Wake Forest University Health Sciences
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).
Inclusion Criteria: * 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 Exclusion Criteria: \- Does not meet inclusion criteria
participant-administered urine-based self-tests (index test)
plasma tenofovir concentrations measured by liquid chromatography-tandem mass spectrometry in the clinic (gold standard)
Arctuva estimate
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