- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01671501
Interventi basati sulle cure primarie per ridurre l'uso di alcol tra i pazienti affetti da HIV
8 ottobre 2018 aggiornato da: University of California, San Francisco
Questo studio clinico randomizzato utilizza lo screening dell'alcool della cartella clinica elettronica (EMR) di un piano sanitario; ed esamina gli interventi comportamentali innovativi, e la loro efficacia in termini di costi, per il bere pericoloso all'interno di una grande clinica di cure primarie per l'HIV.
Confronteremo il colloquio motivazionale (MI) e il feedback via e-mail (EF) con le cure abituali; e valutare l'effetto degli interventi sul consumo malsano di alcol, sull'uso concomitante di droghe, sull'iscrizione a programmi di trattamento dell'uso di sostanze e sugli esiti dell'HIV, tra cui l'aderenza alla terapia antiretrovirale, il controllo dell'HIV RNA e il sesso non sicuro.
Dati i ben noti effetti avversi del bere malsano sulla cura e sui risultati dell'HIV, lo studio proposto ha il potenziale per avere un impatto significativo nella cura dei pazienti affetti da HIV.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Questa applicazione risponde a RFA-AA12-009, Interventi per migliorare l'HIV/AIDS e gli esiti correlati all'alcol (U01).
Lo studio proposto si svolge in una clinica di assistenza primaria per l'HIV e utilizza la cartella clinica elettronica (EMR) del piano sanitario per lo screening; ha il potenziale per fornire un beneficio significativo alle persone con infezione da HIV riducendo il consumo malsano e le complicazioni associate.
Studi precedenti hanno identificato alti tassi di co-occorrenza di HIV e consumo malsano (definito come bere oltre i limiti di soglia, ovvero 4+ drink al giorno o 14+ drink settimanali per gli uomini e 3+ drink al giorno o 7+ drink settimanali per le donne).
Bere a questi livelli può compromettere il trattamento antiretrovirale (ART) e aumentare i tassi di consumo di droghe, depressione, sesso non protetto e mortalità.
Lo studio randomizzato proposto esamina l'efficacia comparativa di due interventi comportamentali altamente implementabili per ridurre il consumo malsano di alcol, ciascuno con una componente adattiva e graduale: 1) Intervista motivazionale (MI), consistente in una sessione di persona con un medico dello studio e due sessioni telefoniche, con tre sessioni telefoniche aggiuntive per coloro che riferiscono di bere malsano a 6 mesi; e 2) Feedback interattivo via e-mail (EF) sui rischi legati all'uso di alcol utilizzando un sistema di messaggistica sicuro integrato nella cartella clinica elettronica (EMR), con ulteriore feedback via e-mail per coloro che segnalano un consumo malsano a 6 mesi.
MI e EF sono erogati dal personale dello studio.
Un terzo braccio sarà solo la solita cura.
I partecipanti a tutti e tre i bracci possono ricevere lo screening dell'alcol, l'intervento breve e il rinvio al trattamento (SBIRT) dal personale della clinica di assistenza abituale.
Valuteremo anche il rapporto costo-efficacia dei due interventi che hanno il potenziale per un'ampia adozione in altri contesti sanitari simili.
I due interventi proposti, MI e EF, sono approcci promettenti per ridurre il consumo di alcol malsano nell'ambito della salute comportamentale e/o delle cure primarie.
EF utilizza anche la messaggistica sicura, una tecnologia emergente che è stata testata in altri contesti sanitari, di cambiamento del comportamento e di trattamento della salute mentale, per problemi che includono l'uso di alcol ma non tra le persone con infezione da HIV.
In questo studio, 600 pazienti (200 per braccio) saranno reclutati da Kaiser Permanente Northern California (KPNC) San Francisco.
La popolazione e la clinica dello studio sono ideali per esaminare tali interventi poiché le domande di screening basate sulla NIAAA sono registrate nell'EMR e sono disponibili dati completi sull'utilizzo dell'assistenza sanitaria, l'aderenza all'ART e gli esiti clinici dell'HIV, incluso il Veterans Aging Cohort Study (VACS) indice, un indice prognostico recentemente validato basato su misurazioni cliniche di laboratorio di routine.
Il team di ricerca è ben qualificato con competenze complementari in psicologia clinica, trattamento dell'abuso di droghe e alcol, epidemiologia dell'HIV e biostatistica.
Pertanto, il team e l'ambiente di studio forniscono l'ambiente ideale per testare MI ed EF, due approcci innovativi per ridurre il consumo malsano di alcol in questa popolazione, e possono fornire strumenti potenti e generalizzabili per assistere le persone con infezione da HIV.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
614
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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California
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San Francisco, California, Stati Uniti, 94115
- Kaiser Permanente Northern California San Francisco Medical Center; 2238 Geary Blvd
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 100 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Criterio di inclusione:
- Adulti di età pari o superiore a 18 anni che cercano servizi per l'HIV presso il centro medico KPNC di San Francisco
- Segnalazione di qualsiasi consumo malsano nell'anno precedente (≥ 3 drink al giorno o 7+ a settimana per le donne e ≥ 4 drink al giorno o 14+ a settimana per gli uomini) e,
- Rapporto di accesso al web al momento dell'assunzione
Criteri di esclusione:
Raccomandazione clinica da parte dei fornitori che i pazienti non sono appropriati a causa di:
- Problemi psichiatrici acuti; O
- Incapacità di comprendere le procedure di consenso
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Colloquio motivazionale
L'intervento consiste in una sessione di persona di 45 minuti seguita da due sessioni telefoniche di 20 minuti. La prima sessione di MI telefonica avrà luogo circa 10 giorni dopo la sessione di persona.
La seconda convocazione avverrà 30 giorni dopo la prima convocazione.
Lo stesso medico ricercatore condurrà sia la sessione di persona che le sessioni telefoniche.
Le chiamate includeranno una revisione del materiale trattato nella sessione iniziale, domande sull'uso di alcol, domande a risposta aperta sull'attuale livello motivazionale dei pazienti e una revisione degli obiettivi iniziali del paziente riguardo al consumo di alcol e dureranno circa 20 minuti.
Se dopo sei mesi si nota un consumo pericoloso, il medico ricercatore terrà altre tre sessioni telefoniche di interviste motivazionali.
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Sperimentale: Feedback via e-mail
Ogni partecipante riceverà fino a tre e-mail dettagliate (se i partecipanti rispondono a una prima e-mail iniziale con informazioni sui rischi dell'uso di alcol).
Le e-mail iniziali e successive saranno di breve durata e includeranno informazioni specifiche sui livelli di consumo pericolosi, dimensioni standard delle bevande; così come consigli per ridurre il consumo di alcol a livelli non pericolosi.
Ogni e-mail si concluderà con i numeri di contatto per i pazienti per ricevere ulteriori informazioni e assistenza se necessario, comprese le informazioni su come accedere facilmente al trattamento SU; e incoraggerà i partecipanti a rispondere al clinico di ricerca con domande.
Se dopo sei mesi viene rilevato un consumo pericoloso, al partecipante verranno consegnate fino a 3 e-mail più dettagliate.
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Altro: Solita cura
I partecipanti a questo braccio riceveranno solo servizi di assistenza primaria di routine.
L'assistenza abituale in questo contesto sanitario può includere lo screening dell'alcol, l'intervento breve e il rinvio al trattamento (SBIRT) forniti dal personale della clinica di assistenza abituale
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Impatto del colloquio motivazionale sul consumo malsano e sui problemi legati all'alcol
Lasso di tempo: 3 anni
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3 anni
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Impatto del feedback via e-mail sul consumo malsano e sui problemi legati all'alcol
Lasso di tempo: 3 anni
|
3 anni
|
Altre misure di risultato
Misura del risultato |
Lasso di tempo |
|---|---|
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Impatto del colloquio motivazionale e degli interventi di feedback via e-mail sull'uso concomitante di droghe
Lasso di tempo: 3 anni
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3 anni
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Impatto del colloquio motivazionale e feedback via e-mail sugli interventi sull'aderenza antiretrovirale
Lasso di tempo: 3 anni
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3 anni
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Collaboratori
Investigatori
- Investigatore principale: Derek Satre, PhD, Associate Professor, University of California, San Francisco and Adjunct Investigator, Division of Research, Kaiser Permanente, Northern California
- Investigatore principale: Michael J Silverberg, PhD, Research Scientist II, Division of Research, Kaiser Permanente, Northern California
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
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Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 marzo 2013
Completamento primario (Effettivo)
1 agosto 2016
Completamento dello studio (Effettivo)
1 agosto 2017
Date di iscrizione allo studio
Primo inviato
20 agosto 2012
Primo inviato che soddisfa i criteri di controllo qualità
22 agosto 2012
Primo Inserito (Stima)
23 agosto 2012
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
10 ottobre 2018
Ultimo aggiornamento inviato che soddisfa i criteri QC
8 ottobre 2018
Ultimo verificato
1 ottobre 2018
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Disordini mentali
- Disturbi indotti chimicamente
- Disturbi correlati all'alcol
- Infezioni da virus a RNA
- Malattie virali
- Infezioni
- Infezioni a trasmissione ematica
- Malattie trasmissibili
- Malattie sessualmente trasmissibili, virali
- Malattie trasmesse sessualmente
- Infezioni da lentivirus
- Infezioni da retroviridae
- Malattie del sistema immunitario
- Malattie da virus lenti
- Disturbi Correlati a Sostanze
- Alcolismo
- Infezioni da HIV
- Sindrome da immunodeficienza acquisita
- Sindromi da deficit immunologico
- Intossicazione alcolica
Altri numeri di identificazione dello studio
- P0048609_Satre
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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