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

NCT ID: NCT04098900

Last Updated: 2020-02-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 309 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-09-16
• Study Completion Date: 2019-12-03

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.

Conditions

Chlamydial Infection; Gonococcal Infection; Trichomoniasis

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Visby Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Therafirst Medical Center

Fort Lauderdale, Florida, United States

Planned Parenthood North Central States

Saint Paul, Minnesota, United States

Planned Parenthood of the St. Louis Region and Southwest Missouri

St Louis, Missouri, United States

Lawrence OB/GYN Clinical Research, LLC

Lawrenceville, New Jersey, United States

Planned Parenthood Gulf Coast

Houston, Texas, United States

Countries

United States

Other Identifiers

TP-000279

Identifier Type: -

Identifier Source: org_study_id