Urine-Based Tests for HIV Risk

(SHE CARES Trial)

KL
KW
Overseen ByKatie Williams, MPH
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Wake Forest University Health Sciences
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

KL

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

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
See 2 more

Exclusion Criteria

Does not meet inclusion 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

Group I: SHE CARES Validation CohortExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+