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
  Purpose

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.


Condition Intervention
Adherence to HIV Treatment and Medication
Behavioral: IMB Gaming Adherence Intervention
Behavioral: Enhanced treatment as usual

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Pilot Gaming Adherence Program for Youth Living With HIV

Resource links provided by NLM:


Further study details as provided by Rhode Island Hospital:

Primary Outcome Measures:
  • number of times the smart pill bottle was opened [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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


Estimated Enrollment: 60
Study Start Date: September 2012
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IMB Gaming Adherence Intervention
Combination of smart pill bottle cap with mobile gaming application tailored for those living with HIV
Behavioral: IMB Gaming Adherence Intervention
Active Comparator: Enhanced treatment as usual
Smart pill bottle cap and mobile phone but no game
Behavioral: Enhanced treatment as usual

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   14 Years to 26 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01887210

Contacts
Contact: Larry K. Brown, MD 401-444-8539 lkbrown@lifespan.org

Locations
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Larry K Brown, MD    401-444-8539    lkbrown@lifespan.org   
Principal Investigator: Larry K Brown, M.D.         
Sponsors and Collaborators
Rhode Island Hospital
Investigators
Principal Investigator: Larry K Brown, MD Rhode Island Hospital
Study Director: Laura Whiteley, MD Rhode Island Hospital
  More Information

No publications provided

Responsible Party: Dr. Larry K. Brown, Professor of Psychiatry and Human Behavior, Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT01887210     History of Changes
Other Study ID Numbers: R01HD074846-01
Study First Received: June 24, 2013
Last Updated: June 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Rhode Island Hospital:
HIV
youth
medical adherence

ClinicalTrials.gov processed this record on October 21, 2014