Supporting Health and Empowerment Through Contingency Management and Affect Regulation (SHE CARES)
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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).
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Kathryn Lancaster, PhD, MPH
- Telefonnummer: 336-716-2412
- E-mail: Kathryn.lancaster@wfusm.edu
Undersøgelse Kontakt Backup
- Navn: Katie Williams, MPH
- E-mail: katie.williams1@advocatehealth.org
Studiesteder
-
-
North Carolina
-
Winston-Salem, North Carolina, Forenede Stater, 27157
- Atrium Health Wake Forest Baptist
-
Kontakt:
- Kathryn Lancaster, MD
- Telefonnummer: 336-716-2412
- E-mail: klancast@wakehealth.edu
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: SHE CARES Validation Cohort
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). |
participant-administered urine-based self-tests (index test) plasma tenofovir concentrations measured by liquid chromatography-tandem mass spectrometry in the clinic (gold standard) |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Sensitivity of the urine-based tenofovir self-test
Tidsramme: 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. |
Day 1
|
|
Specificity of the urine-based tenofovir self-test
Tidsramme: 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. |
Day 1
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Kathryn Lancaster, PhD, MPH, Wake Forest University Health Sciences
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB00147361
- R61DA064042 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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