Clinical Evaluation of the Click Sexual Health Test for the Detection of Neisseria Gonorrhoeae (NG), Trichomonas Vaginalis (TV), and Chlamydia Trachomatis (CT) in Women
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|ClinicalTrials.gov Identifier: NCT04098900|
Recruitment Status : Completed
First Posted : September 23, 2019
Last Update Posted : February 17, 2020
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|Condition or disease||Intervention/treatment|
|Chlamydial Infection Gonococcal Infection Trichomoniasis||Diagnostic Test: Click Sexual Health Test|
|Study Type :||Observational|
|Actual Enrollment :||309 participants|
|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|
|Actual Study Start Date :||September 16, 2019|
|Actual Primary Completion Date :||December 3, 2019|
|Actual Study Completion Date :||December 3, 2019|
- Diagnostic Test: Click Sexual Health 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.
- 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 ]
- 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 ]
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
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|Ages Eligible for Study:||14 Years to 99 Years (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Probability Sample|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04098900
|United States, Florida|
|Therafirst Medical Center|
|Fort Lauderdale, Florida, United States, 33308|
|United States, Minnesota|
|Planned Parenthood North Central States|
|Saint Paul, Minnesota, United States, 55114|
|United States, Missouri|
|Planned Parenthood of the St. Louis Region and Southwest Missouri|
|Saint Louis, Missouri, United States, 63108|
|United States, New Jersey|
|Lawrence OB/GYN Clinical Research, LLC|
|Lawrenceville, New Jersey, United States, 08648|
|United States, Texas|
|Planned Parenthood Gulf Coast|
|Houston, Texas, United States, 77023|
|Responsible Party:||Visby Medical|
|Other Study ID Numbers:||
|First Posted:||September 23, 2019 Key Record Dates|
|Last Update Posted:||February 17, 2020|
|Last Verified:||September 2019|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Product Manufactured in and Exported from the U.S.:||Yes|
Gram-Negative Bacterial Infections
Bacterial Infections and Mycoses
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases