Supporting Health and Empowerment Through Contingency Management and Affect Regulation

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT07792161
Status
Not Yet Recruiting

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Conditions

  • HIV Risk

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • urine-based self-test — DIAGNOSTIC_TEST
    participant-administered urine-based self-tests (index test)
  • urine-based clinic test — DIAGNOSTIC_TEST
    plasma tenofovir concentrations measured by liquid chromatography-tandem mass spectrometry in the clinic (gold standard)

Study Details

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.

Key Dates

First listed
Aug 28, 2026
Start date
Sep 30, 2026
Status verified
Jun 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: SHE CARES Validation Cohort
    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).

Primary Outcome Measure

Sensitivity of the urine-based tenofovir self-test [ Time Frame: Day 1 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Atrium Health Wake Forest BaptistWinston-SalemNorth Carolina27157
Kathryn Lancaster, MD
[email protected]
336-716-2412

Find similar trials in Winston-Salem, NC

By research site
Atrium Health Wake Forest Baptist· Winston-Salem, NC

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