Supporting Health and Empowerment Through Contingency Management and Affect Regulation

NCT07792161 | Not Yet Recruiting FDA Device

• 2 other identifiers: IRB00147361R61DA064042
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Risk

Keywords

Stimulant use; HIV diagnoses; mental health

Outcome Measures

Primary Outcomes (2)

• Sensitivity of the urine-based tenofovir self-test

  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.

  Day 1

• Specificity of the urine-based tenofovir self-test

  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.

  Day 1

Study Arms (1)

SHE CARES Validation Cohort

EXPERIMENTAL

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).

Diagnostic Test: urine-based self-test; Diagnostic Test: urine-based clinic test

Interventions

urine-based self-test DIAGNOSTIC_TEST

participant-administered urine-based self-tests (index test)

SHE CARES Validation Cohort

urine-based clinic test DIAGNOSTIC_TEST

plasma tenofovir concentrations measured by liquid chromatography-tandem mass spectrometry in the clinic (gold standard)

SHE CARES Validation Cohort

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women in North Carolina who use stimulants and are HIV-negative. Participants will include women who are currently using oral PrEP and women who are not currently using PrEP but are eligible for PrEP.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Kathryn Lancaster, PhD, MPH

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathryn Lancaster, PhD, MPH

CONTACT

336-716-2412; Kathryn.lancaster@wfusm.edu

Katie Williams, MPH

CONTACT

katie.williams1@advocatehealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: August 28, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)