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

Gonococcal Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04098900
• Other study ID #: TP-000279
• Status: Completed
• Start date: September 16, 2019
• Est. completion date: December 3, 2019

Study information

• Verified date: September 2019
• Source: Visby Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 309
• Est. completion date: December 3, 2019
• Est. primary completion date: December 3, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chlamydia Infections
• Chlamydial Infection
• Communicable Diseases
• Gonococcal Infection
• Gonorrhea
• Infection
• Trichomonas Infections
• Trichomoniasis

Intervention

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.

Locations

Country	Name	City	State
United States	Therafirst Medical Center	Fort Lauderdale	Florida
United States	Planned Parenthood Gulf Coast	Houston	Texas
United States	Lawrence OB/GYN Clinical Research, LLC	Lawrenceville	New Jersey
United States	Planned Parenthood of the St. Louis Region and Southwest Missouri	Saint Louis	Missouri
United States	Planned Parenthood North Central States	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Visby Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		up to 6 months
Primary	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		up to 6 months
Primary	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		up to 6 months
Secondary	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	up to 6 months