Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07792161

Supporting Health and Empowerment Through Contingency Management and Affect Regulation

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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

HIV Risk Behavior Personal Satisfaction Psychological Well-Being

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

Location contact

Kathryn Lancaster, MD

CONTACT

[email protected]

336-716-2412

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. Sensitivity of the urine-based tenofovir self-test

    Time frame: 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.

  2. Specificity of the urine-based tenofovir self-test

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kathryn Lancaster, PhD, MPH

CONTACT

[email protected]

336-716-2412

Katie Williams, MPH

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Supporting Health and Empowerment Through Contingency Management and Affect Regulation (SHE CARES)

Acronym: SHE CARES

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 28, 2026
Registry last updated
Aug 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.