Clinical trial NCT04098900: Clinical Evaluation of the Click Sexual Health Test for the Detection of Neisseria Gonorrhoeae (NG), Trichomonas Vaginalis (TV), and Chlamydia Trachomatis (CT) in Women
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chlamydial Infection
Gonococcal Infection
Trichomoniasis
Lead sponsor: Visby Medical
Sponsor class: INDUSTRY
First posted: 2019-09-23
Enrollment: 309
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: 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)
timeFrame: up to 6 months
measure: 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
timeFrame: up to 6 months
measure: 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
timeFrame: up to 6 months
Secondary outcomes:
measure: Usability will be measured by 5-point Likert scale responses, yes/no questions, and open text questions from study operators.
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: Therafirst Medical Center
state: Florida
city: Saint Paul
country: United States
facility: Planned Parenthood North Central States
state: Minnesota
city: Saint Louis
country: United States
facility: Planned Parenthood of the St. Louis Region and Southwest Missouri
state: Missouri
city: Lawrenceville
country: United States
facility: Lawrence OB/GYN Clinical Research, LLC
state: New Jersey
city: Houston
country: United States
facility: Planned Parenthood Gulf Coast
state: Texas
Study officials:
References: