[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653947":3},{"organization":4,"outcomesModule":7,"designInfo":17,"detailedDescription":24,"studyPopulation":16,"armGroups":25,"interventions":33,"overallOfficials":43,"centralContacts":47,"locations":55,"responsibleParty":73,"collaborators":75,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":81,"sex":87,"minAge":88,"maxAge":16,"enrollmentInfo":89,"targetDuration":16,"studyType":92,"phases":93,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":101,"whyStopped":16,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Wake Forest University Health Sciences","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":16},[9,13],{"measure":10,"description":11,"timeFrame":12},"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",{"measure":14,"description":15,"timeFrame":12},"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.",null,{"allocation":18,"interventionModel":19,"interventionModelDescription":20,"primaryPurpose":21,"observationalModel":16,"timePerspective":16,"maskingInfo":22},"NA","SINGLE_GROUP","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.","SUPPORTIVE_CARE",{"masking":23,"maskingDescription":16,"whoMasked":16},"NONE","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\u002FMS).",[26],{"label":27,"type":28,"description":29,"interventionNames":30},"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\u002FMS).",[31,32],"Diagnostic Test: urine-based self-test","Diagnostic Test: urine-based clinic test",[34,39],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":16},"DIAGNOSTIC_TEST","urine-based self-test","participant-administered urine-based self-tests (index test)",[27],{"type":35,"name":40,"description":41,"armGroupLabels":42,"otherNames":16},"urine-based clinic test","plasma tenofovir concentrations measured by liquid chromatography-tandem mass spectrometry in the clinic (gold standard)",[27],[44],{"name":45,"affiliation":5,"role":46},"Kathryn Lancaster, PhD, MPH","PRINCIPAL_INVESTIGATOR",[48,52],{"name":45,"role":49,"phone":50,"phoneExt":16,"email":51},"CONTACT","336-716-2412","Kathryn.lancaster@wfusm.edu",{"name":53,"role":49,"phone":16,"phoneExt":16,"email":54},"Katie Williams, MPH","katie.williams1@advocatehealth.org",[56],{"facility":57,"status":16,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Atrium Health Wake Forest Baptist","Winston-Salem","North Carolina","27157","United States","US",{"type":64,"coordinates":65},"Point",[66,67],-80.24422,36.09986,{"lat":67,"lon":66},[70],{"name":71,"role":49,"phone":50,"phoneExt":16,"email":72},"Kathryn Lancaster, MD","klancast@wakehealth.edu",{"type":74,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR",[76],{"name":77,"class":78},"National Institute on Drug Abuse (NIDA)","NIH","100653947","supporting-health-and-empowerment-through-contingency-management-and-affect-regulation-100653947",false,"NCT07792161","Supporting Health and Empowerment Through Contingency Management and Affect Regulation","Supporting Health and Empowerment Through Contingency Management and Affect Regulation (SHE CARES)","SHE CARES","Inclusion Criteria:\n\n* HIV-negative, confirmed at enrollment\n* Reports stimulant use (e.g., methamphetamine, powder cocaine, crack cocaine) within the 12 months\n* Has regular access to an iPhone or Android smartphone\n* Currently using oral PrEP or not currently using PrEP but eligible for PrEP\n* Willing to complete study procedures\n\nExclusion Criteria:\n\n\\- Does not meet inclusion criteria","FEMALE","18 Years",{"count":90,"type":91},60,"ESTIMATED","INTERVENTIONAL",[18],"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.",[96],"HIV Risk",[98,99,100],"Stimulant use","HIV diagnoses","mental health","NOT_YET_RECRUITING","2026-09-23",{"date":104,"type":105},"2026-09-24","ACTUAL",{"date":107,"type":91},"2026-10",{"date":109,"type":91},"2027-05",{"name":5,"class":6},1]