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- Klinische proef NCT01887210
A Pilot Gaming Adherence Program for Youth Living With HIV
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Rhode Island
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Providence, Rhode Island, Verenigde Staten, 02903
- Rhode Island Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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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Actieve vergelijker: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Log10 HIV-1 Viral Load
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Electronically Measured Past 7-day Adherence
Tijdsspanne: 24 weeks
|
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
Tijdsspanne: 24 weeks
|
Number of kept medical appointments since baseline.
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24 weeks
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Information-Motivation-Behavioral Skills (IMB) Antiretroviral Therapy (ART) Behavioral Skills Scale
Tijdsspanne: 24 weeks
|
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
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Larry K Brown, MD, Rhode Island Hospital
- Studie directeur: Laura Whiteley, MD, Rhode Island Hospital
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- R01HD074846-01 (Subsidie/contract van de Amerikaanse NIH)
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