HIV Risk
Conditions
Keywords
Stimulant use, HIV diagnoses, mental health
Brief summary
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.
Detailed description
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).
Interventions
DIAGNOSTIC_TESTurine-based self-test
participant-administered urine-based self-tests (index test)
DIAGNOSTIC_TESTurine-based clinic test
plasma tenofovir concentrations measured by liquid chromatography-tandem mass spectrometry in the clinic (gold standard)
Sponsors
Wake Forest University Health Sciences
National Institute on Drug Abuse (NIDA)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Each validation participant will complete two assessments within a 24-hour period: (1) a clinical assessment using standard laboratory procedures, and (2) a self-assessment of and a urine-based TVF. For participants using LAI PrEP plasma samples will undergo targeted drug-level analysis to validate recent cabotegravir exposure.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of the urine-based tenofovir self-test | Day 1 | 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 | Day 1 | 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. |
Countries
United States
Contacts
CONTACTKathryn Lancaster, PhD, MPH
CONTACTKatie Williams, MPH
PRINCIPAL_INVESTIGATORKathryn Lancaster, PhD, MPH
Wake Forest University Health Sciences
Outcome results
None listed