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.
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
None
Single group
urine-based self-test
Diagnostic testparticipant-administered urine-based self-tests (index test)
urine-based clinic test
Diagnostic testplasma tenofovir concentrations measured by liquid chromatography-tandem mass spectrometry in the clinic (gold standard)
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.
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.
Click on the lead sponsor to view all of their trials.
Wake Forest University Health Sciences
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
