chlamydia
Vaginal self-sampling sensitivity, specificity, positive predictive value, negative predictive value for chlamydia
Measured: 2-3 days
Demographics
Concordance of vaginal self-sampling to provider-performed endocervical sampling
Measured: 2-3 days
Percentage
Acceptance rate vaginal self-sample
Measured: 2-3 days
Rate-Worried
Rate of patients worried about doing vaginal self-sampling and correctly
Measured: 2-3 days
Rate-Prefer
Rate of patients that prefer vaginal self-sample to provider-performed endocervical sampling
Measured: 2-3 days
Numeric
Number of patients that refused vaginal self-sampling
Measured: 2-3 days
Descriptive
Description of reasons for refusal of vaginal self-sampling
Measured: 2-3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start17 Sep 2018
- Primary completion9 Jun 2020
- Study completion9 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chlamydia TrachomatisStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 533 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Central California Faculty Medical Group
- Responsible party
- Sponsor
- Investigators
- Brian Chinnock, MD, Principal investigator, UCSF - Fresno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03676816
- Sponsor's protocol ID
- 2018045
- Status last verified
- Jul 2021
- First submitted
- 17 Sep 2018
- Last updated
- 5 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 12865101Huppert 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.
PubMed 23471445Holley 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.
PubMed 26119905Terkelsen 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.
PubMed 29067905Katz 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.
PubMed 28549097Nelson 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.
PubMed 28100761
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Self-sampling for Rapid Turnaround Gonorrhea/Chlamydia Testing in the Emergency Department
- ClinicalTrials.gov ID
- NCT03676816
- Acronym / sponsor ID
- 2018045
- Conditions
- Chlamydia Trachomatis, Neisseria Gonorrhoeae
- Keywords
- Chlamydia, Gonorrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 533 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Central California Faculty Medical Group
- Study start
- 17 Sep 2018 (actual)
- Primary completion
- 9 Jun 2020 (actual)
- Study completion
- 9 Jun 2020 (actual)
- First posted
- 19 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Initial emergency department history and physical examination (standard procedure).
- Provider identifies patient who is felt to require gonorrhea/chlamydia testing.
- 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.
- Provider who is study staff identifies patient who is felt to require gonorrhea/chlamydia testing.
- Study staff will attempt to consent patient.
- If inclusion criteria are met, and there are no exclusion criteria, written informed consent is obtained.
- 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.
- 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.
- 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.
- The patient obtains vaginal self-sample in the restroom/exam room.
- A preprinted single-use instruction sheet is given to patient detailing sample collection.
- 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.
- 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.
- The patient returns the collection container after obtaining the sample to study staff that consented the patient.
- The collection container will be sent to the lab via pneumatic tube station.
- Vaginal self-sampling result is documented in Epic with designation showing differentiation from provider-performed endocervical sampling.
- 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).
- The collection container is sent to the lab, and the final result is noted in the medical record as per standard practice (standard procedure).
- Retrospective chart review is performed three days after patient consented in order to obtain provider-performed endocervical sampling results.
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaginal self-sampling and provider performed endocervical sampling | Experimental | Procedure: vaginal self sampling, Procedure: provider-performed endocervical samplingPatients will take part in both provider-performed endocervical sampling (standard care) and vaginal self-sampling. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult female emergency department patient felt by the provider to require gonorrhea/chlamydia endocervical testing
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vaginal self samplingAlso: Cepheid, SWAB/A-50This 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. | Procedure or surgery | Vaginal self-sampling and provider performed endocervical sampling |
| provider-performed endocervical samplingprovider-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. | Procedure or surgery | Vaginal self-sampling and provider performed endocervical sampling |
Primary outcome
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%.
9 secondary outcomes
Predictive value
Time frame: 2-3 days
Predictive value-Gonorrhea
Time frame: 2-3 days
Predictive value-Chlamydia
Time frame: 2-3 days
Demographics
Time frame: 2-3 days
Percentage
Time frame: 2-3 days
Rate-Worried
Time frame: 2-3 days
Rate-Prefer
Time frame: 2-3 days
Numeric
Time frame: 2-3 days
Descriptive
Time frame: 2-3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2021.
- Background: PubMed 12865101Levitt 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.
- Background: PubMed 23471445Huppert 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.
- Background: PubMed 26119905Holley 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.
- Background: PubMed 29067905Terkelsen 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.
- Background: PubMed 28549097Katz 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.
- Background: PubMed 28100761Nelson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Chinnock, MD principal investigator
UCSF - Fresno
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vaginal self sampling and provider-performed endocervical sampling in people with Chlamydia Trachomatis and Neisseria Gonorrhoeae, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Noninferiority of vaginal self-sampling compared to provider performed endocervical sampling for gonorrhea/chlamydia diagnosis (time frame: 2-3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03676816, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2021.