Supporting Health and Empowerment Through Contingency Management and Affect Regulation (SHE CARES)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Sensitivity of the urine-based tenofovir self-test
研究概览
简要总结
The goal of the SHE CARES study is to better understand factors that influence engagement in HIV prevention and substance use services among women who use stimulants in North Carolina. This part of the SHE CARES study will assess agreement between a remotely completed, participant-administered urine-based test for PrEP use and an in-person laboratory reference test.
详细描述
Validation study to evaluate the real-world performance of remotely completed, participant-administered urine-based self-tests (index test) compared with clinic-based laboratory reference testing among stimulant-using women who inject drugs in North Carolina. The reference standard will be plasma tenofovir concentrations measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •HIV-negative, confirmed at enrollment
- •Reports stimulant use (e.g., methamphetamine, powder cocaine, crack cocaine) within the 12 months
- •Has regular access to an iPhone or Android smartphone
- •Currently using oral PrEP or not currently using PrEP but eligible for PrEP
- •Willing to complete study procedures
排除标准
- •- Does not meet inclusion criteria
研究组 & 干预措施
SHE CARES Validation Cohort
Women who use stimulants who are currently using oral PrEP or are not currently using PrEP will complete a participant-administered urine-based tenofovir self-test (index test) and clinic-based laboratory reference testing. The reference standard will be plasma tenofovir concentrations measured using liquid chromatography-tandem mass spectrometry (LC-MS/MS).
干预措施: urine-based self-test (Diagnostic Test)
SHE CARES Validation Cohort
Women who use stimulants who are currently using oral PrEP or are not currently using PrEP will complete a participant-administered urine-based tenofovir self-test (index test) and clinic-based laboratory reference testing. The reference standard will be plasma tenofovir concentrations measured using liquid chromatography-tandem mass spectrometry (LC-MS/MS).
干预措施: urine-based clinic test (Diagnostic Test)
结局指标
主要结局
Sensitivity of the urine-based tenofovir self-test
时间窗: Day 1
Percentage of specimens positive for tenofovir by the liquid chromatography-tandem mass spectrometry reference standard that are correctly identified as positive by the self-test.
Specificity of the urine-based tenofovir self-test
时间窗: Day 1
Percentage of specimens negative for tenofovir by the liquid chromatography-tandem mass spectrometry reference standard that are correctly identified as negative by the self-test.
次要结局
未报告次要终点