Sfruttare i CHW per migliorare i test e la mitigazione COVID-19 tra i CJI che accedono a un CBO incentrato sulle correzioni
Sfruttare gli operatori sanitari della comunità per migliorare i test e l'attenuazione del COVID-19 tra le persone coinvolte nella giustizia penale che accedono a un'organizzazione comunitaria incentrata sulle correzioni
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Tipo di studio
Iscrizione (Effettivo)
Iscrizione
Fase
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
Contatto studio
- Nome: Lindsey Riback, MPH
- Numero di telefono: 201-372-4089
- Email: lindsey.riback@einsteinmed.org
Backup dei contatti dello studio
- Nome: Matthew Akiyama, MD MSc
- Numero di telefono: 718-920-7175
- Email: makiyama@montefiore.org
Luoghi di studio
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New York
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Long Island City, New York, Stati Uniti, 11101
- Fortune Society
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The Bronx, New York, Stati Uniti, 10467
- Montefiore Medical Center
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Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Descrizione
Criterio di inclusione:
- 1) Clienti fortunati
- >18 anni
- fluente in inglese o spagnolo
- residenti di New York
- rilasciato dal carcere o dal carcere entro 90 giorni
Criteri di esclusione:
- Impossibilità di fornire il consenso informato
- incapacità di completare le visite di studio per 12 mesi
- Non prevede di risiedere nell'area di New York per il prossimo anno.
- malattia terminale
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Selezione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
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Sperimentale: Punto di cura in loco (o-POC)
I CHW contatteranno i partecipanti per programmare le visite O-PoC.
Durante le visite O-PoC, i CHW forniranno: 1. Istruzione COVID-19; 2. Test PoC Cepheid XpertXpressSARS-CoV-2PCR; 3. Valutazione dei bisogni e accesso facilitato a mascherine e materiale igienico; 4. Navigazione verso siti di vaccinazione (se disponibili) e alloggi monolocali presso i siti di alloggi di supporto di Fortune e rifugi partner o strategie alternative che massimizzeranno la capacità di distanza sociale per coloro che risultano positivi alla PCR; 5. Consulenza di supporto.
A causa dell'enfasi di SCT sull'influenza sociale, sul rinforzo sociale esterno e interno, proponiamo che il nostro intervento O-PoC fornito dai CHW in loco presso le sedi di Fortune per un periodo di 12 mesi porterà a una maggiore diffusione dei comportamenti di mitigazione.
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Guidato dalla teoria cognitiva sociale, O-PoC impiegherà CHW con esperienza vissuta di incarcerazione per fornire: 1) istruzione COVID-19; 2) test SARS-CoV-2 con test PCR Cepheid XpertXpress presso le strutture Fortune; 3) Valutazione dei bisogni e accesso facilitato a mascherine e materiale igienico; 4) Navigazione verso siti di vaccinazione (se disponibili) e alloggi monolocali presso i siti di alloggi di supporto e rifugi partner di Fortune, o strategie alternative che massimizzeranno la capacità di distanza sociale per coloro che risultano positivi alla PCR; 5) Consulenza di supporto.
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Nessun intervento: Standard di cura (SOC)
L'attuale standard di cura (SoC) per i test SARS-CoV-2 per i clienti Fortune è il rinvio a siti di test della comunità fuori sede e istruzione informale e non strutturata.
Nel braccio SoC, lo staff di Fortune fornirà ai clienti un elenco di sedi di test SARS-CoV-2 fuori sede, che sono pubblicate online e disponibili per tutti i residenti di New York.
Quelli senza assicurazione non sono soggetti a un copay.
I partecipanti al SoC continueranno a ricevere la suite di servizi di Fortune così come vengono forniti (a distanza e/o di persona) al momento della partecipazione allo studio.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Testing Uptake
Lasso di tempo: 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
Lasso di tempo: 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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Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Masking Adherence
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Sponsor
Collaboratori
Collaboratori
Investigatori
Investigatori
- Investigatore principale: Matthew Akiyama, MD MSc, ALBERT EINSTEIN COLLEGE OF MEDICINE Montefiore Medical Center
Pubblicazioni e link utili
Pubblicazioni generali
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Collegamenti utili
- 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)
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Inizio studio
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Completamento primario
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Completamento dello studio
Date di iscrizione allo studio
Primo inviato
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Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
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Ultimo aggiornamento inviato che soddisfa i criteri QC
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Maggiori informazioni
Termini relativi a questo studio
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Termini MeSH pertinenti aggiuntivi
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Altri numeri di identificazione dello studio
- 2021-12976
- 5R01MD016744 (Sovvenzione/contratto NIH degli Stati Uniti)
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