- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04878328
Udnyttelse af CHW'er til at forbedre COVID-19-testning og afbødning blandt CJI'er, der får adgang til en korrektionsfokuseret CBO
29. maj 2026 opdateret af: Montefiore Medical Center
Udnyttelse af sundhedsarbejdere i lokalsamfundet til at forbedre COVID-19-testning og afbødning blandt individer, der er involveret i strafferet, og som får adgang til en korrektionsfokuseret lokalsamfundsbaseret organisation
I betragtning af sandsynligheden for, at COVID-19 forbliver en endemisk sygdom blandt højrisikopopulationer, vil etablering af effektive afbødningsforanstaltninger være afgørende for at standse overførsel i samfundet.
Individer, der er involveret i strafferet, er ekstremt vigtige for at reducere samfundsbaseret SARS-CoV-2-overførsel på grund af deres øgede risiko for at pådrage sig SARS-CoV-2, mens de er fængslet, og deres sandsynlighed for at leve i forsamlingsmiljøer efter fængsling.
Efterforskerne vil evaluere en Point-of-Care SARS-CoV-2 test- og uddannelsesstrategi på stedet i en korrektionsfokuseret lokalsamfundsbaseret organisation og dens indvirkning på forbedring af testoptagelse, afhjælpende adfærd (f.eks.
maske, håndhygiejne, social distancering, vaccineoptagelse, når den er tilgængelig) og omkostningseffektivitet.
Studieoversigt
Detaljeret beskrivelse
USA (USA) har oplevet højere dødelighed end nogen anden nation på grund af COVID-19 med næsten 13,5 millioner tilfælde og over 268.103 dødsfald.
På grund af den begrænsede evne til social afstand, dårlig ventilation og begrænsede hygiejneforsyninger, har amerikanske fængsler og fængsler observeret eksplosiv transmission af SARS-CoV-2, der tegner sig for de 10 største amerikanske udbrud.
Fordi 95 % af de strafferetlige involverede individer genindtræder i samfundet, strækker COVID-19-overførslen sig ud over dem, der i øjeblikket er fængslet.
Efterhånden som retfærdighedsinvolverede personer kommer ind i samfundet igen, står de over for høje rater af hjemløshed, og mange andre bor i andre forsamlingsmiljøer, såsom ombyggede hoteller og halvvejshuse.
Den øgede risiko for SARS-CoV-2, mens de er fængslet kombineret med sandsynligheden for at bo i forsamlingsmiljøer efter fængslingen, skaber betingelser modne for hurtig COVID-19-overførsel, som vil være afgørende at håndtere for at få kontrol over COVID-19 i USA. Målet med denne undersøgelse er at teste virkningen og omkostningseffektiviteten af en intervention til at afbøde SARS-CoV-2-overførsel blandt retfærdigt involverede personer, der for nylig er blevet løsladt fra fængsling.
Efterforskerne vil udføre et randomiseret forsøg for at sammenligne effektiviteten af en onsite Point-of-Care SARS-CoV-2-testning og uddannelsesintervention med sundhedsarbejdere i lokalsamfundet (CHW'er) som en central komponent sammenlignet med standarden for pleje på en lokalsamfundsbaseret organisation (CBO), der leverer tjenester til retsinvolverede personer i New York City.
Efterforskerne vil måle omkostningerne til test, uddannelse og navigation og undersøge omkostningseffektiviteten af onsite Point-of-Care-interventionen sammenlignet med standarden for pleje.
De specifikke mål er at: 1) Teste effektiviteten af en onsite PoC SARS-CoV-2-intervention i en korrektionsfokuseret CBO; 2) Modeller omkostningseffektiviteten af en onsite PoC SARS-CoV-2-intervention blandt CJI'er sammenlignet med SoC.
Fordi test, uddannelse og navigation vil blive leveret af CHW'er i et kulturelt følsomt miljø, og testresultater vil blive modtaget på få minutter (i stedet for dage), antager efterforskerne, at O-PoC vil være forbundet med forbedret testoptagelse og modtagelse af test resultater, dæmpende adfærd (maskebæring, håndhygiejne, social distancering), og de, der deltager i flere O-PoC-sessioner, vil have bedre overholdelse af dæmpende adfærd.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
250
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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New York
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Long Island City, New York, Forenede Stater, 11101
- Fortune Society
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The Bronx, New York, Forenede Stater, 10467
- Montefiore Medical Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
- 1) Fortune-kunder
- >18 år gammel
- taler flydende engelsk eller spansk
- indbyggere i NYC
- løsladt fra fængsel eller fængsel inden for 90 dage
Ekskluderingskriterier:
- Manglende evne til at give informeret samtykke
- manglende evne til at gennemføre studiebesøg over 12 måneder
- Planlægger ikke at bo i NYC-området det næste år.
- dødelig sygdom
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Screening
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: onsite Point-of-care (o-POC)
CHW'er vil kontakte deltagerne for at planlægge O-PoC-besøg.
Ved O-PoC-besøg vil CHW'er sørge for: 1. COVID-19-uddannelse; 2. PoC Cepheid XpertXpressSARS-CoV-2PCR-tests; 3. Behovsvurderinger og lettere adgang til masker og hygiejneartikler; 4. Navigation til vaccinationssteder (hvis de er tilgængelige) og enkeltværelsesboliger på Fortunes støttende boligsteder og partnerskabscentre eller alternative strategier, der vil maksimere evnen til social distance for dem, der tester PCR-positive; 5. Støttende rådgivning.
På grund af SCT's vægt på social indflydelse, ekstern og intern social forstærkning, foreslår vi, at vores O-PoC-intervention leveret af CHW'er på stedet på Fortune-lokationer over en 12-måneders periode vil føre til øget optagelse af modvirkningsadfærd.
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Vejledt af social kognitiv teori vil O-PoC ansætte CHW'er med gennemlevet erfaring fra fængsling til at levere: 1) COVID-19 uddannelse; 2) SARS-CoV-2-test med Cepheid XpertXpress PCR-test på Fortune-faciliteter; 3) Behovsvurderinger og lettet adgang til masker og hygiejneartikler; 4) Navigation til vaccinationssteder (hvis de er tilgængelige) og enkeltværelsesboliger på Fortunes støttende boligsteder og partnerskabscentre, eller alternative strategier, der vil maksimere evnen til social afstand for dem, der tester PCR-positive; 5) Støttende rådgivning.
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Ingen indgriben: Standard of Care (SOC)
Den nuværende standard for pleje (SoC) for SARS-CoV-2-testning for Fortune-klienter er henvisning til offsite community-teststeder og uformel, ustruktureret uddannelse.
I SoC-armen vil Fortune-medarbejdere give kunderne en liste over offsite SARS-CoV-2-teststeder, som er offentliggjort online og tilgængelige for alle beboere i NYC.
Dem uden forsikring er ikke omfattet af en kopi.
Deltagere i SoC vil fortsat modtage Fortunes pakke af tjenester, efterhånden som de leveres (fjernadgang og/eller personligt) på tidspunktet for studiedeltagelse.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Testing Uptake
Tidsramme: Up to 12 months
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Testing uptake will be defined as the number and percentage of participants who had tests performed and will be determined using program logs and healthcare record extraction.
To measure testing uptake, a dichotomous outcome of having at least one complete SARS-CoV-2 test over the 12-month study period, defined as having a test performed with results received by participants within two weeks of the test being conducted, was used.
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Up to 12 months
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Number of Participants Who Completed SARS-CoV-2 Tests
Tidsramme: Up to 12 months
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The number/percentage of participants who completed at least one SARS-CoV-2 test for the whole 12-month study period (up to 5 tests available) is summarized by study arm.
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Up to 12 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Masking Adherence
Tidsramme: 12 months post-enrollment
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Masking adherence behavior was measured using a composite weighted variable estimating how frequently participants engaged in activities with potential COVID-19 exposure and how often they wore a mask during those activities in the previous two weeks.
Initial response options were 1=Always, 2=Most of the time, 3=Sometimes, 4=Rarely or 5=Never.
Responses were combined and standardized to a scale of 1 to 100 with higher scores indicating greater masking adherence.
Results are summarized by study arm using descriptive statistics.
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12 months post-enrollment
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Social Distancing Behavior
Tidsramme: 12 months post-enrollment
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Social distancing measured the participants' social distancing behavior by their responses to the following question: "Overall, on a scale of 1-100, how often did you stay greater than 6 feet away from others when you were not masked in the past 2 weeks?
Higher scores were indicative of more frequent social distancing.
Results are summarized by study arm using descriptive statistics.
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12 months post-enrollment
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Hand Washing Adherence
Tidsramme: 12 months post-enrollment
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Participants' hand washing behavior was measured by the following question: Overall, on a scale of 1-100, how often did you wash hands after shaking hands with or touching surfaces that were touched by someone else in the past two weeks?
Higher scores were indicative of more frequent hand washing behavior.
Results are summarized by study arm using descriptive statistics.
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12 months post-enrollment
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Mitigation Measures
Tidsramme: 12 months post-enrollment
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The number/percentage of participants who reported mitigation behaviors in at least one biweekly smartphone survey is summarized by study arm.
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12 months post-enrollment
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Matthew Akiyama, MD MSc, ALBERT EINSTEIN COLLEGE OF MEDICINE Montefiore Medical Center
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
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- Lyu W, Wehby GL. Community Use Of Face Masks And COVID-19: Evidence From A Natural Experiment Of State Mandates In The US. Health Aff (Millwood). 2020 Aug;39(8):1419-1425. doi: 10.1377/hlthaff.2020.00818. Epub 2020 Jun 16.
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- Dinnes J, Deeks JJ, Adriano A, Berhane S, Davenport C, Dittrich S, Emperador D, Takwoingi Y, Cunningham J, Beese S, Dretzke J, Ferrante di Ruffano L, Harris IM, Price MJ, Taylor-Phillips S, Hooft L, Leeflang MM, Spijker R, Van den Bruel A; Cochrane COVID-19 Diagnostic Test Accuracy Group. Rapid, point-of-care antigen and molecular-based tests for diagnosis of SARS-CoV-2 infection. Cochrane Database Syst Rev. 2020 Aug 26;8(8):CD013705. doi: 10.1002/14651858.CD013705.
- Pasomsub E, Watcharananan SP, Boonyawat K, Janchompoo P, Wongtabtim G, Suksuwan W, Sungkanuparph S, Phuphuakrat A. Saliva sample as a non-invasive specimen for the diagnosis of coronavirus disease 2019: a cross-sectional study. Clin Microbiol Infect. 2021 Feb;27(2):285.e1-285.e4. doi: 10.1016/j.cmi.2020.05.001. Epub 2020 May 15.
- Akiyama MJ, Kaba-Diakite F, Dimaulaluan M, Riback LR, Antigua JR, Holmes CS, Ackerman MF, Castillo A, Linder M, Day RF, Travers A, Cunningham CO, Deng Y, Zhang C, Fox AD. Mitigation of COVID-19 through onsite testing and education among formerly incarcerated individuals (the MOSAIC study): an open-label, single-centre, randomised controlled trial. Lancet Public Health. 2026 Jul;11(7):e457-e467. doi: 10.1016/S2468-2667(26)00093-9.
Hjælpsomme links
- Johns Hopkins University. COVID-19 Dashboard by the Center for Systems Science and Engineering (CSSE) at Johns Hopkins University (JHU)
- Federal Bureau of Prisons - Inmate Ethnicity Statistics
- The Marshall Project. A State-by-State Look at Coronavirus in Prisons
- American Civil Liberties Union. COVID-19 Model Finds Nearly 100,000 More Deaths Than Current Estimates, Due to Failures to Reduce Jails
- Prison Policy Initiative - Jails versus Prison
- Covid-19: Testing Inequality in New York City
- No COVID-19 tests available for prisoners at center of New York outbreak, court documents show
- Audit of Brooklyn federal jail claims lack of COVID-19 tests may have masked size of outbreak New York Daily News.
- Nelson J. House Appropriations Committee Approves '21 Funding for DOJ Programs
- Cepheid. Sars-cov-2-test-development-information
- Evidence-Based, Cost-Effective Interventions To Suppress The COVID-19 Pandemic: A Systematic Review
- Facemasks and similar barriers to prevent respiratory illness such as COVID-19
- The Institute for Health Metrics and Evaluation - Daily deaths during the pandemic
- The National Reentry Resource Center. Reentry Services Directory
- Estimating QALY losses associated with deaths in hospital (COVID-19)
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
14. april 2022
Primær færdiggørelse (Faktiske)
22. maj 2025
Studieafslutning (Faktiske)
22. maj 2025
Datoer for studieregistrering
Først indsendt
30. april 2021
Først indsendt, der opfyldte QC-kriterier
4. maj 2021
Først opslået (Faktiske)
7. maj 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
25. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2021-12976
- 5R01MD016744 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
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