Urine-Based Tests for HIV Risk
(SHE CARES Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Kathryn Lancaster, PhD, MPH
Principal Investigator
Wake Forest University Health Sciences
Are You a Good Fit for This Trial?
This trial is for women in North Carolina who use stimulant drugs and are at risk for HIV. Participants should be interested in HIV prevention and substance use services.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Trial Overview
The study compares a urine-based self-test done at home with a clinic-based urine test to check if participants are using PrEP, an HIV prevention medication.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wake Forest University Health Sciences
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
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