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.
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
60
participant-administered urine-based self-tests (index test)
plasma tenofovir concentrations measured by liquid chromatography-tandem mass spectrometry in the clinic (gold standard)
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States
Sensitivity of the urine-based tenofovir self-test
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.
Time frame: Day 1
Specificity of the urine-based tenofovir self-test
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.
Time frame: Day 1
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