A Healthcare Economic Study of the Click Sexual Health Test
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Benefits of the Click Device for the detection of CT, NG, and TV in self-collected vaginal specimens as compared to standard of care
研究概览
简要总结
This is a multicenter study with a minimum of three CLIA-Waived intended operator sites in which prospectively collected vaginal swab specimens will be evaluated with the Click Sexual Health Test as compared to standard of care. The specimen collection will occur over one study visit for each enrolled subject, but study staff will continue to follow the subject through standard of care until the subject receives treatment or she is lost to follow up.
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 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Documentation that the subject has provided informed consent prior to conducting study procedures
- •Subject is symptomatic or asymptomatic for sexually transmitted infections
- •Subject is female and 14 years of age or older at the time of enrollment
- •Able and willing to follow study procedures
排除标准
- •Subject has been previously enrolled in the study
- •Subject has a contraindication, medical condition, serious intercurrent illness or other circumstance that in the investigator's judgement, could jeopordize the subject's safety or could interfere with the study procedures
- •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
Benefits of the Click Device for the detection of CT, NG, and TV in self-collected vaginal specimens as compared to standard of care
时间窗: up to 1 month
Cost-effectiveness of the Click Device for the detection of CT, NG, and TV in self-collected vaginal specimens as compared to standard of care
时间窗: up to 1 month
Preferences of the Click Device for the detection of CT, NG, and TV in self-collected vaginal specimens as compared to standard of care
时间窗: up to 1 month
Usability of the Click Device for the detection of CT, NG, and TV in self-collected vaginal specimens as compared to standard of care
时间窗: up to 1 month
Costs of the Click Device for the detection of CT, NG, and TV in self-collected vaginal specimens as compared to standard of care
时间窗: up to 1 month
Accuracy of treatment/no treatment decisions in light of the outcomes of testing for CT, NG, and TV infections by Click device as compared to standard of care
时间窗: up to 1 month
Usability and Satisfaction will be measured by 5-point Likert scale responses, yes/no questions, and open-text questions from study subjects, study operators, and healthcare providers.
时间窗: up to 1 month
The scale measures responses to questions in the form of: (1) Strongly Disagree, (2) Disagree, (3) Neutral, (4) Agree, and (5) Strongly agree.
次要结局
未报告次要终点