HIV RiskSHE CARESNCT07792161
Supporting Health and Empowerment Through Contingency Management and Affect Regulation
A study testing urine-based self-test and urine-based clinic test in people with HIV Risk, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV Risk
- What is being tested?
- urine-based self-test and urine-based clinic test
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Does not meet inclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Katie Williams, MPH contact
United States1 site
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
Kathryn Lancaster, MD, 336-716-2412, klancast@wakehealth.edu
About this study
Official title: Supporting Health and Empowerment Through Contingency Management and Affect Regulation (SHE CARES)
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.
Read the 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).
- Conditions
- HIV Risk
- Being tested
- urine-based self-test, urine-based clinic test
- Keywords
- Stimulant use, HIV diagnoses, mental health
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urine-based self-testDiagnostic test
participant-administered urine-based self-tests (index test)
urine-based clinic testDiagnostic test
plasma tenofovir concentrations measured by liquid chromatography-tandem mass spectrometry in the clinic (gold standard)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Diagnostic Test: urine-based self-test; Diagnostic Test: urine-based clinic test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study startNov 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV RiskStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Kathryn Lancaster, PhD, MPH, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07792161
- Sponsor's protocol ID
- IRB00147361
- Other IDs
- R61DA064042
- Acronym
- SHE CARES
- Status last verified
- Jun 2026
- First submitted
- 25 Aug 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Health and Empowerment Through Contingency Management and Affect Regulation (SHE CARES)
- ClinicalTrials.gov ID
- NCT07792161
- Acronym / sponsor ID
- SHE CARES / IRB00147361
- Conditions
- HIV Risk
- Keywords
- Stimulant use, HIV diagnoses, mental health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Nov 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 28 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| SHE CARES Validation Cohort | Experimental | Diagnostic Test: urine-based self-test, Diagnostic Test: urine-based clinic testWomen 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Does not meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| urine-based self-testparticipant-administered urine-based self-tests (index test) | Diagnostic test | SHE CARES Validation Cohort |
| urine-based clinic testplasma tenofovir concentrations measured by liquid chromatography-tandem mass spectrometry in the clinic (gold standard) | Diagnostic test | SHE CARES Validation Cohort |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katie Williams, MPH contact
Kathryn Lancaster, PhD, MPH principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing urine-based self-test and urine-based clinic test in people with HIV Risk, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kathryn Lancaster, PhD, MPH (336-716-2412, Kathryn.lancaster@wfusm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of the urine-based tenofovir self-test (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.