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Supporting Health and Empowerment Through Contingency Management and Affect Regulation

NCT07792161 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-08-28

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

urine-based self-test

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

DIAGNOSTIC_TEST

urine-based clinic test

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

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Kathryn Lancaster, PhD, MPH · Wake Forest University Health Sciences

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2027-05-31
Completion
2027-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07792161 on ClinicalTrials.gov