- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01887210
A Pilot Gaming Adherence Program for Youth Living With HIV
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Despite need for consistent adherence to medical care, youth living with HIV (YLWH) have suboptimal rates of retention in care and adherence to antiretroviral medication (ARV) treatment. There are few adherence studies with YLWH and the results are mixed, so there is a great need for the development of novel interventions. Results of adult HIV adherence studies indicate that participants are interested in using technology-based methods and are most receptive toward interventions that couple technological devices with motivational components. Pill taking monitoring devices have been found to be a sensitive measure of adherence to ARV medications, but do not lead to sustained improvements in adherence or intrinsic motivation when used alone. Building on this knowledge, this study will examine a multi-level technology that integrates a medication monitoring device WITH an interactive smartphone based app/game that is attractive and engaging to YLWH. This multi-level approach will integrate theory driven content with novel, but intuitive, technology to improve HIV treatment adherence.
In this study, data on opening of the pill bottle will be transferred wirelessly from the bottle cap and a text on adherence sent to the phone. This developmental project will adapt and refine a smartphone app/game to include content consistent with the Information-Motivation-Behavioral Skills (IMB) Model. Creation and adaptation will occur from in-depth interviews with YLWH on ART (n=25) and an open trial of the Intervention (n=20). While gaming, participants will experience absorbing action-oriented adventures that increase information about their health (e.g. knowledge about HIV treatment), improve motivation (e.g. action-figures experience health benefits of adherence), and build skills (e.g. utilize clinicians as partners). A small randomized controlled pilot study (24 weeks) among 60 YLWH will examine the preliminary efficacy of the IMB Gaming Adherence Intervention (integration of the smart cap with the IMB informed app/game) compared to a comparison group who receive the smart cap and smartphone but no IMB game, on adherence and biological measures.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
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Rhode Island
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Providence, Rhode Island, Stati Uniti, 02903
- Rhode Island Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- English speaking
- in medical care for HIV and receiving antiretroviral treatment
- aware of their HIV status as per clinician and clinical record
- able to give consent/assent and not impaired by cognitive or medical limitations as per clinical assessment
- detectable viral load
Exclusion Criteria:
- none
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: IMB Gaming Adherence Intervention
Combination of smart pill bottle cap with mobile gaming application tailored for those living with HIV
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Combination of smart pill bottle cap with mobile gaming application tailored for those living with HIV
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Comparatore attivo: Enhanced treatment as usual
Smart pill bottle cap and mobile phone but no game
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Smart pill bottle cap and mobile phone but no game
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Log10 HIV-1 Viral Load
Lasso di tempo: 24 weeks
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Log viral load at end of study for participants with available viral load data (Log10 copies/ml)
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24 weeks
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Electronically Measured Past 7-day Adherence
Lasso di tempo: 24 weeks
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Past 7 day medication adherence as measured by electronic medication monitoring device.
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24 weeks
|
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Number of Kept Medical Appointments
Lasso di tempo: 24 weeks
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Number of kept medical appointments since baseline.
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24 weeks
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Information-Motivation-Behavioral Skills (IMB) Antiretroviral Therapy (ART) Behavioral Skills Scale
Lasso di tempo: 24 weeks
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Behavioral Skills subscale from the Information-Motivation-Behavioral Skills (IMB) scale.
This subscale measures self-efficacy for adherence to medical care related to antiretroviral medication and treatment.
Five items were summed to get a total Behavioral Skills subscale score.
Scores range from 5-25 where higher scores indicate greater self-efficacy for adherence to medical care related to ART medication and treatment.
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24 weeks
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Larry K Brown, MD, Rhode Island Hospital
- Direttore dello studio: Laura Whiteley, MD, Rhode Island Hospital
Pubblicazioni e link utili
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Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- R01HD074846-01 (Sovvenzione/contratto NIH degli Stati Uniti)
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 .
Prove cliniche su IMB Gaming Adherence Intervention
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National Taiwan UniversityNon ancora reclutamento