Vaginal Self-sampling for Rapid Turnaround Gonorrhea/Chlamydia Testing in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 533
- 试验地点
- 1
- 主要终点
- Noninferiority of vaginal self-sampling compared to provider performed endocervical sampling for gonorrhea/chlamydia diagnosis
研究概览
简要总结
Consenting adult female patient felt by the provider to require gonorrhea/chlamydia endocervical testing will be asked to provide an additional self sample specimen. The specimen will be sent to the laboratory using conventional diagnostic test for gonorrhea/chlamydia.
详细描述
Study protocol:
- Initial emergency department history and physical examination (standard procedure).
a. Provider identifies patient who is felt to require gonorrhea/chlamydia testing.
i. Provider will contact study staff to consent patient. b. Study staff identifies patient who is felt by provider to require gonorrhea/chlamydia testing. i. Study staff will ask provider if they could move forward with consenting patient.
c. Provider who is study staff identifies patient who is felt to require gonorrhea/chlamydia testing. 2. Study staff will attempt to consent patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult female emergency department patient felt by the provider to require gonorrhea/chlamydia endocervical testing
排除标准
- •Non-English speakers with the exception of Spanish speakers (once a Spanish-language informed consent document is approved by the Community Medical Center Institutional Review Board)
- •Age <18 years old
- •Active psychiatric condition felt to preclude the ability to give informed consent
- •Treated for gonorrhea/chlamydia within previous four weeks
研究组 & 干预措施
Vaginal self-sampling and provider performed endocervical sampling
Patients will take part in both provider-performed endocervical sampling (standard care) and vaginal self-sampling.
干预措施: vaginal self sampling (Procedure)
Vaginal self-sampling and provider performed endocervical sampling
Patients will take part in both provider-performed endocervical sampling (standard care) and vaginal self-sampling.
干预措施: provider-performed endocervical sampling (Procedure)
结局指标
主要结局
Noninferiority of vaginal self-sampling compared to provider performed endocervical sampling for gonorrhea/chlamydia diagnosis
时间窗: 2-3 days
In order for vaginal self-sampling to be considered clinically noninferior to the standard provider-performed endocervical sampling method of collection, we established a minimum sensitivity of 90%. This was based on previous research showing Sexually Transmitted Infection (STI) clinicians' top priority for a point of care STI test is a minimum sensitivity of 90%. In addition, a previous ED study examining urine gonorrhea/chlamydia diagnosis using the same point of care test as this study also used a minimum sensitivity of 90%. (9) Thus, our primary outcome measure was examining for the noninferiority of VSS sensitivity for gonorrhea/chlamydia, with noninferiority being demonstrated if the sensitivity is \>=90%.
次要结局
- Percentage(2-3 days)
- Numeric(2-3 days)
- Predictive value(2-3 days)
- Predictive value-Gonorrhea(2-3 days)
- Demographics(2-3 days)
- Predictive value-Chlamydia(2-3 days)
- Rate-Worried(2-3 days)
- Rate-Prefer(2-3 days)
- Descriptive(2-3 days)