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 Identifier: NCT04098900
• Recruitment Status: Completed
• First Posted: September 23, 2019
• Last Update Posted: February 17, 2020
• Sponsor: Visby Medical
• Information provided by (Responsible Party): Visby Medical

Study Description

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

Study Design

• 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

Groups and Cohorts

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.

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Locations

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

More Information

• Responsible Party: Visby Medical
• ClinicalTrials.gov Identifier: NCT04098900
• Other Study ID Numbers: TP-000279
• First Posted: September 23, 2019
• 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

Additional relevant MeSH terms:

Infections; Communicable Diseases; Chlamydia Infections; Gonorrhea; Trichomonas Infections; Disease Attributes; Pathologic Processes; Chlamydiaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Genital Diseases; Urogenital Diseases; Neisseriaceae Infections; Protozoan Infections; Parasitic Diseases