Chlamydial InfectionNCT04098900
Clinical Evaluation of the Click Sexual Health Test for the Detection of Neisseria Gonorrhoeae (NG), Trichomonas Vaginalis (TV), and Chlamydia Trachomatis (CT) in Women
An observational study of Chlamydial Infection and Gonococcal Infection, run by Visby Medical at 5 sites in United States.
Trial summary
This study is a multi-center study with a minimum of three CLIA-waived intended operator sites in the United States in which prospectively self-collected vaginal specimens obtained from subjects who are symptomatic or asymptomatic for CT, NG, or TV will be evaluated with the Click Sexual Health Test in a Clinical… Read more about this study
- Who is it for?
- Ages 14 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chlamydial Infection, Gonococcal Infection, Trichomoniasis
- What is being tested?
- Click Sexual Health Test
- How many people
- 309 participants
- Where
- 5 sitesUnited States
- Study dates
- 16 Sep 2019to 3 Dec 2019
- Phase
- Observational
- 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 14 to 99 years
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population comprises female subjects greater than or equal to 14 years of age visiting any of the participating clinics for any reason, who may be symptomatic or asymptomatic for STIs at locations including but not limited to: OB/GYN and primary care offices, as well as sexually transmitted disease, teen, public health, and family planning clinics. Any subject who meets the inclusion/exclusion criteria is eligible to participate in this study.
Who may be able to join
- Willing and able to give voluntary written informed consent and assent form (or the parental/legal guardian will provide parental permission) before any study-related procedure is performed.
- Female at birth. (Pregnant and breastfeeding women are eligible).
- Age greater than or equal to 14 years at the time of enrollment
- Able to read and understand the procedural information provided for the study.
- Able and willing to follow all study procedures, including performing self-collection of one vaginal swab and permitting a HCP to collect three additional vaginal swabs.
Who cannot join
- Have a medical condition, serious intercurrent illness, or other circumstance that, in the Investigator's judgement, could jeopardize the subjects's safety, or could interfere with study procedures.
- Enrollment in the DMID 18-0024 and this study previously.
- Use of antiperspirants and deodorants or the following vaginal products: douches, washes, lubricants, vaginal wipes, vaginal moisturizers, or feminine hygiene spray in the genital area, within 48 hours prior to enrollment.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Therafirst Medical Center
Fort Lauderdale, Florida, 33308
Planned Parenthood Gulf Coast
Houston, Texas, 77023
Lawrence OB/GYN Clinical Research, LLC
Lawrenceville, New Jersey, 08648
Planned Parenthood North Central States
Saint Paul, Minnesota, 55114
Planned Parenthood of the St. Louis Region and Southwest Missouri
St Louis, Missouri, 63108
About this study
This study is a multi-center study with a minimum of three CLIA-waived intended operator sites in the United States in which prospectively self-collected vaginal specimens obtained from subjects who are symptomatic or asymptomatic for CT, NG, or TV will be evaluated with the Click Sexual Health Test in a Clinical Laboratory Improvement Amendments (CLIA) waived setting. Subjects interested in participating in this study will be assessed for eligibility and asked to give informed consent and assent, if applicable, by the Investigational Review Board (IRB). Only those subjects who meet the inclusion and exclusion criteria may be enrolled in the study.
- Conditions
- Chlamydial Infection, Gonococcal Infection, Trichomoniasis
- Being tested
- Click Sexual Health Test
- Medical subject headings
- Chlamydia Infections, Gonorrhea, Trichomonas Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Click Sexual Health TestDiagnostic test
The Click Device is a single-use (disposable), fully integrated, rapid, compact, device containing a polymerase chain reaction (PCR)-based nucleic acid amplification test (NAAT) for accurate, qualitative detection and differentiation of deoxyribonucleic acid (DNA) for Neisseria gonorrhea (NG), Trichomonas vaginalis (TV), and Chlamydia trachomatis (CT) organisms.
What is being measured
The primary outcome is the main question the study is designed to answer.
The percent sensitivity and specificity of the Click Device for detection of CT in self-collected vaginal specimens as compared to Patient Infected Status (PIS) using vaginal specimens collected by a qualified Health Care Provider (HCP)
Measured: up to 6 months
The percent sensitivity and specificity of the Click Device for detection of NG in self-collected vaginal specimens as compared to PIS using vaginal specimens collected by a qualified HCP
Measured: up to 6 months
The percent sensitivity and specificity of the Click Device for detection of TV in self-collected vaginal specimens as compared to PIS using vaginal specimens collected by a qualified HCP
Measured: up to 6 months
Secondary outcomes (1)
Usability will be measured by 5-point Likert scale responses, yes/no questions, and open text questions from study operators.
Questions are around three domains of interest: i) instructions, ii) operations, and iii) visual interpretation for the Click device for detection of CT, NG, and TV with patient self-collected specimens.
The 5-point Likert scale will measure responses to questions in the form of: (1) Strongly Disagree, (2) Disagree, (3) Neutral, (4) Agree, and (5) Strongly Agree
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start16 Sep 2019
- Primary completion3 Dec 2019
- Study completion3 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chlamydial InfectionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 309 participants (actual)
Sponsor and investigators
- Lead sponsor
- Visby Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04098900
- Sponsor's protocol ID
- TP-000279
- Status last verified
- Sep 2019
- First submitted
- 19 Sep 2019
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Click Sexual Health Test for the Detection of Neisseria Gonorrhoeae (NG), Trichomonas Vaginalis (TV), and Chlamydia Trachomatis (CT) in Women
- ClinicalTrials.gov ID
- NCT04098900
- Acronym / sponsor ID
- TP-000279
- Conditions
- Chlamydial Infection, Gonococcal Infection, Trichomoniasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 309 participants (actual)
- Lead sponsor
- Visby MedicalIndustry (pharma, biotech, devices)
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 3 Dec 2019 (actual)
- Study completion
- 3 Dec 2019 (actual)
- First posted
- 23 Sep 2019 (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.
This study is a multi-center study with a minimum of three CLIA-waived intended operator sites in the United States in which prospectively self-collected vaginal specimens obtained from subjects who are symptomatic or asymptomatic for CT, NG, or TV will be evaluated with the Click Sexual Health Test in a Clinical Laboratory Improvement Amendments (CLIA) waived setting. Subjects interested in participating in this study will be assessed for eligibility and asked to give informed consent and assent, if applicable, by the Investigational Review Board (IRB). Only those subjects who meet the inclusion and exclusion criteria may be enrolled in the study.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population comprises female subjects greater than or equal to 14 years of age visiting any of the participating clinics for any reason, who may be symptomatic or asymptomatic for STIs at locations including but not limited to: OB/GYN and primary care offices, as well as sexually transmitted disease, teen, public health, and family planning clinics. Any subject who meets the inclusion/exclusion criteria is eligible to participate in this study.
Key inclusion criteria (5 listed)
- Willing and able to give voluntary written informed consent and assent form (or the parental/legal guardian will provide parental permission) before any study-related procedure is performed.
- Female at birth. (Pregnant and breastfeeding women are eligible).
- Age greater than or equal to 14 years at the time of enrollment
- Able to read and understand the procedural information provided for the study.
- Able and willing to follow all study procedures, including performing self-collection of one vaginal swab and permitting a HCP to collect three additional vaginal swabs.
Key exclusion criteria (3 listed)
- Have a medical condition, serious intercurrent illness, or other circumstance that, in the Investigator's judgement, could jeopardize the subjects's safety, or could interfere with study procedures.
- Enrollment in the DMID 18-0024 and this study previously.
- Use of antiperspirants and deodorants or the following vaginal products: douches, washes, lubricants, vaginal wipes, vaginal moisturizers, or feminine hygiene spray in the genital area, within 48 hours prior to enrollment.
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 |
|---|---|---|
| Click Sexual Health TestThe Click Device is a single-use (disposable), fully integrated, rapid, compact, device containing a polymerase chain reaction (PCR)-based nucleic acid amplification test (NAAT) for accurate, qualitative detection and differentiation of deoxyribonucleic acid (DNA) for Neisseria gonorrhea (NG), Trichomonas vaginalis (TV), and Chlamydia trachomatis (CT) organisms. | Diagnostic test | – |
Primary outcome
The percent sensitivity and specificity of the Click Device for detection of CT in self-collected vaginal specimens as compared to Patient Infected Status (PIS) using vaginal specimens collected by a qualified Health Care Provider (HCP)
Time frame: up to 6 months
The percent sensitivity and specificity of the Click Device for detection of NG in self-collected vaginal specimens as compared to PIS using vaginal specimens collected by a qualified HCP
Time frame: up to 6 months
The percent sensitivity and specificity of the Click Device for detection of TV in self-collected vaginal specimens as compared to PIS using vaginal specimens collected by a qualified HCP
Time frame: up to 6 months
1 secondary outcome
Usability will be measured by 5-point Likert scale responses, yes/no questions, and open text questions from study operators.
Time frame: up to 6 months
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 17 Feb 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chlamydial Infection and Gonococcal Infection, run by Visby Medical at 5 sites 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 5 inclusion and 3 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 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
The percent sensitivity and specificity of the Click Device for detection of CT in self-collected vaginal specimens as compared to Patient Infected Status (PIS) using vaginal specimens collected by a qualified Health Care Provider (HCP) (time frame: up to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2020.