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Clinical Evaluation of the Click Sexual Health Test for the Detection of Neisseria Gonorrhoeae (NG), Trichomonas Vaginalis (TV), and Chlamydia Trachomatis (CT) in Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04098900
Recruitment Status : Completed
First Posted : September 23, 2019
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Visby Medical

Brief 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 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.

Condition or disease Intervention/treatment
Chlamydial Infection Gonococcal Infection Trichomoniasis Diagnostic Test: Click Sexual Health Test

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Study Type : Observational
Actual Enrollment : 309 participants
Observational Model: Other
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Drug Information available for: Neisseria


Intervention Details:
  • 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.


Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Secondary Outcome Measures :
  1. 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




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
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.
Criteria

Inclusion Criteria:

  1. 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.
  2. Female at birth. (Pregnant and breastfeeding women are eligible).
  3. Age greater than or equal to 14 years at the time of enrollment
  4. Able to read and understand the procedural information provided for the study.
  5. 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.

Exclusion Criteria:

  1. 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.
  2. Enrollment in the DMID 18-0024 and this study previously.
  3. 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.

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Visby Medical
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Responsible Party: Visby Medical
ClinicalTrials.gov Identifier: NCT04098900    
Other Study ID Numbers: TP-000279
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

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Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Chlamydia Infections
Gonorrhea
Trichomonas Infections
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Genital Diseases, Male
Genital Diseases, Female
Neisseriaceae Infections
Protozoan Infections
Parasitic Diseases