A Pilot Gaming Adherence Program for Youth Living With HIV

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Rhode Island Hospital
Sponsor:
Information provided by (Responsible Party):
Dr. Larry K. Brown, Rhode Island Hospital
ClinicalTrials.gov Identifier:
NCT01887210
First received: June 24, 2013
Last updated: June 25, 2013
Last verified: June 2013

June 24, 2013
June 25, 2013
September 2012
February 2016   (final data collection date for primary outcome measure)
number of times the smart pill bottle was opened [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01887210 on ClinicalTrials.gov Archive Site
  • number of kept medical appointments [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • HIV-1 viral load [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
IMB ART Behavioral Skills Scale [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Self- efficacy for adherence to medical care related to antiretroviral medication and treatment
Same as current
 
A Pilot Gaming Adherence Program for Youth Living With HIV
A Pilot Gaming Adherence Program for Youth Living With HIV

This study will develop and test a novel, technology based intervention to improve treatment adherence among youth living with HIV who are taking antiretroviral medication. In the intervention youth will access an engaging and immersive app/game on their smartphone.Data about the opening of the smart pill bottle will be transferred from the bottle cap wirelessly and will trigger a text message about their adherence. While gaming, participants will gain information about their health, improve motivation for ARV and medical appointment adherence, and practice healthy behaviors. If the Intervention is found to be effective, it can be tested in a larger study and then disseminated to other youth on antiretroviral medications.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Adherence to HIV Treatment and Medication
  • Behavioral: IMB Gaming Adherence Intervention
  • Behavioral: Enhanced treatment as usual
  • Experimental: IMB Gaming Adherence Intervention
    Combination of smart pill bottle cap with mobile gaming application tailored for those living with HIV
    Intervention: Behavioral: IMB Gaming Adherence Intervention
  • Active Comparator: Enhanced treatment as usual
    Smart pill bottle cap and mobile phone but no game
    Intervention: Behavioral: Enhanced treatment as usual
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
August 2016
February 2016   (final data collection date for primary outcome measure)

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

Exclusion Criteria:

  • none
Both
14 Years to 26 Years
No
Contact: Larry K. Brown, MD 401-444-8539 lkbrown@lifespan.org
United States
 
NCT01887210
R01HD074846-01
Yes
Dr. Larry K. Brown, Rhode Island Hospital
Rhode Island Hospital
Not Provided
Principal Investigator: Larry K Brown, MD Rhode Island Hospital
Study Director: Laura Whiteley, MD Rhode Island Hospital
Rhode Island Hospital
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP