Clinical Evaluation of the Click Sexual Health Test for the Detection of Neisseria Gonorrhoeae (NG), Trichomonas Vaginalis (TV), and Chlamydia Trachomatis (CT) in Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 309
- 试验地点
- 5
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
- •Female at birth. (Pregnant and breastfeeding women are eligible).
- •Age greater than or equal to 14 years at the time of enrollment
- •Able to read and understand the procedural information provided for the study.
- •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.
排除标准
- •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.
- •Enrollment in the DMID 18-0024 and this study previously.
- •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.
结局指标
主要结局
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
时间窗: up to 6 months
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)
时间窗: up to 6 months
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
时间窗: up to 6 months
次要结局
- Usability will be measured by 5-point Likert scale responses, yes/no questions, and open text questions from study operators.(up to 6 months)